Quality Assessment/Assurance/Control

Quality control for i-STAT analyzers

GAS-ISE Hct QC is an all-in-one quality-control product with pH, blood gases, electrolytes, metabolites, and hematocrit target values all in one ampule. Designed to save i-STAT analyzer ­users time and money, the product eliminates the need to run more than one control for each liquid QC check and reduces the number of i-STAT cartridges required. The product is available as a three-level control, as well as a five-level calibration verification/linearity panel.

Eurotrol

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QC data management

Unity Real Time 2.0 is designed to manage laboratory quality control (QC) with a comprehensive set of features for bench-level technologists to validate analytical runs. Intended to meet and exceed clinical laboratory requirements, including CLIA and ISO 15189, the solution also provides advanced options for lab supervisors and managers to set up QC design and analyze information. An optional add-on module available is Westgard Advisor 2.0, which automatically recommends and implements optimal QC rules for each test to help decrease false rejections and attain quality goals.

Bio-Rad Laboratories

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Lyophilized reference stock cultures for QC

LYFO DISK is a lyophilized pellet containing a single strain of a microorganism and is an easy-to-use economical reference stock culture option. Simply re-hydrate the pellet and inoculate. LYFO DISK is available in a resealable vial containing 10 pellets. The lyophilized microorganism has a shelf life of 10 to 24 months. Standard features include a selection of more than 700 strains, no pre-incubation, availability in sets, an online certificate of analysis, a product warranty, and traceable to reference cultures.

MicroBioLogics

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Monitor tumor-marker testing procedures

The Lyphochek Tumor Marker Plus Control is a lyphohilized, human-serum-based, third-party quality control for monitoring the precision of tumor-marker-testing procedures. This mulitanalyte control has three levels and features 23 tumor markers including ACTH, aldosterone, AFP, microglobulin, CA 15-3, CA 19-9, CA 27-9, and others. The control has a three-year shelf life when stored at 2°C to 8°C. It includes high target levels of cancer antigens and ferritin, plus a very low level of PSA. Assayed values are provided for manual and automated test methods. The Unity Interlaboratory Program with peer-group comparison is available with this product.

Bio-Rad Laboratories

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New whole-blood quality control verifies accuracy

The CD4 Count is a whole-blood quality control for verifying the accuracy of the BD FACSCount flow cytometer. The easy-to-read CD4 assay includes absolute counts and percent positive ratios on the cellular populations of CD3, CD4, and CD8 T-lymphocytes. These parameters are used in the diagnosis and treatment of HIV/AIDS patients. In addition, CD4 Count’s clinically relevant levels of CD4 cells help clinicians evaluate the instrument’s ability to read both normal and depressed levels. This product offers a 30-day open-vial stability, which allows labs to run the control every day, saving money. The 90-day closed-vial stability means fewer orders and reduced shipping costs.

Streck

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Improved qPCR results quality

The PCS Pipette Calibration System is for use in qPCR applications, and is an ideal solution due to its ability to rapidly measure small liquid volumes at high accuracy and to give NIST (National Institute of Standards and Technology)-traceable results. qPCR assays are becoming increasingly common in labs, are highly volume-dependent, and require several liquid volume steps. Easy to use, the PCS can verify the performance of a pipette’s accuracy and precision in minutes, allowing labs to conduct interim verification checks between regularly scheduled calibrations and before critical assays for stronger confidence in results.

Artel

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Improve testing quality

The hematology program from Randox International Quality Assessment Scheme (RIQAS) offers quick and easy quality analysis for eight analytes. With over 8,100 participants in 70 countries worldwide, RIQAS helps labs assess their analytical performance and compare it to other labs using the same methods and instruments. Liquid-stable whole-blood samples, supplied every three months, are analyzed on a biweekly basis with eight required hematology analytes included in each sample: Hct, Hb, MCH, MCHC, MCV, PLT, RBC, and WBC. As a result of feedback from participants, samples are now supplied in 2-mL primary tubes and can be placed directly in hematology analyzer.

Randox Laboratories

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