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A direct comparison of four high‐risk human papillomavirus tests versus the cobas test: Detecting CIN2+ in low‐resource settings
Author(s) -
Xue Peng,
Gao LiLi,
Yin Jian,
Han LiLi,
Zhao Jing,
Li Li,
Seery Samuel,
Han XueYan,
Li TingYuan,
Jiang Yu,
Chen Wen,
Shen Jie
Publication year - 2019
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.25451
Subject(s) - mcnemar's test , medicine , genotyping , cervical intraepithelial neoplasia , cervical cancer , human papillomavirus , oncology , cervical cancer screening , cervical screening , gynecology , virology , cancer , genotype , biology , statistics , biochemistry , mathematics , gene
Low‐cost, accurate high‐risk human papillomavirus (HR‐HPV) tests are needed for cervical cancer screening in limited‐resource settings. More than 200 cervical cytological specimens from hospital patients were collected and analyzed for a real‐world study. We evaluated the analytical and clinical performance of four widely used HR‐HPV test (Tellgen, Hybribio, Liferiver, and Sansure) based on real‐time polymerase chain reaction technology platforms, compared with the cobas test. Cervical intraepithelial neoplasia grade 2 or worse lesions (CIN2+) were set as the disease endpoint, and all the five HPV tests were performed with equal sensitivity (McNemar's test; P = 0.971) and specificity (McNemar's test; P = 0.953). All genotyping using the INNO‐LiPA HPV test showed that HPV‐16, ‐52, and ‐54 were the most common types among CIN2+ cases. Overall, the four HR‐HPV tests analyzed appear to be as effective as the cobas HPV test in both agreement and clinical performance. Therefore, each of these low‐cost HPV test kits could be implemented in limited‐resource settings to accelerate the control of cervical cancer. However, we suggest that there is a need to further standardize and optimize testing around clinical sensitivity and specificity.