Human papillomavirus (HPV) is a well-studied etiologic agent for cervical cancer dysplasia and neoplasia. Worldwide the most common HR-HPV are 16/18, and approximately 70% of cervical cancer are due to these genotypes. The HPV test, as primary method of cervical cancer screening, decreases the incidence of invasive carcinoma in 60-70%, and its performance is superior when compared to cytology, showing a negative predictive value very close to 100% [Consenso SPG, 2014]
HR-HPV screening is highly sensitive, but specificity depends on subsequent evaluation strategies and screening frequencies. Various methods are available for HPV detection and FDA-approved assays are on the market using either signal or target amplification methodologies. The aim of this study was emphasizing the overall performance of the methods used by Centro Medicina Laboratorial Germano de Sousa (CML GS) and correlate the results with cytological examinations in a 5 years sample population from Hospital Cuf Descobertas using different molecular platforms.
From January-2012 to Decemeber-2016 were analyzed more than 6000 cervical samples by HPV-molecular and conventional-cytology methods. HPV-molecular methods used where: Hybrid-Capture2; Cobas-HPV test; Clart Human papillomavirus 2; PapilloCheck.
The cytological results were registered with SNOMED nomenclature.
This study will contribute for a better understanding of the wide spectrum of HPV infection and provide held information to establish interpretation algorithms in diagnostic management. The results obtained to the incidence and most frequent type of HPV were in agreement with the results particularly described by the Portuguese Society of Human Papillomavirus [Consenso SPG, 2010].
The most frequent HPV HR type in Portuguese population is HPV53, where the malignancy rate is not as high as 16/18, but a shift possibility can occur with universalization of vaccine. The hc2 and 16/18-Cobas accomplished concordance in false positive rate, detection rate and specificity. However some statistically significant differences were seen, particularly 16/18-Cobas yield lower false negative rate for Abnormal Cytological results, subsequently higher negative predictive value. For those reasons 16/18-Cobas testing should be better for triage. When choosing of any HPV assay for cervical screening, quality control and quality assurance aspects should also be considered, in order to maximize the potential of each method in the diagnostic algorithm.