American Association for Clinical Chemistry
Better health through laboratory medicine
May 2008 Clinical Laboratory News: News from the FDA

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May 2008: Volume 34, Number 5


Third Wave’s CF Molecular Test Cleared


Third Wave Technologies announced the FDA clearance of its InPlex CF molecular test that simultaneously detects and identifies cystic fibrosis (CF) mutations in patient DNA samples. The test uses Third Wave’s Invader chemistry system, as well as a microfluidic card. The InPlex CF kit has multiple genotyping applications, including CF carrier screening for adults, an aid in newborn screening, and in confirmatory testing for CF in newborns and children. The test panel includes mutations and variants recommended by the 2004 American College of Medical Genetics.


FDA Clears bioMérieux’s VIDAS NT-proBNP Test


bioMérieux announced FDA clearance of its VIDAS NT-proBNP test for diagnosis of heart failure. The VIDAS NT-proBNP test is a quantitative marker of heart stress that offers a sensitivity of 92.3%, specificity of 92.2%, and a cutoff of 125 pg/mL for those under 75 years and a sensitivity of 92.3%, specificity of 92.2%, and cutoff of 450 pg/mL for patients older than 75. The assay requires 200µL of plasma or serum and has a time to first result of 20 minutes. The test kit includes calibration material, controls, and diluents and is traceable to the Roche Elecsys method.


Ortho-Clinical Gets Approval for New HIV Test


Ortho-Clinical Diagnostics announced the FDA approval of a new diagnostic assay for the detection of anti-HIV-1 and anti-HIV-2. The approval of the VITROS Anti-HIV 1+2 assay marks the first such test capable of being run in full random access mode with other tests and of providing immediate result reporting capability upon test completion. The test runs on the VITROS ECi/ECiQ Immunodiagnostic System, with results in less than 50 minutes.


FDA Clears IgG Test for Autoimmune Diseases


Corgenix Medical Corporation announced the clearance of the company’s IgG Anti-AtherOx test kit that detects antibodies in patients with autoimmune diseases. The test kit detects IgG antibodies to complexes formed by oxidized LDL (oxLDL) with B2-glycoprotein I (B2GPI) in patients with systemic lupus erythematosus (SLE) and lupus-like disorders, such as antiphospholipid syndrome.