UniversityofCalifornia,SanFrancisco ......BarbaraHaller,MD,PhD,Director 48667.305OneStepMulti-drugScreenTestCup(“NexScreen Cup”)UrineDrugScreen Copyofversion1.0(approvedandcurrent)

University of California, San Francisco – Department of Laboratory MedicineZuckerberg San Francisco General Hospital and Trauma Center – Clinical Laboratory

1001 Potrero Avenue, San Francisco, CA 94110Barbara Haller, MD, PhD, Director

48667.305 One Step Multi-drug Screen Test Cup (“NexScreen™ Cup”) Urine Drug Screen

Copy of version 1.0 (approved and current)

Last Approval orPeriodic Review Completed 1/04/2019

Next Periodic ReviewNeeded On or Before 1/04/2021

Effective Date 2/01/2019

Controlled Copy ID 183900

Location For POCT Website

Organization San Francisco General HospitalClinical Lab

AuthorOriginal: Gracialle De Guzman and Clayton Hooper; Revising: Caroline Tolman-Salinas

Description

Updated procedure and Appendix A to reflect the new NexScreen™ Cup package insert which now includesthe additional analyte, buprenorphine.

Comments for version 1.0Initial version in MediaLab (includes buprenorphine)

Approval and Periodic Review Signatures

Type Description Date Version Performed By Notes

Approval Lab Director 1/04/2019 1.0

Barbara Haller

Approval Laboratory Manager 12/19/2018 1.0

Mary Eugenio-Allen

Prior HistoryDate of Original: July 15, 2013Description:

ApprovedBy:

ApprovalDate:

EffectiveDate:

1. Emphasized that positive results arepreliminary / presumptive and must beconfirmed, if necessary or desired.2. Affirmed that NexScreen cup must be labeledin the presence of the patient.3. Clarified that documentation of QC and testresult should be in patient medical record systemin use at POCT location.4. Appendix A: Patient Test Record, deleted.5. Appendix C (now B) renamed and updated toinclude detectable length of time information forCocaine.

EF 8/8/2013 8/15/2013

Version History

Version Status Type Date Added Date Effective Date Retired

1.0 Approved and Current Initial version 12/18/2018 2/01/2019 Indefinite

Author: Original: Gracialle De Guzman and Clayton Hooper; Revising: Caroline Tolman-SalinasApproved by Barbara Haller on 1/04/2019.Reviewed by Barbara Haller on 1/04/2019.

ONE STEP MULTI-DRUG SCREEN TEST CUP (“NEXSCREEN™ CUP”)

URINE DRUG SCREENPURPOSE

The One Step Multi-drug Screen Test Cup (“NexScreen™ Cup”) is a rapid, one step lateral flow chromatographic immunoassay screening test for the simultaneous, qualitative detection of Methamphetamine, Amphetamine, Cocaine, Morphine, EDDP (Methadone Metabolites), Marijuana, Propoxyphene, Benzodiazepines, Ecstasy, Oxycodone, Barbiturates, Phencyclidine, Buprenorphine, Methadone, Tricyclic Antidepressants and the metabolites in human urine.

For specific information on each analyte, please refer to the package insert.

PRINCIPLE

The One Step Multi-drug Screen Test Cup is an immunoassay based on the principle of competitive binding. Drugs that may be present in the urine specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a urine specimen migrates upward by capillary action. A drug, if present in the urine specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody coated on the particles. The antibody-coated particles will then be captured by the immobilized drug conjugate and a visible colored line will show up in the test line region of the specific drug strip. The colored line will not form in the test line region if the drug level is above its cut-off concentration because it will saturate all the binding sites of the antibody coated on the particles.

A drug-positive urine specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative urine specimen or a specimen containing a drug concentration less than the cut-off will generate a line in the test line region. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

TESTING PERSONNEL

Qualified Licensed Registered Nurses (RNs) and approved Health Care Providers.

EQUIPMENT AND MATERIALS

NexScreen™ Cup with affixed Temperature Strip in foil pouch. Timer Disposable gloves

SPECIMEN

A. Universal Precautions should be observed through all phases of the testing procedure.

B. Fresh Urine collected directly into the NexScreen™ Cup. The container should be clean and dry, and must not contain any preservatives.

C. Stability: Test cup and urine samples should be fresh and at room temperature prior to testing.

University of California, San Francisco – Department of Laboratory MedicineZuckerberg San Francisco General Hospital and Trauma Center, 1001 Potrero Avenue, San Francisco, CA 94110Clinical Laboratory – Barbara Haller, MD, PhD, DirectorTitle:One Step Multi-drug Screen Test Cup (“NexScreen™ Cup”) Urine Drug Screen, Document No.: 48667.305 (version 1.0).Approved and current, Effective starting 2/01/2019.

Controlled copy ID 183900. Printed on 5/01/2019 15:21 (PDT). Page 1 of 7

D. Samples must be labeled with Patient’s Identification (two patient identifiers, name and MRN or DOB, are required).

PRECAUTIONS For medical and other professional in vitro diagnostic use only. Do not use after the expiration date. The Test Device should remain in the sealed pouch until use. All specimens should be considered potentially hazardous and handled in the same manner as an

infectious agent. The used Test Device should be discarded.

REAGENTS AND MATERIALS

A. NexScreen 12 Panel Cup tests for AMP/BAR/BZO/COC/MDMA/MET/MTD /OPI300/OXY/PCP/ TCA/THC with a Temperature Strip Indicator.

Each test line in the test panel contains mouse monoclonal antibody-coupled particles and corresponding drug-protein conjugates. A goat antibody is employed in each control line.

Order Number: 60135N

B. Detectabuse STAT-Skreen Liquid Control Urine with MDMA, OXY and BUP 2x Cutoff, 20mL: Biochemical Diagnostics, Inc. Positive Control.

Order Number: 18001248

C. Negative Liquid Urine Control, 20mL: Biochemical Diagnostics, Inc.

Order Number: 19223011

STORAGE AND STABILITY

A. Positive and Negative Liquid Urine Controls:

1. Unopened Vials:

Positive control is stable for one year from the date received when stored at 2-8°C and protected from light.

Negative control is stable until the expiration date when stored at 2-8°C and protected from light.

2. Opened vial is good for one time use only.

3. Allow controls to come to room temperature followed by gentle swirling or inversion before use. DO NOT SHAKE.

4. Positive Detectabuse control must test positive and Negative control must test negative

on the NexScreen Cup.

B. NexScreen Cup:

1. Store as packaged in the sealed pouch at 2-30° C.

2. The NexScreen Cup is stable through the expiration date printed on the sealed pouch.



3. The NexScreen Cup must remain in the sealed pouch until use.

4. Keep away from direct sunlight, moisture and heat.

5. DO NOT FREEZE. Do not use beyond the expiration date.

QUALITY CONTROL

A. Internal Quality Control

1. A procedural control (Internal Quality Control) is included in the test. A colored line appearing in the control line region (C) is considered an internal procedural control. It confirms sufficient specimen volume, adequate membrane wicking and correct procedural technique.

2. If the Control Line is not present, the result is invalid. Do not use the invalid test result. Retest with a new unopened test cup.

3. Internal QC is performed on each patient test and is documented with test results.

B. External Quality Control

1. Positive and Negative controls must be performed:

a. Monthly (once every 30 days).b. Whenever new shipments of control materials or test kits are received.c. Whenever new lots of control materials or test kit are received.

2. Allow controls to come to room temperature followed by gentle swirling or inversion before use. DO NOT SHAKE.

The lot number and expiration date on the bottle of Detectabuse Positive control and Negative control should be documented on the NexScreen Urine Drug Screen External Quality Control Test Record (see Appendix A). Check dates to ensure test kit and QC material has not expired.

PROCEDURE

A. Using two patient identifiers, verify patient’s identity, and explain procedure to patient and / or family.

B. Observe Universal Precautions; wear gloves and other personal protective equipment as appropriate.

C. Ensure that the NexScreen™ Cup is at room temperature (18-30° C).

D. Be careful to remove anything from the restroom that could be added to the specimen. Things that may interfere with the test include: soap, bleach, vinegar, salt, or tap/toilet water.

E. In the presence of the patient, remove the NexScreen Cup from the sealed foiled pouch (with affixed Temperature Strip), attach patient identification label to test cup, and hand it to patient.

F. Ask the patient to urinate directly into the NexScreen™ Cup and return it immediately.



G. Twist on the lid until you hear a click, ensuring that it is not cross-threaded. Tighten the lid completely, turning it as much as possible to prevents leakage.

H. Write down the time the specimen is collected on the test cup. Verify that there is enough of the specimen (minimum 30mL to maximum 110 mL mark on the cup) to perform the test.

I. Verify that the specimen is near body temperature (90-100 °F / 32-38°C). A green color dot on the strip indicates the specimen temperature. If there is no temperature reading or the temperature is out of range, the sample should be discarded. A new sample should be collected with a new test kit.

J. Perform test immediately after collection.

K. Read the analyte results at exactly 5 minutes. DO NOT INTERPRET RESULT AFTER 10 MINUTES.

L. Document test results (see Reporting Results).

M. Discard the test cup in a proper biohazard container after testing.

REPORTING RESULTS

A. Reading the Results

1. Test results show as the presence or absence of red / pink lines on each strip.

2. Any evidence of a line is a line, no matter how faint.

3. Each strip has 2 possible lines:

a. An upper line, called the CONTROL LINE Its presence means that the test is working. Its absence means that the test is invalid.

b. A lower line, called the TEST LINE Its presence means that the test is NEGATIVE for that drug. Its absence means that the test is POSITIVE for that drug.

NOTE: There is no meaning attributed to line color intensity or width.

B. INTERPRETATION OF RESULTS

Image of Strip Visible on Strip Result

C Control Line: PresentTest Line: Absent Patient Result is: POSITIVE

C T

Control Line: PresentTest Line: Present Patient Result is: NEGATIVE

OR T Control Line: Absent

Test Line: Present or AbsentPatient Result is: INVALID

(Discard cup and start over with new, unopened test cup)



C. DOCUMENTING RESULTS

Test results are documented in the patient’s medical record or electronic medical record (EMR).

D. REFERENCE RANGE (manufacturer)

CONFIRMATORY TESTING

One Step Multi-drug Screen Test Cup (“NexScreen™ Cup”) positive results are presumptive positive, i.e., require confirmation, if clinically necessary or desired (see also LIMITATIONS OF METHOD below).

PROCEDURE NOTES AND PERFORMANCE CHARACTERISTERICS

A. Sensitivity: Total 150 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Methamphetamine, Amphetamine, Cocaine, Morphine, Propoxyphene, Ecstasy, EDDP (Methadone Metabolites), Tricyclic Antidepressants, Oxycodone, Barbiturates, Buprenorphine, Phencyclidine, Methadone, Marijuana and Benzodiazepines. The cut-off value for the device is verified. Refer to the package insert for results.



B. Accuracy: 80 clinical urine specimens were analyzed by GC-MS and by the One Step Multi-Drug Screen Test Cup. Each test was performed by three operators. Samples were divided by concentration into five categories: drug-free, less than half the cutoff, near cutoff negative, near cutoff positive, and high positive. Refer to the package insert for results.

C. Specificity: Refer to the package insert for results.

D. Precision: This study is performed two runs/day and lasts 25 days for each format with three lots. Three operators who do not know the sample number system participate in the study. Each of the three operators tests two aliquots at each concentration for each lot per day (2 runs/day). A total of 50 determinations by each operator, at each concentration, were made. Refer to the package insert for results.

E. Effects of Urinary Specific Gravity and pH: Refer to the package insert for study descriptions. The results demonstrated that varying ranges of urinary specific gravity do not affect the test results and those of urinary pH do not interfere with the performance of the test.

F. Refer to the package insert for other performance characteristics.

LIMITATIONS OF METHOD

A. The One Step Multi-Drug Screen Test Cup provides only a qualitative, preliminary analytical result. A secondary analytical method must be used to obtain a confirmed result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.

B. There is a possibility that technical or procedural errors, as well as other interfering substances in the urine specimen may cause erroneous results.

C. Adulterants, such as bleach and/or alum, in urine specimens may produce erroneous results regardless of the analytical method used. If adulteration is suspected, the test should be repeated with another urine specimen.

D. A positive result does not indicate level or intoxication, administration route or concentration in urine.

E. A negative result may not necessarily indicate drug-free urine. Negative results can be obtained when drug is present but below the cut-off level of the test.

F. The test does not distinguish between drugs of abuse and certain medications.G. A positive result might be obtained from certain foods or food supplements.H. The NexScreen™ Cup provides only a preliminary analytical test result. It will be necessary to

confirm a positive NexScreen™ Cup result in a Clinical Laboratory / Reference Laboratory to conclude the test result is confirmed positive.

REFERENCES

A. CLIA Waived NexScreen™ Cup Package Insert, v. B21150-01. NexScreen LLC 9501 Northfield Blvd. Denver, CO 80238, 1.888.956.8989, www.nexscreen.com.

B. Biochemical Diagnostics, Inc., 180 Heartland Blvd, Edgewood, NY 11717, 1.800.223.4835.

APPENDIX A: NexScreen Urine Drug Screen External Quality Control Test Record

DISTRIBUTION

A. Point of Care Master Procedure Book (2M14)

B. POCT Site Manual



http://www.nexscreen.com/

http://www.nexscreen.com/

APPENDIX A:

NexScreen Urine Drug Screen External Quality Control Test Record

Today’s Date: Test Performed by:

Test CUP Lot Number: Test CUP Expiration Date:

Perform Positive QC Test and Negative QC Test monthly and upon new shipments and new lots.

Control Line and Test Line: Circle either P = Present, or A = Absent.Results: Circle either POS = POSITIVE, or NEG = NEGATIVE, or INV = INVALID.

POSITIVE QUALITY CONTROL TEST POSITIVE Control Lot #: _______________ POSITIVE Control Exp Date: _______________

Drug(Analyte) MET PCP COC MD

MA OPI OXY AMP MTD BZO BAR TCA BUP THC

Control Line

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

Test LineP

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

Positive Control Results

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

NEGATIVE QUALITY CONTROL TESTNEGATIVE Control Lot #: ___________ NEGATIVE Control Exp Date: _______________

Drug(Analyte) MET PCP COC MD

MA OPI OXY AMP MTD BZO BAR TCA BUP THC

Control Line

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

Test LineP

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

P

A

Negative Control Results

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

POS

NEG

INV

Review / Approved by: ___________________________ Date: _______________



Documents

UniversityofCalifornia,SanFrancisco ......BarbaraHaller,MD,PhD,Director 48667.305OneStepMulti-drugScreenTestCup(“NexScreen Cup”)UrineDrugScreen Copyofversion1.0(approvedandcurrent)