TY - JOUR
T1 - Optimal positive cutoff points for careHPV testing of clinician- and self-collected specimens in primary cervical cancer screening
T2 - An analysis from rural China
AU - Kang, Le Ni
AU - Jeronimo, Jose
AU - Qiao, You Lin
AU - Zhao, Fang Hui
AU - Chen, Wen
AU - Valdez, Melissa
AU - Zhang, Xun
AU - Bansil, Pooja
AU - Paul, Proma
AU - Bai, Ping
AU - Peck, Roger
AU - Li, Jing
AU - Chen, Feng
AU - Stoler, Mark H.
AU - Castle, Philip E.
PY - 2014/6
Y1 - 2014/6
N2 - careHPV, a lower-cost DNA test for human papillomavirus (HPV), is being considered for cervical cancer screening in low- and middle-income countries. However, not a single large-scaled study exists to investigate the optimal positive cutoff point of careHPV test. We pooled data for 9,785 women participating in two individual studies conducted from 2007 to 2011 in rural China. Woman underwent multiple screening tests, including careHPV on clinician-collected specimens (careHPV-C) and selfcollected specimens (careHPV-S), and Hybrid Capture 2 on clinician-collected specimens (HC2-C) as a reference standard. The primary endpoint was cervical intraepithelial neoplasia grade 3 or more severe (CIN3+) (n =127), and secondary endpoint was CIN2+(n =213). The area under the curves (AUCs) for HC2-C and careHPV-C were similar (0.954 versus 0.948, P=0.166), and better than careHPV-S (0.878; P>0.001 versus both). The optimal positive cutoff points for HC2-C, careHPV-C, and careHPV-S were 1.40, 1.74, and 0.85, respectively. At the same cutoff point, careHPV-C was not significantly less sensitive and more specific for CIN3+than HC2-C, and careHPV-S was significantly less sensitive for CIN3+than careHPV-C and HC2-C. Raising the cutoff point of careHPV-C from 1.0 to 2.0 could result in nonsignificantly lower sensitivity but significantly higher specificity. Similar results were observed using CIN2+endpoint. careHPV using either clinician- or self-collected specimens performed well in detecting cervical precancer and cancer. We found that the optimal cutoff points of careHPV were 2.0 on clinician- collected specimens and 1.0 on self-collected specimens.
AB - careHPV, a lower-cost DNA test for human papillomavirus (HPV), is being considered for cervical cancer screening in low- and middle-income countries. However, not a single large-scaled study exists to investigate the optimal positive cutoff point of careHPV test. We pooled data for 9,785 women participating in two individual studies conducted from 2007 to 2011 in rural China. Woman underwent multiple screening tests, including careHPV on clinician-collected specimens (careHPV-C) and selfcollected specimens (careHPV-S), and Hybrid Capture 2 on clinician-collected specimens (HC2-C) as a reference standard. The primary endpoint was cervical intraepithelial neoplasia grade 3 or more severe (CIN3+) (n =127), and secondary endpoint was CIN2+(n =213). The area under the curves (AUCs) for HC2-C and careHPV-C were similar (0.954 versus 0.948, P=0.166), and better than careHPV-S (0.878; P>0.001 versus both). The optimal positive cutoff points for HC2-C, careHPV-C, and careHPV-S were 1.40, 1.74, and 0.85, respectively. At the same cutoff point, careHPV-C was not significantly less sensitive and more specific for CIN3+than HC2-C, and careHPV-S was significantly less sensitive for CIN3+than careHPV-C and HC2-C. Raising the cutoff point of careHPV-C from 1.0 to 2.0 could result in nonsignificantly lower sensitivity but significantly higher specificity. Similar results were observed using CIN2+endpoint. careHPV using either clinician- or self-collected specimens performed well in detecting cervical precancer and cancer. We found that the optimal cutoff points of careHPV were 2.0 on clinician- collected specimens and 1.0 on self-collected specimens.
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U2 - 10.1128/JCM.03432-13
DO - 10.1128/JCM.03432-13
M3 - Article
C2 - 24671789
AN - SCOPUS:84901650520
SN - 0095-1137
VL - 52
SP - 1954
EP - 1961
JO - Journal of Clinical Microbiology
JF - Journal of Clinical Microbiology
IS - 6
ER -