Specimen Age Stability for Human Papilloma Virus DNA Testing Using BD SurePath.

BACKGROUND: Currently, the BD SurePath liquid-based Papanicolaou (Pap) test is approved by the U.S. Food and Drug Administration (FDA) only for Pap testing; however, these specimens are widely used for human papilloma virus (HPV) testing.
METHODS: We retested, at 21 days after the collection date, 50 BD SurePath specimens that had initially tested positive for high-risk HPV using the Roche Cobas 4800 assay to compare repeat results of aged specimens to original results and evaluate false-negative results.
RESULTS: Of 50 specimens that initially tested positive for HPV DNA with the Roche Cobas 4800 assay (average, 7 days), 8 tested negative when retested at 21 days after the collection date (false-negative rate, 16.0%).
CONCLUSION: Aged BD SurePath-preserved Pap test specimens older than 21 days from collection date may produce false-negative HPV DNA testing results when testing with assays such as Roche Cobas 4800, most likely due to degradation of DNA. Guidelines are needed to limit specimen age to less than 2 weeks to prevent false-negative test results and to improve diagnostic accuracy and patient care. Copyright© by the American Society for Clinical Pathology (ASCP).