Multiplex cfDNA Reference Standard
Set in synthetic plasma
Horizon Discovery Group plc, Cambridge, UK, has launched its first HDx cell-free DNA (cfDNA) reference standard in synthetic plasma. Developed using clinically relevant mutations, the reference standard contains eight cancer-relevant mutations, including BRAF, EGFR, KRAS, NRAS, and PIK3CA at 5%, 1%, and 0.1% allelic frequencies. These mutations are associated with multiple forms of cancer, including breast, colorectal, pancreatic, and particularly lung, where one specific mutation covered in the panel, EGFR T790M, is associated with Iressa (gefitinib) resistance.
Horizon Discovery Group
[email protected]; www.horizondiscovery.com
Multiplexed Inherited Cancer Reference Materials
Focused on seven genes
SeraCare Life Sciences Inc, Milford, Mass, has launched multiplexed reference materials for use in inherited cancer testing by next-generation sequencing (NGS). The Seraseq inherited cancer DNA mix reference materials were developed to validate the ability of synthetic reference materials to address technically challenging variants. Addressing the lack of multiplexed reference materials for targeted NGS assays, the materials are focused on seven genes associated with inherited cancer syndromes, including BRCA1 and BRCA2. The product combines more than 20 pathogenic variants of diverse types in a well-characterized genomic background that can be used for assay development and analytical validation.
SeraCare Life Sciences
(800) 676-1881; www.seracare.com
Quality Control for CO-Oximeter
Contains real hemoglobin derivatives
The CueSee CO-OX PT from Eurotrol, Burlington, Mass, is a quality control for CO-oximeters with real hemoglobin derivatives in one sample. The control is packaged in the ACU-Drop II, a dual-chambered device that keeps the oxyhemoglobin separated from the methemoglobin to provide a long shelf-life. Available in clinically relevant levels, the control is compatible with all common CO-oximeters, providing identical results. The testing material is suited for quality control, method comparisons, analytical measurement range validations, and proficiency testing.
Eurotrol
(978) 598-3779; www.eurotrol.com
Urinalysis Quality Control
3-month shelf life at room temperature
Quantimetrix, Redondo Beach, Calif, has introduced Dipper POCT, a single-use urinalysis dipstick control with room-temperature stability of 3 months, and refrigerated stability of 3 years, from the date of manufacture. The unique slim pouch design allows users to verify full immersion of the dipstick that simulates the dipping method used on patient samples, minimizes the risk of contamination, and reduces the volume required for testing. The Dipper POCT urinalysis dipstick control is suited for urinalysis testing at the point-of-care and for use in traditional testing environments, including central labs, doctor’s offices, nursing stations, and reference labs.
Quantimetrix
(800) 624-8380; quantimetrix.com
Immunodiagnostic Test
Measures kappa and lambda free light chains
The Binding Site Inc, San Diego, Calif, presents Freelite, a pair of highly sensitive and specific immunodiagnostic tests to measure kappa (?) and lambda (?) free light chains in serum. Freelite is FDA-cleared for both diagnosis and monitoring of multiple myeloma, as well as a range of additional plasma cell disorders. The Freelite tests are recommended by name in the International Myeloma Working Group guidelines and supported by more than 3,000 scientific publications.
The Binding Site Inc
(800) 633-4484; www.bindingsite.com
Genetic Testing Reagents
Purifies DNA in 45 minutes
MagMax DNA Multisample Ultra 2.0 reagents from Thermo Fisher Scientific, Waltham, Mass, provide genetic testing companies, labs, and service providers with fast, hassle-free and high-throughput DNA extraction from blood, buccal swabs, buffy coat, and saliva. Using a simplified protocol for either high- or low-volume sample input on Thermo Scientific KingFisher instruments, the reagents can purify DNA from 96 samples in 45 minutes. The ready-to-use reagents require only one manual step before loading plates, without requiring a dedicated sample prep expert. For research use only.
Thermo Fisher Scientific
(866) 356-0354; www.thermofisher.com
Primer Pairs
For use in laboratory-developed tests
DiaSorin Molecular, Cypress, Calif, a manufacturer and distributor of molecular diagnostic products, has introduced two primer pairs—group C and group G Streptococcus—for use in laboratory-developed molecular tests. The new offerings join DiaSorin’s menu of more than 60 molecular reagents for bacterial, viral, and fungal targets, in addition to human genetic mutations. The primer pairs are classified as analyte-specific reagents, which can be used by high-complexity laboratories to develop their own lab-developed tests (LDTs).
Diasorin Molecular
(562) 240-6500; www.diasorin.com
Blood Group Reagents
Designed for extended phenotype testing
The Ortho Sera suite of blood grouping reagents from Ortho Clinical Diagnostics, Raritan, NJ, has received an FDA license for US commercialization for use with the company’s ID-Micro Typing System (ID-MTS) gel card technology. Designed for extended phenotype testing, the Ortho Sera suite of reagents is used to determine the status of a designated antigen on human red blood cells. Ortho Sera provides labs with the only comprehensive menu of antisera for phenotyping available in a gel testing format, covering more than 99% of the most commonly tested blood group antigens.
Ortho Clinical Diagnostics
(800) 828-6316; www.orthoclinical.com
Blood Banking Quality Control
Includes positive, negative red cells and serums
Hemo Bioscience, Morrisville, NC, has received FDA premarket notification (510(k)) clearance for its MQC-CAT, a ready-to-use quality control product for blood bank testing methods that use manual column agglutination technology (CAT). Validated for use in all manual CAT testing systems currently available in the United States, MQC-CAT includes both positive and negative red cells and serums to ensure that ABO, Rh(D), and antibody screening and identification reagents are performing as expected.
Hemo Bioscience
(866) 332 2835; www.hemobioscience.com
Blood Glucose Linearity and Control Kits
Simulates human patient samples
Audit MicroControls Inc, Eatonton, Ga, has released blood glucose linearity and control kits, The materials simulate human samples, and are intended to be used with quantitative assays on clinical laboratory analyzers. The Linearity Drop LQ blood glucose is a ready-to-use liquid consisting of five levels that demonstrate a linear relationship to one another when assayed for glucose. Control Drop LQ blood glucose is intended to simulate human patient samples for use as assayed quality control materials for glucose. Both products have an open vial stability of 7 days when stored at 2–8°C.
Audit MicroControls
(866) 252-8348; www.auditmicro.com
Biochemistry Reagent Portfolio
Features flexible pack sizes
Randox Laboratories Ltd, Crumlin, UK, manufactures a portfolio of such third-party clinical biochemistry reagents as adiponectin, cystatin C, high-density lipoprotein 3, lipoprotein(a), and small-dense low-density lipoprotein cholesterol. The company’s line of products is provided in flexible pack sizes for a comprehensive list of chemistry analyzer applications—including Abbott Architect, Beckman Coulter AU, and Hitachi systems, among others. The liquid, ready-to-use reagents feature excellent correlation to reference methods and wide measuring ranges. As well as the full panel of routine tests, Randox also offers a wide range of niche testing options.
Randox Laboratories
[email protected]; www.randox.com
Data Management Solutions
Tailored for individual labs
Unity quality control (QC) data management solutions from Bio-Rad Laboratories, Hercules, Calif, are designed to support laboratories’ strategies for elevating their quality performance. A Unity strategy is specifically tailored for individual labs, empowering laboratorians to work smarter. The suite of solutions facilitates the comparison, management, and interpretation of QC results. Users can choose from Internet and desktop software options.
Bio-Rad Laboratories
(800) 224-6723; www.bio-rad.com
