Blood Bank Quality Control
Features 63-day shelf life
MQC-CAT from Hemo Bioscience, Morrisville, NC, is a ready-to-use product for quality control testing of routine blood bank reagents used in manual column agglutination technology (CAT) blood typing and antibody screening systems. It is currently the only available product of its type to have FDA premarket notification (510(k)) clearance. Features of MQC-CAT include positive and negative red cells and plasma, color-coded caps for ease of use, and a 63-day shelf life. MQC-CAT provides a cost-effective method for day-of-use quality control testing of reagents and gel cards used in ABO, Rh(D), and antibody screening and identification.
(866) 332-2835; www.hemobioscience.com
Anti-Müllerian Hormone Control
Supports reproductive health testing
Bio-Rad Laboratories Inc, Hercules, Calif, has launched the Liquichek anti-Müllerian hormone (AMH) control, expanding the company’s portfolio of quality control solutions for reproductive health testing. AMH is a protein hormone produced by cells within the ovaries, serving as an important marker to determine a woman’s ovarian reserve. AMH testing offers a quick and reliable method that enables couples to plan a natural pregnancy or to consider fertility treatment. The Liquichek AMH control is a liquid, assayed, human serum-based quality control with clinically relevant levels for monitoring the precision of AMH assays.
(800) 424-6723; www.bio-rad.com
Urinalysis Dipstick Control
Designed to improve performance with a single dip
The Dipper POCT urinalysis dipstick control from Quantimetrix Corp, Redondo Beach, Calif, is a single-use liquid urinalysis dipstick control suited for use in point-of-care settings and in such traditional testing environments as central labs, reference labs, doctor’s offices, and nursing stations. With 3 months of room-temperature stability and up to 3 years of stability at 2–8ºC, Dipper POCT is formulated with native ketones and made with a simulated human urine matrix. The product’s slim pouch design enables users to visually verify full immersion of the dipstick and minimize the risk of contamination.
(800) 624-8380; www.quantimetrix.com
Interlaboratory Data Management Software
Facilitates QC data management
Acusera 24/7 from Randox Laboratories, Crumlin, UK, is an interlaboratory data management and peer group reporting package designed to assist in the management of daily quality control (QC) activities. The software helps meet regulatory requirements, improve error detection, reduce false rejections, and ensure accurate patient results. It features instant access to real-time peer group data, automatically generated QC statistics, and performance metrics, including uncertainty of measurement and sigma metrics, QC multirules, interactive charts, and comprehensive reports.
(866) 472-6369; www.randox.com
Biosynthetic Reference Standards
Specifically designed for next-generation sequencing
Designed specifically for next-generation sequencing (NGS), SeraSeq biosynthetic reference standards from SeraCare Life Sciences, Milford, Mass, are highly multiplexed and provide a stable, commutable source of in-run controls. The iQ NGS quality control (QC) solution provides QC trending, tracking, and reporting for the entire NGS workflow, including library preparation, sequencing instrument metrics, and sample results. Together, SeraSeq reference materials and the iQ NGS QC analysis solution can provide more consistent results, as well as reduced downtime.
SeraCare Life Sciences
(508) 244-6400; www.seracare.com
Data Management Software
Offers extended quality control module
Remisol Advance data management software from Beckman Coulter Diagnostics, Brea, Calif, has an optional extended quality control (EQC) module that enhances QC capabilities to ensure that processes meet defined standards 24 hours a day, 7 days a week. With EQC, labs gain increased confidence in reported results and find instrument and control irregularities faster. EQC establishes two types of QC monitoring systems. The control protocol analyzes data from commercial control materials for quality control. The patient protocol performs statistical analyses using patient results to provide insight regarding potential future QC failures.
Beckman Coulter Diagnostics
(800) 526-3821; www.beckmancoulter.com
Body Fluids Linearity and Calibration Verification Kit
Offers five distinct concentrations
LGC Maine Standards, Cumberland Foreside, Maine, has released Validate Body Fluids, a comprehensive body fluids kit for easier linearity and calibration verification. Provided in a simulated body fluid matrix, the kit assists in the documentation of linearity, calibration verification, and verification of linear range for albumin, amylase, cancer antigen 19-9, carcinoembryonic antigen, cholesterol, creatinine, glucose, lactate, lactate dehydrogenase, total protein, triglycerides, and urea nitrogen. Each liquid, ready-to-use kit offers five distinct concentrations to establish the reportable range. Users dispense the solution from each dropper bottle directly into five sample cups, and run in replicates.
LGC Maine Standards
(800) 377-9684; www.mainestandards.com
Multiplex cfDNA Reference Standard
Detects EGFR mutations from cell-free DNA
Horizon Discovery, Cambridge, UK, has launched a cell line-derived epidermal growth factor receptor (EGFR) multiplex cell-free DNA reference standard. The reference standard enables laboratories and assay developers to optimize, validate, and routinely monitor performance of polymerase chain reaction (PCR)-based tests, next-generation sequencing, and other novel assays designed to detect EGFR mutations from cfDNA. The reference standard covers 10 of the most clinically relevant mutations that predict responsiveness to EGFR tyrosine kinase inhibitors, including C797S, E746-A750del, L858R, and T790M.
Available free of preservatives
The Binding Site, San Diego, has made available a number of new monoclonal antibodies to be used in research and in vitro diagnostic manufacturing applications involving hepatitis B surface antigen (HBsAg). Currently available monoclonal antibodies to HBsAg include those targeted toward HBsAg ‘a’ 188.8.131.52; HBsAg ‘a’ 25; HBsAg ‘a’ S1.9; HBsAg ‘a’ S2 7A; HBsAg ‘a’ S2 A13; HBsAg ‘a’ S2 B3; HBsAg ‘a’ S3; HBsAg ‘d’ AD1; and HBsAg ‘y’ AY1. The monoclonal antibodies are sourced from mice and manufactured to a purity level greater than 95%. In addition, they are supplied preservative-free, demonstrate lot-to-lot consistency, and feature a shelf life of 4 years from the date of manufacture.
The Binding Site
(800) 633-4484; www.bindingsite.com
Calibration Verification, Linearity Control
Consists of five levels
Audit MicroControls Inc, Eatonton, Ga, has added Linearity FD Procalcitonin for the Abbott Architect i series of analyzers to its line of calibration verification and linearity and daily quality control products. The lyophilized product consists of five levels that demonstrate a linear relationship to one another when assayed for procalcitonin. The product has an open vial stability of 5 days when stored at 2–8°C.
(866) 252-8348; www.auditmicro.com