Comparison of two commercially available methods for HPV genotyping: CLART HPV2 and Linear Array HPV Genotyping tests.

OBJECTIVE: To compare the clinical efficiency of two commercially available HPV DNA detection and typing tests. The CLART HPV2 test, a novel HPV test based on DNA microarrays that can identify 35 HPV genotypes, was compared to the Linear Array HPV Genotyping (LA) test, a more widely used test able to identify 37 HPV genotypes. STUDY DESIGN: The CLART test was evaluated by comparing the genotyping results of 538 ThinPrep Pap tests with the LA test as well as with the cytological and histological findings. RESULTS: The exact same types and results were identified in 86.1% of the samples (κ = 0.74). The tests showed excellent agreement in HPV positivity and identification of single and multiple infections (concordance rate 88.7%, κ = 0.827). CONCLUSION: The CLART test demonstrated results comparable to those of the LA test in clinical sensitivity as measured by the positive predictive value of CIN2+ in ASCUS (67.3% vs. 57.1%), while overall it exhibited higher sensitivity, specificity, positive and negative predictive values and area under curves than the LA test in all cytological and histological subgroups analyzed. (Anal Quant Cytopathol Histopathol 2012;34:257– 263)