การเปรียบเทียบผลการตรวจ HPV DNA ชนิดความเสี่ยงสูง (16/18 กับ non 16/18) และความผิดปกติของเซลล์ปากมดลูกระหว่างชนิดของเครื่องและน้ำยาตรวจที่แตกต่างกัน: การศึกษาแบบหลายศูนย์ใน 4 ภูมิภาคของประเทศไทย

Phanchanut Mahantassanapong; Teerapong Wongwiboolchai; Apichat  Chumtong; Suthiporn  Prom-agsorn

doi:10.64960/srimedj.v41i3.271191

Authors

Phanchanut Mahantassanapong Department of Anatomical Pathology, Surin Hospital, Surin Province, Thailand 32000
Teerapong Wongwiboolchai Department of Anatomical Pathology, Sunpasitthiprasong Hospital, Ubon Ratchathani Province, Thailand 34000
Apichat Chumtong Department of Anatomical Pathology, Buddhachinaraj Hospital, Phitsanulok Province, Thailand 65000
Suthiporn Prom-agsorn Department of Anatomical Pathology, Maharaj Nakhon Si Thammarat Hospital, Nakhon Si Thammarat Province, Thailand 80000

DOI:

https://doi.org/10.64960/srimedj.v41i3.271191

Keywords:

human papillomavirus DNA tests, HPV 16/18 genotypes, cervical cytology, diagnostic reagents and equipment, multicenter study

Abstract

Background and objective: HPV DNA testing is a key tool recommended by the World Health Organization (WHO) for cervical cancer screening, particularly for detecting high-risk HPV (hrHPV) types such as HPV 16 and 18, which are strongly associated with cervical cancer. However, test performance (sensitivity and specificity) may vary across different platforms and reagent kits, potentially influencing clinical interpretation and management. This study aimed to compare different testing platforms and reagents in detecting high risk HPV DNA with liquid-based cytology (LBC), and colposcopy biopsy findings.

Methods: This retrospective descriptive study collected data from HPV screening records of Thai women in Surin, Ubon Ratchathani, Phitsanulok, and Nakhon Si Thammarat provinces who participated in the national cervical cancer screening program under the Ministry of Public Health, Thailand, between January 1 and December 31, 2024. HPV detection was performed by Real-time PCR using STARlet AIOS-Surin (STARlet), Abbott HPV Alinity m-Ubon Ratchathani (Abbott), Cobas 6800 system-Phitsanulok (Cobas 6800) and Cobas 4800 system-Nakhon Si Thammarat (Cobas 4800) with accompanying cervical colposcopy biopsy and liquid-based cytology (LBC). All data recorded on a non-duplicated, individual basis.

Results: A total of 12,552 Thai women underwent cervical cancer screening using high-risk HPV DNA testing by Real-time PCR in 2024. The overall HPV positivity rate was 10.0% (95%CI 9.4–10.5). Among HPV-positive cases, HPV 16/18 accounted for 27.8%, while non-16/18 high-risk HPV accounted for 79.7%. Surin Province showed the highest HPV positivity rate (19.7%), whereas Nakhon Si Thammarat showed the lowest (6.3%). Comparison of HPV DNA results from various HPV testing platforms against LBC and colposcopy biopsy results revealed that the STARlet instrument showed significantly higher detection rates of abnormal results for both HPV 16/18 and non-16/18 groups compared to all other platforms. Meanwhile, Abbott and Cobas 6800 instruments showed no difference in abnormal results, while the Cobas 4800 showed the lowest proportion of abnormal results.

Conclusions: This study found that HPV detection rates using Real-time PCR in Thai women, compared across four study sites using different test platform and kits, showed no statistically significant differences in the proportions of HPV 16/18 and non-16/18 detections. Comparison of HPV DNA results from various HPV testing platforms against LBC and colposcopy biopsy results revealed that the proportions of normal and abnormal findings differed significantly across platforms (p<0.001).

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