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

Peng XueLi-Li GaoJian YinLi-Li HanJing ZhaoLi LiSamuel SeeryXue-Yan HanTing-Yuan LiYu JiangWen ChenJie Shen
Published in: Journal of medical virology (2019)
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.
Keyphrases
  • high grade
  • cervical cancer screening
  • low cost
  • healthcare
  • high resolution
  • newly diagnosed
  • dna methylation
  • liquid chromatography
  • patient reported outcomes
  • drug induced
  • patient reported