PRODUCTS AND SERVICES TO SUPPORT YOUR ISO 15189 ACCREDITATION Controls Calibrators Reference Plasmas Training & Support
Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk 1 2 Medical Laboratory Accreditation Both NHS and private practices rely heavily on the quality of the diagnostic testing provided by medical laboratory services and pathology laboratories. The updated ISO 15189 standard brings a modern approach to Quality Control making it even easier for laboratories to implement. Laboratories are responsible for delivering hundreds of throusands of tests every day in support of the nation’s health services. From blood tests to biopsies covering diagnosis or the ability to monitor treatment progress, medical labs provide the vital test results that inform treatment decisions and health outcomes. Thus the provision of accurate and consistent examination, result validation and authorisation interpretation and reporting is essential for many patient pathways. ISO/IEC 15189 is a globally recognised standard that specifies the requirements for quality and competence particular to medical laboratories. It is for use by medical laboratories in developing their quality management systems and assessing their competence. The standard focuses on the continuum of care directly connected with improved patient safety, risk mitigation and operational efficiency, specifically in medical laboratories. ISO 15189 accreditation underpins confidence in the quality of medical laboratories through a process that verifies their integrity, impartiality and competence. Assessments under UKAS accreditation ensure labs meet the relevant requirements including the operation of a quality management system and the ability to demonstrate that specific activities are performed within the criteria set out in the relevant standard. Working to 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. If your laboratory is working to ISO 15189 accreditation standards 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/s Streck Cellular Controls Follow the Patient Pathway Streck and STATS® QC Programme 3-4 Flow Cytometry Controls 5 Haematology Controls 7 - Point of Care Controls 13 - Reticulocytes Controls 14 - Tests & Controls for Sickle Cell Screening 16 Controls for ESR Testing 17 Haematology Calibrators 18 Precision Biologic Frozen Plasma Products Improve Quality Haemostasis Controls 19 - Control/Reference Plasma 20 - Lupus Anticoagulation Testing 23 - vWF Reference Plasma 24 - Factor Deficient Substrate 24 - Light Transmission Aggregometers (LTA) Quality Control 25 Blood Grouping Controls 26 Body Fluid Controls 27 Clinical Chemistry Controls 28 Temperature Control Monitoring 35 Alpha Lab Service 36
Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier email order sales@alphalabs.co.uk freefax order 0800 614249 4 Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk 3 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 Streck STATS ® Programme 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. ■ Flow cytometry controls ■ Haematology controls ■ Cellular urine control for automated microscopy Cellular Controls Follow the Patient Pathway
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 5 6 Flow Cytometry Controls Flow Cytometry Controls CD-Chex Plus® is a complete, positive procedure control manufactured from normal human peripheral blood leukocytes and erythrocytes. The CD-Chex Plus® range includes CD4 Low control which offers decreased levels of CD4 positive cells (~ 200 cells/µl) 30-day open-vial stability and 90-day closed-vial stability Free participation in STATS® 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: Satisfies both CAP and CDC quality control requirements Provides two levels of CD4+ T-cells Verification of mAb reagents Validation of instrument performance Validation of operator technique Verification of red blood cell lysis CD-Chex Plus® CD-Chex Plus in a new plastic vial with pierceable caps. Compatible with BD FACS™ Sample Prep Assistant Assayed for 30 CD markers and parameters CD-Chex Plus® – Cap-Pierceable Vials CD-Chex Plus® – Cap-Pierceable Vials Product Code Description Pack Size 213323 CD-Chex Plus 1 x 3ml 213365 CD-Chex Plus 2 x 3ml 213367 CD-Chex Plus 5x 3ml 213324 CD-Chex Plus, CD4 Low 1 x 3ml 213366 CD-Chex Plus, CD4 Low 2 x 3ml 213368 CD-Chex Plus, CD4 Low 5 x 3ml 213391 CD-Chex Plus CD4 Low, Normal 2 x 3ml 213369 CD-Chex Plus CD4 Low, Normal 4 x 3ml 213370 CD-Chex Plus CD4 Low, Normal 10 x 3ml Streck Flow Cytometry Controls A whole blood control for enumerating CD34 positive cells by flow cytometry. 30-day open-vial stability and 90-day closed-vial stability Compatible with Stem-Kit and ProCOUNT enumeration kits and systems using the ISHAGE protocols Represents samples containing CD34 positive cells having characteristics similar to progenitor cells Offered in three levels CD-Chex CD34® CD-Chex CD117® Plus 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 CD117® Plus eliminates the need for labs to hold and validate patient samples to use as a control for CD117, CD25 and CD71. Save lab time and money Compatible with BD Biosciences and Beckman Coulterflow cytometry systems CD-Chex CD34® Product Code Description Level Pack Size 213337 CD-Chex CD34 1 2 x 1ml 213347 CD-Chex CD34 2 2 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® Plus Product Code Description Pack Size 213557 CD-Chex CD117 1 x 1ml 213558 CD-Chex CD117 2 x 1ml Streck Positive Procedural Control for Immunophenotyping CD-Chex Plus® BC is a positive procedural control for monitoring immunophenotyping by flow cytometry. It provides the most assayed CD markers in the industry on a single control, including those on the HIV panel of markers recommended by the CDC and a normal level of CD34+ cells. CD-Chex Plus BC is manufactured from normal human peripheral blood leukocytes and erythrocytes. Available in two clinically relevant levels of CD4+ cells. CD-Chex Plus® BC CD-Chex Plus® BC Product Code Description Pack Size 213372 CD-Chex Plus BC - CD4-L 2 x 3ml 213374 CD-Chex Plus BC - Normal WBC 2 x 3ml 213375 CD-Chex Plus BC - Normal WBC + CD4-L 4 x 3ml Streck CD-Chex CD103® Plus CD-Chex CD103™ Plus is a positive procedural control that includes CD103, CD30, CD38, CD56, CD138 and cytoplasmic Lambda. The product possesses surface antigens and intracellular antigens detectable with fluorescent monoclonal antibodies by flow cytometry. Suitable for BD Biosciences and Beckman Coulter® flow cytometry systems. CD-Chex CD103® Plus Product Code Description Pack Size 213567 CD-Chex CD103 1 x 1ml 213568 CD-Chex CD103 2 x 1ml Streck CD-Chex TdT Plus is the only commercially available flow cytometry control assayed for TdT, CD1a, CD34 and cCD3 in a single control. The assay provides percent positive values for each assayed marker on abnormal leukocytes. CD-Chex TdT Plus can be used as quality control material for evaluating intracellular and surface antigens including CD1a, CD2, CD4, CD5, CD7, CD8, CD34, cytoplasmic CD3 and nuclear TdT (Terminal deoxynucleotidyl transferase). When stained with fluorescent antibodies and analysed by flow cytometry, CD-Chex TdT Plus provides reference values for abnormal cells often found in certain types of hematopoietic neoplasms. CD-Chex TdT Plus® CD-Chex TdT Plus® Product Code Description Pack Size 213565 CD-Chex TdT Plus 1 x 1ml 213566 CD-Chex TdT Plus 2 x 1ml Streck
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 7 8 Haematology Product Selector 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 … Brand and product names of the instruments are trademarks of their respective holders. Instrument Control Page Calibrator Page Reticulocytes Page Abbott Laboratories CELL-DYN 1400 Para 12 Extend 12 CELL-DYN 1600, 1700 Para 12 Extend 12 CELL-DYN 1800 Para 12 Extend CVA for CELL-DYN 12 9 Cal-Chex 18 CELL-DYN 3200 Para 12 Plus CVA for CELL-DYN 11 9 Cal-Chex A Plus 18 CELL-DYN 3500, 3700 Para 12 Plus CVA for CELL-DYN 11 9 Cal-Chex A Plus 18 Retic-Chex II 14 CELL-DYN Sapphire CVA for CELL-DYN 9 CELL-DYN Ruby Cell-Chex Auto CVA for CELL-DYN Para 12 Plus 9 9 11 Cal-Chex A Plus 18 CELL-DYN Emerald CVA for CELL-DYN 9 Horiba Medical ABX Micros 60 Para 12 Extend CVA 12 9 Cal-Chex 18 Beckman Coulter AcT™ series, inc. diff and diff 2 Para 12 Extend 12 Cal-Chex 18 AcT™ diff 5 CVA 9 DxH® 690T StaK-Chex Plus Retics 14 LH500 StaK-Chex Plus Retics CVA 14 9 Retic-Chex II 14 LH750/LH755/LH780/LH785 StaK-Chex Plus Retics CVA Cell-Chex Auto 14 9 9 Cal-Chex 18 Instrument Control Page Calibrator Page Reticulocytes Page HmX. StaK-Chex Plus Retics CVA 14 9 Cal-Chex 18 Retic-Chex II 14 DxH™ 600/800 StaK-Chex Plus Retics CVA Cell-Chex Auto 14 9 9 Cal-Chex 18 HTI MicroCC-20 Plus Para 12 Extend 12 MicroCC-25 Plus Para 12 Plus 11 HemoCue Inc. Hb201+ HQ-Chex Para 4 CVA 10 12 9 Glucose 201 HQ-Chex 13 Siemens Healthcare Diagnostics ADVIA® 60 Para 12 Extend 12 Cal-Chex 18 ADVIA® 120/2120/2120i Cell-Chex Auto 9 Sysmex XE-2100, XE-5000 Cell-Chex Auto 9 Retic-Chex Linearity 15 XT-1800i, XT-2000i, XT-4000i Cell-Chex Auto 9 Retic-Chex Linearity 15 XN-10, XN-20 Retic-Chex Linearity 15 Other Analysers EKF Diagnostics Haemata STAT II Para 4 12 ERMA PCE-210 Para 12 Extend 12 Mindray BC-3200, 3600 Para 12 Extend 12 Nihon Kohden Celltac α MEK-6400 Series /MEK-6500 Para 12 Extend 12 Diatron Abacus Jr Para 12 Extend 12 ESR Systems Diesse Ves-Matic 10/20/30/60/Easy ESR-Chex 17 Diesse Mini-Ves ESR-Chex 17 Streck ESR-Auto Plus, ESR-8, ESR-100 ESR-Chex 17 Polymedco Sedimat 60 ESR-Chex 17 Vital Diagnostics Excyte 10 ESR-Chex 17 I use a…. I am looking for a … Haematology Product Selector CD-Chex Select® 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. Assayed positive procedural control that can be handled like a patient sample. Established means and ranges provide the user confidence in instrument results CD-Chex Select® Product Code Description Pack Size 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.
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 9 10 Haematology Controls The first automated body fluid cell count control, designed to provide confidence that instrument counts are accurate. ■ 30-day open-vial stability and 75-day closed-vial stability ■ 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 3200, Sapphire and Ruby Beckman Coulter LH750/755/780/785 DxH™ 800 Sysmex XE-2100, XE-5000, XT-1800i, XT-2000i, XT-4000i Siemens Helathcare Diagnostics ADVIA® 120/2120/2120i Cell-Chex ® Auto Product Code Description Pack Size 200066 Cell-Chex Auto Level 1, 2 & 3 3 x 3ml 200065 Cell-Chex Auto Level 2 & 3 2 x 3ml 200067 Cell-Chex Auto Level 1 3 x 3ml 200068 Cell-Chex Auto Level 2 3 x 3ml 200069 Cell-Chex Auto Level 3 3 x 3ml Streck Haematology Controls Cell-Chex® is a body fluid procedural control for red blood cell (RBC) and white blood cell (WBC) counts, crystal identification, and white blood cell differentiation. Cell-Chex is a spinal and body fluid control with distinct white blood cell and red blood cell populations for manual counts. The control is available with three vial options, Level 1 with urate crystals, Level 1 with CPPD crystals and Level 2 with higher cell counts and no crystals. Cell-Chex® Product Code Description Pack Size 212420 Cell-Chex L1-UC, L2 4 x 2ml 212424 Cell-Chex L2 6 x 2ml 212429 Cell-Chex L1-CC 2 x 2ml 212430 Cell-Chex L1-CC 6 x 2ml 212431 Cell-Chex L1-UC, L1-CC, L2 3 x 2ml 212432 Cell-Chex L1-UC 6 x 2ml Streck Cell-Chex® 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. ■ 5-day open-vial stability and 120-day closed-vial stability ■ 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 ■ Free participation in STATS® CVA/CVA for CELL-DYN® Product Selection Guide Manufacturer Instrument Compatible Abbott CELL-DYN 1800 or lower CELL-DYN 3200 or higher Horiba Medical ABX Micros 60 Beckman Coulter LH500, DxH™ 800, HmX LH500/750/780/785 CVA/CVA for CELL-DYN® Product Code Description Pack Size 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 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. Ready to use liquid control Open-vial stability of 30 days 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® Product Code Description Pack Size 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. Ready to use liquid control Open-vial stability of 7 days Closed-vial stability of 105 days A1c Cellular® Linearity Control Product Code Description Pack Size 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: ■ Abbott ARCHITECT® c Systems ■ 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, G8A Assay Mean Level 1 4 - 7% HbA1c 20 - 53 mmol/mol Level 2 9 - 13% HbA1c 75 - 119 mmol/mol Typical ranges for A1c-Cellular Linearity Level 1 2% - 4% Level 2 6% - 9% Level 3 10% - 13% Level 4 14% - 17% Level 5 18% - 21% HbA1c Controls
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 11 12 Haematology Controls Haematology Controls A five-part whole blood differential control for the Abbott CELL-DYN 3200, 3500 and 3700. 7-day open-vial stability and 75-day closed-vial stability Packaged in a 3ml vials pierceable caps and bar-coded labels Assay file available for download Also provides 3-part differential for CELL-DYN 1600 & 1700 Stable and reproducible scattergrams assist detection of malfunctions including laser Free participation in STATS® Para 12® Plus Para 12® Plus Product Code Description Pack Size 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 Product Selection Guide Manufacturer Instrument Compatible Abbott CELL-DYN 3200, 3500 and 3700 First-of-its-kind quality control designed to meet the standards for verifying the entire analytical process of BioFire BCID2 sepsis assays from sample lysis to result reporting. Simultaneously tests a single positive blood culture sample to giving results for 33 different organisms and organism groups that cause bloodstream infections and 10 antimicrobial resistance genes – one of the largest testing panels currently on the market. Storage conditions - 2 C to 25 C ■ Cost savings – only uses 2 BioFire BCID2 panel pouches to deliver complete target coverage ■ Allows for continued verification to ensure accurate Rapid Multiplex PCR–Based Blood Culture Identification for sepsis ■ Quality control for BioFire® FilmArray 2.0® and FilmArray® Torch systems MDx-Chex for BCID2 MDx-Chex for BCID2 Product Code Description Pack Size 250065 MDx-Chex™ for BCID2 Quality Control 2 x 1ml Streck A three-part differential control with distinct populations of lymphocytes, mononuclear cells, and granulocytes, but with extended stability suitable for the smaller laboratory. 30-day open-vial stability and 190-day closed-vial stability Available in a 2.5ml vial or a 4.5ml pierceable cap vial Pierceable cap suitable for instruments with single closed-vial sampling or continuous closed-vial auto-sampling capability Varying levels of lymphocytes, mononuclear cells, and granulocytes available at low, normal and high levels Free participation in STATS® Para 12® Extend Product Selection Guide Manufacturer Instrument Compatible Abbott CELL-DYN 1400, 1600, 1700, and 1800 Horiba Medical ABX Micros 60 Beckman Coulter Ac•T/Ac•T diff/Ac•T diff2 Siemens Advia 60 Para 12® Extend Product Code Description Pack Size 218750 Para 12 Extend Tri-level 18 x 2.5ml 218770 Para 12 Extend Tri-level 18 x 4.5ml 218758 Para 12 Extend Normal 6 x 2.5ml Streck The perfect partnership for your Sickle Cell testing SICKLEDEX® Solubility Kits Sickle-Chex® Whole Blood Control see page 16 for more details
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 13 14 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. ■ 14-day open-vial stability and 110-day closed-vial stability ■ Available in glass or plastic squeeze dropper vials ■ Assay parameters are Hgb, WBC, RBC, Hct and platelets ■ Free participation in STATS® Para 4® Product Selection Guide Manufacturer Instrument Compatible HemoCue® Inc. B-Haemoglobin Photometer Hb 201+ Para 4® Product Code Description Pack Size 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 Vials Product Code Description Pack Size 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 A whole blood glucose and haemoglobin control to evaluate the accuracy and precision of point of care instruments. ■ 30-day open-vial stability and 180-day closed-vial stability ■ Available in three clinically significant levels ■ Package in convenient plastic squeeze dropper vials ■ Specially formulated for HemoCue® analysers ■ Free participation in STATS® HQ-Chex Product Selection Guide Manufacturer Instrument Compatible HemoCue, Inc. B-Hemoglobin Photometer Hb 201+ Analyzer Glucose 201 Analyzer HQ-Chex Product Code Description Pack Size 232753 HQ-Chex Level 1 6 x 2.5ml 232754 HQ-Chex Level 2 6 x 2.5ml 232755 HQ-Chex Level 3 6 x 2.5ml 232756 HQ-Chex Level 1, 2 & 3 6 x 2.5ml Streck Point of Care Controls Point of Care Controls A five-part differential control with values for all parameters, including reticulocytes and nucleated red blood cells. ■ 14-day open-vial stability and 105-day closed-vial stability ■ 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 ■ Free participation in STATS® ■ Assayed for LH500, LH750/755, LH780/785, HmX and DxH™800 STaK-Chex® Plus Retics Typical assay range for STaK-Chex® Plus Retics WBC (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 Product Selection Guide Manufacturer Instrument Compatible Beckman Coulter STKS™ MAXM™ HmX DxH™800 LH500 LH750/755/780/785 STaK-Chex® Plus Retics Product Code Description Pack Size 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 Streck 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. ■ 14-day open-vial stability and 75-day closed-vial stability ■ Available in plastic squeeze dropper vials ■ Can be used for manual & automated methods ■ Free participation in STATS® Retic-Chex® II Product Selection Guide Manufacturer Instrument Compatible Abbott CELL-DYN 3500 and 3700 Beckman Coulter STKS, MAXM, HMX and LH500 Manual Methods Miller Ocular Two Slide Retic-Chex® II Product Code Description Pack Size 285106 Retic-Chex II Tri-Level (plastic) 6 x 1ml 285104 Retic-Chex II Level 1 (plastic) 4 x 1ml 285204 Retic-Chex II Level 2 (plastic) 4 x 1ml 285304 Retic-Chex II Level 3 (plastic) 4 x 1ml Streck Reticulocytes Controls Reticulocytes Controls
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 15 16 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 Product Selection Guide Manufacturer Instrument Compatible Beckman Coulter STKS™, MAXM™, HmX, GEN•S, DxH™800, LH 500, LH750/755 and LH780/785 Sysmex XE-2100™, XE-5000™, XT-2000i™, XT4000i™, XN-10 and XN-20 Retic-Chex® Linearity Product Code Description Pack Size 285532 Retic-Chex Linearity for Sysmex 5 x 2.5ml 285535 Retic-Chex Linearity for Beckman Coulter 5 x 3ml Streck 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. STATS ILQC Programme See page 4 for more information Reticulocytes Controls 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® Product Code Description Pack Size 217661 SICKLEDEX qualitative Solubility Test Kit 12 tests 217660 SICKLEDEX qualitative Solubility Test Kit 50 tests 217657 SICKLEDEX qualitative Solubility Test Kit 100 tests 217659 SICKLEDEX Test Rack Each Streck Sickle-Chex® Product Code Description Pack Size 217653 Sickle-Chex Positive and Negative Controls 2 x 2.5ml 217654 Sickle-Chex Positive and Negative Controls 4 x 2.5ml Streck Sickle-Chex® Tests and Controls for Sickle Cell Screening
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 17 18 Controls for ESR Testing Controls for ESR Testing ESR Vacuum Tubes These 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 2-10 C. 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. ■ 95-day open-vial stability and 365-day closed-vial stability ■ Verifies the accuracy of both manual and automated methods ■ Available in two levels ■ Used in the same manner as patient samples ■ Free participation in STATS® ESR-Chex Product Selection Guide Manufacturer Instrument Compatible Diesse Ves-Matic Mini-Ves Streck ESR-Auto ESR-Chex Product Code Description Pack Size 214104 ESR-Chex Level 1 & 2 4 x 9ml 214108 ESR-Chex Level 1 & 2 8 x 9ml 214112 ESR-Chex Level 1 & 2 12 x 9ml 240408 ESR-Chex Plus Level 1 & 2 12 x 3ml Streck ESR-10 Manual Rack Catalogue Number Description Pack Size 240321 ESR-10 Manual Rack Each Streck ESR-10 Manual Rack The ESR-10 Manual Rack is a 10-position manual Modified Westergren system used for determining the Erythrocyte Sedimentation Rate (ESR) of whole blood in 30 minutes using 1.2ml Streck ESR-Vacuum Tubes. The ESR-10 Manual Rack exhibits >96% correlation to Modified Westergren method. ESR-10 Manual Rack features a closed blood collection system and is a non-automated (CLIA waived) testing procedure. ESR-Vacuum Tubes Catalogue Number Description Pack Size 240362 ESR-Vacuum Tubes 1.2ml 12 x 100 240378 ESR-Vacuum Tubes 1.2ml, Safety Coated 12 x 100 240364 ESR-Vacuum Tubes 2.0ml 12 x 100 Streck 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. ■ 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 Plus Product Selection Guide Manufacturer Instrument Compatible Abbott CELL-DYN 1400, 1600, 1700, 1800 Horiba Medical ABX Micros 60 Beckman Coulter Ac•T series (exl 5 diff) LH500/LH750/LH755/LH780/LH785 STKS, MAXM, HMX DxH™800 Siemens Helathcare Diagnostics ADVIA® 60 Cal-Chex Product Code Description Pack Size 221101 Cal-Chex 1 x 3ml 221103 Cal-Chex 3 x 3ml Streck Product Selection Guide Manufacturer Instrument Compatible Abbott CELL-DYN Sapphire, Ruby CELL-DYN 3200, 3500/3700 Cal-Chex A Plus Product Code Description Pack Size 221106 Cal-Chex A Plus 1 x 3ml 221107 Cal-Chex A Plus 2 x 3ml Streck Haematology Calibrators Haematology Calibrators
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 19 20 CRYOcheck™Lupus Negative Control CRYOcheck™ Lupus Negative Control is prepared from human source plasma and is recommended as a negative control in assays for lupus anticoagulant. For in vitro diagnostic use. It contains citrated human plasma collected from donors that have tested negative in accordance with the revised criteria of the SSC Subcommittee for the Standardisation of Lupus Anticoagulants. ■ 8-hour stability once thawed if refrigerated at 2 C to 8 C in the original capped vial ■ Source plasmas are screened negative for all FDArequired tests CRYOcheck™ Lupus Negative Control Product Code Description Pack Size CCLN-05 Lupus Negative Control 25 x 0.5ml CCLN-10 Lupus Negative Control 25 x 1ml Precision Biologic Control/Reference Plasma Specially formulated weak sensitivity controls, designed to stress testing platforms. Validated for use in column technologies Derived from a pool of donations Polyclonal material which presents as a normal weak sample Different specificities demonstrates ability to detect a range of weak antibodies Sensitivity Controls Sensitivity Controls Product Code Description Pack Size Z250 ALBAsure Sensitivity Control Kit Anti-K, Anti-c, Anti-E, Anti-S 4 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 Quotient 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 Frozen Plasma Products Improve Quality 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. Haemostasis Plasma for the calibration of quantitative haemostasis assays. Assayed for over 20 fibrinolytic and coagulation parameters against international reference standards No reconstitution is required so confidence is assured Product stable for 8 hours after thawing Assay certificate supplied with each lot CRYOcheck™ Normal Reference Plasma Control/Reference Plasma Plasma for controlling the accuracy of quantitative haemostasis assays in the normal range. Assayed for over 20 fibrinolytic and coagulation parameters against international reference standards Product stable for 8 hours after thawing Assay certificate supplied with each lot CRYOcheck™ Reference Control Normal frozen plasma Plasma for controlling the accuracy of quantitative assays in the borderline and pathological range. Donor-pool adjusted to provide a borderline abnormal control and a pathological abnormal control Assayed for over 20 fibrinolytic and coagulation parameters against international reference standards Product stable for 8 hours after thawing Assay certificate supplied with each lot CRYOcheck™ Gold Standard Abnormal Reference Control frozen plasma CRYOcheck™ Normal Reference Plasma Product Code Description Pack Size CCNRP-10 Normal Reference Plasma 25 x 1.0ml CCNRP-05 Normal Reference Plasma 25 x 0.5ml Precision Biologic CRYOcheck™ Reference Control Normal Product Code Description Pack Size RCN-10 Reference Control Normal 25 x 1.0ml Precision Biologic CRYOcheck™ Abnormal Reference Plasma Product Code Description Pack Size ARPI-10 Abnormal 1 Reference Control 25 x 1.0ml ARPII-10 Abnormal 2 Reference Control 25 x 1.0ml Precision Biologic frozen plasma Haemostasis
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 21 22 Control/Reference Plasma Normal control for the one-stage Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and Fibrinogen. Designed for use in mixing studies Pool of 20 or more carefully screened donors who are a mixture of males and females aged 18 to 66 An alternative to in-house collected normal plasma pools Platelet-poor (<10,000 Platelets/µl) 24 hours stability once thawed CRYOcheck™ Pooled Normal Plasma Abnormal control for the one-stage Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT). Pool of 20 healthy donors treated to contain reduced levels of clotting factors 2, 7, 9 and 10 24 hours stability once thawed Available in two levels designed to suit varying control procedures CRYOcheck™ Abnormal Controls frozen plasma frozen plasma CRYOcheck™ Pooled Normal Plasma Product Code Description Pack Size CCN-10 Pooled Normal Plasma 80 x 1.0ml CCN-15 Pooled Normal Plasma 80 x 1.5ml CCN-40 Pooled Normal Plasma 81 x 4.0ml Precision Biologic CRYOcheck™ Abnormal Controls Product Code Description Pack Size CCA1-10 Abnormal 1 Control 80 x 1.0ml CCA2-10 Abnormal 2 Control 80 x 1.0ml Precision Biologic Control/Reference Plasma 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 frozen plasma CRYOcheck™ Low Fibrinogen Control Product Code Description Pack Size CCLF-80 Low Fibrinogen Control 80 x 1ml Precision Biologic 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 8 hour stability once thawed n Used to supplement or replace in-house controls CRYOcheck™ APCR Positive Control frozen plasma CRYOcheck™ APCR Positive Control Product Code Description Pack Size 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™ frozen plasma CRYOcheck™ CorPac™ Product Code Description Pack Size 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 phospholipiddependent assays CRYOcheck™ Normal Donor Set Product Code Description Pack Size CCNS-10 Normal Donor Set 25 x 1.0ml Precision Biologic frozen plasma
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 23 24 Lupus Anticoagulant Testing Controls Lupus Anticoagulant Testing A weak positive LA control that challenges an assay’s sensitivity to LA. Encourages confidence that weak LA positive patient samples will be accurately detected Plasma from donors confirmed to have circulating LA 8-hour stability once thawed Ready to use in minutes CRYOcheck™ Lupus Positive Control Intended for use as a positive control in assays for lupus anticoagulants (LA). Plasma from donors with non-specific circulating anticoagulants Platelet poor for consistent results Stable for 8 hours once thawed frozen plasma CRYOcheck™ Weak Lupus Positive Control Product Code Description Pack Size CCWLP-05 Weak Lupus Plasma 25 x 0.5ml CCWLP-10 Weak Lupus Plasma 25 x 1ml Precision Biologic CRYOcheck™ Lupus Positive Control Product Code Description Pack Size CCLP-05 Lupus Positive Control 25 x 0.5ml CCLP-10 Lupus Positive Control 25 x 1ml Precision Biologic CRYOcheck™ Weak Lupus Positive Control frozen plasma Intended to verify sensitivity and performance of vWF assay. Lyophilised, depleted human plasma Can be used on most optical systems 8-hour stability after reconstitution Material Expected Values Normal Reference Plasma 90-100% activity Abnormal Control Plasma Less than 45% activity vWF Reference Plasma Product Code Description Pack Size 101269 vWF Normal Reference Plasma 3 x 0.5ml 101270 vWF Abnormal Reference Plasma 3 x 0.5ml BioData Corporation Factor Deficient Substrate CRYOcheck™Factor Deficient Substrate CRYOcheck™Prekallikrein Deficient Substrate Collected from: Congenital donor who has been assayed to have less than 1% activity for Prekallikrein 8 hour stability once thawed Certificate of Analysis supplied with each lot frozen plasma Manufactured from fresh frozen, 100% human plasma, no bovine additives. Certified by antigenic and functional assays to have less than 1% activity All other coagulation factors are assayed within normal activity levels Assay certificate supplied with each lot number Ready to use in minutes 8 hour stability once thawed Shelf life of 3 years from the date of manufacture CRYOcheck™ Factor Deficient Substrate Product Code Description Pack Size FDP2-10 Factor 2 Deficient Plasma 25 x 1ml FDP5-10 Factor 5 Deficient Plasma 25 x 1ml FDP7-10 Factor 7 Deficient Plasma 25 x 1ml FDP8-10 Factor 8 Deficient Plasma 25 x 1ml FDP9-10 Factor 9 Deficient Plasma 25 x 1ml FDP10-10 Factor 10 Deficient Plasma 25 x 1ml FDP11-10 Factor 11 Deficient Plasma 25 x 1ml FDP12-10 Factor 12 Deficient Plasma 25 x 1ml Precision Biologic CRYOcheck™ Prekallikrein Deficient Substrate Product Code Description Pack Size FDPK-10 Prekallikrein Deficient Plasma 10 x 1ml Precision Biologic vWF Reference Plasma vWF Reference Plasma / Factor Deficient Substrate CRYOcheck™ Lupus Negative Control CRYOcheck™ Lupus Negative Control is prepared from human source plasma and is recommended as a negative control in assays for lupus anticoagulant. Comprised of platelet-poor plasma from donors screened negative for LA Source plasmas are screened negative for all FDArequired tests Stable for 8 hours once thawed if refrigerated at 2 °C to 8 °C CRYOcheck™ Lupus Negative Control Product Code Description Pack Size CCLN-05 Lupus Negative Control 25 x 0.5ml CCLN-10 Lupus Negative Control 25 x 1ml Precision Biologic frozen plasma
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 25 26 Light Transmission Aggregometers (LTA) Quality Control 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 Functionality System 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 Control Ranges 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 ■ Standardise 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 Kit Product Code Description Pack Size 107117 LTA Check™ Kit 18 tests BioData Corporation 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. Four different group format vials cover ABO and Rh/K antigens, plus anti-D and anti-Kell antibodies Supplied in 6ml vials of 15% RBC suspension Manufactured on a 4 weekly cycle – subscription product best seller Blood Grouping Controls 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®-BGS Product Code Description Pack Size Z489 ALBAcheck-BGS Whole Blood SP control 4 x 6ml Quotient ALBAcheck®-BGS High Titre Controls Kit 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. Unique product Open-vial stability: 2 weeks ALBAcheck®-BGS High Titre Controls Kit Product Code Description Pack Size Z257 ALBAcheck-BGS High Titre Controls Kit 4 x 6ml Quotient 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. Kit consists of: 10 randomly selected serum samples Results available ‘on-line’ – please enquire Ready to use, store at 2-8 C Closed vial stability: 1 year Validated for use in column technology and tube systems ALBAcheck® -BGS Competency Test Kit ALBAcheck®-BGS Competency Test Kit Product Code Description Pack Size Z276 ALBAcheck-BGS Competency Test Kit 10 x 2ml Quotient Blood Grouping Reagents
Pricing and Online Ordering at www.alphalabs.co.uk Pricing and Online Ordering at www.alphalabs.co.uk ISO 15189 Made Easier ISO 15189 Made Easier freephone order 0800 387732 buy online at www.alphalabs.co.uk email order sales@alphalabs.co.uk freefax order 0800 614249 27 28 Reagent Red Cells ALBAcyte® Control Cells Red Cell Panels for conventional manual tube and microplate testing. All ALBAcyte® red cell reagents comply with UK BTS Guidelines. For both conventional tube and microplate testing Panels manufactured from pre-selected donors to provide consistent quality Comply with UK BTS Guidelines Available on 4-weekly subscription order to ensure 28-day shelf life on receipt ALBAcyte® Control Cells Catalogue Number Description Suspension Pack Size Recommended Use Z401-1 A1 Cells 3% 10ml Reverse grouping controls Z401-3 A1 Cells 3% 3 x 10ml Reverse grouping controls Z401-10 A1 Cells 3% 10 x 10ml Reverse grouping controls Z406-1 A2 Cells 3% 10ml Reverse grouping controls Z406-3 A2 Cells 3% 3 x 10ml Reverse grouping controls Z406-10 A2 Cells 3% 10 x 10ml Reverse grouping controls Z411-1 B Cells 3% 10ml Reverse grouping controls Z411-3 B Cells 3% 3 x 10ml Reverse grouping controls Z411-10 B Cells 3% 10 x 10ml Reverse grouping controls Z416-1 O R1r Cells 2-3% 10ml Controls Z416-3 O R1r Cells 2-3% 3 x 10ml Controls Z416-10 O R1r Cells 2-3% 10 x 10ml Controls Z421-1 Orr Cells 2-3% 10ml Controls Z421-3 Orr Cells 2-3% 3 x 10ml Controls Z421-10 Orr Cells 2-3% 10 x 10ml Controls Z441-1 IgG Sensitised Cells 3-5% 10ml Confirmation and controls Z441-3 IgG Sensitised Cells 3-5% 3 x 10ml Confirmation and controls Z441-10 IgG Sensitised Cells 3-5% 10 x 10ml Confirmation and controls Quotient 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 Reagents Product Code Description Pack Size Z271 Reagent Control for Anti-D (Use with Z031, Z036, Z039, Z041) 10 x 10ml Z281 AB Serum (human) 10 x 5ml Quotient Body Fluid Controls Sperm-Chex® Sperm-Chex is a manual sperm count control that contains real stabilized sperm cells and can be handled like a patient sample. It is available in two clinically significant levels to help validate the quantification of sperm counting by manual methods. Same chamber loading or optical characteristics as a patient sample Compatible with hemacytometers and other counting chambers 42-day open-vial stability 12-month closed-vial stability Sperm-Chex® Product Code Description Pack Size 230200 Sperm-Chex Post Vasectomy Control 2 x 300uL 230202 Sperm-Chex Sperm Count Control 2 x 300uL Streck Multi-parametric Calibrators for Chemistry Assays Multi-parametric Calibrators for Chemistry Assays Analyte Method Traceability Albumin Bromocresol Green ERM-DA 470 Alkaline Phosphatase IFCC IFCC recommended formulation Alanine Aminotransferase IFCC with/without P5P Original IFCC formulation Aspartamine Aminotransferase IFCC with/without P5P ɛ NADH Alpha-Amylase EPS G-7 (mod. IFCC) ɛ p-Nitrophenol Alpha-Amylase CNP-G3 ɛ p-Nitrophenol Pancreatic Amylase EPS G-7 (ET-G7PNP) ɛ p-Nitrophenol Direct Bilirubin DCA Jendrassik-Grof Direct Bilirubin Jendrassik-Grof Jendrassik-Grof Total Bilirubin DCA SRM 916a Total Bilirubin Jendrassik-Grof Jendrassik-Grof Calcium Arsenazo III AAS Chloride Thiocyanate SRM 999 Cholesterol CHOD-PAP GC-IDMS Cholinesterase Butyrylthiocholin DGKC recommended formulation Creatine Kinase DGKC, IFCC Original IFCC formulation Creatinine Jaffé (+/- compensation) GC-IDMS Creatinine Enzymatic PAP GC-IDMS Gamma Glutamyltransferase IFCC Original IFCC formulation Gamma Glutamyltransferase Szasz Original form. Persijn/v.d. Slik 1976 Glutamate Dehydrogenase DGKC DGKC recommended formulation Glucose GOD-PAP ID-MS Glucose HK/G6P-DH ID-MS Iron Ferene SRM 682 Lactate Enzymatic (LDH) UV Primary Reference Material Lactate Dehydrogenase IFCC, DGKC 1994 Original IFCC formulation Lipase Colorimetric Molar extinction coefficinet Magnesium Xylidyl-blue AAS Phosphorus Molbydate UV Internal Standard Total Protein Biuret Modified Biuret method Triglycerides GPO-PAP GC-IDMS Unsaturated Iron Binding Capacity Ferene Internal Standard Urea Urease UV SRM 909b Level I Urea Colorimetric end-point SRM 909b Level I Uric Acid TBHBA GC-IDMS Uric Acid AOX, TOOS GC-IDMS Diacal Auto (Dialab) Lyophilised calibrator based on human serum. Once reconstituted, stable for 2 days at 2-8°C or 30 days at -20°C if aliquoted into small volumes. Each aliquot should only be thawed once. Bilirubin (Direct and Total) is stable for 8h at 2-8°C (in the dark) or 14 days at -20°C. Diacal Auto (Dialab) Product Code Description Pack Size D98485SV Diacal Auto 1x3ml D98485 Diacal Auto 5x3ml Reagent Red Cells / Body Fluid Controls
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