Open AccessComparison of Three Different Commercial Kits for the Human Papilloma Virus Genotyping
Author(s) -
Lim Yong Kwan,
Choi JeeHye,
Park Serah,
Kweon Oh Joo,
Park Ae Ja
Publication year - 2016
Publication title -
journal of clinical laboratory analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.536
H-Index - 50
eISSN - 1098-2825
pISSN - 0887-8013
DOI - 10.1002/jcla.21989
Subject(s) - genotyping , concordance , polymerase chain reaction , genotype , human papilloma virus , cervical cancer , virology , gold standard (test) , biology , medicine , cancer , genetics , gene
Background High‐risk type human papilloma virus ( HPV ) is the most important cause of cervical cancer. Recently, real‐time polymerase chain reaction and reverse blot hybridization assay‐based HPV DNA genotyping kits are developed. So, we compared the performances of different three HPV genotyping kits using different analytical principles and methods. Methods Two hundred positive and 100 negative cervical swab specimens were used. DNA was extracted and all samples were tested by the MolecuTech REBA HPV ‐ ID , Anyplex II HPV 28 Detection, and HPVDNAC hip. Direct sequencing was performed as a reference method for confirming high‐risk HPV genotypes 16, 18, 45, 52, and 58. Results Although high‐level agreement results were observed in negative samples, three kits showed decreased interassay agreement as screening setting in positive samples. Comparing the genotyping results, three assays showed acceptable sensitivity and specificity for the detection of HPV 16 and 18. Otherwise, various sensitivities showed in the detection of HPV 45, 52, and 58. Conclusions The three assays had dissimilar performance of HPV screening capacity and exhibited moderate level of concordance in HPV genotyping. These discrepant results were unavoidable due to difference in type‐specific analytical sensitivity and lack of standardization; therefore, we suggested that the efforts to standardization of HPV genotyping kits and adjusting analytical sensitivity would be important for the best clinical performance.