Evaluation of real-time PCR kits to detect high-risk human papillomavirus

Abstract

Introduction: The use of molecular techniques for the diagnosis of high oncogenic risk human papillomavirus (hrHPV) is crucial for the early detection of cervical cancer.

Objective: To evaluate the analytical performance of two real-time PCR kits, commercialized by the Cuban Immunoassay Center, to detect hrHPV.

Methods: Two DNA panels from cervical samples were used: one with 150 samples to validate the SUMASIGNAL HPV 16/18 kit, the DNA extraction process and its usefulness as a quantitative test; and another with 163 samples to evaluate the HPV 13+2 kit. The clinical utility of the HPV 13+2 kit was determined in 55 self-collected cervicovaginal samples. The analytical performance indicators of both kits were calculated with respect to reference tests.

Results: Performance indicators for SUMASIGNAL HPV 16/18 were excellent (>95%), concordance 96%, kappa index=0.93 [0.85-1.01]. DNA extraction showed 100% clinical and analytical specificity and 95% analytical sensitivity. Good correlation was obtained with the quantitative reference test (r = + 0.688). The HPV 13+2 kit had 100% clinical specificity and sensitivity, analytical specificity was 84% due to cross-reactivity with other hrHPVs. Its clinical application revealed a high frequency of infection (41.8%): 23.6% with hrHPV, particularly in young women (50%). The self-collected sample was viable (100%).

Conclusion: The assays evaluated showed high quality standards, which would allow their use with national coverage in a technological platform available for the whole country.