2022 · 2021. 7. 30. · 8 800.333.0958 Alcohol Program Description 2 mL serum - For quantitative Alcohol, Ethylene Glycol, Isopropanol, Methanol, and qualitative Acetone (ketone)

AmericanProficiencyInstitute

2022CATALOG OF PROGRAMSACCEPTED BY: CAP, CMS, COLA, TJCISO Accredited by A2LA: Cer t. #3094.01 - see p. 6

Innovative Solutions.

Technical Excellence.

Technical expertise. Responsive service. Constant innovation. We’re proficient at all of them.

When it comes to proficiency testing, reliability is everything. You need a provider that fully supports you with technical expertise and prompt, personal service.

At API, we work with over 20,000 laboratories, covering all areas of laboratory medicine. Impressive numbers, for sure. But our reputation as a leader has

grown because we are committed to providing the best customer service in the industry. We handle each contact promptly and professionally, so you don’t wait for answers. Our technical experts fully understand the laboratory so they can assist you with a wide range of needs. We also provide automated result transmission, creative online services, and free Continuing Education credits.

The end result? With API, you have people and results you can rely on to meet all your proficiency testing needs.

Find out more at api-pt.com

API DataDirect

Eliminate the #1 cause of Proficiency Testing failures, Clerical Errors!

API is accepted by:CAP · CMS · COLA · TJC

Accredited by:A2LA (ISO/IEC 17043, cert. #3094.01)

UPLOAD YOUR PROFICIENCY TESTING RESULTS WITHOUT AN INTERFACE!

Automated mapping of test names

Quantitative and Qualitative results

No middleware or software installation

No additional cost - it’s free!





Over 4 million results have been successfully uploaded using this revolutionary technology!

The process is simple:

DataDirect utilizes the ability of your LIS to run a report and create a data file which is uploaded on API’s website.

Register PT Samples in your LIS

Order and complete testing

Export PT data & save in a file

Upload the file to API

Review & submit results

GET STARTED TODAY!Contact us at 800-333-0958 or at [email protected] and an API DataDirect specialist will walk you through the process.

Enrollment Information 5

Highlights for 2022 6

Proficiency Testing Programs

Chemistry 7 - 27

Urine Chemistry & Body Fluid Analysis 28 - 31

Hematology 32 - 63

2 & 3-Part Differential Programs 33

5-Part Differential Programs 34 - 39

Miscellaneous Hematology 39 - 44

Andrology 45 - 47

Coagulation 48 - 55

Urinalysis, Microscopy, & Miscellaneous Tests 56 - 62

Microbiology 63 - 94

Bacteriology 64 - 79

Mycobacteriology 79 - 80

Mycology 81 - 83

Parasitology 83 - 85

Virology 86 - 92

Molecular Multiplex Programs 93 - 95

Immunology 96 - 108

Immunohematology 109 - 114

Additional Programs

Remedial Proficiency Testing 115

Troubleshooting Samples 115

Verification Programs (for secondary instruments or methods) 115

Continuing Education Credit 115

Table of Contents

Enrollment1. Use this catalog to select the programs you need and record the selections on the order form. Please follow the instructions below to complete the form. Make sure to include:

3. To Order:

4. After processing your order, we will send you an “Order Confirmation” showing products ordered and pre-set shipping dates:

2. Ensure the “TOTAL” includes the $110 Annual Enrollment fee which covers shipping, administrative costs of setting up customer files, data processing, and reports.

Partial Year OrdersAPI makes every effort to accommodate new orders or order changes throughout the year. Except for the annual enrollment fee, we will prorate the prices for orders received after the first shipment.

CancellationsWe will credit any charges for unshipped specimens if we receive notification four weeks prior to the next shipment. In accordance with our cancellation policy, all credits expire within 120 days of the credit memo date. The annual enrollment fee is nonrefundable.

International and Non-Continental U.S. CustomersAPI is able to service many international locations and non-continental U.S. customers. Some locations, including the state of Hawaii, U.S. territories and commonwealths, as well as international locations, may require import permits for API shipments. Local authorities can assist you in determining if any permits are required for your location. Please note: It is the responsibility of the testing facility to obtain any required import permits.

Additional shipping charges for international and non-continental U.S. locations may apply. Please contact Customer Service at [email protected] for more information.

2022 Shipping ScheduleBelow is a general shipping schedule. A printable shipping and reporting schedule is available on our website. Shipping dates will also be printed on your order confirmation.

1st Event 2nd Event 3rd Event

Chemistry - Core Jan. 10 May 16 Aug. 22

Chemistry - Miscellaneous Apr. 18 Oct. 10 -

Hematology / Coagulation Mar. 7 Jul. 11 Nov. 7

Immunology / Immunohematology Mar. 28 Aug. 1 Nov. 28

Microbiology Feb. 7 Jun. 13 Sep. 19

Enrollment Information

a. Email your order to [email protected]. Fax the order form to us at 855-900-6119c. Call us at 800-333-0958 and speak with a Customer Service Representatived. Mail orders to: American Proficiency Institute Department 9526 P.O. Box 30516 Lansing, MI 48909-8016

a. Shipping Addressb. Billing Address (if different than shipping address)c. Regulatory Information (CLIA number, CAP, TJC, or COLA, etc. )d. Payment Method If paying by check, mail to: American Proficiency Institute Department 9526 P.O. Box 30516 Lansing, MI 48909-8016

a. Mark your calendar with the shipment dates. If your kit does not arrive within 3 business days after the shipment date, call us so we can track the kit or issue a replacement.b. Inspect your kit immediately upon receipt. Call us within 3 days if any sample is missing or damaged to request a replacement. Please call prior to discarding any damaged samples or refusing a kit.

Enrollment (continued)c. Read the instructions carefully before beginning a test. Some samples require special handling before testing.d. Keep a copy of any result forms mailed to API.

6 800.333.0958 | www.api-pt.com

New 2022 Programs!• Advanced Body Fluid Microscopy (Virtual only) - catalog #262 on page 39.

• Anti-Müllerian Hormone - catalog #155* on page 9.

• Blood Culture Staph aureus (molecular) - catalog #355 on page 65.

• CSF Bacterial Antigen (latex) - catalog #318 on page 69.

• Joint Infection Panel - catalog #390 on page 94.

• Respiratory Virology SARS/Flu/RSV (molecular) - catalog #388 on page 89.

• Trichomonas (Virtual only) - catalog #263 on page 59.

• UTI Panel - catalog #389 on page 95.

*Contains some analytes that are not yet CAP accepted.

If you have any questions or need assistance with ordering, please email [email protected] or call us at 800-333-0958. Visit our website, api-pt.com, to view our catalog and full shipping and reporting schedule.

API Proficiency Testing Programs are CAP Accepted!We are pleased to report that the College of American Pathologists continues to accept proficiency testing programs from the American Proficiency Institute. This means CAP accredited laboratories can use API’s proficiency testing programs. Please refer to the index on pages 116 through 119 for a complete listing of CAP accepted analytes. API programs are also accepted by CMS, COLA, TJC, and state regulatory agencies including New York state.

Track Proficiency Performance using API DataDashboardWith API’s DataDashboard, laboratories can quickly and easily view proficiency testing performance over the most recent six test events. The dashboard includes trend data by analyte, percentage of acceptable results compared to all API labs, failure count by test event, and analytes with unsatisfactory performance. Customers can log in to their API Paperless PT account to access their dashboard. Contact us at [email protected] or call us if you need assistance.

Automated Proficiency Results with API DataDirectUsing their laboratory information system (LIS) or middleware, laboratories may now transmit proficiency testing results directly to API, a process that revolutionizes proficiency testing for clinical laboratories. No more manual data entry, no more clerical errors, no new technology systems to purchase, and no additional fees! DataDirect is easy to use and saves time! Contact us at [email protected] or call us for a demonstration and free Test Drive.

2022 Highlights

API is ISO Accredited!We are proud to be accredited as a proficiency testing provider to the requirements of ISO/IEC 17043:2010. We are accredited by the American Association for Laboratory Accreditation (A2LA) under certificate number 3094.01 (www.A2LA.org). A2LA is a signatory to the ILAC Mutual Recognition Arrangement (MRA) which provides global recognition of PT accreditations. Programs included under the scope of this accreditation are marked with a in this catalog.* Evaluations for accredited analytes can be used by ISO 15189-accredited laboratories to fulfill PT requirements.

*Printed versions of the catalog may not have the most current scope information; please see online catalog for current status.

Enhanced 2022 Programs!• HSV 1 & 2 Antibody - HSV-1 Antibody added - catalog #430* on page 101.

• Mycology and Aerobic Actinomycetes - Antifungal Susceptibility added - catalog #331* on page 83.

• Respiratory Panel - Bocavirus and Parechovirus added - catalog #370 on page 95.

*Contains some analytes that are not yet CAP accepted.

CHEMISTRY

Chemistry - Core 1st Event 2nd Event 3rd Event

Ship Dates Jan. 10 May 16 Aug. 22

Replacement Deadline Jan. 18 May 24 Aug. 30

PT Results Due Date Feb. 2 Jun. 8 Sep. 14

Verification Due Date Feb. 16 Jun. 22 Sep. 28

Evaluations Available Online Feb. 22 Jun. 28 Oct. 4

Chemistry - Miscellaneous 1st Event 2nd Event

Ship Dates Apr. 18 Oct. 10

Replacement Deadline Apr. 26 Oct. 18

PT Results Due Date May 11 Nov. 2

Verification Due Date May 18 Nov. 9

Evaluations Available Online May 31 Nov. 22

8 800.333.0958 | www.api-pt.com

Alcohol

Program Description2 mL serum - For quantitative Alcohol, Ethylene Glycol, Isopropanol, Methanol, and qualitative Acetone (ketone) testing. For quantitative Beta-hydroxybutyrate testing, see catalog #174 - B-Ketone on page 10.

Program Information137 Alcohol A37 Alcohol - Verification Program

Analytes

Acetone

Isopropanol

Alcohol

Methanol

Ethylene Glycol

Format5 samples x 3 shipments

Shipping DatesJan. 10, May 16, Aug. 22

Analyte is not CAP accepted. Program is included in our A2LA scope of accreditation. See A2LA link on our website for analyte exceptions.

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Ammonia

Program Description2 mL serum

Program Information138 Ammonia A38 Ammonia - Verification Program

Analytes

Ammonia


Shipping DatesApr. 18, Oct. 10

Program is included in our A2LA scope of accreditation.

All analytes in bold type are regulated for proficiency testing by CMS. Laboratories enrolling in programs to satisfy CMS requirements for PT are responsible for ensuring they are testing five samples, three times per year.

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Amniotic Fluid pH

Program Description0.5 mL simulated amniotic fluid - For Nitrazine methods.



AnalytespH (nitrazine) pH (interpretation)

Program Information166 Amniotic Fluid pH

Anti-Müllerian Hormone

Program Description2 mL liquid



Analytes AMH

Program Information155 Anti-Müllerian Hormone


Anti-epileptic Drugs

Program Description4 mL lyophilized serum



AnalytesGabapentin Levetiracetam Oxcarbazepine

Program Information190 Anti-epileptic Drugs

NEW!!

Analyte is not CAP accepted.

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B-Ketone

Program Description1 mL liquid - For quantitative Beta-hydroxybutyrate testing performed on chemistry analyzers or whole blood glucometers. For qualitative testing using Bayer Acetest, see catalog #137 - Alcohol on page 8.



AnalytesBeta-hydroxybutyrate

Program Information174 B-Ketone


Blood Gas

Program Description3 mL ampule - For i-STAT see catalog #145 - i-STAT Chemistry on page 20.

Program Information111 Blood Gas 187 Additional Blood Gas AmpulesA11 Blood Gas - Verification Program

Analytes

pCO2 pH pO2





Apolipoproteins




AnalytesApolipoprotein A1 Apolipoprotein B Lipoprotein (a)

Program Information130 Apolipoproteins

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Blood Gas Plus

Program Description3 mL ampule - For combination blood gas/electrolyte analyzers with or without hematocrit option. For i-STAT see catalog #145 - i-STAT Chemistry on page 20.

Program Information112 Blood Gas Plus 187 Additional Blood Gas AmpulesA12 Blood Gas Plus - Verification Program

Analytes



pCO2

BUN

Creatinine

Hemoglobin, calculated

Potassium

pH

Calcium, ionized

Glucose

Lactate

Sodium

pO2

Chloride

Hematocrit

Magnesium, ionized

tCO2

Analyte is not CAP accepted. Program is included in our A2LA scope of accreditation.

Blood Lead - 5

Program Description6 mL hemolysate - Designed for LeadCare I, Plus, and Ultra.

Program Information172 Blood Lead - 5

Analytes

Lead




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Blood Lead (Waived)

Program Description6 mL hemolysate - Designed for the LeadCare II.

Program Information173 Blood Lead (Waived)

Analytes

Lead



Blood Oximetry

Program Description2 mL ampule - Hemoglobin source is bovine.

Program Information114 Blood Oximetry A14 Blood Oximetry - Verification Program

Analytes

Carboxyhemoglobin

Methemoglobin

Hematocrit, calculated

Oxyhemoglobin

Hemoglobin, total





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Cardiac Markers - 5

Program Description1.5 mL liquid - CAP accredited labs must test five samples for all Cardiac Markers except D-dimer, Myoglobin, and waived BNP.

Program Information140 Cardiac Markers - 5 165 Additional Sample VolumeA40 Cardiac Markers - Verification Program



Analytes

BNP

D-dimer

Troponin I

Troponin T (high-sensitivity)

CK, total

Myoglobin

Troponin I (high-sensitivity)

CK-MB

NT pro-BNP

Troponin T ( qualitative)


Cardiac Markers - 2

Program Description1.5 mL liquid - CAP accredited labs must test five samples for all Cardiac Markers except D-dimer, Myoglobin, and waived BNP.

Program Information920 Cardiac Markers - 2 J20 Cardiac Markers - Verification Program

Analytes

BNP ( non-waived)

NT pro-BNP

Troponin T

D-dimer

Troponin I

Troponin T (high-sensitivity)

Myoglobin

Troponin I (high-sensitivity)




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Basic Chemistry

Program Description5 mL serum - Cholestech users see catalog #176/976 - Lipid Plus on page 22. For quantitative HCG, see catalog #409 - Serum HCG on page 24.

Analytes

ALT (SGPT)

Bilirubin, total

Cholesterol

Glucose

Potassium

Urea Nitrogen (BUN)

AST (SGOT)

Calcium

CO2

HDL Cholesterol

Sodium

Uric Acid

Bilirubin, direct

Chloride

Creatinine

LDL, calculated and measured

Triglycerides



Program Information121 Basic Chemistry 141 Additional Sample VolumeA21 Basic Chemistry - Verification Program


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Comprehensive Chemistry

Program Description5 mL serum - OCD Vitros labs performing thyroid tests, see catalog #175 - Thyroid - Special on page 26. Cholestech users see catalog #176/976 - Lipid Plus on page 22. For quantitative HCG, see catalog #409 - Serum HCG on page 24.

Program Information122 Comprehensive Chemistry 141 Additional Sample VolumeA22 Comprehensive Chemistry - Verification Program

Analytes

Albumin

ALT (SGPT)

Bilirubin, direct

Calcium, ionized

Cholinesterase

Creatine Kinase (CK)

Glucose

Lactic Acid

Lipase

Phosphorus

T Uptake

TIBC, measured

Total Protein

TSH

Uric Acid

Alkaline Phosphatase

Amylase

Bilirubin, total

Chloride

CO2

Creatinine

HDL Cholesterol

LDH

Magnesium

Potassium

Thyroxine (T4)

Free T3

Triglycerides

UIBC, measured

Alpha-fetoprotein

AST (SGOT)

Calcium

Cholesterol

Cortisol

GGT

Iron

LDL, calc. and measured

Osmolality

Sodium

TIBC (iron based calculation)

Free T4

Triiodothyronine (T3)

Urea Nitrogen (BUN)




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Chemistry - Endocrinology

Program Description5 mL serum - OCD Vitros labs performing thyroid tests, see catalog #175 - Thyroid - Special on page 26. For quantitative HCG, see catalog #409 - Serum HCG on page 24.

Analytes

Alpha-fetoprotein

Free T4


Cortisol

T Uptake

TSH

Free T3

Thyroxine (T4)



Program Information125 Chemistry - Endocrinology


Chemistry - waived

Program Description5 mL serum - For waived methods. Cholestech users see catalog #976 - Lipid Plus - 2 samples on page 22.



Program Information144 Chemistry - waived A44 Chemistry - waived - Verification Program

Analytes

Albumin

Amylase

Calcium

CO2

GGT

LDL, calc. and measured

Sodium

Urea Nitrogen (BUN)


AST (SGOT)

Chloride

Creatine Kinase (CK)

Glucose

Phosphorus

Total Protein

Uric Acid

ALT (SGPT)

Bilirubin, total & direct

Cholesterol

Creatinine

HDL Cholesterol

Potassium

Triglycerides


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Cystatin C


Program Information170 Cystatin C

Analytes

Cystatin C



Program Information142 Fetal Fibronectin

Fetal Fibronectin


Analytes

Fetal Fibronectin




Program Information131 Fetal ROM

Fetal ROM

Program Description0.5 mL simulated amniotic fluid for ROM methods. Compatible with Actim Prom, AmniSure ROM, and Clinical Innovations ROM Plus.

Analytes

Fetal Membranes Rupture Test




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Program Information135 Fructosamine

Fructosamine


Analytes

Fructosamine



Glycohemoglobin

Program Description0.7 mL hemolysate - CAP accredited labs using a non-waived method must test five samples for glycohemoglobin. For Afinion see catalog #134 - Glycohemoglobin - whole blood on page 19.

Program Information126 Glycohemoglobin - 5 samples 179 Glycohemoglobin - Additional Sample Volume - 5 samples127 Glycohemoglobin - 2 samples 167 Glycohemoglobin - Additional Sample Volume - 2 samplesA27 Glycohemoglobin - Verification Program - 2 samples

Analytes

Glycohemoglobin (as HbA1c)

Format3 shipments



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134 Glycohemoglobin - whole blood

Glycohemoglobin - whole blood

Program Description0.5 mL liquid - For laboratories using Afinion analyzers for HbA1c testing.

Analytes

Glycohemoglobin (as HbA1c)



Program Information128 HemoCue - 5 samples 928 HemoCue - 2 samples J28 HemoCue - Verification Program - 2 samples

HemoCue

Program Description1 mL hemolysate - For HemoCue 201 Series, HemoCue 301 analyzers, and HemoCue 801.

Analytes

Glucose Hemoglobin

Format3 shipments




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i-STAT Chemistry - waived

Program Description3 mL ampule - For i-STAT analyzers for waived testing or non-scored analytes.

Program Information945 i-STAT Chemistry - waived J45 i-STAT Chemistry - waived - Verification Program

Analytes

Calcium, ionized

Glucose

Lactate

tCO2

Chloride

Hematocrit

Potassium

Urea Nitrogen (BUN)

Creatinine

Hemoglobin

Sodium



i-STAT Chemistry

Program Description3 mL ampule - For ACT testing see catalog #215 - i-STAT ACT on page 53. For BNP, CK-MB, & Troponin I, see catalog #140/920 - Cardiac Markers programs on page 13. For quantitative hCG see catalog #409 - Serum HCG on page 24.

Program Information145 i-STAT Chemistry 188 Additional i-STAT Chemistry AmpulesA45 i-STAT Chemistry - Verification Program

Analytes

Calcium, ionized

pH

Glucose

Lactate

tCO2

Chloride

pO2

Hematocrit

Potassium

Urea Nitrogen (BUN)

pCO2

Creatinine

Hemoglobin

Sodium





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Immunoassay - Special


Program Information182 Immunoassay - Special - 5 samples

160 Immunoassay - Special - 2 samples A60 Immunoassay - Special - Verification Program - 2 samples

Analytes

1-25-(OH)2 Vitamin D (D3)

C-peptide

IGF-1

PTH

25-OH Vitamin D

Calcitonin

Insulin

Renin Activity

ACTH

Gastrin

Osteocalcin

Renin (Direct Concentration)

Format3 shipments


Immunoassay


Program Information180 Immunoassay - 5 samples

133 Immunoassay - 2 samples A33 Immunoassay - Verification Program - 2 samples

Analytes

11-Deoxycortisol

CEA

Estriol

Folate

LH

Progesterone

Testosterone

Vitamin B12

17-OH-Progesterone

DHEA-S

FSH

Growth Hormone

PAP

Prolactin

TIBC (transferrin based calc)

Androstenedione

Estradiol

Ferritin

Homocysteine

Prealbumin

PSA, total

Transferrin

Format3 shipments




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Program Information189 Immunosuppressive Drugs

Immunosuppressive Drugs

Program Description1 mL whole blood

Analytes

Cyclosporin Tacrolimus




Program Information208 Lamellar Body Count

Lamellar Body Count

Program Description2 mL liquid - For lamellar body counts performed on Hematology analyzers.

Analytes

Lamellar Body Count


Shipping DatesApr. 18 Oct. 10


Lipid Plus

Program Description1 mL serum - For laboratories using the Cholestech analyzer. Catalog #976 is not scored for CMS.

Program Information176 Lipid Plus - 5 samples 976 Lipid Plus - 2 samples

Analytes

Cholesterol

LDL Cholesterol, calc.

Glucose

Triglycerides

HDL Cholesterol

Format3 shipments




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Neonatal Bilirubin

Program Description1 mL serum - Bilirubin levels targeted to be representative for those seen in newborns. Catalog #129 is not scored for CMS.

Program Information147 Neonatal Bilirubin - 5 samples 129 Neonatal Bilirubin - 2 samples A29 Neonatal Bilirubin - Verification Program - 2 samples

Analytes

Bilirubin, direct Bilirubin, total

Format3 shipments




POC Glucose A

Program Description1 mL liquid - For waived blood glucose meters. Per CMS, only one set of proficiency results may be reported. Facilities using more than one meter should also enroll in X23, A23, X18, or J18. True Metrix and True Metrix Pro users see catalog #979 - POC Glucose B on page 24.

Program Information123 POC Blood Glucose A - 5 samples 192 Additional Volume POC Glucose A - 5X23 Extra results POC Glucose A - Verification Program - report results for up to 20 additional meters using #123 samples A23 POC Glucose A - Verification Program - report up to 20 results - 5 samples918 POC Glucose A - 3 samples 992 Additional Volume POC Glucose A - 3X18 Extra results POC Glucose A - Verification Program - report results for up to 20 additional meters using #918 samplesJ18 POC Glucose A - Verification Program - report up to 20 results - 3 samples

Analytes

Glucose

Format2 shipments



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Program Description2 mL liquid - For True Metrix and True Metrix Pro glucose meters. Per CMS, only one set of proficiency results may be reported. Facilities using more than one meter should also enroll in X79 or J79.

Program Information979 POC Glucose BX79 Extra results POC Glucose B - Verification Program - report results for up to 20 additional meters using #979 samplesJ79 POC Glucose B - Verification Program - report up to 20 results - 3 samples

Analytes

Glucose



Program Information169 Procalcitonin

Procalcitonin

Program Description2 mL lyophilized samples

Analytes

Procalcitonin




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191 Psychoactive Drugs

Psychoactive Drugs


Analytes

Amitriptyline Nortriptyline




Serum HCG

Program Description1 mL serum - For quantitative and qualitative serum HCG methods. Due to CLIA regulations, to report results for both quantitative and qualitative serum HCG, order catalog #409 and #D09.

Program Information409 Serum HCG D09 Serum HCG - Verification Program

Analytes

HCG





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Program Information171 SHBG and Testosterone

SHBG and Testosterone

Program Description2 mL lyophilized samples

Analytes

Sex Hormone Binding Globulin

Testosterone, free

Testosterone, bioavailable Testosterone, total




Therapeutic Drugs

Program Description5 mL serum - For Anti-epileptic Drugs, Immunosuppressive Drugs, and Psychoactive Drugs, see catalog #189, #190, #191, on pages 9, 22, and 24.

Program Information132 Therapeutic Drugs 136 Therapeutic Drugs - add on option to #121 or 122 A36 Therapeutic Drugs - Verification Program

Analytes

Acetaminophen

Carbamazepine

Lidocaine

Phenobarbital

Theophylline

Vancomycin

Amikacin

Digoxin

Lithium

Phenytoin

Tobramycin

Caffeine

Gentamicin

Methotrexate

Salicylates

Valproic Acid




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175 Thyroid - Special

Thyroid - Special

Program Description0.75 mL serum - Designed for the OCD Vitros analyzers.

Analytes

Free T3


Free T4

TSH

Thyroxine (T4)

T Uptake




Tumor Markers


Analytes

Beta-2 Microglobulin

CA 19-9

PSA, complexed

PSA, total

CA 125

CA 27.29

PSA (free/total ratio)

Thyroglobulin

CA 15-3

CEA

PSA, free

Format3 shipments


Program Information183 Tumor Markers - 5 samples

150 Tumor Markers - 2 samples



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URINE CHEMISTRY AND BODY FLUID ANALYSIS

CSF & Body Fluid Chemistry

Program DescriptionCSF Chemistry - 3 samples; Body Fluid Chemistry - 3 samples. For Manual Cell Count and Body Fluid Crystals see catalog #277 - Cell Count & Body Fluid Crystals on page 40.

Analytes - CSF Chemistry

Analytes - Body Fluid Chemistry

Albumin

IgG

Sodium

Chloride

Lactic Acid

Total Protein

Glucose

LDH

Albumin

Bilirubin, total

Cholesterol

LDH

Potassium

Triglycerides


Calcium

Creatinine

Lipase

Sodium

Urea Nitrogen

Amylase

Chloride

Glucose

pH

Total Protein

Uric Acid



Program Information177 CSF & Body Fluid Chemistry


Acute Kidney Injury Risk Assessment

Program Description1.5 mL lyophilized simulated urine - For use with the NEPHROCHECK test system.



AnalytesAKI Risk Score (IGFBP-7 * TIMP-2)

Program Information186 Acute Kidney Injury Risk Assessment

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Micro

Program Information236 Microalbumin

Microalbumin

Program Description3 mL urine - For semi-quantitative dipstick or quantitative analysis. Recommended for Afinion users. If your lab is also performing other urine chemistry tests, see catalog #143 - Urine Chemistry on page 30.

Analytes

Microalbumin Urine Creatinine


Shipping DatesApr. 18 Oct. 10

Program Information163 Sweat Analysis

Sweat Analysis

Program Description3 mL liquid - For sweat analysis.

Analytes

Chloride (qualitative)

Osmolality

Chloride (quantitative)

Sodium

Conductivity





Program Information148 Ethyl Glucuronide

Ethyl Glucuronide

Program Description5 mL urine - For qualitative testing.

Analytes

Ethyl glucuronide (EtG)




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Urine Chemistry

Program Description10 mL urine - For quantitative analysis. If your lab is performing only microalbumin and/or creatinine, or for the Afinion microalbumin, see catalog #236 - Microalbumin on page 29.

Analytes



Program Information143 Urine Chemistry

Program Information146 Urine Adulteration Test

Urine Adulteration Test

Program Description10 mL urine - Qualitative or quantitative tests for urine adulteration. For Urine Drug Screen see catalog #139 on page 31.

Analytes

Creatinine

pH

Nitrite

Specific Gravity

Oxidants




Amylase

Creatinine

Microalbumin

Phosphorus

Total Nitrogen

Uric Acid

Calcium

Glucose

Microalbumin/Creatinine Ratio

Potassium

Total Protein

Chloride

Magnesium

Osmolality

Sodium

Urea Nitrogen

Program is included in our A2LA scope of accreditation. See A2LA link on our website for analyte exceptions.

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Urine Drug Screen

Program Description10 mL urine - Qualitative or quantitative tests for urine drug screen.

Program Information139 Urine Drug Screen (qual)

A39 Urine Drug Screen - Verification Program

Analytes

6-Acetylmorphine

Amphetamines

Buprenorphine

Cocaine Metabolites

Fentanyl

MDMA

Methamphetamines

Oxycodone

Tramadol

Acetaminophen

Barbiturates

Cannabinoids

Cotinine

Hydrocodone

Meperidine

Methaqualone

Phencyclidine

Tricyclic Antidepressants

Alcohol

Benzodiazepines

Carisoprodol

EDDP

LSD

Methadone

Opiates

Propoxyphene

Zolpidem



Only qualitative testing is included in our A2LA scope of accreditation.

Hematology / Coagulation 1st Event 2nd Event 3rd Event

Ship Dates Mar. 7 Jul. 11 Nov. 7

Replacement Deadline Mar. 15 Jul. 19 Nov. 15

PT Results Due Date Mar. 30 Aug. 3 Nov. 30

Verification Due Date Apr. 6 Aug. 10 Dec. 7

Evaluations Available Online Apr. 19 Aug. 23 Dec. 20

HEMATOLOGY / COAGULATION

33800.333.0958 | www.api-pt.com

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2 & 3-PART DIFFERENTIAL PROGRAMS

Hematology - 3

Program Description2 mL simulated whole blood - For automated techniques, including 2 and 3-part differentials or manual techniques for hematocrit, WBC (ammonium oxalate only), and platelet count.


Shipping DatesMar. 7, Jul. 11, Nov. 7

Program Information221 Hematology - 3 B21 Hematology - 3 - Verification Program

Analytes

Automated Differential

MCH

MPV

RDW

Hematocrit

MCHC

Platelet Count

WBC

Hemoglobin

MCV

RBC

Hematology - 3S

Program Description2 mL simulated whole blood - For the CDS Medonic M-Series, Sysmex KX Series, pocH-100i, and XP-300.



Program Information227 Hematology - 3S B27 Hematology - 3S - Verification Program

Analytes


MCH

MPV

RDW-CV

Hematocrit

MCHC

Platelet Count

RDW-SD

Hemoglobin

MCV

RBC

WBC




34 800.333.0958 | www.api-pt.com

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5-PART DIFFERENTIAL PROGRAMS

Hematology - 5A

Program Description2.5 mL simulated whole blood - For the Horiba Medical Pentra 60, 60+, 80, 120 and the Coulter AcT 5-Diff.



Program Information231 Hematology - 5A B31 Hematology - 5A - Verification Program

Analytes


MCH

MPV

RDW

Hematocrit

MCHC

Platelet Count

WBC

Hemoglobin

MCV

RBC


Hematology - 5B

Program Description4 mL simulated whole blood - For the Siemens Advia 120, 2120, and 2120i.



Program Information240 Hematology - 5B B40 Hematology - 5B - Verification Program

Analytes


MCH

MPV

RDW

Hematocrit

MCHC

Platelet Count

WBC

Hemoglobin

MCV

RBC


35800.333.0958 | www.api-pt.com


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Hematology - 5C

Program Description2 mL simulated whole blood - For the Coulter UniCel DxH600, DxH800, DxH900, and LH750, LH755, LH780, LH785.


Shipping DatesMar.7, Jul. 11 Nov. 7

Program Information230 Hematology - 5C B30 Hematology - 5C - Verification Program

Analytes


IRF

MCV

Platelet Count

RDW-SD

Hematocrit

MCH

MPV

RBC

Reticulocyte Count

Hemoglobin

MCHC

nRBC

RDW-CV

WBC


Hematology - 5D

Program Description3 mL simulated whole blood - For the Abbott Cell-Dyn 3000-3700, 4000, Ruby, Sapphire, and the Diatron Abacus 5.


Shipping DatesMar. 7, Jul. 11 Nov. 7

Program Information242 Hematology - 5D B42 Hematology - 5D - Verification Program

Analytes


IRF

MCV

Platelet Count

Reticulocyte Count

Hematocrit

MCH

MPV

RBC

WBC

Hemoglobin

MCHC

nRBC

RDW


36 800.333.0958 | www.api-pt.com


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Hematology - 5H

Program Description2.5 mL simulated whole blood - For the Coulter DxH500 and DxH520.



Program Information279 Hematology - 5H B79 Hematology - 5H - Verification Program

Analytes


MCH

MPV

RDW-CV

Hematocrit

MCHC

Platelet Count

RDW-SD

Hemoglobin

MCV

RBC

WBC


Hematology - 5O

Program Description3 mL simulated whole blood - For the Sight OLO instrument.


Shipping DateMar. 7, Jul. 11, Nov. 7

Analytes

Program Information290 Hematology - 5O


MCH

Platelet Count

WBC

Hematocrit

MCHC

RBC

Hemoglobin

MCV

RDW

37800.333.0958 | www.api-pt.com


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Hematology - 5S

Program Description2 mL simulated whole blood - For all Sysmex XE, XN, XS, and XT analyzers.



Analytes


IG# and IG%

MCH

MPV

RBC

RET-He

Hematocrit

IPF

MCHC

nRBC

RDW-CV

Reticulocyte Count

Hemoglobin

IRF

MCV

Platelet Count

RDW-SD

WBC

Program Information238 Hematology - 5S B38 Hematology - 5S - Verification Program


38 800.333.0958 | www.api-pt.com


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BLOOD CELL IDENTIFICATION

For laboratories that perform both Blood Cell Identification and Automated Differentials:CMS allows for the transmission of only one of these scores each test event. Results for both tests are graded and will appear on your evaluation, but only one score can be sent to CMS. If you would like your score for Blood Cell ID to be sent to CMS, enroll in catalog #224 or #286. If you would like your score for auto differential to be sent to CMS, enroll in catalog #225 or #291.

Blood Cell Identification

Program DescriptionTwo Wright stained peripheral blood smears for blood cell identification. One case study will include 5 annotated cells/objects for identification and will be scored. The second case study is educational and will include 5 cells/objects for identification with a manual 100 WBC differential and platelet estimate. Catalog #224 and #225 are virtual programs and do not include printed photographs. To receive printed photographs, order catalog #286 or #291. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.

Format10 photographs x 3 shipments


AnalytesBlood Cell Identification Educational Blood Cell ID Manual Differential

Program Information224 Blood Cell ID (CMS Scored) (Virtual only) 286 Blood Cell ID (CMS Scored) (Catalog #224 + Photos) 225 Blood Cell ID (Not CMS Scored) (Virtual only) 291 Blood Cell ID (Not CMS Scored) (Catalog #225 + Photos)

Program Information259 Advanced Blood Cell ID (Virtual only)

Advanced Blood Cell ID (Virtual only)

Program DescriptionOne virtual Wright stained peripheral blood smear for blood cell identification. The case study will include seven cells/objects chosen for ID and an educational commentary. This option is designed to offer case studies that are more challenging and complex. Not CMS scored or reported to CAP. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.



Analytes

Blood Cell Identification



39800.333.0958 | www.api-pt.com


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MISCELLANEOUS HEMATOLOGY

Program Information262 Advanced Body Fluid Microscopy (Virtual only)

Advanced Body Fluid Microscopy (Virtual only)Program DescriptionOne whole slide virtual image of body fluid from various sources. The case study will include five formed elements, cells, or crystals for identification with a manual WBC differential. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.


Shipping DatesMar. 7, Nov. 7

Analytes

Identification of formed elements Manual Differential

NEW!!

Program Information206 Body Fluid Cell Count - C

Body Fluid Cell Count - C

Program Description3 mL liquid - For Abbott, Coulter, Sysmex and Advia analyzers. For manual cell counts see catalog #277 - Cell Count & Body Fluid Crystals on page 40.

Format1 sample x 3 shipments


Analytes

MN

TC-BF

PMN

WBC

RBC


40 800.333.0958 | www.api-pt.com

Body Fluid Cell Count - I

Program Description4 mL liquid - For Iris IQ®. For manual cell counts see catalog #277 - Cell Count & Body Fluid Crystals on page 40.



Analytes

RBC Nucleated Cells

Program Information207 Body Fluid Cell Count – I


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Program Information168 Body Fluid Microscopy (Virtual only) 181 Body Fluid Microscopy (Catalog #168 + Photos)

Program Information277 Cell Count & Body Fluid Crystals

Body Fluid MicroscopyProgram DescriptionThree images for the identification of crystals and other formed elements/cells in various body fluids. This program includes 2 shipments per year. Catalog #168 is a virtual program and does not include printed photographs. To receive printed photographs, order catalog #181. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.



Analytes

Identification of formed elements

Cell Count & Body Fluid Crystals

Program DescriptionManual Cell Count - 2 samples; Body Fluid Crystals - 2 samples. For CSF and Body Fluid Chemistry, see catalog #177 - CSF & Body Fluid Chemistry on page 28.



Analytes

Crystals

WBC Differential

RBC WBC



41800.333.0958 | www.api-pt.com

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Program Information229 Flow Cytometry

Flow Cytometry

Program Description2.5 mL simulated whole blood - For lymphocyte phenotyping.



Analytes

CD3 (T Cells)

CD19 (B Cells)

CD4 (T Helper)

CD45 (Leukocytes)

CD8 (T Cytotoxic)

CD56 / CD16+56 (NK Cells)


Program Information210 Fetal Hemoglobin

Fetal Hemoglobin

Program Description1.2 mL simulated gastric fluid - For qualitative fetal hemoglobin. For Whole Blood Fetal Screen see catalog #515 - Fetal RBC on page 114.



Analytes

Fetal Hemoglobin (gastric fluid)


42 800.333.0958 | www.api-pt.com

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Program Information223 Reticulocyte Count

Reticulocyte Count

Program Description1 mL simulated whole blood - For manual (new methylene blue stain only) and automated reticulocyte techniques.



Analytes

Reticulocyte Count


HemoCue White Blood Cell Count

Program Description2 mL simulated whole blood - For HemoCue WBC System.



Analytes

WBC

Program Information209 HemoCue White Blood Cell Count



43800.333.0958 | www.api-pt.com

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Program Information202 Sedimentation Rate - C

Sedimentation Rate - C

Program Description6 mL simulated whole blood - For HemaTechnologies ESR STAT Plus and ESR STAT 6.



Analytes

Sedimentation Rate

Program Information201 Sedimentation Rate - B

Sedimentation Rate - B

Program Description6 mL simulated whole blood - For Polymedco Sedimat 15, 15 Plus.



Analytes

Sedimentation Rate

Program Information228 Sedimentation Rate - A

Sedimentation Rate - A

Program Description5 mL simulated whole blood - For manual methods and most automated methods.



Analytes

Sedimentation Rate




44 800.333.0958 | www.api-pt.com

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Sedimentation Rate - D

Program Description4.5 mL simulated whole blood - For the Alcor i-SED and Alcor miniiSED.



Analytes

Sedimentation Rate

Program Information203 Sedimentation Rate - D

Sedimentation Rate - E

Program Description3 mL simulated whole blood - For Alifax ESR analyzers.

Shipping3 samples x 3 shipments


Analytes

Sedimentation Rate

Program Information280 Sedimentation Rate - E

Program Information237 Sickle Cell Screen

Sickle Cell Screen

Program Description2.5 mL simulated whole blood - For screening kits and electrophoresis screening methods.



Analytes

Sickle Cell Screen



45800.333.0958 | www.api-pt.com

Program Information154 Antisperm Antibody

Program Information185 Automated Post-Vasectomy Sperm Analysis

ANDROLOGY

Antisperm Antibody

Program Description0.5 mL serum - Human serum for antisperm antibody.



Analytes Antisperm Antibody

Automated Post-Vasectomy Sperm Analysis

Program Description1.0 mL stabilized sperm - Designed for automated sperm analyzers.



Analytes

Sperm Count Sperm, presence/absence


Program Information184 Automated Sperm Count

Automated Sperm Count

Program Description1.0 mL stabilized sperm - Designed for automated sperm analyzers.



Analytes

Sperm Count


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Y

46 800.333.0958 | www.api-pt.com

Program Information162 Post-Vasectomy Sperm Analysis

Post-Vasectomy Sperm Analysis

Program Description0.3 mL stabilized sperm - Designed for manual methods.



Analytes

Sperm Count Sperm, presence/absence


Program Information151 Sperm Count

Sperm Count

Program Description0.3 mL stabilized sperm - Designed for manual methods.



Analytes

Sperm Count


Sperm Morphology

Program Description1 unstained semen smear and 1 virtual image (online only) for specific sperm morphology.



Analytes

Sperm Morphology

Program Information152 Sperm Morphology

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47800.333.0958 | www.api-pt.com

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Y

Program Information161 Sperm Motility (Virtual only)

Sperm Motility (Virtual only)

Program DescriptionWeb based video footage for sperm motility and progressive motility. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.



AnalytesSperm Motility Sperm Progressive Motility

Program Information153 Sperm Viability

Sperm Viability

Program DescriptionGlass slides - Eosin-Nigrosin stained smears.



Analytes

Sperm Viability



48 800.333.0958 | www.api-pt.com

COAGULATION

Program Description3 mL lyophilized samples - For the Hemochron Response, 801, Helena Laboratories Actalyke, and Cascade POC.

Format3 shipments


Analytes

Activated Clotting Time

Program Information211 Activated Clotting Time - 5 samples916 Activated Clotting Time - 2 samplesJ16 Activated Clotting Time - Verification Program - 2 samples

Activated Clotting Time (Hemochron/Helena)

Program Description3 mL lyophilized samples - For the Medtronic ACT and HMS Plus.

Analytes


Program Information212 Activated Clotting Time - 5 samples917 Activated Clotting Time - 2 samplesJ17 Activated Clotting Time - Verification Program - 2 samples

Activated Clotting Time (Medtronic)

Format3 shipments


CO

AG

UL

AT

ION

49800.333.0958 | www.api-pt.com

CO

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ION

Program Description1 mL lyophilized plasma - For plasma-based coagulation analyzers.



Analytes

APTT

Prothrombin Time

Fibrinogen INR

Program Information217 Coagulation B17 Coagulation - Verification Program

Coagulation

Program Description1 mL lyophilized plasma



Analytes

Antithrombin III Activity

Factor VII Activity

Factor X Activity

Plasminogen

Thrombin Time

Factor II Activity

Factor VIII Activity

Factor XI Activity

Protein C

von Willebrand Factor Activity

Factor V Activity

Factor IX Activity

Factor XII Activity

Protein S

von Willebrand Factor Antigen

Program Information281 Coagulation, Supplemental282 Additional Sample Volume283 Coagulation, Supplemental - add on to #217

Coagulation, Supplemental



50 800.333.0958 | www.api-pt.com

Program Information245 D-dimer/FDP - Qualitative

Program Description0.5 mL liquid - For qualitative D-dimer and FDP methods.



Analytes

D-dimer Fibrin degradation products

D-dimer/FDP - Qualitative

Program Description0.5 mL plasma - For quantitative D-dimer methods.



Analytes

D-dimer

Program Information246 D-dimer - Quantitative B46 D-dimer - Quantitative - Verification Program

D-dimer - Quantitative

Program Description0.7 mL lyophilized samples - For the Hemochron Jr., Signature, Signature +, Signature Elite, and IL Gem PCL. For use with ACT + Cuvette.



Analytes


Program Information248 Hemochron Jr. ACT +B48 Hemochron Jr. ACT + - Verification Program

Hemochron Jr. ACT +



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51800.333.0958 | www.api-pt.com

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Program Description0.7 mL lyophilized samples - For the Hemochron Jr., Signature, Signature +, Signature Elite, and IL Gem PCL. For use with ACT-LR cuvette.



Analytes


Program Information247 Hemochron Jr. ACT - LRB47 Hemochron Jr. ACT - LR - Verification Program

Hemochron Jr. ACT - LR

Program Information252 Hemochron Jr. Citrate APTT

Program Description0.7 mL lyophilized samples - For the Hemochron Jr. II, Signature, Signature +, Signature Elite. For use with Citrate cuvette.



Analytes

APTT

Hemochron Jr. Citrate APTT


52 800.333.0958 | www.api-pt.com


Program Description0.7 mL lyophilized samples - For the Hemochron Jr. Signature, Signature +, Signature Elite, IL Gem PCL, and Gem PCL Plus. For use with whole blood cuvette.



Analytes

INR Prothrombin Time

Program Information250 Hemochron Jr. PT

Hemochron Jr. PT

Program Information249 Hemochron Jr. Citrate PT

Program Description0.7 mL lyophilized samples - For the Hemochron Jr. Signature, Signature +, Signature Elite, IL Gem PCL, and Gem PCL Plus. For use with Citrate cuvette.



Analytes


Hemochron Jr. Citrate PT

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53800.333.0958 | www.api-pt.com

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Program Information278 Heparin Assay

Program Description1.0 mL lyophilized plasma - For testing Low Molecular Weight Heparin (LMWH) and Unfractionated Heparin (UFH) levels. Not CMS scored or reported to CAP.



AnalytesAnti-Xa

Prothrombin Time

APTT

Thrombin Time

INR

Heparin Assay

Program Description1 mL lyophilized samples - For the i-STAT analyzer.



Analytes


Program Information215 i-STAT ACT B15 i-STAT ACT - Verification Program

i-STAT ACT

Program Information255 Platelet Function - Aspirin Test

Program DescriptionPellet - For aspirin-induced inhibition. Designed for use with the Accumetrics VerifyNow System.



AnalytesAspirin induced inhibition

Platelet Function - Aspirin Test




54 800.333.0958 | www.api-pt.com

Program Information256 Platelet Function - PRUTest

Program DescriptionPellet - For P2Y12 inhibition (Plavix® and Effient®). Designed for use with Accumetrics VerifyNow System.



Analytes

P2Y12 inhibition

Platelet Function - PRUTest

Program DescriptionLyophilized plasma - Point of Care coagulation for CoaguChek XS (INR only), XS Plus, and XS Pro. Catalog #914 is not CMS scored or reported to CAP.

Format3 shipments


Analytes


Program Information214 POC Coagulation A - 5 samples 914 POC Coagulation A - 2 samples B14 POC Coagulation A - Verification Program - 5 samplesJ14 POC Coagulation A - Verification Program - 2 samples

POC Coagulation A

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55800.333.0958 | www.api-pt.com


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Program Description1 mL lyophilized samples - Point of Care coagulation for i-STAT PCA, i-STAT I, and Coag-Sense (CoaguSense).



Analytes


Program Information216 POC Coagulation B B16 POC Coagulation B - Verification Program

POC Coagulation B

Program Information244 Thromboelastogram

Program Description1 mL lyophilized samples - For the Haemonetics TEG 5000, TEG 6s, and TEM International ROTEM® analyzers.



Analytes

Thromboelastometry

Thromboelastogram



56 800.333.0958 | www.api-pt.com

URINALYSIS, MICROSCOPY, & MISCELLANEOUS TESTS

Program Information270 Automated Urine Microscopy - I

Program Description10 mL simulated urine - Designed for IRIS instruments.



AnalytesCrystals

WBC

Non-Squamous Epithelial Cells

RBC

Automated Urine Microscopy - I

Program Description10 mL simulated urine - Designed for Sysmex and the Arkray Aution AU-4050.



AnalytesBacteria

Epithelial Cells

Casts

RBC

Crystals

WBC

Automated Urine Microscopy - S

Program Information271 Automated Urine Microscopy - S



Program Information261 Fecal Lactoferrin

Program Description0.5 mL simulated stool samples - For qualitative detection of fecal lactoferrin.



Analytes

Fecal Lactoferrin

Fecal Lactoferrin


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57800.333.0958 | www.api-pt.com

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Program Description1.5 mL simulated stool samples - For guaiac or immunoassay methods.



Analytes

Fecal Occult Blood

Program Information284 Fecal Occult Blood 285 Fecal Occult Blood - add on option to #232 or 272 B84 Fecal Occult Blood - Verification Program

Fecal Occult Blood

Program Description2 mL simulated gastric samples - For gastric occult blood and pH.



Analytes

Gastric Occult Blood pH

Program Information239 Gastric Occult Blood B39 Gastric Occult Blood - Verification Program

Gastric Occult Blood



58 800.333.0958 | www.api-pt.com

Program DescriptionImages for microscopy. For KOH preparations of skin, hair, or nails, see catalog #333 - KOH Preparation on page 82. This program includes two challenges for urine sediment and one challenge for all other analytes. Catalog #233 and #B33 are virtual programs and do not include printed photographs. To receive printed photographs, order catalog #287 or #B87. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.

Format3 shipments

Shipping DatesMar. 7 Jul. 11, Nov. 7

Analytes

Fecal WBC

Pinworm Preparation

Vaginal Wet Prep

Fern Test

Sperm, pos/neg ( post-vas)

Vaginal Wet Prep (KOH)

Nasal Smear

Urine Sediment

Program Information233 Microscopy Package (Virtual only) 287 Microscopy Package (Catalog #233 + Photos) B33 Microscopy Package (Virtual only) - Verification ProgramB87 Microscopy Package (Catalog #B33 + Photos) - Verification Program

Microscopy Package

Program Information260 Rapid Urease

Program DescriptionSimulated gastric biopsy samples - For use with CLOtest, PyloriTek, or similar methods.


Shipping DatesFeb. 7, Sep.19

AnalytesUrease

Rapid Urease



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59800.333.0958 | www.api-pt.com

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Program Description10 mL urine - For dipstick analysis. HCG is intended for waived methods. For Iris dipsticks, see catalog #272 - Urinalysis & HCG - I on page 60. For automated urine microscopy see catalog #270 and #271 on page 56. For Fecal Occult Blood testing see catalog #285 - Fecal Occult Blood - add on, on page 57.



AnalytesBilirubin

Creatinine

Ketones

pH

Reducing Substance

Bilirubin, confirmatory

Glucose

Leukocyte Esterase

Protein

Specific Gravity

Blood/Hemoglobin

HCG

Nitrite

Protein, confirmatory

Urobilinogen

Program Information232 Urinalysis & HCG B32 Urinalysis & HCG - Verification Program

Urinalysis & HCG


Program DescriptionWeb based video footage of a vaginal wet preparation for the presence of Trichomonas vaginalis. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.



Analytes

Trichomonas vaginalis

Program Information263 Trichomonas (Virtual only)

Trichomonas (Virtual only) NEW!!

60 800.333.0958 | www.api-pt.com

Program Information273 Urine Crystals

Program Description1.5 mL urine - For identification of urine crystals.



Analytes

Urine Crystal Identification

Urine Crystals


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Program Information272 Urinalysis & HCG - I

Program Description10 mL urine - For Iris iChem, iVelocity, and vChem dipstick analysis. HCG is intended for waived methods. For automated urine microscopy see catalog #270 and #271 on page 56. For Fecal Occult Blood testing see catalog #285 - Fecal Occult Blood - add on, on page 57.



AnalytesBilirubin

Glucose

Leukocyte Esterase

Protein

Specific Gravity

Bilirubin, confirmatory

HCG

Nitrite

Protein, confirmatory

Urobilinogen

Blood/Hemoglobin

Ketones

pH

Reducing Substance

Urinalysis & HCG - I


61800.333.0958 | www.api-pt.com

Program Information258 Urine Eosinophils (Virtual only) 289 Urine Eosinophils (Catalog #258 + Photo)

Program DescriptionOne image for the presence or absence of urine eosinophils. Catalog #258 is a virtual program and does not include a printed photograph. To receive a printed photograph, order catalog #289. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.

Format1 photograph x 3 shipments


Analytes

Urine Eosinophils

Urine Eosinophils


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Program Description1 mL simulated urine - For non-waived methods such as latex agglutination or FIA. Also may be ordered by laboratories that wish to test 5 samples for waived methods.



Analytes

HCG

Program Information235 Urine HCG - Qualitative B35 Urine HCG - Qualitative - Verification Program

Urine HCG - Qualitative



62 800.333.0958 | www.api-pt.com

Program DescriptionFor waived methods and commonly performed microscopy procedures. HemoCue users see catalog #128/928 on page 19. True Metrix and True Metrix Pro users see catalog #979 - POC Glucose B on page 24. For KOH preparations of skin, hair, or nails, see catalog #333 on page 82. The numbers shown to the right indicate the number of challenges per test event.

Format3 shipments


Analytes

Fecal Occult Blood (1)

Hematocrit (2)

Urine Sediment (2)

Whole Blood Glucose (2)

Group A Strep Antigen (2)

Hemoglobin (2)

Vaginal Wet Prep (1)

HCG (1)

Urinalysis (1)

Vaginal Wet Prep-KOH (1)

Program Information251 Waived & Microscopy Package X51 Extra Results WBG - Waived Package - Verification Program - report results for up to 20 additional glucose metersB51 Waived & Microscopy Package - Verification Program - for all analytes listed below

Waived & Microscopy Package


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Program DescriptionTwo images for identification of formed elements in urine sediment. Catalog #234 is a virtual program and does not include printed photographs. To receive printed photographs, order catalog #288. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.



Analytes

Urine Sediment

Identification of formed elements

Program Information234 Urine Sediment (Virtual only) 288 Urine Sediment (Catalog #234 + Photos)


Microbiology Enrollment Requirements

waived method mid-year, you are responsible for ensuring you maintain five challenges per test event for the remaining non-waived tests in that sub-specialty.

Programs listed that have fewer than five samples are to be used as add-on options to other programs in the same sub-specialty.

Susceptibility testing counts as one challenge regardless of the number of drugs reported.

Urine colony count is not a regulated test and cannot be included as one of the five challenges.

For assistance, please contact Technical Support at 800-333-0958 or [email protected].

CLIA requires laboratories performing microbiology tests that are regulated for proficiency testing to test five regulated challenges per test event in each sub-specialty where regulated testing is performed. The five sub-specialties are Bacteriology, Mycobacteriology, Mycology, Parasitology, and Virology. All non-waived tests in a sub-specialty can be combined to meet the five-challenge requirement. For molecular testing of direct specimens, CMS considers only bacteriology, virology, and yeast in blood cultures to be regulated tests. Regulated tests are indicated in bold type.

Challenges tested with waived methods (e.g., Rapid Group A Strep) cannot be included in the five regulated challenges. Furthermore, if one of your methods becomes waived or you change to a

Microbiology 1st Event 2nd Event 3rd Event

Ship Dates Feb. 7 Jun. 13 Sep. 19

Replacement Deadline Feb. 15 Jun. 21 Sep. 27

PT Results Due Date Mar. 2 Jul. 6 Oct.12

Verification Due Date Mar. 9 Jul. 13 Oct. 19

Evaluations Available Online Mar. 22 Jul. 26 Nov. 1

Mycology 1st Event 2nd Event 3rd Event

Ship Dates Jan. 10 May 16 Aug. 22

Replacement Deadline Jan. 18 May 24 Aug. 30

PT Results Due Date Mar. 2 Jul. 6 Oct. 12

Evaluations Available Online Mar. 22 Jul. 26 Nov. 1

Mycobacteriology 1st Event 2nd Event

Ship Dates Feb. 28 Aug. 15

Replacement Deadline Mar. 8 Aug. 23

PT Results Due Date May 4 Oct. 19

Evaluations Available Online May 13 Oct. 28

MICROBIOLOGY, MYCOLOGY, MYCOBACTERIOLOGY

64 800.333.0958 | www.api-pt.com

Program DescriptionFor laboratories performing non-waived Group A Strep Antigen testing, Throat Cultures, and Urine Cultures. The numbers shown to the right of each analyte indicate the number of challenges per test event.


Shipping DatesFeb. 7, Jun. 13 Sep. 19

AnalytesGroup A Strep Antigen (2)

Urine Colony Count (1)

Susceptibility Testing, Urine (1)

Urine Culture (1)

Throat Culture (2)

Basic Bacteriology Package

Program Information321 Basic Bacteriology Package


BACTERIOLOGY

Program Information324 Affirm VP

Program DescriptionSwab - For the BD Affirm VP III. For other rapid molecular methods see catalog #362 - Trichomonas on page 85.


Shipping DatesFeb. 7, Jun. 13, Sep. 19

Affirm VP

Analytes

Candida sp. Gardnerella vaginalis Trichomonas vaginalis



MIC

RO

BIO

LO

GY

65800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY


Program Information359 Bacterial Vaginosis

Program Description1 mL liquid - For OSOM BVBlue.


Shipping DatesFeb. 7, Jun. 13 Sep. 19

AnalytesBacterial Vaginosis Screen

Bacterial Vaginosis


Program Information361 Blood Culture

Program DescriptionPellet + 12 mL rehydration fluid - For aerobic and anaerobic blood cultures with susceptibility testing as indicated. Use as an add on to other Bacteriology programs - 2 shipments per year.


Shipping DatesFeb. 7, Sep. 19

Analytes

Blood Culture Susceptibility Testing

Blood Culture


Program Information355 Blood Culture Staph aureus (molecular)

Program Description1 mL liquid - For molecular detection of Staphylococcus aureus. Use as an add on to other Bacteriology programs.


Shipping DatesFeb. 7, Jun 13, Sep. 19

Analytes

Methicillin Resistant Staphylococcus aureus Staphylococcus aureus

Blood Culture Staph aureus (molecular) NEW!!

66 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Description1 mL liquid - For C. difficile toxin / antigen test kits and molecular methods.

Format3 shipments


C. difficile Toxin/Antigen

Analytes

C. difficile Antigen C. difficile Toxin

Program Information350 C. difficile Toxin/Antigen - 5 samples 347 C. difficile Toxin/Antigen - Add on - 2 samples C47 C. difficile Toxin/Antigen - Verification Program - 2 samples


Program Information363 Bordetella pertussis/parapertussis (molecular)

Program Description1 mL liquid - For molecular methods for Bordetella pertussis and Bordetella parapertussis. Use as an add on to other Bacteriology programs.



Analytes

Bordetella pertussis Bordetella parapertussis

Bordetella pertussis/parapertussis (molecular)


67800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information360 Campylobacter

Program DescriptionInocu-Swab II - For detection of Campylobacter sp. using antigen or culture methods. Use as an add on to other Bacteriology programs.



Campylobacter

Analytes

Campylobacter sp.


Program Information380 Carbapenem-resistant Organisms

Program DescriptionSwab - For detection of carbapenem resistant organisms (CRO) using molecular methods.



Carbapenem-resistant Organisms

AnalytesIMP

OXA

KPC

VIM

NDM

68 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Description1 mL liquid - For Chlamydia antigen detection kits.

Format3 shipments


Chlamydia Antigen

Analytes

Chlamydia Antigen

Program Information316 Chlamydia Antigen - 5 samples 930 Chlamydia Antigen - Add on - 2 samples


Program Information311 Chlamydia/GC (molecular)

Program Description1 mL liquid - For nucleic acid probe or amplification methods.



Chlamydia/GC (molecular)

AnalytesChlamydia trachomatis Neisseria gonorrhoeae


69800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program DescriptionFor laboratories performing a variety of bacteriology procedures. The numbers to the right of each analyte indicate the total number of challenges sent per year. For molecular methods for Group A Strep see catalog #364/964 - Strep Pharyngeal (molecular) on page 77.

Format3 shipments


Comprehensive Bacteriology

AnalytesBlood Culture (w/educ. susceptibility) (1)

Ear/Eye Culture (1)

GC/Group B Strep Culture (2)

Stool Culture (2)

Urine Culture (3)

Campylobacter Antigen (2)

Gram Stain (15)

Educational Culture & Susc. (3)

Susceptibility Testing, Urine (3)

Urine Colony Count (3)

CSF Culture (w/educ. susceptibility) (1)

Group A Strep Antigen (3)

Sputum Culture (2)

Throat Culture (1)

Wound Culture (aerobic & anaerobic) (2)

Program Information328 Comprehensive Bacteriology


Program Information318 CSF Bacterial Antigen (latex)

Program Description1 mL lyophilized samples - For rapid antigen detection of Group B Streptococcus; Haemophilus influenzae type b; Streptococcus pneumoniae; and Neisseria meningitidis group A, C, Y, W135, or N. meningitidis group B / E. coli K1 from latex agglutination kit tests. Use as an add on to other Bacteriology programs - 2 shipments per year.



CSF Bacterial Antigen (latex)

Analytes

Bacterial Antigen Detection (CSF)

NEW!!

70 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information320 Gram Stain 330 Additional Gram Stain Slides

Program DescriptionFixed unstained glass slides for Gram stain and morphology.



Gram Stain

Analytes

Gram Stain Gram Stain Morphology


Program Information383 Extended Bacteriology - Educational

Program DescriptionInocu-Swab II - Educational culture and susceptibility challenges for laboratories performing complete bacterial identification and susceptibility testing.



Extended Bacteriology - Educational

Analytes

Bacterial Identification Susceptibility Testing

71800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information319 Gram Stain - Vaginitis (Virtual only)

Program DescriptionVirtual images of Gram stained vaginal smears for the detection of bacterial vaginosis. Not CMS scored or reported to CAP. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.



Gram Stain - Vaginitis (Virtual only)

Analytes

Bacterial Vaginosis (Gram stain) Nugent Score


Program Information329 Gram Stain - Direct Smears (Virtual only)

Program DescriptionVirtual images of Gram stained direct smears from various sources such as blood, sputum, CSF, and wound. Not CMS scored or reported to CAP. Please Note: Laboratories ordering only virtual programs must access paperwork and images online.



Gram Stain - Direct Smears (Virtual only)

Analytes

Gram Stain

Stain Quality

Leukocytes Sputum Quality


72 800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY

Program DescriptionSwab - For rapid Group A Strep antigen detection kits. For molecular methods see catalog #364/964 - Strep Pharyngeal (molecular) on page 77.

Format3 shipments


Group A Strep Antigen

AnalytesGroup A Strep Antigen

Program Information312 Group A Strep Antigen - 5 samples 913 Group A Strep Antigen - Add on option or waived methods - 3 samples 912 Group A Strep Antigen - Add on option or waived methods - 2 samples J12 Group A Strep Antigen - Verification Program - 2 samples



Program DescriptionSwab - For molecular methods for Group B Strep.

Format3 shipments


Group B Strep (molecular)

Analytes

Group B Strep

Program Information365 Group B Strep (molecular) - 5 samples 965 Group B Strep (molecular) - Add on - 2 samples


73800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY


Program Information351 H. pylori Antigen, Stool

Program Description0.5 mL fecal suspension - For detection of H. pylori antigen. Use as an add on to other Bacteriology programs - 2 shipments per year.



H. pylori Antigen, Stool

Analytes

Helicobacter pylori Antigen


Program Information340 Legionella Antigen

Program Description0.5 mL liquid - For Legionella antigen detection methods in urine. Use as an add on to other Bacteriology programs.



Legionella Antigen

Analytes

Legionella Antigen


Program DescriptionInocu-Swab II - Culture for N. gonorrhoeae and Group B Strep. For molecular methods see catalog #365/965 - Group B Strep (molecular) on page 72.

Format3 shipments


GC/Group B Strep Culture

AnalytesN. gonorrhoeae Culture Group B Strep Culture

Program Information315 GC/Group B Strep Culture - 5 samples 929 GC/Group B Strep Culture - Add on - 2 samples


74 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program DescriptionSwab - For molecular detection of MRSA and Staphylococcus aureus. Use as an add on to other Bacteriology programs.



MRSA / Staph aureus (molecular)

Analytes

Program Information366 MRSA/Staph aureus (molecular)


Methicillin Resistant Staphylococcus aureus Staphylococcus aureus

Program DescriptionSwab - For laboratories using culture methods for MRSA. Use as an add on to other Bacteriology programs. For molecular methods see catalog #366 - MRSA/Staph aureus (molecular) on page 74.



MRSA Culture

Analytes

Program Information356 MRSA Culture

Methicillin Resistant Staphylococcus aureus


75800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information384 Mycoplasma genitalium (molecular)

Mycoplasma genitalium

Program Description1 mL liquid - For detection of Mycoplasma genitalium using molecular methods. Use as an add on to other Bacteriology programs.



Mycoplasma genitalium (molecular)

Analytes

Program Information374 Mycoplasma pneumoniae (molecular)

Mycoplasma pneumoniae

Program Description1 mL liquid - For detection of Mycoplasma pneumoniae using molecular methods. Use as an add on to other Bacteriology programs.



Mycoplasma pneumoniae (molecular)

Analytes


76 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information341 S. pneumoniae Antigen

Program Description0.5 mL liquid - For S. pneumoniae antigen detection methods in urine. Use as an add on to other Bacteriology programs.



S. pneumoniae Antigen

Analytes

S. pneumoniae Antigen


Program Information343 Shiga Toxin

Shiga Toxin 1 Shiga Toxin 2 Shiga Toxin 1 and/or 2

Program Description1 mL liquid - For detection of Shiga Toxins 1 and 2 using rapid kits.



Shiga Toxin

Analytes


77800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program DescriptionInocu-Swab II - For laboratories performing cultures for Group A Strep. For molecular methods see catalog #364/964 - Strep Pharyngeal (molecular) on page 77.

Format3 shipments


Throat Culture

AnalytesThroat Culture

Program Information313 Throat Culture - 5 samples 953 Throat Culture - Add on - 3 samples 952 Throat Culture - Add on - 2 samples


Program DescriptionSwab - For detection of Group A and Group C/G Strep by molecular methods.

Format3 shipments


Strep Pharyngeal (molecular)

Analytes

Group A Strep Group C/G Strep

Program Information364 Strep Pharyngeal (molecular) - 5 samples 964 Strep Pharyngeal (molecular) - Add on - 2 samples C64 Strep Pharyngeal (molecular) - Verification Program - 2 samples


78 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information357 VRE Culture

Program DescriptionSwab - For culture methods for VRE. Use as an add on to other Bacteriology programs. For molecular methods see catalog #367 - VRE (molecular) on page 79.



VRE Culture

AnalytesVancomycin Resistant Enterococci


Program DescriptionQuantitated pellet and dilution fluid - For culture (including screening tubes, paddles, and agar plates) for bacterial colony count and/or ID. Antimicrobial susceptibility testing can be performed on one sample per test event.

Format3 shipments


Urine Culture

Analytes

Susceptibility Testing Urine Colony Count Urine Culture

Program Information314 Urine Culture - 5 samples 924 Urine Culture - Add on - 2 samples


79800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program DescriptionSwab - For molecular methods for VRE. Use as an add on to other Bacteriology programs.



VRE (molecular)

AnalytesVancomycin Resistant Enterococci

Program Information367 VRE (molecular)


Program Information335 Acid Fast Smears

MYCOBACTERIOLOGY

Program DescriptionFixed unstained glass slides - Shipped two times per year as allowed by CMS.


Shipping DatesFeb. 28, Aug. 15

Acid Fast Smears

Analytes

Acid Fast Bacilli Smears


80 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information344 Mycobacteriology Culture

Program DescriptionLiquid samples and lyophilized samples - For culture and identification of mycobacteria. Antimycobacterial susceptibility testing can be performed on one sample per test event. Shipped two times per year as allowed by CMS.


Shipping DatesFeb 28, Aug. 15

Mycobacteriology Culture

AnalytesMycobacteriology Susceptibility TestingMycobacteriology Identification


Program Information372 M. tuberculosis (molecular)

Program Description1 mL liquid - For detection of M. tuberculosis and rifampin resistance using molecular methods.



M. tuberculosis (molecular)

Analytes

M. tuberculosis detection Rifampin resistance screen


81800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Description1 mL liquid - For Cryptococcal antigen detection.



Cryptococcal Antigen

AnalytesCryptococcal Antigen

Program Information345 Cryptococcal Antigen


Program Information317 Candida Culture

Program DescriptionInocu-Swab II - For Candida culture.



Candida Culture

MYCOLOGY

Analytes

Candida Culture


82 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information339 India Ink

Program Description1 mL liquid - For presence or absence of encapsulated yeast using India ink methods.



India Ink

Analytes

India Ink

Program Information333 KOH Preparation

Program Description6Glass slide prepared to represent a KOH examination of skin, nail or hair.



KOH Preparation

Analytes

KOH Preparation



Program Information332 Dermatophyte Culture

Program DescriptionInocu-Swab II - For culture methods for dermatophytes.



Dermatophyte Culture

Analytes

Dermatophyte Culture


83800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information331 Mycology and Aerobic Actinomycetes

Program DescriptionInocu-Swab II - For culture and identification of yeasts, molds, and aerobic actinomycetes.



Mycology and Aerobic Actinomycetes

Analytes

Antifungal Susceptibility Testing NEW Mycology Culture


Program DescriptionTwo virtual blood smears plus three Giemsa-stained thick and/or thin blood smears for the identification of blood parasites.



Blood Parasites

PARASITOLOGY

AnalytesBlood Parasite Identification % Parasitemia

Program Information336 Blood Parasites


Enhanced!!

84 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Information334 Parasitology

Program DescriptionPhotographs, formalin concentrates for direct examination and modified acid fast stain, and a zinc-based PVA slide. For labs performing a variety of parasitology tests. The numbers shown to the right of each analyte indicate the number of challenges per test event. For Cryptosporidium antigen see catalog #342/932 - Giardia & Cryptosporidium Antigens on page 84. For Blood Parasites see catalog #336 on page 83.



Parasitology

AnalytesBlood Smear Photo (1)

Stool Prep Photo (1)

Formalin Concentrates (2)

PVA Slide (1)


Program Description1 mL liquid - For EIA & DFA test methods.

Format3 shipments


Giardia & Cryptosporidium Antigens

AnalytesCryptosporidium Antigen Giardia Antigen

Program Information342 Giardia & Cryptosporidium Antigens - 5 samples 932 Giardia & Cryptosporidium Antigens - Add on - 2 samples


85800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY

Program Information362 Trichomonas

Program Description2 mL liquid - For molecular methods and Sekisui OSOM Rapid Trichomonas test. For laboratories using the BD Affirm VP III see catalog #324 - Affirm VP on page 64.



Trichomonas

AnalytesTrichomonas vaginalis


Program Information382 Rapid Malaria

Program Description0.5 mL stabilized whole blood - For rapid malaria detection. Compatible with methods that detect Plasmodium falciparum specific histidine-rich protein 2 (HRP2).



Rapid Malaria

AnalytesRapid malaria detection

86 800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY

VIROLOGY

Program Information442 HBV Viral Load

Program Description1.5 mL plasma - For molecular quantification of HBV DNA.



HBV Viral Load

Analytes HBV Viral Load


Program Information439 HCV Viral Load

Program Description1.5 mL plasma - For molecular detection and quantification of HCV.



HCV Viral Load

Analytes HCV, qualitative HCV genotyping HCV viral load


Program Information440 HIV Viral Load

Program Description1.5 mL plasma - For molecular quantification of HIV-1 RNA Viral Load.



HIV Viral Load

Analytes

HIV-1 RNA Viral Load


87800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY


Program Description1 mL liquid - For detection of high risk HPV using molecular methods. Use as an add on to other Virology programs - 2 shipments per year.



HPV (molecular) - 2

AnalytesHPV HPV genotyping (16, 18, & 18/45)

Program Information975 HPV (molecular) - 2 samples


Program Description1 mL liquid - For detection of high risk HPV using molecular methods.



HPV (molecular) - 5

Analytes

HPV HPV genotyping (16, 18, & 18/45)

Program Information375 HPV (molecular) - 5 samples


Program Information373 HSV 1 & 2 (molecular)

Program Description1 mL liquid - For detection of HSV 1 and 2 using molecular methods.



HSV 1 & 2 (molecular)

AnalytesHerpes Simplex Virus Type 1 Herpes Simplex Virus Type 2


88 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program DescriptionSwab - For Silaris Influenza A&B Test kits. For other methods see catalog #933 - Virology Package - waived on page 92.



Influenza A&B (Silaris)

Analytes Influenza A Influenza B

Program Information977 Influenza A&B (Silaris)


Program Description1 mL liquid - For detection of Cytomegalovirus (CMV), Enterovirus, Human Metapneumovirus (hMPV), and Varicella-zoster virus (VZV) using molecular methods. Use as an add-on option - 2 challenges per analyte.



Molecular Virology

AnalytesCytomegalovirus

Varicella-zoster virus

Enterovirus Human Metapneumovirus

Program Information381 Molecular Virology

89800.333.0958 | www.api-pt.com

Program Description1 mL liquid - For detection of Norovirus using molecular methods. Use as an add on to other Virology programs - 2 shipments per year.



Norovirus

AnalytesNorovirus

Program Information379 Norovirus


MIC

RO

BIO

LO

GY

Program Description1 mL liquid - For molecular detection of SARS-CoV-2, Influenza A, Influenza B and RSV. For Abbott ID NOW users, see catalog #322 - Virology Package - 5 on page 92 and catalog #386 - SARS-CoV-2 swab (molecular) on page 91.



Respiratory Virology SARS/Flu/RSV (molecular)

AnalytesInfluenza A or B RSV SARS-CoV-2

Program Information388 Respiratory Virology SARS/Flu/RSV (molecular)

NEW!!

90 800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program DescriptionSwab - For detection of SARS-CoV-2 antigen.



SARS-CoV-2 Antigen

AnalytesSARS-CoV-2

Program Information387 SARS-CoV-2 AntigenC87 SARS-CoV-2 Antigen - Verification Program

Program Description1 mL liquid - For detection of Rotavirus antigen.

Format3 shipments


Rotavirus

AnalytesRotavirus Antigen

Program Information348 Rotavirus - 5 samples 349 Rotavirus - Add on - 3 samples


91800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY

Program DescriptionSwab - For detection of SARS-CoV-2 (COVID-19) by molecular methods. Contains the whole genome, providing sequence targets compatible with swab based methods such as Abbott ID NOW and Mesa Biotech Accula.



SARS-CoV-2 swab (molecular)

AnalytesSARS-CoV-2

Program Information386 SARS-CoV-2 swab (molecular)C86 SARS-CoV-2 swab (molecular) - Verification Program

Program Description1.5 mL liquid - For detection of SARS-CoV-2 (COVID-19) using molecular methods. Contains the whole genome, providing sequence targets compatible with liquid based molecular assays.



SARS-CoV-2 liquid (molecular)

AnalytesSARS-CoV-2

Program Information385 SARS-CoV-2 liquid (molecular) C85 SARS-CoV-2 liquid (molecular) - Verification Program


92 800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY

Program Description1 mL liquid - For Influenza A and/or B, RSV, and Adenovirus. Compatible with antigen detection kits and most molecular methods. For Silaris Influenza A&B, see catalog #977 - Influenza A&B (Silaris) on page 88.

Format3 shipments


Virology Package

AnalytesAdenovirus Influenza A or B RSV

Program Information322 Virology Package - 5 samples 942 Virology Package - Add on - 2 samples C22 Virology Package - Verification Program - 5 samples


Program Description1 mL liquid - For waived Influenza A and/or B, RSV, and Adenovirus. Compatible with antigen detection kits and most molecular methods. For Silaris Influenza A&B, see catalog #977 - Influenza A&B (Silaris) on page 88.



Virology Package - waived

Analytes

Adenovirus Influenza A or B RSV

Program Information933 Virology Package - waived methods J33 Virology Package - waived methods - Verification Program



93800.333.0958 | www.api-pt.com


MIC

RO

BIO

LO

GY

Program Description1 mL liquid - For molecular multiplex panels.



Blood Pathogen Panel

AnalytesIdentification of Bacteria Identification of Yeasts Resistance Genes

Program Information368 Blood Pathogen Panel


MOLECULAR MULTIPLEX PROGRAMS

For molecular testing of direct specimens, CMS considers bacteriology, virology, and yeast in blood cultures to be regulated tests. If the only regulated bacteriology, virology or mycology testing you perform is using a multiplex analyzer, you are required to participate in five challenges, three times a year for compliance with CLIA. Technical Support is available at 800-333-0958.

Program Information369 GI Panel




GI Panel

Analytes


Identification of Bacteria

Identification of Viruses

Identification of Bacterial Toxins Identification of Parasites

94 800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY


Program Information371 Meningitis Panel




Meningitis Panel

AnalytesIdentification of Bacteria Identification of Viruses Identification of Yeasts


Program Information378 Pneumonia Panel

Program Description0.5 mL liquid - For molecular multiplex panels.



Pneumonia Panel

AnalytesIdentification of Bacteria Identification of Viruses Resistance Genes

Program Information390 Joint Infection Panel

Program Description1 mL liquid - For molecular multiplex panels. Use as an add on to other Bacteriology programs.



Joint Infection Panel

AnalytesIdentification of Bacteria Identification of Yeasts Resistance Genes

NEW!!

95800.333.0958 | www.api-pt.com

MIC

RO

BIO

LO

GY


Program Information370 Respiratory Panel




Respiratory Panel

AnalytesIdentification of Bacteria Identification of Viruses


Program Information376 Vaginal Panel

Program Description0.5 mL liquid - For detection of vaginitis/vaginosis using molecular multiplex panels.



Vaginal Panel

AnalytesIdentification of Bacteria Identification of Candida Identification of Trichomonas

Program Information389 UTI Panel

Program Description1 mL lyophilized samples - For molecular multiplex panels. Use as an add on to other Bacteriology programs.



UTI Panel

AnalytesIdentification of Bacteria Identification of Yeast Resistance Genes

NEW!!

Enhanced!!

Immunology / Immunohematology 1st Event 2nd Event 3rd Event

Ship Dates Mar. 28 Aug. 1 Nov. 28

Replacement Deadline Apr. 5 Aug. 9 Dec. 6

PT Results Due Date Apr. 13 Aug. 17 Dec. 14

Verification Due Date Apr. 20 Aug. 24 Dec. 21

Evaluations Available Online May 3 Sep. 6 Jan. 3, 2023

IMMUNOLOGY / IMMUNOHEMATOLOGY

97800.333.0958 | www.api-pt.com

IMM

UN

OL

OG

Y


Program Description0.5 mL serum - Qualitative reporting only. Designed for ANA methods other than latex agglutination. For latex agglutination methods see catalog #429 - ANA (latex kits) on page 97.


Shipping DatesMar. 28, Aug. 1, Nov. 28

ANA

IMMUNOLOGY

AnalytesANA

Anti-RNP

Anti-SSA

Anti-DNA (ds, ss)

Anti-Sm

Anti-SSB

Anti-RNP / Sm

Anti-SSA/SSB

Antichromatin Antibody

Program Information421 ANA

Program Information429 ANA (latex kits)

Program Description0.5 mL serum - Designed for latex agglutination methods.



ANA (latex kits)

Analytes

ANA


98 800.333.0958 | www.api-pt.com

IMM

UN

OL

OG

Y


Program Information423 Anti-CCP

Program Description1 mL serum - For qualitative, quantitative, and semi-quantitative testing.



Anti-CCP

AnalytesAnti-Cyclic Citrullinated Peptide

Program Information424 ASO

Program Description1 mL serum - For qualitative, quantitative, and semi-quantitative (titer) methods. Qualitative and titer testing are scored for CMS.



ASO

Analytes

Anti-Streptolysin O



Program Description0.5 mL serum - For qualitative and quantitative CRP procedures that measure levels >1.0 mg/dL.



C-Reactive Protein

Analytes

C-Reactive Protein

Program Information431 C-Reactive Protein


99800.333.0958 | www.api-pt.com


IMM

UN

OL

OG

Y

Program Description0.3 mL serum - For qualitative, quantitative, and screening methods.



Celiac Serology

AnalytesAnti-DGP, qual (IgG & IgA)

Anti-DGP/tTG, screen (IgA & IgG)

Anti-tTG Antibody, IgA, qual & quant

Anti-DGP, quant (IgA & IgG)

Anti-gliadin Antibody, qual (IgA & IgG)

Anti-tTG Antibody, IgG, qual & quant

Anti-DGP, screen (IgA & IgG)

Anti-gliadin Antibody, quant (IgA & IgG)

Program Information448 Celiac Serology


Program Description2 mL serum - For quantitative IgE and specific allergens. Specific allergens may be reported qualitatively or quantitatively.



Diagnostic Allergy

AnalytesSpecific Allergens Total IgE

Program Information419 Diagnostic Allergy 437 Additional Sample Volume


100 800.333.0958 | www.api-pt.com

IMM

UN

OL

OG

Y

Program Information420 H. pylori Antibody

Program Description0.5 mL serum - For kits that detect Helicobacter pylori antibody. For H. pylori antigen see catalog #351 - H. pylori Antigen, Stool on page 73.



H. pylori Antibody

AnalytesH. pylori Antibody


Program Description0.5 mL serum - For hsCRP procedures that measure levels between 0-1.5 mg/dL.

Format3 shipments


High Sensitivity CRP

AnalyteshsCRP


Program Information443 High Sensitivity CRP - 5 samples 425 High Sensitivity CRP - 2 samples

101800.333.0958 | www.api-pt.com

IMM

UN

OL

OG

Y

Program Information430 HSV 1 & 2 Antibody

Program Description0.5 mL serum



HSV 1 & 2 Antibody

Analytes

HSV-1 Antibody NEW HSV-2 Antibody


Program Information407 Immunology Package

Program DescriptionSerum samples - Cost savings for sites that perform all of the included tests. ASO, Rubella, and Rheumatoid Factor may be reported as qualitative, quantitative, or as a titer; qualitative and titer testing are scored for CMS.

Format3 shipments


Immunology Package

AnalytesAnti-Streptolysin O

Rubella

Infectious Mononucleosis

Rheumatoid Factor


Enhanced!!


102 800.333.0958 | www.api-pt.com

IMM

UN

OL

OG

Y

Program Description1 mL serum - For quantitative testing.



Immunoproteins/C3 & C4

AnalytesAlpha-1-Antitrypsin

Complement C4

IgD

IgG Subclass Proteins

Ceruloplasmin

Haptoglobin

IgE

IgM

Complement C3

IgA

IgG

Kappa/Lambda ratio

Program Information436 Immunoproteins/C3 & C4



Program Description0.5 mL lyophilized defibrinated plasma samples - 1 analyte per sample. Not CMS scored or reported to CAP. Please Note: As a regulated analyte, Rubella also requires enrollment in 5 samples, 3 times per year to meet CMS and CAP requirements. See catalog #415 - Rubella on page 106 or catalog #407 - Immunology Package on page 101.



Infectious Disease Serology

Analytes

Program Information438 Infectious Disease Serology

Cytomegalovirus (IgG & IgM)

Rubeola Virus IgG

Mumps Virus IgG

Toxoplasma gondii (IgG & IgM)

Rubella (IgG & IgM)

Varicella Zoster Virus (VZV) IgG


103800.333.0958 | www.api-pt.com

IMM

UN

OL

OG

Y


Program Description0.6 mL serum - For all Infectious Mononucleosis kits. Catalog #910 is not scored for CMS.

Format3 shipments



Analytes


Program Information410 Infectious Mononucleosis - 5 samples 910 Infectious Mononucleosis - waived - 2 samples


Program Information411 Infectious Mononucleosis & Rheumatoid Factor

Program DescriptionSerum samples - Cost savings for labs that perform both tests. Rheumatoid Factor results may be reported as qualitative, quantitative, or as a titer; qualitative and titer testing are scored for CMS.

Format3 shipments


Infectious Mononucleosis & Rheumatoid Factor

AnalytesInfectious Mononucleosis Rheumatoid Factor


104 800.333.0958 | www.api-pt.com

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Program Information418 Lyme Disease

Program Description0.6 mL serum - For IgG and IgM antibody detection to Borrelia burgdorferi.



Lyme Disease

Analytes

Lyme Disease Antibody


Program Information428 Mycoplasma Antibody

Program Description0.5 mL serum - For kits that detect Mycoplasma pneumoniae antibody.



Mycoplasma Antibody

Analytes

Mycoplasma Antibody


Program Information445 Rapid Anti-HCV

Program Description0.5 mL - For rapid or waived methods only.


Shipping DatesMar. 28, Aug. 1 Nov. 28

Rapid Anti-HCV

Analytes

Anti-HCV


105800.333.0958 | www.api-pt.com

IMM

UN

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Y


Program DescriptionFor laboratories using a rapid method to test for anti-HIV and/or HIV-1 p24 antigen. For other antigen/antibody methods, see Viral Markers alo #

Rapid HIV

Analytes

Anti-HIV-1/2 HIV-1 p24 Antigen

Program Information432 Rapid HIV - 5 samples 433 Rapid HIV - waived methods - 2 samples D33 Rapid HIV - Verification Program - 2 samples

Program Description1 mL serum - For laboratories using a rapid method to test for anti-HIV and/or HIV-1 p24 antigen. For other antigen/antibody methods see catalog #417 - Viral Markers on page 108. Catalog #433 is not scored for CMS.

Format3 shipments


Rapid HIV


Program Information447 Rheumatic Disease Serology

Program Description1 mL liquid - 1 sample per analyte.



Rheumatic Disease Serology

Analytes

Anti-Jo-1 Anti-Scl-70

106 800.333.0958 | www.api-pt.com

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Program Information415 Rubella




Rubella

Analytes

Rubella


Program Information408 Rheumatoid Factor




Rheumatoid Factor

Analytes

Rheumatoid Factor


107800.333.0958 | www.api-pt.com

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Program Information416 Syphilis Serology

1

Program Description1 mL serum - For qualitative and semi-quantitative (titer) methods for serum and CSF. Designed for RPR, VDRL, FTA, and Treponemal Antibody methods.



Syphilis Serology

Analytes

Syphilis


Program Description0.75 mL plasma, non-infectious - For qualitative reporting by methods detecting the presence of antibodies against SARS-CoV-2.



SARS-CoV-2 Serology

AnalytesSARS-CoV-2 (Total Ab, IgG, IgM, IgA)

Program Information444 SARS-CoV-2 SerologyD44 SARS-CoV-2 Serology - Verification Program

108 800.333.0958 | www.api-pt.com


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UN

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Y

Program Description3 mL plasma - For anti-HIV, HIV antigen and/or Hepatitis testing. Anti-HIV and HIV-1 p24 antigen is for standard or confirmatory methods only. For rapid HIV antibody and antigen methods see catalog #432/433 - Rapid HIV on page 105. For rapid Anti-HCV methods see catalog #445 - Rapid Anti-HCV on page 104.



Viral Markers

AnalytesAnti-HAV (total & IgM)

Anti-HBs, qualitative & quantitative

Anti-HIV-2

Anti-HIV-1/2, p24 Antigen

Anti-HAV (IgG)

Anti-HCV

Anti-HIV-1/2

HBsAg

Anti-HBc (total & IgM)

Anti-HIV-1

Anti-HIV-1/2 Confirmatory

HBsAg Confirmatory

Program Information417 Viral Markers


Program Information164 Thyroid Antibodies

Program Description0.5 mL serum - For quantitative testing.



Thyroid Antibodies

Analytes

Thyroglobulin Antibody (Anti-TG) Thyroid Microsomal Antibody (Anti-TPO)


109800.333.0958 | www.api-pt.com


IMM

UN

OH

EM

AT

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Y

Program Information511 ABO/Rh

Program Description3 mL - 4% cell suspensions for ABO/Rh testing.



IMMUNOHEMATOLOGY

ABO/Rh

AnalytesABO Group ABO Subgroup D (Rho) Type

Program Information516 Antibody Elution

Program Description2 mL - 50% cell suspensions for antibody elution for non-ABO antibody testing.



Antibody Elution

AnalytesAntibody Elution



110 800.333.0958 | www.api-pt.com

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Program Information520 Antibody Titer - D

Program Description2 mL serum for anti-D titer. One 3 mL red cell sample (4% suspension) to be used as titer cell.



Antibody Titer - D

AnalytesAnti-D titer

Program Description2 mL serum - One sample each for anti-A and anti-D titer and one 3 mL red cell sample (4% suspension) to be used as titer cell.



Antibody Titer - AD

Analytes

Anti-A (IgM and IgG) titer Anti-D titer

Program Information521 Antibody Titer - AD

Program Information519 Antibody Titer - A

Program Description2 mL serum for Anti-A titer. One 3 mL red cell sample (4% suspension) to be used as titer cell.



Antibody Titer - A

AnalytesAnti-A (IgM and IgG) titer




111800.333.0958 | www.api-pt.com

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Program DescriptionIncludes five 4 mL tubes of CPD anticoagulated whole blood. One 2 mL donor red cell suspension is included for compatibility testing and antigen typing which are compatible with Bio-Rad, Grifols, Immucor, and Ortho blood bank analyzers.

Format3 shipments


Automated Blood Bank

AnalytesABO Group

Antibody Screen

D (Rho) Type

ABO Subgroup

Antigen Typing

Antibody Identification

Compatibility Testing

Program Information517 Automated Blood Bank E17 Automated Blood Bank - Verification Program

Program Information537 Automated Blood Bank with Electronic Crossmatch

Program DescriptionIncludes five 4 mL tubes of CPD anticoagulated whole blood. One 2 mL donor red cell suspension is included for compatibility testing and antigen typing which are compatible with Bio-Rad, Grifols, Immucor, and Ortho blood bank analyzers. In addition, two donor red cell suspensions with corresponding simulated ISBT donor unit labels are included for electronic crossmatch.

Format3 shipments


Automated Blood Bank with Electronic Crossmatch

AnalytesABO Group

Antibody Screen

D (Rho) Type

ABO Subgroup

Antigen Typing

Electronic Crossmatch






112 800.333.0958 | www.api-pt.com

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Program DescriptionIncludes five 2 mL samples of a 4% red cell suspension and five 3 mL samples of corresponding serum. One 2 mL donor red cell suspension is included for compatibility testing and antigen typing. For Automated Blood Bank see catalog #517/E17 on page 111.

Format3 shipments


Blood Bank

AnalytesABO Group

Antibody Screen

D (Rho) type

ABO Subgroup

Antigen Typing



Program Information512 Blood Bank E12 Blood Bank - Verification Program

Program DescriptionIncludes five 2 mL samples of a 4% red cell suspension and five 3 mL samples of corresponding serum. One 2 mL donor red cell suspension is included for compatibility testing and antigen typing. In addition, two donor red cell suspensions with corresponding simulated ISBT donor unit labels are included for electronic crossmatch. For Automated Blood Bank with Electronic Crossmatch see catalog #537 on page 111.

Format3 shipments


Blood Bank with Electronic Crossmatch

AnalytesABO Group

Antibody Screen

D (Rho) Type

ABO Subgroup

Antigen Typing

Electronic Crossmatch



Program Information532 Blood Bank with Electronic Crossmatch



113800.333.0958 | www.api-pt.com

IMM

UN

OH

EM

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Y

Program Description1 mL - 4% cell suspensions for DAT.



DAT

Analytes

Direct Antiglobulin Testing

Program Information514 DAT E14 DAT - Verification Program

Program Information534 DAT - Automated

Program Description4 mL - 15% red cell suspensions for automated DAT methods.



DAT - Automated

AnalytesDirect Antiglobulin Testing



114 800.333.0958 | www.api-pt.com

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Program Description2 mL simulated whole blood - For fetal screen, Kleihauer-Betke, and flow cytometry.



Fetal RBC

Analytes F Cell Value (by flow cytometry) Fetal Screen Hemoglobin F, quantitative

Program Information515 Fetal RBC


Program Information518 Educational Blood Bank

Program DescriptionOne case study - Sample volume varies by event. 1-2 serum samples and/or 1-2 red cell samples for special challenges that may include ABO Group, D (Rho) Type, Antibody Screen, Antibody Identification, Antigen Typing, or Compatibility Testing.

Format3 shipments


Educational Blood Bank

Analytes


ABO Group

Antigen Typing



Antibody Screen

D (Rho) Type

Program Description0.5 mL - 35-45% cell suspensions for sites that use slide methodology or Eldoncards for Rh typing.



Rh Slide Test

AnalytesD (Rho) Type

Program Information513 Rh Slide Test



115800.333.0958 | www.api-pt.com

Free Continuing Education CreditsPhysicians, medical technologists, and technicians enrolled with API are eligible to earn FREE continuing education credit through online self-assessment activities offered in conjunction with the American Society for Clinical Pathology (ASCP). The number of credits that can be earned depends on individual participation.

For more information, go to our website at api-pt.com and select “Learn More” under the Continuing Education heading, or call us at 800-333-0958 to speak with a Customer Service Representative.

API DataDirectUsing their own laboratory information system (LIS) or middleware, laboratories may now transmit proficiency testing results directly to API, a process that revolutionizes proficiency testing for clinical laboratories. No more manual data entry, no more clerical errors, no new technology systems to purchase, and no additional fees! DataDirect is easy to use and saves time! Contact us at [email protected] or call us for a demonstration.

Remedial Proficiency TestingRemedial proficiency testing is a service API offers to those who need to test specimens in addition to regular proficiency testing. This is usually required when a laboratory has had poor performance on a particular analyte in two of three test events. If your laboratory encounters a need for this service (which includes a written performance evaluation), call to speak with a Technical Specialist for more details. Remedial evaluations are not included in our A2LA scope of accreditation.

Troubleshooting SamplesOccasionally, laboratories wish to re-test a proficiency testing sample as part of a corrective action plan. Most API samples are available for this purpose at a nominal charge. Our Technical Specialists can give you further information.

Supplemental Products957 API Binder with Tabs958 Tabs only

Verification Programs for Secondary InstrumentsCLIA regulations state that if a laboratory uses multiple methods to test an analyte they must designate one instrument/method as primary for the proficiency event and test the PT samples using that instrument/method. Laboratories are not to test proficiency samples during the PT event with more than one instrument unless that is how they test all patient specimens. This restriction also applies to non-regulated analytes and to analytes categorized as waived under CLIA.

Laboratories may test proficiency samples with multiple instruments/methods after the PT due date. API’s Verification programs offer the convenience of using proficiency samples and statistics to verify secondary instruments and methods, while remaining compliant with CLIA regulations. Verification samples are shipped along with PT samples. Laboratories are directed to test after the PT due date and submit results for verification samples online. Verification evaluations are available online, when the evaluations for proficiency programs are released.

Where available, verification programs are listed in the main body of the catalog along with regular PT programs. Scores from verification programs are not reported to regulatory agencies such as CMS, CAP, or The Joint Commission. Verification programs are not included in our A2LA scope of accreditation.

CE Credits, Automated Results, and Other Products and Services

Outstanding Online Features and ServicesPaperless Proficiency Testing has unique features that can help you manage your proficiency testing more efficiently. Visit www.api-pt.com to learn more!

• Email is sent with shipping dates, package tracking information, and when your evaluation is ready.• Submit, review, and print results online.• DataDashboard trends performance over the most recent six test events.• Free Continuing Education credits.• Management reports for multiple labs.


800.333.0958

www.api-pt.com

201S 2022

Documents

2022 · 2021. 7. 30. · 8 800.333.0958 Alcohol Program Description 2 mL serum - For quantitative Alcohol, Ethylene Glycol, Isopropanol, Methanol, and qualitative Acetone (ketone)