AcroMetrix, a leading manufacturer of quality control standards and controls for clinical diagnostic and blood testing laboratories, announced the release of the first standardized quality control for molecular Group B Streptococcus (GBS) testing. The OptiQual GBS Positive Control is designed to help clinical laboratories comply with CLIA guidelines for qualitative molecular assays that detect Group B Streptococcus DNA, ensuring accuracy and precision throughout the testing procedure.

Colonization of an expectant mother with Group B Streptococcus can pose an extreme threat to the newborn, potentially causing pneumonia, sepsis, or meningitis. In order to appropriately manage prevention of GBS transmission, obstetricians and labor and delivery nurses are beginning to utilize the more rapid and sensitive methods of PCR-based GBS detection.

"As rapid, point-of-care molecular assays for Group B Streptococcus begin to replace the traditional culture-screening method, doctors and clinical laboratory technologists will want appropriate quality control materials to accurately monitor the performance of their assays," says Michael J. Eck, President and CEO of AcroMetrix. "Ultimately, the goal is for doctors to more efficiently administer antibiotic prophylaxis in order to prevent GBS transmission from a mother to her newborn. AcroMetrix is dedicated to helping doctors achieve this goal by providing quality control products such as the OptiQual GBS Positive Control."

The OptiQual GBS Positive Control is unassayed and contains inactivated whole Group B Streptococcus bacteria, providing a safer method of monitoring the entire molecular testing procedure from extraction through amplification and detection. Convenient and ready to use, the OptiQual GBS Positive Control is stored at refrigerated temperatures. This product is for in vitro diagnostic use.

OptiQual is a registered trademark of AcroMetrix.

Source
AcroMetrix