September 2015 Product Focus – Infectious Disease

MP Biomedicals, LLC is pleased to announce FDA approval of its HTLV Blot 2.4 confirmatory assay. This assay confirms and differentiates antibodies to HTLV-I and HTLV-II in blood donors. An important differentiator of the HTLV Blot 2.4 design is the incorporation of the patented GD21 recombinant envelope protein, recombinant proteins specific to HTLV-I and HTLV-II, and HTLV viral lysate. Sensitivity and specificity are greatly enhanced, providing laboratories with reliable results for both conformation and differentiation between HTLV-I and HTLV-II infections.
For more information, please visit: http://www.mpbio.com/news.php?nid=21

The Verigene Enteric Pathogens Test (EP) (510(k) cleared) is a multiplexed, automated test for the detection of the most common causes of acute gastroenteritis, including Salmonella, Shigella, Campylobacter, Vibrio, Yersinia enterocolitica, Shiga Toxin 1, Shiga Toxin 2, Norovirus, and Rotavirus. EP provides identification within 2 hours from a stool sample in Cary-Blair and is an easy-to-use, cost-effective alternative to traditional stool diagnostics. The Verigene System allows for true random access test processing, enabling 24/7 on-demand testing with less than 5 minutes of hands-on time per test.
For more information, please visit: http://www.nanosphere.us/products/enteric-pathogens-test

Randox Biosciences Respiratory Multiplex Array is a comprehensive screening test for infections of both the upper and lower respiratory tracts, simultaneously detecting 22 bacterial and viral pathogens from a single sputum, lavage or nasopharyngeal sample. Pathogen detection via NAATs offers rapid, multiplex detection of viral, bacterial and protozoan pathogens. Following nucleic acid extraction target DNA/cDNA is amplified in a single reaction and subsequently hybridised to a biochip array containing multiple pathogen-specific probes. This highly sensitive and specific process enables identification of primary and co-infections simultaneously, often in asymptomatic patients, therefore enabling antibiotic stewardship.
For more information, please visit: http://www.randoxbiosciences.com/respiratory-multiplex-array/

Herpes simplex viruses (HSV) are one of the most common causes of sexually transmitted infections and encephalitis. Nearly 1 in 6 individuals between the ages of 14 and 49 has a genital HSV infection. Encephalitis occurs in all ages, from neonates to adults, and during all seasons. HSV encephalitis may have devastating results. Untreated HSV CNS infection can reach mortality rates as high as 70% and for those who survive, only a minority will achieve full recovery. IDSA guidelines recommend HSV PCR testing on CSF from patients exhibiting signs of encephalitis infection. ACOG has recognized that HSV PCR is 1.5 – 4 times more sensitive than viral culture, samples are easier to maintain, and PCR is the test of choice for diagnosis of infections of the CNS. The product is for sale in nations accepting the CE Mark. In the USA, the product is cleared only for use with CSF. Use with genital swabs is pending 510(k) clearance.
For more information, please visit: http://www.focusdx.com/

PositiveID’s Firefly Dx is designed to provide real-time, accurate diagnostic results in a handheld device, thereby leading to treatment scenarios at the point of need that are not possible with existing systems, which require lab-based equipment, highly trained personnel, and can take hours or even days to provide results. Firefly’s applications include point-of-need, lab-quality, detection of pathogenic organisms; agricultural screening in both domestic sectors and developing countries; and detection of biological agents associated with weapons of mass destruction. Firefly Dx is does not require additional equipment or separate steps for sample preparation and purification.
For more information, please visit: http://www.psidcorp.com/our-products/firefly-dx