April 2017 Product Focus – Virology

March 21, 2017
Fecal specimen handling

Many labs perform molecular testing for enteric pathogens, especially for viruses where culture methods are labor-intensive and time-consuming. Fecal samples in traditional containers can represent a challenge because too much sample can result in interference. FecalSwab provides an optimal ratio of sample to media to support molecular platforms. FecalSwab converts solid or semi-solid fecal specimens into liquid phase, using a flocked swab and 2mL Cary-Blair media. In addition to FDA clearance for bacterial culture, FecalSwab is widely used with molecular tests for viruses causing gastrointestinal infections.

Hepatitis C assay

Hologic announces FDA approval for the Aptima HCV Quant Dx assay for the detection and quantitation of hepatitis C virus on the fully automated Panther system. The assay has ultrasensitive, highly precise performance in confirmation of active infection and sustained virologic response. There is high viral load result agreement between Aptima HCV Quant Dx assay and comparators for confidence in switching assays without disrupting patient care. This assay is the latest in the growing virology portfolio from Hologic, following the recent launch and FDA approval of the Aptima HIV-1 Quant assay. Visit Hologic

Herpes simplex virus assay

The ARIES HSV 1 & 2 Assay is a real-time polymerase chain reaction (rt-PCR)-based qualitative in vitro diagnostic test for the direct detection and typing of herpes simplex virus (HSV 1 & 2) DNA in cutaneous or mucocutaneous lesion specimens from symptomatic patients, or in cerebrospinal fluid (CSF) from patients suspected of HSV infections of the central nervous system. The test is indicated for use with symptomatic individuals to aid in the diagnosis of HSV infections. The assay is not intended to be used for prenatal screening. The ARIES HSV 1 & 2 Assay is indicated for use on the Luminex ARIES System. Visit Luminex

STD assays

Puritan’s UniTranz-RT Universal Transport Systems with PurFlock Ultra flocked swabs can be used to conclusively collect and test viruses, chlamydia, mycoplasma, and ureaplasma specimens. Features include: (a) safe, effective, and easy-to-use transport system; (b) available in 1mL or 3ML fill configurations, with or without swabs; (c) fully compatible with automation systems, EIA, PCR, DFA, and molecular assays; (d) a shelf life of 18 months at room temperature (25°C maximum); and (e) helps prevent unnecessary delays and costs. Product is in stock and ready to ship now. Made in the USA. Visit Puritan

HSV 1+2/VZV assays

Solana HSV 1+2/VZV, a multiplex in vitro diagnostic test, detects and differentiates herpes simplex virus type 1, type 2, and varicella-zoster virus in 60 minutes. Solana HSV 1+2/VZV offers a scalable and flexible molecular solution that delivers highly accurate results in an actionable timeframe. Solana’s workflow is easy and flexible, capable of testing a single specimen or batching up to 12 tests at a time. Solana HSV 1+2/VZV is used with Solana, a small bench-top instrument that combines Quidel’s proprietary helicase-dependent amplification with fluorescence detection to deliver molecular results. Visit Quidel

Dual-target HIV-1 PCR test

Built upon the unique dual-target assay design from Roche, the cobas HIV-1 viral load test simultaneously amplifies and detects two separate regions of the HIV-1 genome, which are not subject to selective drug pressure. This allows for more reliable results and supports physicians in making informed treatment decisions for HIV-1 patients undergoing antiretroviral therapy. The test is performed on the fully automated cobas 6800 and 8800 systems, which also run the FDA-approved cobas HBV and cobas HCV viral load tests from Roche. The systems offer fasttime to results, high throughput and long walk-away time. Visit Roche

Bacterial vaginitis assay

Bacterial vaginitis (BV) is the most common cause of infectious vaginitis that affects millions of women worldwide. The goal of a BV diagnostic test is to accurately and rapidly detect infection by the organisms causing BV, and thereby enable initiation of appropriate treatment as soon as possible. The OSOM BVBlue by Sekisui Diagnostics, is a rapid test that detects sialidase activity in a vaginal sample from the following bacterial pathogens: Gardnerella, Bacteroides, Prevotella, and Mobiluncus. OSOM BVBlue is an easy-to-use, cost-efficient, point-of-care diagnostic test that provides rapid results, allowing a test-and-treat approach to the management of patients with BV. Visit Sekisui Diagnostics

Herpes simplex virus assays

The HSV Molecular Proficiency Testing product consists of three samples which are shipped twice per year. The liquid samples are designed for molecular detection of herpes simplex virus (HSV) 1 & 2. Molecular testing provides laboratories quicker turnaround times and reliable results. WSLH PT offers proficiency testing compatible with laboratory-developed PCR tests or numerous molecular manufacturer assays. Visit WSLH Proficiency Testing

ELISA test systems

The menu of ZEUS ELISA Test Systems includes, among many others, assays for detection of IgG and IgM antibodies to Epstein-Barr virus, measles, mumps, rubella, varicella zoster, cytomegalovirus, and herpes simplex virus 1 and 2. ZEUS ELISA Test Systems use common reagents and a universal protocol across nearly the entire menu, and offer flexible incubation times for fast, simple programming on open automation platforms and easier integration into the laboratory. Virtually the entire menu is also available in Gold SmartKit format for use with the Dynex Agility to deliver random access automation at the cost of ELISA. Visit ZEUS