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Journal of Clinical Microbiology, January 2008, p. 109-117, Vol. 46, No. 1
0095-1137/08/$08.00+0     doi:10.1128/JCM.01667-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Comparison of Linear Array and Line Blot Assay for Detection of Human Papillomavirus and Diagnosis of Cervical Precancer and Cancer in the Atypical Squamous Cell of Undetermined Significance and Low-Grade Squamous Intraepithelial Lesion Triage Study{triangledown}

Philip E. Castle,* Patti E. Gravitt,2 Diane Solomon,3 Cosette M. Wheeler,4 and Mark Schiffman1

Division of Cancer Epidemiology and Genetics and Division of Cancer Prevention,3 National Cancer Institute, National Institutes of Health, Bethesda, Maryland 20892,1 Departments of Epidemiology and Molecular Microbiology and Immunology, Johns Hopkins University, Baltimore, Maryland 21205,2 Departments of Molecular Genetics and Microbiology and Obstetrics and Gynecology, University of New Mexico Health Sciences Center, School of Medicine, University of New Mexico, Albuquerque, New Mexico 871314

Received 21 August 2007/ Returned for modification 4 October 2007/ Accepted 25 October 2007

We evaluated Linear Array (LA), a newly commercialized PGMY09/11 L1 consensus primer PCR test that detects 37 human papillomavirus (HPV) genotypes by reverse line blot hybridization, for the detection of individual HPV genotypes and carcinogenic HPV and its clinical performance for detecting 2-year cumulative cervical precancer and cancer using archived specimens from the Atypical Squamous Cell of Undetermined Significance (ASCUS) and Low-Grade Squamous Intraepithelial Lesion Triage Study. LA testing was conducted on enrollment specimens from women referred because of an ASCUS Pap test. To gauge the performance of the new test, the results were compared to those of its prototype predecessor assay, Line Blot Assay (LBA), restricted to paired results (n = 3,335). LA testing was done masked to LBA results and clinical outcomes. The results of LA and LBA testing were compared for detection of carcinogenic HPV and clinical outcomes of cervical precancer and cancer. Overall, 50% and 55% of the women tested positive for carcinogenic HPV by LBA and LA, respectively (P < 0.0001). The percent agreement for carcinogenic HPV detection was 88%, percent positive agreement was 80%, and kappa was 0.76 for detection of carcinogenic HPV by the two assays. There was a significant increase in detection by LA for most of the 37 HPV genotypes targeted by both assays, including for 13 of 14 carcinogenic HPV genotypes. LA detected more multiple-genotype infections for all HPV genotypes among HPV-positive women (P < 0.0001) and for carcinogenic HPV genotypes among carcinogenic-HPV-positive women (P < 0.0001). LA was more sensitive (92.3% versus 87.1%; P = 0.003) and less specific (48.2% versus 54.0%; P < 0.0001) than LBA for 2-year cumulative cervical precancer and cancer as diagnosed by the Pathology Quality Control Group. In conclusion, we found LA to be a promising assay for the detection of HPV genotypes and carcinogenic HPV, and it may be clinically useful for the detection of cervical precancer and cancer in women with equivocal cytology.

* Corresponding author. Mailing address: Division of Cancer Epidemiology and Genetics, National Cancer Institute, 6120 Executive Blvd., Room 5004, EPS MSC 7234, Bethesda, MD 20892-7234. Phone: (301) 435-3976. Fax: (301) 402-0916. E-mail: castlep{at}mail.nih.gov

{triangledown} Published ahead of print on 7 November 2007.

Journal of Clinical Microbiology, January 2008, p. 109-117, Vol. 46, No. 1
0095-1137/08/$08.00+0     doi:10.1128/JCM.01667-07
Copyright © 2008, American Society for Microbiology. All Rights Reserved.



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