Published in Medical Letter on the CDC and FDA, August 13th, 2006
According to a study from Slovenia, "The hybrid capture 2 HPV DNA test (hc2) (Digene Corporation, Gaithersburg, MD) is, at present, the only FDA-approved assay for routine detection of human papillomavirus (HPV) infections. A significant analytical inaccuracy of the hc2 near the cut-off was reported recently. To address this problem, 240 samples with repeatedly borderline/equivocal/indeterminate hc2 results (samples with repeated RLU/CO values between 0.4 and 4.0) were tested using the PGMY09/PGMY11 consensus PCR and...
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