Ortho Clinical Diagnostics received the FDA approval of a diagnostic assay for the detection of antibodies to human immunodeficiency virus (HIV) types 1+2 (Anti-HIV 1+2) for use on the VITROS® 5600 Integrated and VITROS® 3600 Immunodiagnostic Systems. This is the first HIV diagnostic assay approved for an integrated system in the US, allowing laboratories to run HIV and other routine tests on a single testing platform and eliminating the need for expensive batch testing of multiple patient samples.

Ortho Clinical Diagnostics announced 510(k) clearance from the United States Food and Drug Administration (U.S. FDA) for its VITROS(R) 3600 Immunodiagnostic System. This new high-capacity immunoassay system provides laboratories with a truly innovative solution to address their quality, labor and cost challenges. The VITROS(R) 3600 delivers high-quality and dependable results by offering a broad and comprehensive immunoassay menu based on world-class VITROS(R) technologies. This is the second clearance for Ortho Clinical Diagnostics this quarter, following 510(k) clearance of the VITROS(R) 5600 Integrated System in October.

Oxford Expression Technologies (OET) has introduced baculoQUANT™, a novel one-step virus titration kit which can give an accurate result within 2 hours without the need for plaque assays or immunoassays. baculoQUANT™ is based on a technique called quantitative PCR (QPCR) and is a fast and cost-effective method of recombinant virus titration. This novel titration method has been proven to be a very accurate, reproducible and fast way to titrate recombinant baculoviruses1, both for single-use titrations and for high throughput applications on automated systems.

The Roche Diagnostics Elecsys Anti-HCV (hepatitis C virus) assay has now been approved for use in Europe for modular analytics and the e 601 module for the cobas 6000 platform. The assay is already available on the Elecsys 2010 and the cobas e 411 instruments. “The addition of anti-HCV assay to the E 170 analyser for modular analytics and the e 601 module for the cobas 6000 platform complements Roche’s already comprehensive menu of hepatitis immunodiagnostic and liver function assays, all of which can be accurately and simultaneously measured on a single blood sample to identify the underlying liver disorder,” the head of Roche Professional Diagnostics said.

Japan’s Eisai and its diagnostic subsidiary, Sanko Junyaku, have launched the Lumipulse KL-6 and Lumipulse Presto KL-6 Eisai test kits, which detect KL-6, a marker of interstitial pneumonia. These diagnostic systems use automated chemiluminescence enzyme immunoassay system marketed by Fujirebio. In 2006, the three companies entered into an agreement to develop new KL-6 test kits.