TY - JOUR
T1 - The borderline or weakly positive Hybrid Capture II HPV test
T2 - A statistical and comparative (PCR) analysis
AU - Federschneider, Jerome M.
AU - Yuan, Liping
AU - Brodsky, Joshua
AU - Breslin, Gillian
AU - Betensky, Rebecca A.
AU - Crum, Christopher P.
PY - 2004/9
Y1 - 2004/9
N2 - 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.
AB - 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.
KW - Cervical neoplasms
KW - HPV testing
KW - Human papillomavirus
KW - Hybrid capture
KW - Papanicolaou smear
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U2 - 10.1016/j.ajog.2004.03.077
DO - 10.1016/j.ajog.2004.03.077
M3 - Article
C2 - 15467536
AN - SCOPUS:4644303264
SN - 0002-9378
VL - 191
SP - 757
EP - 761
JO - American Journal of Obstetrics and Gynecology
JF - American Journal of Obstetrics and Gynecology
IS - 3
ER -