Author/Editor		Seme, Katja; Fujs, Kristina; Kocjan, Boštjan J; Poljak, Mario
Title		Resolving repeatedly borderline results of Hybrid Capture 2 HPV DNA Test using polymerase chain reaction and genotyping
Type		članek
Source		J Virol Methods
Vol. and No.		Letnik 134, št. 1-2
Publication year		2006
Volume		str. 252-6
Language		eng
Abstract		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.
Descriptors		REAGENT KITS, DIAGNOSTIC FALSE NEGATIVE REACTIONS FALSE POSITIVE REACTIONS GENES, VIRAL NUCLEIC ACID HYBRIDIZATION POLYMERASE CHAIN REACTION PREDICTIVE VALUE OF TESTS SENSITIVITY AND SPECIFICITY SPECIES SPECIFICITY