The borderline or weakly positive Hybrid Capture II HPV test: A statistical and comparative (PCR) analysis - 25/08/11
Reprint requests: Christopher P. Crum, MD, Department of Pathology, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115.Abstract |
Objectives |
Recent studies have hypothesized that laboratory contamination may influence interpretation of Hybrid Capture II (HCII) human papillomavirus (HPV) detection assay values.
Study design |
To test this hypothesis, 572 consecutive HCII samples were statistically evaluated to test the null hypothesis that cross-well contamination was not present. In addition, 874 consecutive paired samples from patients followed by both HCII and polymerase chain reaction (PCR) analysis were compared.
Results |
A Kendall's tau measure of association among adjacent wells yielded a P value of .016, rejecting the null hypothesis of no contamination. Analysis of relative light unit values between 0.8 and 1.5 rejected the null hypothesis at P=.077. Moreover, PCR positivity was significantly higher for samples with HCII values above 1.5 vs 0.8 to 1.5 (P=.001).
Conclusion |
Cross-well contamination of samples occurs during processing, and may influence interpretation of some borderline positives. The proportion of cases at risk is low (<3%). Nevertheless, this information may be germane to the interpretation and reporting of marginally positive HCII test values.
Le texte complet de cet article est disponible en PDF.Keywords : Human papillomavirus, Hybrid capture, Cervical neoplasms, Papanicolaou smear, HPV testing
Plan
Vol 191 - N° 3
P. 757-761 - septembre 2004 Retour au numéro
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