Comparison of two commercially available methods for HPV genotyping CLART HPV2 and linear array HPV genotyping tests

摘要

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.