Concordant testing results between various Human Papillomavirus assays in primary cervical cancer screening: systematic review

OBJECTIVES: Human Papillomavirus (HPV) assays are increasingly used for primary cervical screening and HPV vaccination effect monitoring. We undertook a systematic literature review to determine the concordance in positive test results (i.e., detection of HPV infections) between Hybrid Capture 2 (HC2) and other assays.

METHODS: We searched PubMed, Embase and Scopus for studies of primary screening with HC2 and ≥one more assay, with cross-tabulated testing results for the assays. Two authors applied inclusion criteria and three authors extracted data from included studies. For each inter-assay comparison, we calculated the concordance by comparing the number of concordant samples with the number of samples that tested positive on at least one assay.

RESULTS: Sixteen studies fulfilled inclusion criteria, comparing nine assays to HC2, and including 392 to 6000 patients each. The calculated concordance varied between assays and studies between 48% and 69% for HC2 and APTIMA, Cobas, Abbott RealTime, Cervista, GP5+/6+, CLART, BD HPV test, Amplicor, Linear Array, i.e. 31-52% of all positive tests on any pair of compared assays were discordant. Although modest variation in the degree of concordance with HC2 was suggested for particular assays, the numbers of studies per assay were generally low. No pronounced systematic patterns were observed by study (e.g. liquid medium) or population characteristics.

CONCLUSIONS: The ten commercially available assays do not detect the same HPV infections. Even in the most favorable case, the two assays provided discordant test results in 31% of all detected infections.