Rapid genotyping of carcinogenic human papillomavirus by loop-mediated isothermal amplification using a new automated DNA test (Clinichip HPV™).

This study was designed to evaluate the Clinichip HPV test, a new DNA test that detects carcinogenic human papillomavirus (HPV) rapidly by loop-mediated isothermal amplification and performs genotyping of all 13 carcinogenic types using automated DNA chip technology with an assay time 2.5h. Using this test, 247 Japanese women (109 with normal cytology, 43 with cervical intraepithelial neoplasia grade 1, 60 with cervical intraepithelial neoplasia grade 2/3 and 35 with invasive cervical cancer) were tested for carcinogenic HPV genotypes. The results were compared to those obtained by the polymerase chain reaction-amplified DNA sequencing using 13 type-specific primers. Overall, there was very good agreement for the detection of carcinogenic HPV between the Clinichip test and direct sequencing, with 95.5% total agreement and a kappa value of 0.91. Comparison of the detection of individual HPV types shows that the overall agreement was also high (range: 96.8-100%). In women with cervical intraepithelial neoplasia grade 2 or worse, the detection rate of carcinogenic HPV was 95.7% by both the Clinichip test and the direct-sequencing method, indicating complete agreement between the two methods. In conclusion, it was found that the Clinichip test is a promising new laboratory method for genotyping of carcinogenic HPV.

[1]  C. Wheeler,et al.  Human papillomavirus genotypes and the cumulative 2-year risk of cervical precancer. , 2006, The Journal of infectious diseases.

[2]  David R. Scott,et al.  Improved Amplification of Genital Human Papillomaviruses , 2000, Journal of Clinical Microbiology.

[3]  T. Kanda,et al.  Biased amplification of human papillomavirus DNA in specimens containing multiple human papillomavirus types by PCR with consensus primers , 2011, Cancer science.

[4]  M. Bissell.  Visual Detection of High-Risk Human Papillomavirus Genotypes 16, 18, 45, 52, and 58 by Loop-Mediated Isothermal Amplification with Hydroxynaphthol Blue Dye , 2013 .

[5]  C. Meijer,et al.  A general primer GP5+/GP6(+)-mediated PCR-enzyme immunoassay method for rapid detection of 14 high-risk and 6 low-risk human papillomavirus genotypes in cervical scrapings , 1997, Journal of clinical microbiology.

[6]  Y. Hirai,et al.  Predicting the progression of cervical precursor lesions by human papillomavirus genotyping: A prospective cohort study , 2011, International journal of cancer.

[7]  J. T. Cox,et al.  Interim Guidance for the Use of Human Papillomavirus DNA Testing as an Adjunct to Cervical Cytology for Screening , 2004, Obstetrics and gynecology.

[8]  W. Quint,et al.  Technical Advance Novel Short-Fragment PCR Assay for Highly Sensitive Broad-Spectrum Detection of Anogenital Human Papillomaviruses , 1998 .

[9]  Mark Sherman,et al.  The 2001 Bethesda System: terminology for reporting results of cervical cytology. , 2002, JAMA.

[10]  S. Walter,et al.  Randomized controlled trial of human papillomavirus testing versus Pap cytology in the primary screening for cervical cancer precursors: Design, methods and preliminary accrual results of the Canadian cervical cancer screening trial (CCCaST) , 2006, International journal of cancer.

[11]  P. Castle.  The potential utility of HPV genotyping in screening and clinical management. , 2008, Journal of the National Comprehensive Cancer Network : JNCCN.

[12]  U Menon,et al.  Management of women who test positive for high-risk types of human papillomavirus: the HART study , 2003, The Lancet.

[13]  J. Arseneau,et al.  Atypical squamous cells of undetermined significance. A cytohistologic study of 52 cases. , 1997, Acta cytologica.

[14]  T. Limpaiboon,et al.  Rapid detection of the most common high-risk human papillomaviruses by loop-mediated isothermal amplification. , 2011, Journal of virological methods.

[15]  David R. Scott,et al.  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. , 2005, Journal of the National Cancer Institute.

[16]  H. Nakagawa,et al.  Loop‐mediated isothermal amplification method for detection of human papillomavirus type 6, 11, 16, and 18 , 2007, Journal of medical virology.

[17]  W. Quint,et al.  Molecular diagnosis of human papillomavirus (HPV) infections. , 2005, Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology.

[18]  Robert P Fields.  Human papillomavirus DNA versus papanicolaou screening tests for cervical cancer. , 2008, The New England journal of medicine.

[19]  A. Reingold,et al.  Genital human papillomavirus infection in female university students as determined by a PCR‐based method , 1991, JAMA.

[20]  Yasuhiko Ohta,et al.  Construction of an electrochemical DNA chip for simultaneous genotyping of single nucleotide polymorphisms. , 2005, The Analyst.

[21]  H. Yoshikawa,et al.  Human papillomavirus infections among Japanese women: age‐related prevalence and type‐specific risk for cervical cancer , 2009, Cancer science.

[22]  J. Cuzick,et al.  Overview of the European and North American studies on HPV testing in primary cervical cancer screening , 2006, International journal of cancer.

[23]  The Absolute Risk of Cervical Abnormalities in High-Risk Human Papillomavirus-Positive, Cytologically Normal Women Over a 10-Year Period , 2007 .

[24]  H. Yoshikawa,et al.  Detection and Typing of Multiple Genital Human Papillomaviruses by DNA Amplification with Consensus Primers , 1991, Japanese journal of cancer research : Gann.

[25]  J. Dungan.  Short term persistence of human papillomavirus and risk of cervical precancer and cancer: population based cohort study , 2010 .

[26]  Chien-Jen Chen,et al.  Persistence of type-specific human papillomavirus infection and increased long-term risk of cervical cancer. , 2011, Journal of the National Cancer Institute.