Criteria for second generation comparator tests in validation of novel HPV DNA tests for use in cervical cancer screening

Marc Arbyn*, Kate Cuschieri, Jesper Bonde, Rob Schuurman, Clementina Cocuzza, Davy Vanden Broeck, Fang Hui Zhao, Remila Rezhake, Murat Gultekin, Silvia de Sanjosé, Karen Canfell, David Hawkes, Marion Saville, Peter Hillemanns, Joakim Dillner, Johannes Berkhof, Jean Luc Prétet, Tarik Gheit, Gary Clifford, Partha BasuMaribel Almonte, Nicolas Wentzensen, Mario Poljak

*Corresponding author af dette arbejde
1 Citationer (Scopus)

Abstract

While HC2 and GP5+/6+ PCR-EIA were pivotal in test validation of new HPV assays, they represent the first generation of comparator tests based upon technologies that are not in widespread use anymore. In the current guideline, criteria for second-generation comparator tests are presented that include more detailed resolution of HPV genotypes. Second-generation comparator tests should preferentially target only the 12 genotypes classified as carcinogenic (IARC-group I), and show consistent non-inferior sensitivity for CIN2+ and CIN3+ and specificity for ≤CIN1 compared to one of the first-generations comparators, in at least three validation studies using benchmarks of 0.95 for relative sensitivity and 0.98 for relative specificity. Validation should take into account used storage media and other sample handling procedures. Meta-analyses were conducted to identify the assays that fulfill these stringent criteria. Four tests fulfilled the new criteria: (1) RealTime High-Risk HPV Test (Abbott), (2) Cobas-4800 HPV test (Roche Molecular System), (3) Onclarity HPV Assay (BD Diagnostics), and (4) Anyplex II HPV HR Detection (Seegene), each evaluated in three to six studies. Whereas the four assays target 14 carcinogenic genotypes, the first two identify separately HPV16 and 18, the third assay identifies five types separately and the fourth identifies all the types separately.

OriginalsprogEngelsk
Artikelnummere29881
TidsskriftJournal of Medical Virology
Vol/bind96
Udgave nummer9
Sider (fra-til)e29881
ISSN0146-6615
DOI
StatusUdgivet - sep. 2024

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