About 30~40% ASCUS women and 80% LSIL women are high risk HPV (HR-HPV) positive, while the prevalence of CIN2+ is about 3~9% and 15%, respectively. This indicated that there may be clinical benefit in stratifying HR-HPV positive women with ASCUS/LSIL by HPV genotypes. In this study, we evaluated the clinical performance of onclarity HPV test for partial HPV genotypes among women with ASCUS/LSIL cytology.
320 (221 ASCUS and 99 LSIL) women with cytological ASCUS/LSIL were recruited in the study. All those participants were referred colposcopy and directed biopsy, four-quadrant cervical biopsy was conducted when no visible lesions were found under colposcopy. All of the cervical samples were tested by cobas HPV test and onclarity HPV test with nine typing channels: HPV16, HPV18, HPV31, HPV45, HPV51, HPV52, HPV33/35, HPV35/39/68 and HPV56/59/66.
The agreement rate between cobas HPV test and onclarity HPV test was satisfactory for testing 14 types HR-HPV, HPV16, HPV18 and HPV non-16/18, as for positivity agreement rate and kappa value, those two tests also showed preferably performance except HPV 18. BD onclarity HPV test can provide more HPV genotypes information that can be used for evaluation of ASCUS/LSIL triage. On the basis of HPV16/18, other HPV types by their risk grade were sequentially added into 6 groups, marked as subG1 (HPV16/18/31), subG2 (HPV16/18/31/33/58), subG3 (HPV16/18/31/33/58/35/39/68), subG4 (HPV16/18/31/33/58/39/68/35/52), subG5 (HPV16/18/31/33/58/39/68/35/52/45) and subG6 (HPV16/18/31/33/58/39/68/35/52/45/51). We found that the AUC increased when HPV31, HPV33/58, and HPV35/39/68 were added into the groups (AUC: subG1=0.687, subG2=0.746, and subG3=0.755), while it decreased when HPV52, HPV45, HPV51, and HPV59/66/68 were added into other groups (AUC: subG4=0.748, subG5=0.746, subG6=0.743, and pooled 14 HR-HPV=0.709). AR (absolute risk) of CIN2+ was lower among women with HPV52/45/51/66/68 positive than that of pooled 14 HR-HPV types positive in cytological ASCUS/LSIL women [17.1% (95%CI: 9.93%-27.8%) vs. 35.0% (95%CI: 28.0%-42.8%)]. Compared with women with HPV52/45/51/66/68 positive, the risk of CIN2+ among women with HPV 16/18, HPV31, and HPV33/58 positive were 3.35 (95%CI:1.89-10.1), 2.43 (95%CI:1.04-5.66) and 2.22 (95%CI: 1.17-4.23), respectively.
The management of women with HPV 16/18/31/33/58 positive should be different from women with other 9 types HPV positive in China. Women with cytology ASCUS/LSIL and HPV 16/18/31/33/58 positive referred to colposcopy seemed to be of better clinical performance.