OraSure Obtains CLIA Waiver for HCV Test
FDA has granted OraSure Technologies, Inc. a CLIA waiver for its OraQuick HCV Rapid Antibody Test for use with fingerstick, whole-blood, and venous whole-blood specimens. The OraQuick HCV Rapid Antibody Test is designed for detecting antibodies to the hepatitis C virus (HCV). This waiver allows more than 180,000 sites in the U.S., such as outreach clinics, community-based organizations, and physician offices, to use the device.
Clearance for Abbott's Vitamin D Test
Abbott has received FDA clearance to market its fully-automated test to measure vitamin D levels. The ARCHITECT 25-OH Vitamin D assay measures the stable form of vitamin D, 25-hydroxyvitamin D (25-OH vitamin D), the body's repository of vitamin D.
Group B Strep Test Cleared
FDA has cleared Meridian Bioscience's molecular diagnostic test for Group B Streptococcus (GBS). The illumigene GBS test uses loop-mediated isothermal DNA amplification technology to detect Streptococcus agalactiae in enriched cultures of samples from pregnant women. S. agalactiae is a major prenatal pathogen for mothers and their infants, and is associated with significant morbidity and mortality. The test allows labs to comply with recommendations from the Centers for Disease Control and Prevention calling for universal culture-based screening to be performed at 35 to 37 weeks of gestation.
Supplemental Test for Chagas Disease Approved
FDA approved Abbott's ESA Chagas test for use as an additional, more specific test on human serum or plasma specimens found to be positive for antibodies to Trypanosoma cruzi. The test is an in vitro enzyme strip assay designed to qualitatively detect antibodies to T. cruzi, the parasite responsible for Chagas disease, a serious and potentially fatal parasitic infection.