A comprehensive evaluation of the accuracy of cervical pre-cancer detection methods in a high-risk area in East Congo

Abstract

BACKGROUND: Given the high burden of cervical cancer in low-income settings, there is a need for a convenient and affordable method for detecting and treating pre-cancerous lesions. METHODS: Samples for comparing the accuracy of cytology, virology and histology were collected. Identification of HPV E6/E7 mRNA was performed using PreTect HPV-Proofer. HPV DNA detection was performed by GP5 þ /6 þ PCR, followed by reverse line blot (RLB) for typing. RESULTS: A total of 343 women, aged 25 -60 years, attending gynaecological polyclinics in DR Congo were included for sample enrolment. The test positivity rate was conventional and liquid-based cytology (LBC) at cutoff ASCUS þ of 6.9 and 6.6%, respectively; PreTect HPV-Proofer of 7.3%; and consensus DNA PCR for 14 HR types of 18.5%. Sixteen cases of CIN2 þ lesions were identified. Of these, conventional cytology identified 66.7% with a specificity of 96.2%, LBC identified 73.3% with a specificity of 96.9%, all at cutoff ASCUS þ. HR-HPV DNA detected all CIN2 þ cases with a specificity of 85.9%, whereas PreTect HPV-Proofer gave a sensitivity of 81.3% and a specificity of 96.6%. CONCLUSION: Both HPV detection assays showed a higher sensitivity for CIN2 þ than did cytological methods. Detecting E6/E7 mRNA from only a subset of HR HPVs, as is the case with PreTect HPV-Proofer, resulted in a similar specificity to cytology and a significantly higher specificity than consensus HR HPV DNA (Po0.0001).

Effectiveness of a two‐stage strategy with HPV testing followed by visual inspection with acetic acid for cervical cancer screening in a low‐income setting

“…These estimates are consistent with accuracy of HPV testing by PCR assay for CIN21 detection in other studies carried out in Africa. 16,39 This result suggests that self-HPV may be a suitable tool for primary cervical cancer screening in lowincome settings. Although sensitivity of self-HPV is consistently higher than that of VIA, specificity however is lower.…”

“…Those who agreed were led to a room within the hospital where they collected vaginal samples without assistance of health care workers. Samples were analyzed in Switzerland using polymerase reaction chain (PCR) system of the Abbott RealTime High Risk HPV assay (Abbott Laboratories, Abbott Park, IL) which detects separately HPV 16, HPV 18 and 12 other high-risk types as a group (31,33,35,39,45, 51, 52, 56, 58, 59, 66 and 68).…”

E6/E7 proteins are potential markers for the screening and diagnosis of cervical pre‑cancerous lesions and cervical cancer in a Chinese population

“…The sensitivity of E6/E7 mRNA detection gradually increases when the number of HR-HPV types increases (17,19,20). When the number of HR-HPV types was >9, the sensitivity was >90%, with a satisfactory specificity (19,20). In addition, the sensitivity of HPV E6/E7 protein detection was higher than that of E6/E7 mRNA detection (71.3 vs. 56.3%, respectively) with regard to HPV types 16 and 18 (19).…”

“…According to previous studies, the sensitivity of E6 protein detection by OncoE6 Cervical Test was only 42.4%, which is lower than the 71.3% of HPV E6/E7 protein detection, but it exhibited 99.1% specificity for E6 protein detection (18). The sensitivity of E6/E7 mRNA detection gradually increases when the number of HR-HPV types increases (17,19,20). When the number of HR-HPV types was >9, the sensitivity was >90%, with a satisfactory specificity (19,20).…”

Overview on Molecular Markers to Implement Cervical Cancer Prevention: Challenges and Perspectives

“…Several cross(sectional studies evaluated the accuracy of VIA in developing countries. Pooled estimates of the sensitivity of the test in detecting CIN2+ lesions vary from 62 to 80%, and the specificity from 77 to 84% Gaffikin et al, 2008;Hovland et al, 2010). The greatest reduction in incidence and mortality rates are observed for the 30(39 years of age group.…”