{"title":"External quality assessment program for human papillomaviruses DNA testing in Thailand","authors":"Pilailuk Akkapaiboon Okada, Suratchana Mitrat, Archawin Rojanawiwat","doi":"10.1016/j.plabm.2023.e00352","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Since 2020, the National Health Security Office includes the human papillomavirus DNA testing for cervical cancer screening in the government's healthcare schemes. HPV DNA testing has become primary screening in many laboratories in Thailand. External quality assurance scheme is crucial for assessment of laboratory performance.</p></div><div><h3>Objectives</h3><p>The aim of this study was to develop a pilot program using LBC samples for the EQA of molecular methods and to review the methods used by participants to detect the presence of high risk HPV genotypes.</p></div><div><h3>Study design</h3><p>Four pilot distributions were shipped between December 2021 and May 2023, six months apart of two panels, each consisting of five different specimens.</p></div><div><h3>Results</h3><p>All participants achieved 100 % accuracy in correctly identifying the presence or absence of high-risk genotypes in all 5 EQA samples. The most used HPV DNA test for detecting the presence of high-risk HPV DNA was the two specific high-risk genotypes and 12 other high-risk HPV genotypes. There was an observed increase in the use of assays that could detect 14 HPV HR genotypes. It suggests expanding testing methods to include a broader range of high-risk HPV genotypes, which could improve the comprehensiveness of the testing.</p></div><div><h3>Conclusions</h3><p>The HPV DNA testing scheme provides a standardised, homogeneous and characterised clinical specimen. These results indicate that the LBC samples are suitable for utilisation in an EQA scheme. EQA of HPV molecular screening programme is essential for monitoring the performance of laboratory networks.</p></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":"38 ","pages":"Article e00352"},"PeriodicalIF":1.7000,"publicationDate":"2024-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S235255172300046X/pdfft?md5=61ada9388b561bef7cb4782b0dc85f5f&pid=1-s2.0-S235255172300046X-main.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Practical Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S235255172300046X","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
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Abstract
Background
Since 2020, the National Health Security Office includes the human papillomavirus DNA testing for cervical cancer screening in the government's healthcare schemes. HPV DNA testing has become primary screening in many laboratories in Thailand. External quality assurance scheme is crucial for assessment of laboratory performance.
Objectives
The aim of this study was to develop a pilot program using LBC samples for the EQA of molecular methods and to review the methods used by participants to detect the presence of high risk HPV genotypes.
Study design
Four pilot distributions were shipped between December 2021 and May 2023, six months apart of two panels, each consisting of five different specimens.
Results
All participants achieved 100 % accuracy in correctly identifying the presence or absence of high-risk genotypes in all 5 EQA samples. The most used HPV DNA test for detecting the presence of high-risk HPV DNA was the two specific high-risk genotypes and 12 other high-risk HPV genotypes. There was an observed increase in the use of assays that could detect 14 HPV HR genotypes. It suggests expanding testing methods to include a broader range of high-risk HPV genotypes, which could improve the comprehensiveness of the testing.
Conclusions
The HPV DNA testing scheme provides a standardised, homogeneous and characterised clinical specimen. These results indicate that the LBC samples are suitable for utilisation in an EQA scheme. EQA of HPV molecular screening programme is essential for monitoring the performance of laboratory networks.
期刊介绍：
Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.
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