Comparing the Performance of Hybrid Capture II and Polymerase Chain Reaction (PCR) for the Identification of Cervical Dysplasia in the Screening and Diagnostic Settings

Abstract

ObjectiveBoth PCR and Hybrid Capture II (HCII) have been used for identifying cervical dysplasia; however, comparisons on the performance between these two tests show inconsistent results. We evaluated the performance of HCII and PCR MY09/11 in both screening and diagnostic populations in sub-sample of 1,675 non-pregnant women from a cohort in three clinical centers in the United States and Canada.MethodsSensitivity, specificity, positive predictive value, negative predictive value, and concordance between the two tests were calculated.ResultsSpecificity of HCII in detecting low-grade squamous intraepithelial lesion (LSIL) was higher in the screening group (88.7%; 95% CI: 86.2%–90.8%) compared to the diagnostic group (46.3%; 95% CI: 42.1%–50.6%); however, specificity of PCR was low in both the screening (32.8%; 95% CI: 29.6%–36.2%) and diagnostic (14.4%; 95% CI: 11.6%–17.6%) groups. There was comparable sensitivity by both tests in both groups to detect high-grade squamous intraepithelial lesion (HSIL); however, HCII was more specific (89.1%; 95% CI: 86.8%–91.0%; 66.2%; 95% CI: 62.0%–70.1%) than PCR (33.3%; 95% CI: 30.2%–36.5%; 17.9%; 95% CI: 14.8%–21.6%) in the screening and diagnostic groups, respectively. Overall agreement for HPV positivity was approximately 50% between HCII and PCR MY09/11; with more positive results coming from the PCR MY09/11.ConclusionIn the current study, PCR MY09/11 was more sensitive but less specific than HCII in detecting LSIL, and HCII was more sensitive and specific in detecting HSIL than PCR in both screening and diagnostic groups.

Efficacy of a real time optoelectronic device (TruScreen™) in detecting cervical intraepithelial pathologies: a prospective observational study

“…The negative predictivity rate and specificity of HPV DNA testing were found to be 83% and 75.4%, respectively, in our study. In a meta-analysis, the specificity HPV DNA testing was calculated as 71% for ASCUS and LSIL and as 77% for HSIL lesions on screening, which is similar to our results (14). As an objective, standardized test HPV DNA test is a promising screening modality; however, in daily circumstances, there are some doubts about the test's cost-effectivity especially for larger populations.…”

Frequency of Human papillomavirus in women attending cervical cancer screening program in Chile

“…In other hand, PCR-reverse line blotting assay used to genotype HPV was able to detect single and multiple infections easily, because several genotypes can be detected in a single assay, while others methodologies, such as Hybrid Capture 2 assay, only can discriminate between LR and HR genotypes, but it is not capable of indicate the specific genotypes of HPV [39]. Also, there is evidence, that this technique has a high sensitivity, been capable of detect 0.1 fg of HPV [24].…”

Evolução da técnica de PCR: sua contribuição no diagnóstico da infecção por HPV

“…Das técnicas abordadas nesta revisão, a metodologia Nested PCR se sobressai no diagnóstico precoce dos genes oncogênicos de alto grau, no caso de infecção persistente do HPV, aumentando a chance de cura através do tratamento das lesões precursoras, o que reduz a progressão do câncer do colo do útero. Esses exames de biologia molecular identificam principalmente os casos de infecção latente por HPV, presente em 30% das mulheres sexualmente ativas (LUU et al, 2013). Todas essas lesões são passíveis de cura em até 100% dos casos, quando tratadas precocemente.…”