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Bio-Rad Quality Control Products Receive FDA Clearance

PHILADELPHIA (GenomeWeb) – At the American Association for Clinical Chemistry annual meeting here today, BioRad Laboratories announced that it has received 510(k)clearance from the US Food and Drug Administration for a multi-analyte quality control designed to monitor the performance of in vitro nucleic acid tests for viral load assays used in the diagnosis of human immunodeficiency type 1, hepatitis B, and hepatitis C viruses.

The company also reported that it has received de novo clearance from the FDA for a multi-analyte quality control that monitors the performance of in vitro nucleic acid test systems for healthcare associated infections, including C. difficile, methicillin-resistant Staphylococcus aureus, andmethicillin-sensitive Staphylococcus aureus. The company also expects to soon receive clearance for a multi-analyte quality control that monitors the performance of in vitro nucleic acid test systems for sexually transmitted infections encompassing Neisseria gonorrhoeae and Chlamydia trachomatis, and human papilloma virus.

Quality issues are expensive for large- and small-volume labs. The larger labs need to manage large volumes of samples that have been affected when a problem is discovered. In the smaller labs, quality issues can take a long time to detect, also leading to an increasing volume of affected samples.

There are multiple advantages to these molecular quality controls, according to the firm. They are independent, meaning they are manufactured independently from instruments, reagents, and calibrators. They are similar to patient samples, in that pathogens undergo an analytical process that includes extraction, amplification, and detection. And they enable consistency between lots and the use of quality control management software and inter-laboratory peer comparison programs, Bio-Rad officials said.

Bio-Rad's quality control products unite the processes of small- and large-volume labs, enabling lab staff to maintain the same level of quality across the board, according to the firm.