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J Med Virol. 2019 Jul;91(7):1342-1350. doi: 10.1002/jmv.25451. Epub 2019 Mar 21.

A direct comparison of four high-risk human papillomavirus tests versus the cobas test: Detecting CIN2+ in low-resource settings.

Author information

1
Department of Cancer Epidemiology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
2
School of Public Health, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
3
Department of Women's Health Care, Beijing Obstetrics and Gynecology Hospital, Capital Medical University Beijing Maternal and Child Health Care Hospital, Beijing, China.
4
School of Humanities and Social Sciences, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

Abstract

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.

KEYWORDS:

INNO-LiPA; cervical screening; cobas HPV test (cobas); human papillomavirus (HPV); real-time polymerase chain reaction (PCR)

PMID:
30854653
DOI:
10.1002/jmv.25451

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