EVALUATION OF BIOHIT HPV SCREENING AND TYPING KITS IN DETECTION OF HUMAN PAPILLOMAVIRUS DNA FROM LESIONS OF ANOGENITAL TRACT

The Biohit HPV Screening and Typing kits for in situ hybridization of human papillomavirus (HPV) DNA are now commercially available. The HPV Screening kit contains a cocktail of HPV probes, and the Typing kit c ontains separated hybridization probes for HPV 6, 11, 16, 18, 31, and 33. They were evaluated by comparison with an in situ hybridization (I SH) method, using the Pathogene HPV probes 6/11, 16/18, 31/33/51. One hundred anogenital biopsies from 78 women and 22 men were tested. Amon g them, 43% showed normal or inflammatory mucosa, 44%, koilocytosis or mild dysplasia, and 13%, moderate to severe dysplasia. Altogether, 60 specimens were positive with the ISH reference method: 17 with the HP V 6/11 probe, 12 with the HPV 16/18 probe, 16 with the HPV 31/33/51 pr obe, and 15 had mixed infections. The agreement between the Screening test and the homemade ISH is 91%. The Screening test has a sensitivity of 93% and a specificity of 87%. As for the Biohit Typing test, four false-negative samples, and partial or total discordance in nine and f our samples, respectively, were observed when compared to our referenc e method. Thus the agreement between both typing ISH tests is 92%. The sensitivity of the Biohit Typing test is 93%, and the specificity, 91 %. The sensitivity decreases to 72% when the 31 and 33 probes are eval uated separately. The Biohit Screening assay is simple, reliable, repr oducible, and suitable for rapid routine screening. The Biohit Typing test allows the detection of a specific type of HPV DNA and also permi ts, in mixed HPV infection, definition of the type of associated HPV D NA. It might be of clinical value in the diagnosis or prognosis of HPV infection.