Comparison of Three Different Commercial Kits for the Human Papilloma Virus Genotyping.
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 HPV28 Detection, and HPVDNAChip. 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.
Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Yong Kwan
YK
Lim
Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Jee-Hye
JH
Choi
Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Serah
S
Park
Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Oh Joo
OJ
Kweon
Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea. ajcp@unitel.co.kr.
Ae Ja
AJ
Park
D000328:Adult; D005260:Female; D020869:Gene Expression Profiling; D005838:Genotype; D006801:Humans; D008297:Male; D008875:Middle Aged; D020411:Oligonucleotide Array Sequence Analysis; D027383:Papillomaviridae / Q000145:classification / Q000235:genetics*; D030361:Papillomavirus Infections / Q000175:diagnosis / Q000821:virology*; D011933:Reagent Kits, Diagnostic / Q000592:standards*; D060888:Real-Time Polymerase Chain Reaction; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D055815:Young Adult
D011933:Reagent Kits, Diagnostic
comparison; genotyping; human papilloma virus