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Clinical performance of the HPV DNA Array genotyping assay in detection of CIN2+ lesions with BS GP5+/6+ MPG Luminex tested cervical samples
Author(s) -
Pesic Aleksandra,
Krings Amrei,
Hempel Matthias,
Preyer Rosemarie,
Kaufmann Andreas M.
Publication year - 2020
Publication title -
journal of medical virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.782
H-Index - 121
eISSN - 1096-9071
pISSN - 0146-6615
DOI - 10.1002/jmv.25583
Subject(s) - genotyping , multiplex , colposcopy , medicine , cervical cancer , cervical intraepithelial neoplasia , multiplex polymerase chain reaction , virology , polymerase chain reaction , papillomaviridae , genotype , cancer , biology , bioinformatics , genetics , gene
Human papillomavirus (HPV) detection is used for screening of cervical cancer and genotype‐specific persistence has shown to be mandatory for dysplasia development. Aim of this study was to evaluate the clinical performance of HPV DNA Array for cervical intraepithelial neoplasia 2+ (CIN2+) lesion detection. HPV DNA Array is a polymerase chain reaction‐based assay that targets E1 sequences of 29 HPV types (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 44, 45, 51, 52, 53, 54, 56, 58, 59, 66, 67, 68, 69, 70, 73, 82, 85, and 97). The clinical evaluation was performed against the reference assay, BS‐GP5+/6+ multiplex genotyping (MPG)‐Luminex, with 600 cervical smear samples of a referral population. HPV DNA Array detected CIN2+ lesions with a sensitivity of 90.2%, identical to that of MPG‐Luminex. Detection of CIN3+ lesions was with a sensitivity of 90.3%, as compared with 88.7% of MPG‐Luminex. It demonstrated very good agreement for HPV detection, irrespective of type, of 91.5% ( κ = 0.832). HPV DNA Array is a simple and robust assay, with a short protocol of 4 hours hands‐on time and automated readout by ELISpot AiDot software. It permits testing of up to 96 samples in one run and may be considered for use in organized screening programs and low resource settings.