ROCHE reports that the US Food and Drug Administration (FDA) has accepted the use of the Roche MycoTool PCR-based mycoplasma detection test for release testing of one of the company’s biopharmaceutical products.
This makes MycoTool the first commercially-available mycoplasma polymerase chain reaction (PCR) test to win such approval, enabling it to replace slower conventional mycoplasma detection assays based on culture methods.
Traditional detection tests for mycoplasms, known as a contaminant in biopharmaceutical manufacturing, tissue engineering, and vaccine production, rely on in vitro assays and growth on culture plates in order to identify and detect contaminating organisms. This can take as long as 28 days to complete.
The MycoTool kit includes all reagents needed to complete a PCR test for mycoplasms. Roche says it offers high sensitivity (better than 1 CFU/ml for most isolates) and is compatible with many sample types including human, canine, primate, and rodent cells, and also detects the broad panel of Mollicute species encompassing mycoplasma, spiroplasma, and acholeplasma.
The test is also said to minimise false negative and false positive results, through the use of lysis controls to eliminate undetected intracellular mycoplasma in the matrix and verify potential PCR inhibition. Reagents are free of nucleic acid to prevent false positives, and the use of uracil-DNA glycosylase minimises the chance of PCR carryover contamination.