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Comparison of Cobas 4800 HPV test with PANA RealTyper HPV screening kit for detection of high risk human papillomavirus
( Ji Young Kim ) , ( Awon Lee ) , ( Seoung Eun Bak ) , ( Min Jong Song ) , ( Eun Young Ki )
UCI I410-ECN-0102-2021-500-000665868
This article is 4 pages or less.

Objective: The aim of this study was to compare the detection of high risk human papillomavirus(HPV) using Cobas 4800 HPV test and PANA RealTyper HPV screening kit in women with abnormal cytologic results or high risk of HPV infection. Methods: Cervical swab specimens, which were obtained for cytologic exam, were collected from a total of 672 women at Seoul St. Mary’s hospital between January 2015 and October 2018. HPV testing were performed by using cobas 4800 HPV test, PANA RealTyper HPV screening kit and direct sequencing. Results: The overall concordance rate between the cobas 4800 HPV test and PANA RealTyper HPV screening kit was 93.8% in detection of high risk HPV. Between both HPV tests, the positive agreement was 83.5% and negative agreement was 97.8% (κ-value =0.83) in detection of HPV 16. Also, the positive agreement was 93.3% and negative agreement was 99.4% (κ-value =0.93) in detection of HPV 18. The sensitivity and specificity of cobas 4800 HPV test for detection of ≥high grade squamous intraepithelial lesion(HSIL) were 100%(95% CI 79.6-100) and 61.6%(95% CI 57.3-65.7), respectively. The sensitivity and specificity of PANA RealTyper HPV screening kit were 93.3%(95% CI 70.2-98.8) and 61.6%(95% CI 57.3-65.7), respectively. The positive predictive value of cobas 4800 HPV test and PANA RealTyper HPV screening kit were 7.1%( 95% CI 4.4-11.4) and 6.7%(95% CI 4.0-10.9), respectively. And the negative predictive values of those were 100%(95% CI 98.8-100) and 99.7%(95% CI 98.2-99.9), respectively. Conclusion: The results showed high concordance rate between cobas 4800 HPV test and PANA RealTyper HPV screening kit and similar ability to detect high risk HPV. As a result, PANA RealTyper HPV screening kit was as effective as cobas 4800 HPV test.

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