Comparison of Analytical and Clinical Performance of HPV 9G DNA Chip, PANArray HPV Genotyping Chip, and Hybrid-Capture II Assay in Cervicovaginal Swabs
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Background: Human papillomavirus (HPV) infection can be detected by using several molecular methods, including Hybrid-Capture II (HC2) assay and variable HPV DNA chip tests, although each method has different sensitivities and specificities. Methods: We performed HPV 9G DNA Chip (9G) and PANArray HPV Genotyping Chip (PANArray) tests on 118 cervicovaginal swabs and compared the results with HC2, cytology, histology, and direct sequencing results. Results: The overall and high-risk HPV (HR-HPV) positivity rates were 62.7% and 44.9% using 9G, and 61.0% and 30.5% using PANArray, respectively. The positivity rates for HR-HPV with these two chips were significantly lower than 55.1% when HC2 was used. The sensitivity of overall HPV positivity in detecting histologically confirmed low-grade cervical squamous intraepithelial lesions or higher was 88.7% for all three tests. The specificity was 58.5% for 9G and 61.5% for PANArray, which was significantly lower than the 72.3% for HC2. With the HR-HPV+ genotype threshold, the sensitivity decreased to 75.5% for 9G and 52.8% for PANArray, which was significantly lower than the 88.7% for HC2. Comparison of the two chips showed concordant results in 55.1% of the samples, compatible results in 16.9%, and discordant results in 28.0%, exhibiting poor agreement in detecting certain HPV genotypes. Compared with direct sequencing, 9G yielded no discordant results, whereas PANArray yielded 31 discordant results (26.7%). Conclusions: Compared with HC2, the HPV genotyping tests showed lower sensitivity in histologic correlation. When the two chips were compared, the 9G was more sensitive and accurate for detecting HR-HPV than the PANArray.
Abstract
Background: Human papillomavirus (HPV) infection can be detected by using several molecular methods, including Hybrid-Capture II (HC2) assay and variable HPV DNA chip tests, although each method has different sensitivities and specificities. Methods: We performed HPV 9G DNA Chip (9G) and PANArray HPV Genotyping Chip (PANArray) tests on 118 cervicovaginal swabs and compared the results with HC2, cytology, histology, and direct sequencing results. Results: The overall and high-risk HPV (HR-HPV) positivity rates were 62.7% and 44.9% using 9G, and 61.0% and 30.5% using PANArray, respectively. The positivity rates for HR-HPV with these two chips were significantly lower than 55.1% when HC2 was used. The sensitivity of overall HPV positivity in detecting histologically confirmed low-grade cervical squamous intraepithelial lesions or higher was 88.7% for all three tests. The specificity was 58.5% for 9G and 61.5% for PANArray, which was significantly lower than the 72.3% for HC2. With the HR-HPV+ genotype threshold, the sensitivity decreased to 75.5% for 9G and 52.8% for PANArray, which was significantly lower than the 88.7% for HC2. Comparison of the two chips showed concordant results in 55.1% of the samples, compatible results in 16.9%, and discordant results in 28.0%, exhibiting poor agreement in detecting certain HPV genotypes. Compared with direct sequencing, 9G yielded no discordant results, whereas PANArray yielded 31 discordant results (26.7%). Conclusions: Compared with HC2, the HPV genotyping tests showed lower sensitivity in histologic correlation. When the two chips were compared, the 9G was more sensitive and accurate for detecting HR-HPV than the PANArray.
참고문헌 (29)
- Kurman RJ, "WHO classification of tumours of female reproductive organs" (2014), IARC Press
- Bzhalava D, "A systematic review of the prevalence of mucosal and cutaneous human papillomavirus types", Virology, 445, pp.224~231 (2013)
- Muñoz N, "Epidemiologic classification of human papillomavirus types associated with cervical cancer", N Engl J Med, 348, pp.518~527 (2003)
- Walboomers JM, "Human papillomavirus is a necessary cause of invasive cervical cancer worldwide", J Pathol, 189, pp.12~19 (1999)
- Kjaer SK, "Type specific persistence of high risk human papillomavirus (HPV) as indicator of high grade cervical squamous intraepithelial lesions in young women:population based prospective follow up study", BMJ, 325, pp.572~ (2002)
- Elfgren K, "Rate of human papillomavirus clearance after treatment of cervical intraepithelial neoplasia", Obstet Gynecol, 100(5 Pt 1), pp.965~971 (2002)
- Khan MJ, "The elevated 10-year risk of cervical precancer and cancer in women with human papillomavirus (HPV) type 16 or 18 and the possible utility of type-specific HPV testing in clinical practice", J Natl Cancer Inst, 97, pp.1072~1079 (2005)
- Bosch FX, "Human papillomavirus and cervical cancer: burden and assessment of causality", J Natl Cancer Inst Monogr, (31), pp.3~13 (2003)
- Cuschieri KS, "The role of human papillomavirus testing in cervical screening", J Clin Virol, 32(Suppl 1), pp.S34~S42 (2005)
- Rozendaal L, "PCR based high risk HPV testing is superior to neural network based screening for predicting incident CIN III in women with normal cytology and borderline changes", J Clin Pathol, 53, pp.606~611 (2000)
- Denise Zielinski G, "High-risk HPV testing in women with borderline and mild dyskaryosis: long-term follow-up data and clinical relevance", J Pathol, 195, pp.300~306 (2001)
- Poljak M, "Comparative evaluation of first- and second-generation digene hybrid capture assays for detection of human papillomaviruses associated with high or intermediate risk for cervical cancer", J Clin Microbiol, 37, pp.796~797 (1999)
- Sandri MT, "Comparison of the Digene HC2 assay and the Roche AMPLICOR human papillomavirus (HPV) test for detection of high-risk HPV genotypes in cervical samples", J Clin Microbiol, 44, pp.2141~2146 (2006)
- Castle PE, "Interlaboratory reliability of Hybrid Capture 2", J Clin Pathol, 122, pp.238~245 (2004)
- Huh W, "What is the role of HPV typing in the United States now and in the next five years in a vaccinated population?", Gynecol Oncol, 117, pp.481~485 (2010)
- Lindemann ML, "Analytical comparison of the cobas HPV Test with Hybrid Capture 2 for the detection of high-risk HPV genotypes", J Mol Diagn, 14, pp.65~70 (2012)
- Solomon D, "The 2001 Bethesda System:terminology for reporting results of cervical cytology", JAMA, 287, pp.2114~2119 (2002)
- Oh SY, "Development of an ammonium sulfate DNA extraction method for obtaining amplifiable DNA in a small number of cells and its application to clinical specimens", Biomed Res Int, 2013, pp.546727~ (2013)
- An H, "HPV 9G DNA chip: 100% clinical sensitivity and specificity", J Clin Microbiol, 50, pp.562~568 (2012)
- Choi JJ, "Peptide nucleic acid-based array for detecting and genotyping human papillomaviruses", J Clin Microbiol, 47, pp.1785~1790 (2009)
- An HJ, "Correlation of cervical carcinoma and precancerous lesions with human papillomavirus (HPV) genotypes detected with the HPV DNA chip microarray method", Cancer, 97, pp.1672~1680 (2003)
- Lee GY, "Human papillomavirus (HPV) genotyping by HPV DNA chip in cervical cancer and precancerous lesions", Int J Gynecol Cancer, 15, pp.81~87 (2005)
- 이아원, "질 확대경상 비정상 소견을 보인 환자에서 HPV DNA chip과 Hybrid-Capture II assay의 임상적 유용성 비교", 대한세포병리학회지, 19(2), pp.119~125 (2008), 대한세포병리학회
- 송혜정, "Comparison of the performance of the PANArray™ HPV test and DNA chip test for genotyping of human papillomavirus in cervical swabs", BioChip Journal, 4(3), pp.167~172 (2010), 한국바이오칩학회
- Um TH, "Comparison of HPV genotyping assays and Hybrid Capture 2 for detection of highrisk HPV in cervical specimens", Ann Clin Lab Sci, 41, pp.48~55 (2011)
- 박경선, "Comparison of the Digene HPV Genotyping LQ Test and the PANArray HPV Genotyping Chip for Detection of High-Risk or Probable High-Risk Human Papillomavirus Genotypes", Annals of Laboratory Medicine, 34(4), pp.279~285 (2014), 대한진단검사의학회
- de Cremoux P, "Efficiency of the hybrid capture 2 HPV DNA test in cervical cancer screening. A study by the French Society of Clinical Cytology", Am J Clin Pathol, 120, pp.492~499 (2003)
- Trope A, "Performance of human papillomavirus DNA and mRNA testing strategies for women with and without cervical neoplasia", J Clin Microbiol, 47, pp.2458~2464 (2009)
- Clavel C, "Human papillomavirus testing in primary screening for the detection of high-grade cervical lesions:a study of 7932 women", Br J Cancer, 84, pp.1616~1623 (2001)