{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,3]],"date-time":"2025-10-03T00:22:44Z","timestamp":1759450964298,"version":"build-2065373602"},"reference-count":33,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2024,2,25]],"date-time":"2024-02-25T00:00:00Z","timestamp":1708819200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100009592","name":"Beijing Municipal Science and Technology Commission","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100009592","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Journal of Medical Virology"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>The detection of high\u2010risk human papillomaviruses (HPVs) is crucial for early screening and preventing cervical cancer. However, the substantial workload in high\u2010level hospitals or the limited resources in primary\u2010level hospitals hinder widespread testing. To address this issue, we explored a sample\u2010to\u2010answer genotyping system and assessed its performance by comparing it with the traditional real\u2010time polymerase chain reaction\u00a0(PCR) method conducted manually. Samples randomly selected from those undergoing routine real\u2010time PCR detection were re\u2010analyzed using the fully automatic GenPlex\u00ae system. This system identifies 24 types of HPV through a combination of ordinary PCR and microarray\u2010based reverse hybridization. Inconsistent results were confirmed by repeated testing with both methods, and the <jats:italic>\u03ba<\/jats:italic> concordance test was employed to evaluate differences between the two methods. A total of 365 samples were randomly selected from 7259 women. According to real\u2010time PCR results, 76 were high\u2010risk HPV negative, and 289 were positive. The GenPlex\u00ae system achieved a <jats:italic>\u03ba<\/jats:italic> value greater than 0.9 (ranging from 0.920 to 1.000, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001) for 14 types of high\u2010risk HPV, except HPV 51 (<jats:italic>\u03ba<\/jats:italic>\u2009=\u20090.697, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001). However, the inconsistent results in high\u2010risk HPV 51 were revealed to be false positive in real\u2010time PCR by other method. When counting by samples without discriminating the high\u2010risk HPV type, the results of both methods were entirely consistent (<jats:italic>\u03ba<\/jats:italic>\u2009=\u20091.000, <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.0001). Notably, the GenPlex\u00ae system identified more positive cases, with 73 having an\u00a0HPV type not covered by real\u2010time PCR, and 20 potentially due to low DNA concentration undetectable by the latter. Compared with the routinely used real\u2010time PCR assay, the GenPlex\u00ae system demonstrated high consistency. Importantly, the system's advantages in automatic operation and a sealed lab\u2010on\u2010chip format respectively reduce manual work and prevent aerosol pollution. For widespread use of GenPlex\u00ae system, formal clinical validation following international criteria should be warranted.<\/jats:p>","DOI":"10.1002\/jmv.29496","type":"journal-article","created":{"date-parts":[[2024,2,25]],"date-time":"2024-02-25T14:04:55Z","timestamp":1708869895000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Analytical evaluation of the automated genotyping system (GenPlex) compared to a traditional real\u2010time PCR assay for the detection of high\u2010risk human papillomaviruses"],"prefix":"10.1002","volume":"96","author":[{"given":"Lijuan","family":"Zhang","sequence":"first","affiliation":[{"name":"The Fifth Medical Center of Chinese PLA General Hospital Beijing China"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yan","family":"Ju","sequence":"additional","affiliation":[{"name":"The Fifth Medical Center of Chinese PLA General Hospital Beijing China"},{"name":"The 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