Diagnostics Product Guide » Immunoassays

First HIV diagnostic assay approved

admin — Tue, 20 Oct 2009 07:26:29 +0000

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.

VITROS(R) 3600 Immunodiagnostic System Receives 510(k) Clearance From The FDA

admin — Fri, 02 Jan 2009 08:46:02 +0000

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 launches one-step virus titration kit

admin — Tue, 13 May 2008 16:44:32 +0000

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.

Use of Roche Diagnostics Elecsys Anti-HCV assay expanded

admin — Thu, 24 Apr 2008 18:46:37 +0000

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.

Eisai, Sanko Junyaku launch pneumonia test kits

admin — Tue, 25 Mar 2008 15:01:59 +0000

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.