ISO 15189 Made Easier

ISO 15189

HELPING YOU TO MEET THE STANDARD

Controls

Calibrators

Reference Plasmas

Pipette Service and Calibration

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ISO 15189 Made Easier

n freephone order 0800 387732 n buy online at www.alphalabs.co.uk1

Both NHS and private practices rely heavily on the quality of the diagnostic testing provided by medical laboratory services and pathology laboratories. The provision of accurate and consistent examination, result validation and authorisation interpretation and reporting is essential for many patient pathways.

Assessments such as the 2014 NHS England Pathology Quality Assurance Review, chaired by Dr Ian Barnes, have highlighted the importance of accreditation of medical laboratories to assure the quality of the services being provided.

The United Kingdom Accreditation Service (UKAS) is moving to accredit pathology services against the internationally recognised standard: ISO 15189.

Regarding accreditation, the Barnes review recommended:

Adopting the new ISO 15189 standards will increase confidence in the results produced by elimination, wherever possible, of all causes of variability in test protocols and procedures. Significant focus should be on those sections relating to method validation, system calibration, internal quality control and assurance and result consistency. ISO 15189 Quality Management System criteria encompass:

■ 5.3.1.4 equipment calibration and metrological traceability

■ 5.3.2.3 reagents and consumables acceptance testing

■ 5.5.1.2 verification of examination procedures

■ 5.5.1.3 validation of examination procedures

■ 5.5.1.4 measurement uncertainty of measured values

■ 5.6.2.2 quality control materials

Alpha Laboratories can provide help and support for laboratories implementing ISO 15189 through its many products and services.

“In order that patients and clinicians can rely on accreditation status as shorthand for a quality assured service, the accreditation of pathology services must be updated showing clearly which laboratories are meeting minimum requirements, and which are excelling to provide first-rate service quality. UKAS has agreed to undertake this work.”


2

If your laboratory is aiming for ISO 15189 accreditation you need to demonstrate that your testing service follows defined quality assurance levels, performing with competence and consistency.

Commercially available control, calibrator and reference materials provide third party verification of your system.

Those that follow the patient pathway provide greater confidence in test system results, over controls that use artificial materials, or that do not enumerate accurately over a number of parameters.

Together with regularly validated and calibrated equipment they help you to achieve and maintain accreditation.

Supporting ISO 15189 Compliance

Contents Page/sClinical Chemistry Calibrators & Standards 3

Clinical Chemistry Controls 4

HbA1c Controls 5

Haematology Product Selector Guide 7

Streck STATS® Quality Control Programme

8

Haematology Calibrators 9

Haematology Controls 10-14

Sickle Cell Tests and Controls 15

UA-Cellular™ Urine Controls 16

Temp-Chex Thermometers 16

ESR Testing 17

Light Transmission Aggregometry Performance Validation

18

Flow Cytometry Controls 19-20

Flow Cytometry Product Selector Guide 20

Lupus Anticoagulation Controls 21

Factor Deficient Substrates 22

Reference Plasma 23

Control Plasma 24-25

Blood Grouping Control Reagents 26-27

Fastrak and Laboratree 28

Pipette Service and Calibration, plus Pipetting Academies

29-30

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Clinical Chemistry Calibrators and Standards

Clinical Chemistry Calibrator (Sentinel):

ACP (Acid Phosphatase), Albumin, ALP (Alkaline phosphatase), ALT (Alanine Aminotransferase), Amylase, AST (Aspartate aminotransferase), Bile Acids, BIL-D, BIL-T, Calcium, Cholinesterase, Total Cholesterol, Chlorides, Creatinine, Copper, Iron, GGT, GLDH (Glutamate Dehydrogenase), Glucose, HBDH, β-Hydroxybutyrate. Lactate, LDH (Lactate Dehydrogenase), Lipase, Magnesium, Phosphate, Triglycerides, Total Protein, Uric Acid, Urea, Zinc.

Plasma Protein Calibrator (Sentinel): α-2-Macroglobulin, α-1-Antitrypsin, α-1-Acid Glycoprotein, Albumin, Antithrombin III, C3, C4, C1-esterase inhibitor, Ceruloplasmin, Haptoglobin, IgA, IgG, IgM, Kappa & Lambda Light Chains, Prealbumin, Transferrin.

Diacal Auto (Dialab): ALP (Alkaline phosphatase), Albumin, ALT (Alanine Aminotransferase), Amylase, AST (Aspartate aminotransferase), BIL-D, BIL-T, Calcium, Cholinesterase, Total Cholesterol, Chlorides, Creatinine, Copper, Iron, GGT, Glucose, HBDH. HDL-C,Lactate, LDH (Lactate Dehydrogenase), LDL-C, Lithium, Lipase, Magnesium, Phosphorus, Phospholipids, Triglycerides, Total Protein, Uric Acid, Urea.

Protein Calibrator High/Low (Dialab): α-1-Antitrypsin, α-1-Acid Glycoprotein Albumin, α-2-Macroglobulin, Antithrombin III, C3, C4, C1-esterase inhibitor, Ceruloplasmin, Haptoglobin, IgA, IgG, IgM, Kappa & Lambda Light Chains, Prealbumin, Transferrin.

Multi-Constituent Calibrators

Multi-Constituent Calibrators

Catalogue Number

Description Pack Size

16550 Clin Chem Calibrator 4x3ml

D98485SV Diacal Auto 1x3ml

11200D Plasma Protein Calibrator 3x1ml

A00580 Protein Calibrator High 1x1ml

A00701 Protein Calibrator Low 1x1ml

Single Constituent Calibrators & Standards

Single Constituent Calibrators & Standards

Catalogue Number


B-ACK-CA ACE Standard 1x2ml

A00735 β-2-Microglobulin Calibrator 4x1ml

903210 Bile Acids Standard 1x3ml

419-73295 Bilirubin Calibrator 4x3ml

D06520SV Carbon Dioxide Standard 41x3ml

416-51095 HDL Calibrator 4x3ml

419-24032 LDL Calibrator 4x1ml

997-43801 CH50 Calibartor 5x0.5ml

460-25801 CRP Calibrator 5x2ml

11532 CRP Calibrator Set 7x2ml

11533 CRP Ultra-Sensitive Calibrator 1x2ml

16299C CK-MB Calibrator 2x1ml

Z05880 Ethanol Calibrator/Control 4x1ml

11525A Ferritin Calibrator Set 1x19;1x10ml

Y04705SV Haemoglobin Calibrator 1x2ml

993-71115 HA Calibrator 5x2ml

A05746 IgD Calibrator 1x0.5ml

412-73791 Ketone Bodies Calibrator 4x5ml

270-77000 NEFA Standard 2x10ml

910180SV Potassium Standards Set 2x3ml

419-77902 Rheumatoid Factor Calibrator 5x1ml

11523D RF Calibrator Set 5x1ml

A00960 Transferrin Calibrator 5x1ml

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n email order [email protected] n freefax order 0800 614249 4

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Clinical Chemistry Controls

Multi-Constituent Assayed Control Serum

Single Constituent Controls

Assayed Clinical Chemistry Control 1 & 2 (Sentinel): Acid Phosphatase, Albumin, ALD, Alkaline phosphatase, Alanine Aminotransferase, Amylase, Aspartate aminotransferase, BIL-D, BIL-T, Calcium, Cholinesterase, Total Cholesterol, Creatine Kinase, Chlorides, Creatinine, Copper, Iron, Gamma GT, Glucose, HBDH. HDL-C, Potassium, Lactate, Lactate Dehydrogenase, LDL-C, Lithium, Lipase, Magnesium, Sodium, Phosphorus, Phospholipids, Triglycerides, Total Protein, Uric Acid, UIBC, Urea, Zinc.

Assayed Control Serum I & II (Wako): NEFA, Creatinine, BIL-T, BIL-D, HDL-C, LDL-C, Zinc.

Assayed Diacon N & P (Dialab): Albumin, Alkaline phosphatase, Alanine Aminotransferase, Amylase, Aspartate aminotransferase, Bile Acids, BIL-D, BIL-T, Calcium, Cholinesterase, Total Cholesterol, Creatine Kinase, Chlorides, Creatinine, Copper, Iron, Gamma GT, Glucose, Glutamate Dehydrogenase, HBDH. HDL-C, Lactate, Lactate Dehydrogenase, LDL-C, Lithium, Lipase, Magnesium, Potassium, Phenylalanine, Sodium, Phosphorus, Triglycerides, Total Protein, Uric Acid, Urea, Zinc.

Assayed Immuno Control Set (Sentinel): α-2-Macroglobulin, α-1-Antitrypsin, α-1-Acid Glycoprotein, Albumin, Anti-streptolysin O, Antithrombin III, β2M, C3, C4, C1-esterase inhibitor, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Kappa & Lambda Light Chains, Prealbumin, Rheumatoid Factor, Transferrin.

Assayed Protein Control (Dialab): α-1-Antitrypsin, α-1-Acid Glycoprotein Albumin, α-2-Macroglobulin, Anti-streptolysin O, Antithrombin III C3, C4, C1-esterase inhibitor, Ceruloplasmin, CRP, Ferritin, Haptoglobin, IgA, IgG, IgM, Kappa & Lambda Light Chains, Prealbumin, Rheumatoid Factor, Transferrin.

Multi-Constituent Controls

Catalogue Number


16150 Clin Chem Control Level I 6x5ml

16250 Clin Chem Control Level II 6x5ml

410-00104 Control Serum Level I 4x5ml

416-00204 Control Serum Level II 4x5ml

D98481SV Diacon Normal Control 1x5ml

D98482SV Diacon Pathological Control 1x5ml

11211A Immuno Control Set (2 levels) 2x(2x1)ml

A00590 Protein Control 1x1ml

A08591 Protein Control Low 1x1ml

Single Constituent Controls

Catalogue Number


16635 Ammonia Control (3 levels) 3x(1x5)ml

B-ACK-CONSET ACE (2 levels) 2x2ml

A00818 β-2 Microglobulin Control 1x1ml

16002A Bile Acids (2 levels) 2 x (2x3ml)

16299S CK-MB Control 2x1ml

991-43701 CH-50 Control (2 levels) 10x0.5ml Low/10x0.5ml High

11540 CRP Ultra-Sensitive Control 3x2ml

16352 Fructosamine Control Level I 4x1ml

16353 Fructosamine Control Level II 4x1ml

Y04706 Haemoglobin Control Set 6x2ml

16370S Homocysteine Controls 3x(1x1.5)ml

998-71165 HA Control (2 levels) 2x(2x2)ml

125001 Microalbumin Control (2 levels) 2x(5x7)ml

910190SV Potassium Control Set (2 levels) 2x3ml

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HbA1c Controls

A1c-Cellular®

Streck’s A1c-Cellular is a whole blood cellular control for HbA1c and is the only A1c control on the market with intact red blood cells. A1c-Cellular tests the entire HbA1c performance, including the lysing of the red blood cell - a step omitted with other controls. This important step ensures the entire system, instrument and reagents, is working properly and providing accurate patient results.

n Ready to use liquid control

n Open-vial stability of 30 days

n Closed-vial stability of 6 months

Technical information:

A1c-Cellular is available in cap-pierceable plastic vials, which allows autosampling for HbA1c analysers with such capabilities.

It is appropriate for immunoassay and ionic exchange HPLC methodologies and is assayed for:

■ Abbott ARCHITECT® c Systems

■ ARKRAY Menarini ADAMS™ A1c HA-8160

■ Beckman Coulter® Synchron® Systems, UniCel® DxC Systems

■ Bio-Rad® D-10, Variant II™, Variant II™ Turbo

■ Siemens Dimension™ Series

■ Ortho-Clinical Diagnostics VITROS® 5,1 FS; VITROS® 5600

■ Roche Diagnostics Cobas INTEGRA®, Cobas® 6000

■ Tosoh G7, G8, A1c 2.2 Plus

A1c-Cellular is available in two clinically significant levels:

A1c Cellular Control

Catalogue Number


211130 A1c-Cellular - Levels 1 & 2 2 x 2.0ml

211124 A1c-Cellular - Levels 1 & 2 6 x 2.0ml

Streck

A1c-Cellular® Linearity

Streck’s A1c-Cellular Linearity evaluates the accuracy and precision of HbA1c procedures over instrument reportable range.

A1c-Cellular Linearity is a 5-level assayed linearity material used to assess instrument accuracy and verify the reportable range of the Haemoglobin A1c (HbA1c) parameter. It is the only commercially-available linearity/calibration verification material containing intact red blood cells. It tests the entire reportable range of the instrument for bias, including the lyse step.

n Ready to use liquid control

n Open-vial stability of 7 days

n Closed-vial stability of 105 days

A1c Cellular Control

Catalogue Number


285536 A1c-Cellular Linearity 5 level control 5 x 2.0ml

Streck

Technical information:

A1c-Cellular Linearity is available in cap-pierceable plastic vials, which allows autosampling for HbA1c analysers with such capabilities. Vials also include barcodes.

Instrument specific target values and expected ranges are provided for immediate instrument accuracy verification. Assayed Instruments:

■ Beckman Coulter® Synchron CX®/LX® &, UniCel® DxC 600/800 Synchron®

■ Bio-Rad® Variant II™, Variant II™ Turbo & D-10™

■ Ortho-Clinical Diagnostics VITROS® 5,1 FS & VITROS® 5600

■ Roche COBAS Integra®, Cobas® 6000

■ Siemens Dimension™ Series

■ Tosoh G7, G8AAssay Mean

Level 1 2 - 5% HbA1c

20 - 53 mmol/mol

Level 2 7 - 12% HbA1c

75 - 119 mmol/mol

Typical ranges for A1c-Cellular Linearity

Level 1 0% - 2%

Level 2 4% - 7%

Level 3 9% - 12%

Level 4 14% - 16%

Level 5 17% - 21%


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Streck, has a long pedigree in developing controls and support products. Their controls are renowned for closely resembling and performing like patient samples.

Together with the STATS® programme, this helps you ensure quality control, confirming the accuracy of your test system and the reliability of patient results.

Streck controls contain true cellular material that undergoes the same procedural conditions as a patient sample. Available for numerous analytes each control provides at least two clinically relevant ranges.

■ Haematology controls

■ Cellular urine control for automated microscopy

■ Flow cytometry controls

The PrecisionBiologic CRYOcheck™ frozen plasma range can enhance your quality procedures compared to traditional lyophilised plasma controls.

■ Ready-to-use buffered, frozen product - consistent vial to vial

■ Prevents reconstitution errors - no pipetting inaccuracy risks

■ Every lot has an assay certificate - fully traceable

■ Saves time, ready to use in just 5 minutes

Cellular Controls Follow the Patient Pathway

Frozen Plasma Products Improve Quality

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Haematology Product Selector Guide

The quickest way to find the right control, calibrator or reticulocyte control:

Simply select your instrument and then the product. If you require additional help, please contact Alpha Laboratories.

I use a…. I am looking for a …

Instrument Control Page Calibrator Page Reticulocytes PageAbbott Laboratories

CELL-DYN 1400 Para 12 Extend 11 Cal-Chex 9

CELL-DYN 1600, 1700 Para 12 Extend 11 Cal-Chex 9

CELL-DYN 1800 Para 12 Extend

CVA for CELL-DYN

11

10

Cal-Chex 9

CELL-DYN 3200 Para 12 Plus

Cell-Chex Auto

CVA for CELL-DYN

11

9

10

Cal-Chex A Plus 9 Retic-Chex Linearity 13

CELL-DYN 3500, 3700 Para 12 Plus

CVA for CELL-DYN

11

10

Cal-Chex A Plus 9 Retic-Chex II

Retic-Chex Linearity

12

13

CELL-DYN Sapphire Cell-Chex Auto

CVA for CELL-DYN

9

10


CELL-DYN Ruby Cell-Chex Auto

CVA for CELL-DYN

9

10


CELL-DYN Emerald CVA for CELL-DYN 10

Horiba Medical ABX

Micros 60 Para 12 Extend 11 Cal-Chex 9

Beckman Coulter

AcT™ series, inc. diff and diff 2 Para 12 Extend 11 Cal-Chex 9

LH500 StaK-Chex

StaK-Chex Plus Retics

CVA

13

14

10

Cal-Chex 9 Retic-Chex Linearity for BC 13

LH750/LH755/LH780/LH785 StaK-Chex Plus Retics

CVA

Cell-Chex Auto

LBC-Chex

14

10

9

10

Cal-Chex 9

STKS™, MAXM StaK-Chex 13 Cal-Chex 9 Retic-Chex II 12

HmX. StaK-Chex Plus Retics

CVA

Cell-Chex Auto

14

10

9

Cal-Chex 9 Retic-Chex Linearity 13

DxH™ 800 StaK-Chex Plus Retics

CVA

Cell-Chex Auto

LBC-Chex

14

10

9

10

Cal-Chex 9 Retic-Chex Linearity 13

HemoCue Inc.

B-Haemoglobin Photometer Para 4

CVA

12

10

Hb201+ HQ-Chex

Para 4

CVA

10

12

10

B-Glucose HQ-Chex 10

Glucose 201 HQ-Chex 10

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Brand and product names of the instruments are trademarks of their respective holders.

Streck STATS® Programme

All standing order customers qualify for participation in

STATS® which offers you the opportunity to compare the

accuracy of your instrument with a world-wide cohort using

the same lot number and instrument type.

STATS® provides statistical and graphical presentation of

quality control data which includes:

■ Cumulative data

■ Peer group comparisons

■ Levey-Jennings graphs

Data is submitted by mail, fax or e-mail and turnaround time

is fast with reports being produced every month.

In addition to current reports, archived reports are also

available.

Now STATS-Link® offers:

■ Email notification that reports are ready

■ View and download STATS® reports online

■ Access to reports 24 hours a day

■ Manager’s Report providing a summary report for multi-laboratory operations

Enrolment

Once your standing order is established, enrolment is

simple. Please contact Alpha Laboratories for more details.

Free of charge inter-laboratory quality control programme


Instrument Control Page Calibrator Page Reticulocytes PageSiemens Healthcare Diagnostics

ADVIA 60 Para 12 Extend 11

Sysmex

XE-2100, XE-5000 Cell-Chex

Auto LBC-Chex

9

10

Retic-Chex Linearity 13

XT-1800i, XT-2000i, XT-4000i Cell-Chex Auto 9 Retic-Chex Linearity 13

XN-10, XN-20 LBC-Chex 10 Retic-Chex Linearity 13

Other Analysers

Haemata STAT II Para 4 12

ESR Systems

Ves-Matic ESR-Chex 17

Min-Ves ESR-Chex 17

ESR-Auto Plus ESR-Chex 17

ESR-100 ESR-Chex 17

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A calibrator assayed for Beckman Coulter, Abbott and Horiba

Medical ABX instruments.

Assayed on analysers calibrated with whole blood using

standard reference methods, it ensures accurate and reliable

calibration of haematology analysers.

■ 5-day open-vial stability and 45-day closed-vial stability

■ Supplied with pierceable caps for closed-tube systems

■ System specific values for 9 parameters

Cal-Chex

A calibrator assayed for the Abbott CELL-DYN 1700, 3000,

3200, 3500, 3700, 4000 as well as the Ruby and Sapphire

analysers. Assayed on analysers calibrated with whole blood

using standard reference methods, it ensures accurate and

reliable calibration of haematology analysers.


■ Supplied with pierceable caps for closed-tube systems

■ System specific values for 9 parameters

Cal-Chex A Plus

The first automated body fluid cell count control, designed to

provide confidence that instrument counts are accurate.


■ Available in 3 levels

■ All levels are lower than the levels found in abnormal haematology controls and calibrators

■ Free participation in STATS®

Cell-Chex Auto

Product Selection Guide

Manufacturer Instrument Compatible

Abbott CELL-DYN 1400, 1600, 1700, 1800 3

Horiba Medical ABX Micros 60 3

Beckman Coulter Ac•T series (exl 5 diff)

LH500/LH750/LH755/LH780/LH785

STKS, MAXM, HMX

DxH™800

3

Cal-ChexCatalogueNumber


221101 Cal-Chex 1 x 3ml

Streck



Abbott CELL-DYN Sapphire, Ruby

CELL-DYN 3200, 3500/3700

3

Cal-Chex A PlusCatalogueNumber


221106 Cal-Chex A Plus 1 x 3ml

221107 Cal-Chex A Plus 2 x 3ml

Streck



Abbott CELL-DYN 3200, Sapphire and Ruby 3

Beckman Coulter LH750/755/780/785 DxH™ 800 3

Sysmex XE-2100, XE-5000, XT-1800i, XT-2000i,

XT-4000i

3

Cell-Chex AutoCatalogueNumber


200065 Cell-Chex Auto Level 1 & 2 2 x 3ml

200066 Cell-Chex Auto Level 1, 2 & 3 3 x 3ml

200067 Cell-Chex Auto Level 1 3 x 3ml



Streck

Haematology Calibrators

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A range of assayed linearity control kits that can be used to

verify calibration and patient reportable range of 3-part and

5-part haematology instruments.


■ Each kit has customised ranges appropriate for instrument model

■ Kit provides instrument-specific assay values for the WBC, Platelet, RBC and haemoglobin parameters

■ Also measures the linear performance of the analyser


CVA and CVA for CELL-DYN

A whole blood glucose and haemoglobin control to evaluate

the accuracy and precision of point of care instruments.


■ Available in three clinically significant levels

■ Package in convenient plastic squeeze dropper vials

■ Specially formulated for HemoCue® analysers


HQ-Chex

The first lamellar body count control. Lamellar bodies can be

analysed as an indirect estimate of fetal lung maturity and as

a potential indicator of respiratory distress syndrome.

■ 30-day open-vial stability and 105 day closed-vial stabillity

■ Verifies instrument accuracy by testing the lower platelet limits that standard controls and calibration material fail to assess

■ Provides laboratory scientists with confidence their instrument counts are accurate for patient samples

■ No dilution required

LBC-Chex™



Beckman Coulter LH700 series, UniCel® DxH™ 800 3

Sysmex XE-2100™, XE-5000™, XN-10™, XN-20™ 3

LBC-ChexCatalogueNumber


200098 LBC-Chex Level 1, 2 & 3 (RUO) 3 x 3ml

200099 LBC-Chex Level 1 (RUO) 3 x 3ml

200100 LBC-Chex Level 2 (RUO) 3 x 3ml

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HemoCue, Inc. B-Glucose Analyzer

B-Hemoglobin Photometer

Hb 201+ Analyzer

Glucose 201 Analyzer

3

HQ-ChexCatalogueNumber


232753 HQ-Chex Level 1 6 x 2.5ml



232756 HQ-Chex Level 1, 2 & 3 6 x 2.5ml

Streck



Abbott CELL-DYN 1800 or lower

CELL-DYN 3200 or higher

3

3


Beckman Coulter LH500, DxH™ 800, HmX

LH500/750/780/785

3

CVA and CVA for CELL-DYNCatalogueNumber


291712 CVA for DxH 800, LH500/750/780/785 18 x 3ml

291715 CVA for CELL-DYN 1800 or lower 12 x 3ml

291718 CVA for CELL-DYN 3200 or higher 16 x 3ml

Streck

Haematology Controls

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A three-part differential control with distinct populations of

lymphocytes, mononuclear cells, and granulocytes, but with

extended stability suitable for the smaller laboratory.

n 30-day open-vial stability and 190-day closed-vial stability

n Available in a 2.5ml vial or a 4.5ml pierceable cap vial

n Pierceable cap suitable for instruments with single closed-vial sampling or continuous closed-vial auto-sampling capability

n Varying levels of lymphocytes, mononuclear cells, and granulocytes available at low, normal and high levels

n Free participation in STATS®

Para 12® Extend

The perfectpartnership

for your Sickle Cell testing

SICKLEDEX® Solubility Kits

Sickle-Chex® Whole Blood Control

see page 15 for more details

A five-part whole blood differential control for the Abbott

CELL-DYN 3200, 3500 and 3700.


n Packaged in a 3ml vials pierceable caps and bar-coded labels

n Assay file available for download

n Also provides 3-part differential for CELL-DYN 1600 & 1700

n Stable and reproducible scattergrams assist detection of malfunctions including laser


Para 12® Plus

Para 12® PlusCatalogueNumber


218924 Para 12 Plus Low 4 x 3ml

218914 Para 12 Plus Normal 4 x 3ml

218934 Para 12 Plus High 4 x 3ml

218913 Para 12 Plus Tri-Level 12 x 3ml

Streck



Abbott CELL-DYN 3200, 3500 and 3700 3



Abbott CELL-DYN 1400, 1600, 1700, and 1800 3


Beckman Coulter Ac•T/Ac•T diff/Ac•T diff2 3

Siemens Advia 60 3

Para 12® ExtendCatalogueNumber


218750 Para 12 Extend Tri-level 18 x 2.5ml

218770 Para 12 Extend Tri-level 18 x 4.5ml

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A four-parameter haematology control designed for point

of care testing or the small laboratory performing a limited

number of tests, utilising manual or semi-automated

methods.


■ Available in glass or plastic squeeze dropper vials

■ Assay parameters are Hgb, WBC, RBC, Hct and platelets


Para 4®

A whole blood control, manufactured with reticulocytes that

resemble the appearance of patient samples for accurate

identifications. Available in three levels which are well

positioned to monitor the haemostatic response.


■ Available in glass vials for automated methods

■ Packaged in plastic squeeze dropper vials for manual methods

■ Retic-Chex Stain also available


Retic-Chex® II



HemoCue® Inc. B-Haemoglobin Photometer

Hb 201+

3

3

Para 4®

CatalogueNumber


215106 Para 4 Low 6 x 1.5ml

215107 Para 4 Normal 6 x 1.5ml

215108 Para 4 High 6 x 1.5ml

215112 Para 4 Tri-Level 12 x 1.5ml

Para 4® Glass VialsCatalogueNumber


215426 Para 4 Low 6 x 1.5ml

215416 Para 4 Normal 6 x 1.5ml

215436 Para 4 High 6 x 1.5ml

215412 Para 4 Tri-Level 12 x 1.5ml

Streck



Abbott CELL-DYN 3500 and 3700 3

Beckman Coulter STKS, MAXM, HMX and LH500 3

Manual Methods Miller Ocular

Two Slide

3

3

Retic-Chex® IICatalogueNumber


285106 Retic-Chex II Tri-Level (plastic) 6 x 1ml

285104 Retic-Chex II Level 1 (plastic) 4 x 1ml



285410 Retic-Chex Stain 2 x 15

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A five-part differential control manufactured at clinically

significant low, normal and high levels for all parameters.


■ Pierceable cap compatible with all cassette systems

■ Bar-coded vials assists daily QC data collection

■ The same lot number can be used for 3 months making trends easier to detect

■ Assay sheets are barcoded for uploading assay values for STKS™, MAXM ™, and HmX


STaK-Chex® Retic-Chex® Linearity

Retic-Chex® Linearity is designed to establish the patient

reportable range and linearity of the system.

■ Available in five-vial sets with instrument-specific assay values

■ The vials have pierceable caps

■ Open-vial stability: 5 days

■ Closed-vial stability: 105 days



Abbott CELL-DYN® 3200, 3500, 3700, Ruby and Sapphire

3

Beckman Coulter STKS™, MAXM™, HmX, GEN•S, DxH™800,LH 500, LH750/755 and LH780/785

3

Sysmex XE-2100™, XE-5000™, XT-2000i™,

XT4000i™, XN-10 and XN-20

3

Retic-Chex® LinearityCatalogueNumber


285532 Retic-Chex Linearity for Sysmex 5 x 2.5ml

285535 Retic-Chex Linearity BC/Beckman Coulter 5 x 3ml

Streck



Beckman Coulter STKS™

MAXM™

HmX

LH500

3

3

3

3

STaK-Chex®

CatalogueNumber


225512 STaK-Chex Tri-Level 12 x 4ml

225524 STaK-Chex Low 4 x 4ml

225514 STaK-Chex Normal 4 x 4ml

225534 STaK-Chex High 4 x 4ml

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Hae

mat

olog

y C

ontr

ols

A five-part differential control with values for all parameters,

including reticulocytes and nucleated red blood cells.


■ Assay contains automated/manual reticulocyte values at three clinically significant levels

■ Bar-coded vials to ensure correct data input

■ Pierceable cap vial with unlimited piercing

■ All-in-one controls assists purchase, inventory and QC records

■ The same lot number can be used for 3 months making trends easier to detect

■ Assay values available for upload for all instruments


■ Assayed for LH500, LH750/755, LH780/785, HmX and DxH™800

STaK-Chex® Plus Retics

Typical assay range for STaK-Chex® Plus ReticsWBC (109/L) 2.5 - 22.0

RBC (1012/L) 2.60 - 5.40

MCV (fL) 70 - 100

PLT (109/L) 70 - 625

RETICS (%) 0.1 - 10.0



Beckman Coulter STKS™

MAXM™

HmX

DxH™800

LH500

LH750/755/780/785

3

3

3

3

3

3

STaK-Chex® Plus ReticsCatalogueNumber


225480 STaK-Chex Plus Retics Low 4 x 4.5ml

225481 STaK-Chex Plus Retics Normal 4 x 4.5ml

225482 STaK-Chex Plus Retics High 4 x 4.5ml

225483 STaK-Chex Plus Retics Normal 12 x 4.5ml

225485 STaK-Chex Plus Retics Tri-Level 12 x 4.5ml

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Sick

le C

ell S

cree

ning

Tes

ts a

nd C

ontr

ols

Tests and Controls for Sickle Cell Screening

Designed to detect the presence of Haemoglobin S with just

20µl of sample.

The kit offers:

■ 45-day open-vial stability and 12-month closed-vial stability

■ Superior open-vial stability: three times as long as other products on the market

■ Squeeze bottle (buffer) convenience to minimise waste

■ Only 20µl of patient/control sample required

■ Choice of pack sizes available to suit workload requirements including the 12-test kit which includes all items necessary to perform a sickle cell screening test

■ Ten-place test-tube reading rack is also available

SICKLEDEX®

A positive and negative whole blood control to test for the

presence of Haemoglobin S in solubility tests.

■ 100-day open-vial stability and 6-month closed-vial stability

■ Compatible with most other manufacturers’ sickle cell screening kits

■ Packaged in 2.5ml squeeze dropper vials for easy sample dispensing

■ Vial dispenses accurate sample volume

SICKLEDEX®

CatalogueNumber


217661 SICKLEDEX qualitative Solubility Test Kit 12 tests



217659 SICKLEDEX Test Rack 1

Streck

Sickle-Chex®

CatalogueNumber


217653 Sickle-Chex Positive and Negative Controls 2 x 2.5ml

217654 Sickle-Chex Positive and Negative Controls 4 x 2.5ml

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UA

-Cel

lula

r™ C

ellu

lar

Uri

ne C

ontr

ol/T

emp-

Che

x Th

erm

omet

ers

Red Spirit

UA-Cellular™

Cellular Urine Control for Sysmex® UF seriesand Iris iQ200 instruments

Instrumentation controls should represent the same

procedural processes and reflect similar values to those

expected by patient samples.

UA-Cellular for UF and UA-Cellular for IQ is a unique product

that contains components at two clinically significant levels.

The product evaluates an instrument’s ability to identify and

quantify white blood cells, red blood cells, non-squamous

epithelial cells and crystals.

Stability for UA-Cellular for UF and UA-Cellular for iQ

■ Store at 2 - 10C

■ 30 day open-vial stability and 105 day closed-vial stability

Typical RBC, WBC and non-squamous epithelial (NSE) levelsfor UA-Cellular for UF

WBC RBC EC BACT

Level 1 30-50 cells/µl 5-15 cells/µl 10-20 cells/µl 150-250 cells/µl

Level 2 180-220 cells/µl 40-60 cells/µl 20-80 cells/µl 600-800 cells/µl

Level 1 contains crystals, Level 2 contains casts

Typical RBC, WBC and non-squamous epithelial (NSE) levels for UA-Cellular for iQ

WBC RBC NSE

Level 1 30-60 cells/µl 30-60 cells/µl 10-30 cells/µl

Level 2 180-240 cells/µl 180-240 cells/µl 60-120 cells/µl

Level 2 contains casts

UA-Cellular™ for UF and UA-Cellular™ for iQCatalogueNumber


213465 Level 1 & 2 (UF) 2 x 120ml

213396 Level 1 & 2 (iQ) 2 x 45ml

Streck

Temp-Chex Thermometers

Streck manufactures a number of quality control devices,

including the Temp-Chex Red Spirit thermometers with scales

in 1/2-degree increments to monitor refrigerators, freezers,

and incubators/room temperatures.

Safe, Reliable, and Accurate Monitoring of Laboratory Temperatures

■ Red Spirit Temp-Chex thermometers monitor refrigerators,

freezers, incubators, and room temperatures.

■ Each thermometer is engraved with a serial number

traceable to NIST/DKD with scales in 1/2º increments*,

allowing the laboratory to meet CAP and CLIA standards.

■ Contained in a vial of propylene glycol, Temp-Chex

thermometers attach to your refrigerator, freezer, or

incubator wall magnetically or adhesively. The Temp-Chex

thermometer and vial are enclosed in a plastic tube to

protect the thermometer and to contain contents in case

of breakage. A temperature wall chart is included with

each Temp-Chex.

■ All Temp-Chex thermometers are mercury-free.

*Ultra-Low thermometer features 1º gradation.

Please note: calibrators, linearity products, PVS, and thermometers are not available as a sample.

Temp-Chex ThermometersCatalogueNumber


240043 Temp-Chex Red Spirit -5 ºC to 15 ºC Each

240046 Temp-Chex Red Spirit -30 °C to 1 °C Each

240047 Temp-Chex Red Spirit -90 °C to 25 °C Each

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ESR

Test

ing

Con

trol

s

ESR Testing

ESR-Auto Plus®

ESR Vacuum Tubes

The ESR-Auto Plus® is a 10-position automated ESR analyzer.

Results are measured in millimeters per hour (Modified

Westergren Method) and are available in 30 minutes.

The instrument features:

■ Random access

■ Built-in printer

■ Sample ID capability

■ Barcode scanner

■ 15-minute prediction mode

The ESR-Auto Plus incorporates a quality control system for

monitoring the laboratory’s quality control program and data

can be downloaded to a Laboratory Information System.

Collect, transport and analyse the Erythrocyte Sedimentation

Rate (ESR) of whole blood in the clinical laboratory with ESR

tubes. The tubes are specifically designed for use with the

Streck ESR-10 Manual Racks

and ESR-Auto-Plus automated

sedimentation rate analysers.

Stable

ESR tubes preserve the integrity of the patient sample for up to 72 hours from the time of blood collection when transported and stored at 2-10C.

Convenient

Only 1.2ml of whole blood is required to analyse samples in the ESR-Auto Plus.

Safe

ESR tubes are a safe alternative to traditional ESR blood collection systems offering direct-draw blood collection that eliminates unnecessary exposure to patient samples. Patient samples may also be transfrerred from an EDTA blood collection tube into an ESR tube.

Reduces Risk

Safety-coated ESR-Vacuum Tubes are designed with an outer Mylar® coating that contains glass and blood specimen in the event of breakage, reducing the risk of injury and potential exposure to blood-borne pathogens.

Impact Resistant

An independent packaging consultant has reported that ESR-Vacuum Tubes are significantly more impact resistant than glass collection tubes, greatly reducing accidental breakage.

ESR Vacuum Tubes – Safety Coated

Safety Coated ESR-Vacuum Tube struck with metal rod

Crushed tube remains intact

A two-level control used to monitor erythrocyte sedimentation

rates. Manufactured from human red blood cells, ESR-Chex

verifies the precision and accuracy of manual and automated

methods.


■ Verifies the accuracy of both manual and automated methods

■ Available in two levels

■ Used in the same manner as patient samples


ESR-Chex

ESR-Auto Plus® and ESR-Vacuum TubesCatalogueNumber


240207 ESR-Auto Plus Instrument 1 unit

240362 ESR-Vacuum Tubes 1.2ml 12 x 100

240378 ESR-Vacuum Tubes 1.2ml, Safety Coated 12 x 100

Streck



Diesse Ves-Matic

Mini-Ves

3

3

Streck ESR-Auto 3

ESR-ChexCatalogueNumber


214102 ESR-Chex Level 1 & 2 2 x 9ml



Streck

ESR Vacuum Tubes – Safety Coated

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Ligh

t Tr

ansm

issi

on A

ggre

gom

etry

Per

form

ance

Ver

ifica

tion

The ISO 15189 document states that laboratories should have documentation on the calibration of equipment that directly or indirectly affects examination results (clause 5.3.1.4)

LTA-Check™ is a product that has been specifically designed to verify the performance of the PAP 8 and other Light Transmission Aggregometers, which are multi-channel instruments.

System FunctionalitySystem functionality is determined by the ability of a plasma and ristocetin to induce agglutination of a standardised platelet suspension.

The agglutination is defined by two parameters:

■ Aggregation

■ Slope (rate of reaction)

These results when generated on a regular basis may be used to evaluate the aggregation test system in the laboratory and will generate ongoing information on the functionality of the instrument test system.

Quality ControlRanges and limits for this quality control and system functionality can be documented by the laboratory and may be used to verify the functionality of the system on a “Channel to Channel” and a “Performance to Performance” basis.

Within Specifications?When tested on a periodic basis the specific lot combination of reagents will generate a mean and a deviation that is established by the laboratory. The deviation of a test of less than 10% from established ranges is expected. Deviations greater than 10% may represent problems with the instrument and corrective action is necessary.

■ Verify Aggregometer Function

■ Standardize Instrumentation

■ Ensure Precision and Reliability of Test Results

■ Document Reagent System

■ Comply with Laboratory Regulations

■ Identify & Reduce QC Variables

■ Assure Consistent Results Across Multiple Sites

Light Transmission Aggregometers (LTA) Quality Control

LTA-Check™

Performance Monitoring Test KitCatalogue Number


107117 LTA Check™ Kit 18 tests

BioData Corporation

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Flow

Cyt

omet

ry C

ontr

ols

CD-Chex Plus™ is a complete, positive procedure control

manufactured from normal human peripheral blood

leukocytes and erythrocytes.

The range has been extended to match the changing needs

of laboratories and now includes:

n CD-Chex Plus – Screw-Cap Vials

n CD-Chex Plus – Cap-Pierceable Vials

n CD-ChexPlus BC

Each range includes CD4 Low control which offers decreased

levels of CD4 positive cells (~ 200 cells/µl)



Benefits of CD-Chex Plus™:

CD-Chex Plus determines the accuracy and reproducibility

of all the steps involved in the process of the

immunophenotyping procedure including:

n Satisfies both CAP and CDC quality control requirements

n Provides two levels of CD4+ T-cells

n Verification of mAb reagents

n Validation of instrument performance

n Validation of operator technique

n Verification of red blood cell lysis

CD-Chex Plus™

CD-Chex Plus is supplied in a format that can be used on any

platform.

n Assayed for 26 of the most common lymphoid and myeloid CD markers

CD-Chex Plus™ – Screw-Cap Vials

CD-Chex Plus™ – Screw-Cap VialsCatalogue Number


213326 CD-Chex Plus 2 x 2.5ml

213331 CD-Chex Plus CD4 Low 2 x 2.5ml

213340 CD-Chex Plus CD4 Low, Normal 2 x 2.5ml



Streck

CD-Chex Plus in a new plastic vial with pierceable caps.

n Compatible with BD FACS™ Sample Prep Assistant


CD-Chex Plus™ – Cap-Pierceable Vials

CD-Chex Plus™ BC

Optimised for Beckman Coulter flow cytometers.

n Compatible with Coulter PrepPlus™ automated sample processing instruments


CD-Chex Plus™– Cap-Pierceable VialsCatalogue Number


213365 CD-Chex Plus 2 x 3ml

213366 CD-Chex Plus, CD4 Low 2 x 3ml

213391 CD-Chex Plus CD4 Low, Normal 2 x 3ml



Streck

CD-Chex Plus BC™Catalogue Number


213373 CD-Chex Plus BC 1 x 3ml

213374 CD-Chex Plus BC 2 x 3ml

213371 CD-Chex Plus BC CD4 Low 1 x 3ml

213372 CD-Chex Plus BC CD4 Low 2 x 3ml


Streck

Flow Cytometry Controls

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Flow

Cyt

omet

ry C

ontr

ols

A whole blood control

for enumerating CD34

positive cells by flow

cytometry.


n Compatible with both ISHAGE, Stem-Kit and ProCOUNT gating strategies

n Represents samples containing CD34 positive cells having characteristics similar to progenitor cells

n The product can be used with a variety of systems, reagents and Class III antibodies

CD-Chex CD34™ CD-Chex CD117™ Plus

Flow Cytometry Product Selector Guide

The quickest way to find the control is to simply select your instrument and then the product.

If you require additional help, please contact Alpha Laboratories.


Typical Assay Value Ranges:Level 1: 0.05% (3-5 cells/µl)

Level 2: 0.5% (30-50 cells/µl)

Level 3: 1.75% (90-150 cells/µl)

CD-Chex Select™

CD-Chex CD117™Plus eliminates the need for labs to hold

and validate patient samples to use as a control for CD117,

CD25 and CD71.

n Save lab time and money

n Compatible with BD Biosciences and Beckman Coulterflow cytometry systems

CD-Chex Select™, the first and only commercially available

control with selected group of CD Markers.

- Sample 1 provides % positive vales for CD26, CD41, CD57,

CD64, FMC7, TCR α/β, TCR γ/δ.

- Sample 2 provides % positive values for CD58, CD61,

intracellular CD79a and intracellular MPO.

n Assayed positive procedural control that can be handled like a patient sample.

n Established means and ranges provide the user confidence in instrument results

CD-Chex CD34™Catalogue Number

Description Level Pack Size

213336 CD-Chex CD34 1 1 x 1ml

213337 CD-Chex CD34 1 2 x 1ml

213346 CD-Chex CD34 2 1 x 1ml

213347 CD-Chex CD34 2 2 x 1ml

213382 CD-Chex CD34 3 1 x 1ml

213383 CD-Chex CD34 3 2 x 2ml

213338 CD-Chex CD34 1 & 2 2 x 1ml

213339 CD-Chex CD34 1 & 2 4 x 1ml

Streck

CD-Chex CD117™ PlusCatalogue Number


213557 CD-Chex CD117 1 x 1ml

213558 CD-Chex CD117 2 x 1ml

Streck

CD-Chex™ SelectCatalogue Number


213554 CD-Chex Select (Sample 1, Sample 2) 2 x 3ml

213555 CD-Chex Select (Sample 1, Sample 2) 4 x 3ml

Streck Sample 1 and 2 are not sold separately.

Instrument Control PageBD BiosciencesFACS Series CD-Chex Plus 19

CD-Chex Plus CD4 Low 19

CD-Chex CD34 20

CD-Chex CD117 20

CD-Chex Select 20

Instrument Control PageBeckman Coulter

EPICS XL CD-Chex Plus 19

CD-Chex Plus CD4 Low 19

CD-Chex CD34 20

CD-Chex Plus BC 19

CD-Chex Plus BC CD4 Low 19

CD-Chex Select 20

CD-Chex CD117 20

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Lupu

s A

ntic

oagu

lant

Tes

ting

Con

trol

s

vWF Abnormal Control Plasma

Intended to verify sensitivity and performance of vWF assay.

n Lyophilised, depleted human plasma

n Can be used on most optical systems

n 8-hour stability after reconstitution

Material Expected ValuesNormal Reference Plasma 90-100% activity

Abnormal Control Plasma Less than 45% activity

vWF Reference PlasmaCatalogue Number


101269 vWF Normal Reference Plasma 3 x 0.5ml

101270 vWF Abnormal Reference Plasma 3 x 0.5ml

BioData Corporation

Lupus Anticoagulant Testing

A weak positive LA control that challenges an assay’s

sensitivity to LA.

n Encourages confidence that weak LA positive patient samples will be accurately detected

n Plasma from donors confirmed to have circulating LA

n 8-hour stability once thawed

n Ready to use in minutes

CRYOcheck™ Lupus Positive Control

Intended for use as a positive control in assays for

lupus anticoagulants (LA).

n Plasma from donors with non-specific circulating anti-coagulants

n Platelet poor for consistent results

n Stable for 8 hours once thawed

frozenplasma

frozenplasma

CRYOcheck™ Weak Lupus Positive ControlCatalogue Number


CCWLP-05 Weak Lupus Plasma 25 x 0.5ml

CCWLP-10 Weak Lupus Plasma 25 x 1ml

Precision Biologic

CRYOcheck™ Lupus Positive ControlCatalogue Number


CCLP-05 Lupus Plasma 25 x 0.5ml

CCLP-10 Lupus Plasma 25 x 1ml

Precision Biologic

Precision Biologic has developed a reputation globally for its innovative and extensive CryoCheck™ range of frozen plasmas for calibration, controls and reagents. These are becoming increasingly important with the advent of ISO 15189 laboratory accreditation. Using commercially available controls and calibrators that are treated exactly as patient samples means better and more realistic quality control.

Control Plasma

CRYOcheck™ Weak Lupus Positive Control

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Fact

or D

efic

ient

Sub

stra

tes

Factor Deficient Substrate

CRYOcheck™ Factor Deficient Substrates

CRYOcheck™ Prekallikrein Deficient Substrate

Collected from:

n Congenital donor who has been assayed to have less than 1% activity for Prekallikrein

n 8 hour stability once thawed

frozenplasma

Manufactured from fresh frozen, 100% human plasma, no

bovine additives.

n Certified by antigenic and functional assays to have less than 1% activity

n All other coagulation factors are assayed within normal activity levels

n Assay certificate supplied with each lot number

n Ready to use in minutes


n Shelf life of 3 years from the date of manufacture

Lyophilised Factor Deficient Plasma

Prepared from immunodepleted human plasma.

n Contains <1% of the deficient factor

n Stable for 1 hour at 37C after reconstitution

n Maximum shelf life, from date of manufacture, is 3 years

CRYOcheck™ Factor Deficient Substrates Catalogue Number


FDP2-10 Factor 2 Deficient Plasma 25 x 1ml








Precision Biologic

Lyophilised Factor Deficient PlasmaCatalogue Number


P5000-010 Factor 2 Deficient Plasma 1 x 1ml








TECO Medical

CRYOcheck™ Prekallikrein Deficient Substrate Catalogue Number


FDPK-10 Prekallikrein Deficient Plasma 10 x 1ml

Precision Biologic

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Refe

renc

e Pl

asm

a

Plasma for the calibration of quantitative haemostasis assays.

n Assayed for over 20 fibrinolytic and coagulation parameters against international reference standards

n No reconstitution is required so confidence is assured

n Product stable for 8 hours after thawing

n Assay certificate supplied with each lot

CRYOcheck™ Normal Reference Plasma

Reference Plasma

Plasma for controlling the accuracy of quantitative

assays in the borderline and pathological range.

n Donor-pool adjusted to provide a borderline abnormal control and a pathological abnormal control




CRYOcheck™ Abnormal Reference Control

Plasma for controlling the accuracy of quantitative haemostasis

assays in the normal range.




CRYOcheck™ Reference Control Normal

frozenplasma

frozenplasma

frozenplasma

CRYOcheck™ Normal Reference Plasma Catalogue Number


CCNRP-10 Normal Reference Plasma 25 x 1.0ml

CCNRP-05 Normal Reference Plasma 25 x 0.5ml

Precision Biologic

CRYOcheck™ Reference Control NormalCatalogue Number


RCN-10 Reference Control Normal 25 x 1.0ml

Precision Biologic

CRYOcheck™ Abnormal Reference Plasma Catalogue Number


ARPI-10 Abnormal 1 Reference Control 25 x 1.0ml

ARPII-10 Abnormal 2 Reference Control 25 x 1.0ml

Precision Biologic

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Con

trol

Pla

sma

Normal control for the one-stage Prothrombin Time

(PT), Activated Partial Thromboplastin Time (APTT), and

Fibrinogen.

n Designed for use in mixing studies

n Pool of 20 or more carefully screened donors who are a mixture of males and females aged 18 to 66

n An alternative to in-house collected normal plasma pools

n Platelet-poor (<10,000 Platelets/µl)

n 24 hours stability once thawed

CRYOcheck™ Pooled Normal Plasma

Abnormal control for the one-stage Prothrombin Time (PT)

and Activated Partial Thromboplastin Time (APTT).

n Pool of 20 healthy donors treated to contain reduced levels of clotting factors 2, 7, 9 and 10

n 24 hours stability once thawed

n Available in two levels designed to suit varying control procedures

CRYOcheck™ Abnormal Controls

Control Plasma

Intended for use as controls to monitor the performance of

routine coagulation assays.

n 8 hours stability at room ambient temperature

n TEControl N is formulated to have PT, APTT, and Fibrinogen values in the normal range

n TEControl A and TEControl A Plus have been adjusted to have prolonged PT & APTT

n Actual values recovered depend on the instrument and reagent used

TEControl Coagulation Control Plasma

frozenplasma

frozenplasma

CRYOcheck™ Pooled Normal Plasma Catalogue Number


CCN-10 Pooled Normal Plasma 80 x 1.0ml



Precision Biologic

CRYOcheck™ Abnormal Controls Catalogue Number


CCA1-10 Abnormal 1 Control 80 x 1.0ml

CCA2-10 Abnormal 2 Control 80 x 1.0ml

Precision Biologic

Coagulation Control PlasmaCatalogue Number


P6001-010 TEControl N 10 x 1.0ml

P6101-010 TEControl A 10 x 1.0ml

P6200-010 TEControl A Plus 10 x 1.0ml

TECO Medical

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Con

trol

Pla

sma

Recommended for use as an abnormal control in

quantitative fibrinogen assays.

n Assayed by Clauss Fibrinogen method

n Stable for 72 hours once thawed

n Modified to exhibit hypofibrinogenemic characteristics

CRYOcheck™ Low Fibrinogen Control

A positive control for clot-based assays for

activated Protein C resistance.

n Collected from donors tested positive for factor VLeiden by PCR not on oral anticoagulant therapy


n Used to supplement or replace in-house controls

CRYOcheck™ APCR Positive Control

Frozen Control Plasma Range - No Reconstitution Errors

frozenplasma

frozenplasma

CRYOcheck™ Low Fibrinogen ControlCatalogue Number


CCLF-80 Low Fibrinogen Control 80 x 1ml

Precision Biologic

CRYOcheck™ APCR Positive Control Catalogue Number


APCR-05 APCR Positive Control 25 x 0.5ml

Precision Biologic

30 individual vials containing human plasma with distinct Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and fibrinogen profiles spanning the normal and pathological range.

n Donors are screened negative for Lupus Anticoagulants

n Source plasmas are screened negative for all FDA-required tests

CRYOcheck™ CorPac™

frozenplasma

CRYOcheck™ CorPac™Catalogue Number


CCCP-15 CorPac™ 30 x 1.5ml

Precision Biologic

CRYOcheck™ Normal Donor Set

Manufactured from screened donors and supplied in sets of 25 representative individuals.

n Sets of 25 different donors, 1.0ml aliquots

n Mix of male and female donors who are non-medicated and taking no oral contraceptives

n Platelet-poor and therefore usable in phospholipid-dependent assays

CRYOcheck™ Normal Donor SetCatalogue Number


CCNS-10 Normal Donor Set 25 x 1.0ml

Precision Biologic

frozenplasma

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Bloo

d G

roup

ing

Con

trol

Rea

gent

s

This comprehensive set provides ultimate

control. It gives extra confidence in the correct

functioning of your automated blood grouping

system and its sensitivity to detect clinically

significant antibodies.

n Four different group format vials cover ABO and Rh/K antigens, plus anti-D and anti-Kell antibodies

n Supplied in 6ml vials of 15% RBC suspension

n Manufactured on a 4 weekly cycle – subscription product

bestseller

Blood Grouping Control Reagents

Simulated whole blood controls for automated

grouping systems.

These consistent and affordable simulated whole

blood controls from the ALBAcheck® range

offer ABO and Rh testing for both donors and

patients.

n Twice the stability of standard controls -14 day open vial: Less wastage

n 15% cell suspension for greater volume of useable sera: More tests for your money

n Two of each 6ml vials are supplied: Just one kit needed per month

n Meets the BCSH and transfusion guidelines

n Available on a 4 week cycle for continuity of supply

ALBAcheck®-DUO

Vial Phenotype Antibody

Vial 1 Group A2B rr (ccdee) Anti-D (0.1 IU/ml)

Vial 2 Group O R1R1 (CCDee) Anti-A, Anti-B &

Anti-c

ALBAcheck®-DUOCatalogue Number


Z483 ALBAcheck-DUO Whole Blood Control 4 x 6ml

Quotient

ALBAcheck®-BGS Whole Blood Controls

Vial Phenotype Antibody

Vial 1 Group A R1R1, K Pos Anti-B

Vial 2 Group B R1R2, K Neg Anti-A and Anti-K

Vial 3 Group O R2R2, K Neg Anti-A and Anti-B

Vial 4 Group AB rr, K Neg Anti-D

ALBAcheck®-BGSCatalogue Number


Z489 ALBAcheck-BGS Whole Blood SP control 4 x 6ml

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ALBAcheck®-BGS High Titre Controls Kit

Intended for use as an internal, self assessment QA scheme.

It assesses the ability of an individual and/or the capability of

a method for detecting weak antibodies.

n Kit consists of: l 10 randomly selected serum samples l Results available ‘on-line’ – please enquire

n Ready to use, store at 2-8 C

n Closed vial stability: 1 year

n Validated for use in column technology and tube systems

For the control of high titre anti-A and anti-B testing of

blood donations. The kit provides a positive and negative

control (2 vials each), which should be tested in the same

way as the donation test samples.

In accordance with the Guidelines for Blood Transfusion

Services in the United Kingdom 7th Edition, the positive

control has a potency of greater than 1/128 and the

negative control less than 1/128.

n Unique product

n Open-vial stability: 2 weeks

Specially formulated weak sensitivity controls, designed to

stress testing platforms.

n Validated for use in column technologies

n Derived from a pool of donations

n Polyclonal material which presents as a normal weak sample

n Different specificities demonstrates ability to detect a range of weak antibodies

Sensitivity ControlsALBAcheck® -BGS Competency Test Kit

ALBAcheck®-BGS Competency Test KitCatalogue Number


Z276 ALBAcheck-BGS Competency Test Kit 10 x 2ml

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ALBAcheck®-BGS High Titre Controls KitCatalogue Number


Z257 ALBAcheck-BGS High Titre Controls Kit 4 x 6ml

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Sensitivity ControlsCatalogue Number


Z251 Anti-D 0.3iu/ml 10 x 10ml

Z252 ALBAcheck-BGS Anti-c (weak) 3 x 5ml

Z253 ALBAcheck-BGS Anti Fya (weak) 3 x 5ml

Z262 Anti-D Control 0.1 iu/ml Anti-D 3 x 5ml

Z263 Anti-D Control 0.05 iu/ml Anti-D 3 x 5ml

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A range of control reagents, which enables the user to

validate and control testing on an individual or batch basis.

Other Control Reagents

Other Control ReagentsCatalogue Number


Z256 Enzyme Control 10 x 10ml

Z271 Reagent Control for Anti-D (Use with Z031, Z036, Z039, Z041)

10 x 10ml

Z281 AB Serum (human) 10 x 5ml

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Reagent Red Cells

ALBAcyte® 2-3% Control Cells

2-3% Red Cell Panels for conventional manual tube and

microplate testing. All ALBAcyte® red cell reagents comply

with UK BTS Guidelines.

n For both conventional tube and microplate testing

n Panels manufactured from pre-selected donors to provide consistent quality

n Comply with UK BTS Guidelines

n Available on 4-weekly subscription order to ensure 28-day shelf life on receipt

ALBAcyte® 2-3% Control CellsCatalogue Number

Description Pack Size Recommended Use

Z401 A1 Cells 10ml Reverse grouping controls

Z406 A2 Cells 10ml Controls

Z411 B Cells 10ml Reverse grouping controls

Z416 O R1r Cells 10ml Controls

Z421 Orr Cells 10ml Controls

Z427 DVI Cells 5ml Controls

Z441 IgG Sensitised Cells 10ml Confirmation and controls

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At Alpha Laboratories we are proud to have achieved the international environmental management standard certification BS EN ISO 14001 : 2004. The standard provides a straight-forward approach to using less energy resource and reducing waste.

But we go beyond that, building into our business ways to help you and your laboratory become greener too...

■ Fastrak® - the most eco-friendly tip refill system

■ Laboratree tree planting programme - regenerating UK woodlands

■ Free plastic recycling scheme

Find out more at our website

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Pipette Servicingand Calibration

Regular service and calibration will ensure that the precision and accuracy of pipettes are

maintained and your laboratory’s results are not compromised. Through our experienced

calibration partner, we offer a full range of service options for all popular pipettes and dispensers

either at your own site or at our UKAS-accreditated calibration laboratory.

Workshop ServiceSend your pipettes into our workshop where qualified technicians will perform the service and calibration in a purpose-built, environmentally controlled area.

On-site ServiceOur technicians will bring their equipment to you and perform an on-site pipette clinic. This is ideally suited to larger quantities of pipettes and can be set up as a one-off visit or on a regular scheduled basis.

Service Levels

QUIKCHECKA quick and simple performance check

for when extensive measurements and

calibration are not required.

4 readings are taken at a single volume.

Every channel is checked across multichannel pipettes.

An ISO calibration certificate is included.

QUIKCHECK

UKASCalAccreditation by UKAS gives you the

confidence of full pipette calibration

traceability. 10 readings are taken at

each of the min/mid/max volumes and

a full UKAS certificate is issued.

UKAScalibration

FULLCHECKThis service includes cleaning, servicing

and a full range performance check

with 6 readings taken at the min/mid/

max volumes for complete linearity

assessment.

An ISO calibration certificate is supplied.

FULLCHECK

FixCheckThis service is for pipettes that are

no longer performing within the

manufacturer’s tolerances or are

damaged. It includes dismantling,

cleaning, servicing and a full range performance check.

An ISO calibration certificate is supplied.

This service is not available at on-site clinics.

FIXCHECK

For further information and a price guide, visit www.alphalabs.co.uk/pipette-service or call us on

0800 387 732 for a customised quotation.

Calibrations are carried out to DIN12650, ISO17025 and UKAS accreditation levels.

For all service levels, spare parts are detailed and charged separately.

Enjoy Your Work!Pipetting Academy™ for Better Ergonomics

Improve Your Liquid Handling Skills with Free Pipetting Academy™Seminars

n Get practical training on pipetting techniques to help you achieve more accurate and precise results.n Understand how to minimise the ergonomic risks of pipetting by choosing appropriate working postures, liquid handling instruments and accessoriesn Learn how to avoid strain injuries and make work more enjoyable.

Contact us or find out more at www.alphalabs.co.uk

Pipetting is the most common laboratory technique, yet it is frequently overlooked when it comes to user training.

A pipette’s performance is heavily dependent on the skill and expertise of the operator so incorrect handling can compromise the quality of results and cause repetitive strain injuries.

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Alpha Laboratories Limited40 Parham DriveEastleigh, HampshireSO50 4NU United Kingdom

Tel: 023 8048 3000Fax: 023 8064 3701Email: [email protected]: www.alphalabs.co.uk

Customer Account Number

ISO 9001Registered

QualityManagement 015

ISO 14001Registered

EnvironmentalManagement 015

Documents

ISO 15189 Made Easier