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

February 2008: Volume 34, Number 2

FDA Clears Two-Hour MRSA Test

Becton Dickinson (Franklin Lakes, N.J.) announced the FDA clearance of its GeneOhm StaphSR assay, making it the first test available to rapidly differentiate two deadly healthcare-associated infections: Staphylococcus aureus and MRSA. The assay provides results in 2 hours, directly from positive blood cultures, thereby helping physicians to implement the right antimicrobial thearapy. Traditional microbiology algorithms can take up to 2 days to generate results. BD said it has submitted subsequent applications to the FDA to add nasal swab and wound claims to the StaphSR assay.

FDA Clears Multiplex Respiratory Viral Test

Luminex Corporation (Austin, Texas) announced the FDA clearance of its xTAG Respiratory Viral Panel (RVP), the first cleared assay to simultaneously identify 12 viruses and viral subtypes that account for more than 85% of respiratory viral infections. The panel is also the first to detect and differentiate influenza subtypes H1 and H3, and to identify human metapneumovirus (hMPV). Testing for the viruses separately with traditional methods would take several days for diagnosis, while the xTAG assay provides qualitative results within a few hours. Other viruses identified by the panel include: influenza B; respiratory syncytial virus subtype A and B; parainfluenza 1, 2, and 3; rhinovirus; and adenovirus.

   FDA Clears Three-Virus Flu Test 

The FDA cleared Prodess’s (Waukesha, Wis.) real-time PCR ProFlu+ assay that detects influenza A, B, and RSV from a single specimen. It’s the first cleared, real-time molecular test to detect as many as three viruses simultaneously. Results of the test are available in about 3 hours.

   Automated Hepatitis B Test Approved

Abbott (Abbott Park, Ill.) announced it received premarket approval from the FDA for its ARCHITECT CORE-M automated hepatitis B assay, a chemiluminescent microparticle immunoassay for the qualitative detection of IgM antibodies to hepatitis B core antigen virus. The test is approved to aid in the diagnosis of acute or recent hepatitis B viral infection.

  Plague and Tularemia Kits Cleared

Idaho Technology (Salt Lake City, Utah) announced FDA clearance of two new biothreat detection kits, the JBAIDS Plague and JBAIDS Tularemia detection kits. Both tests use real-time PCR and run on the company’s JBAIDS instrument, designed for on-site analysis of dangerous biological pathogens. The kits can be used to test blood, sputum, positive blood cultures, and colonies, yielding results in less than four hours.