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“Aptima detected 20 samples that were not detected with the HPS/CTM. Fifteen of these were below the lower limit of quantitation on the HPS/CTM system. There was also one sample detected with HPS/CTM at a low but quantifiable level that was negative in the Aptima test. In addition, two samples were detected by both assays that were below the limit of quantitation, and 17 were detected and quantifiable by Aptima that were detected but below the limit of quantitation of the HPS/CTM test.”
NEW YORK (GenomeWeb) – Researchers in a clinical lab in Germany have validated the Hologic Aptima hepatitis C virus assay on the firm’s Panther system, showing it provides superior performance at low viral loads when compared to a widely used HCV assay from Roche.
The investigator-initiated study, published online earlier this month in the Journal of Clinical Microbiology, used reagents provided by Hologic and the data was convincing enough that the lab will now switch to the Aptima HCV test from the Roche test it had been using for decades, Gunnar Schalasta, lead author on the study and a microbiologist at the Labor Enders diagnostics lab, told GenomeWeb.
Labor Enders is a private clinical lab in Stuttgart, Germany, accredited according to European standards as well as those of CAP and CLIA. It offers a broad range of medical services to physicians, hospitals, and university hospitals in the fields of virology, molecular biology, clinical chemistry, and bacteriology, Schalasta said.
Read more…https://www.genomeweb.com/pcr/hologic-hepatitis-c-viral-load-test-fares-well-german-validation