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Journal of Clinical Microbiology, August 2008, p. 2759-2765, Vol. 46, No. 8
0095-1137/08/$08.00+0 doi:10.1128/JCM.00188-08
Copyright © 2008, American Society for Microbiology. All Rights Reserved.

Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland,1 Communications Engineering Branch, National Library of Medicine, Bethesda, Maryland,2 Department of Pathology, University of Oklahoma Health Sciences Center, Oklahoma City, Olahoma,3 Department of Obstetrics and Gynecology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma4
Received 29 January 2008/ Returned for modification 24 March 2008/ Accepted 2 June 2008
Variations in biological behavior suggest that each carcinogenic human papillomavirus (HPV) type should be considered individually in etiologic studies. HPV genotyping assays might have clinical applications if they are approved for use by the FDA. A widely used genotyping assay is the Roche Linear Array HPV genotyping test (LA). We used LA to genotype the HPV isolates from cervical specimens from women with the full spectrum of cervical disease: cervical cancer, cervical intraepithelial neoplasia (CIN), and HPV infections. To explore the feasibility and value of the automated reading of the LA results, we custom-designed novel, optical imaging software that provides optical density measurements of LA bands. We compared unmagnified visual examination with the automated measurements. The two measurements were highly associated. By either method, the threshold between a negative and a positive result was fairly sharp, with a clear bimodal distribution. Visually, most positive results were judged to be strong or medium, with fewer equivocal results categorized as weak (9.5% of positive samples), very weak (6.5% of positive samples), or extremely weak (7.7% of positive samples). The automated measurements of the intensities were significantly associated with the strength of the visual categories (P < 0.001). At the extremes of the automated signal intensities (
20 units or
120 units), the bands were almost always categorized visually as negative and positive, respectively. In the equivocal zone (20 to 119 units), specimens were more increasingly likely to be judged to be visually positive as the number of other, definite infections on the same strip increased (P for trend < 0.001). Multiple, concurrent infections comprise
25% of HPV infections; thus, any systematic visual tendency that influences their evaluation when the result is equivocal should be minimized. Therefore, automated reading is probably worth development if easy-to-calibrate hardware and software can be optimized.
Published ahead of print on 11 June 2008.
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