JOURNAL ARTICLE

Resolving repeatedly borderline results of Hybrid Capture 2 HPV DNA Test using polymerase chain reaction and genotyping

Katja Seme, Kristina Fujs, Bostjan J Kocjan, Mario Poljak
Journal of Virological Methods 2006, 134 (1): 252-6
16417931
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 to 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 genotyping in order to resolve their high-risk HPV status. All PGMY09/PGMY11 PCR negative samples were tested in addition using CPI/IIg consensus PCR. A false negative rate of 11.3% and false positive rate of 19.1% were recorded in the samples with repeatedly borderline hc2 results. The corresponding hc2 false reactivity rates in 95 samples selected at random which were clearly hc2 negative (samples with RLU/CO values less than 0.4) and 124 samples selected at random which were clearly hc2 positive (samples with RLU/CO values more than 4.0) were 4.2% and 5.6%, respectively. The proportion of hc2 false reactivity increased with proximity to the hc2 cut-off value. According to the results of the present study, the introduction of an hc2 grey-zone and retesting of samples with repeatedly borderline hc2 results by an alternate HPV detection method, such as the PGMY09/PGMY11 consensus PCR and genotyping, is recommended.

Full Text Links

Find Full Text Links for this Article

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read
16417931
×

Save your favorite articles in one place with a free QxMD account.

×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"