January 2018 Product Focus – Assays

Dec. 21, 2017
Quantitative two-step immunoassay

The Glucagon ELISA kit, a quantitative two-step sandwich type immunoassay, provides materials for the quantitative measurement of Glucagon in human plasma and other biological fluids. Same-day results and a simple two-step procedure with total 2.5 hour incubation at RT avoid the complex or overnight procedures inherent in some current Glucagon assays. Measures Glucagon (1-29) with no detectable cross-reactivity to Glicentin, Oxyntomodulin, GLP-1, GLP-2, or GRPP. Sensitive to 2.1 pg/mL (0.6 pmol/L). Analytical measurable range of 20-313 pg/mL (6-89 pmol/L) allows for accurate quantitations on both hyperglycemiac and hypoglycemiac samples. Sample size of 50 μL, no extraction needed, no special collection tube required. AnshLabs

Serum free light chain testing

Freelite is a pair of highly sensitive and specific immunodiagnostic tests to measure kappa (κ) and lambda (λ) 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. Recommended by name in the International Myeloma Working Group guidelines and supported by more than 3,000 scientific publications. Binding Site

Measuring PCT levels to guide antibiotic use

In February 2017, bioMérieux, Inc., received clearance from the U.S. Food and Drug Administration (FDA) for the expanded use of VIDAS B•R•A•H•M•S PCT, an automated assay measuring procalcitonin (PCT) levels, to aid clinicians’ decisions regarding the use of antibiotics in two common clinical situations: lower respiratory tract infections (LRTI) and sepsis. Using VIDAS B•R•A•H•M•S PCT in these clinical situations will help reduce inappropriate and unnecessary antibiotic use, avoiding associated side effects while slowing and preventing the emergence of resistant bacteria. bioMérieux, Inc.

RT-qPCR assay for detection of HCV RNA

The AMPIPROBE HCV Assay Kit is a quantitative reverse transcription polymerase chain reaction (RT-qPCR) assay for the quantitative detection of human hepatitis C virus (HCV) RNA in plasma or serum. Enzo’s AMPIPROBE technology incorporates probe detection technology in primer design. It employs a combination of fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA, akin to traditional PCR. The proprietary primer mix included in the kit is specific for HCV genotypes 1 through 6. It allows for high sensitivity, low input volume and reduced processing time, thereby enabling cost-effective diagnostic testing. The kit includes titered high, medium, and low HCV controls which enable virus quantitation in IU/mL. In addition, the kit contains an extraction control to ensure proper sample nucleic acid extraction. Enzo

HSV 1 & 2 assay

The Aptima HSV 1 & 2 assay on the Panther system incorporates testing for herpes types 1 and 2 with your current testing portfolio and joins the growing list of nucleic acid amplification tests (NAATs) on the fully automated Panther system. NAAT is the preferred testing method for genital herpes diagnosis. The Aptima HSV 1 & 2 assay distinguishes between HSV 1 and 2, which is recommended in all patients with first-episode genital herpes. The assay may be used with an Aptima Multitest Swab Specimen Collection Kit or viral transport media (VTM) on anogenital skin lesions. Hologic

Remnant lipoprotein cholesterol assay

Kamiya Biomedical is introducing a new automated colorimetric assay for the quantitative measurement of remnant lipoprotein cholesterol (RLP-C) in serum samples on chemistry analyzers. Research studies have reported that RLP-C may be an important risk factor for coronary artery disease, myocardial infarction, and arteriosclerosis. The assay uses a specific enzymic method to directly detect RLP-C. Applications are available for most chemistry analyzers. For research use only in the U.S. Kamiya Biomedical

ZIKA test for use in U.S. under EUA

The ADVIA Centaur Zika test* is intended for in vitro diagnostic use in the presumptive qualitative detection of IgM antibodies to the Zika virus in human serum and plasma using the ADVIA Centaur XP and ADVIA Centaur XPT Systems. The detection of IgM antibodies to the Zika virus is determined by combining in an algorithm the measurements of the ADVIA Centaur Zika Ab (ZikaAb) assay and, as applicable, the ADVIA Centaur Zika IgM (ZikaM) assay. The test can be used with serum and plasma samples and has good onboard stability and a long calibration interval. *Only for use in the United States under Emergency Use Authorization. Siemens Healthineers