Clinical comparison of two human papillomavirus detection assays: GenoFlow and reverse line blot

Abstract

Introduction: Human papillomavirus (HPV) infection is typically critical in the oncogenesis of cervical cancer. However, available HPV detection kits differ in their ability and sensitivity to detect various types of HPV, and this variability has led to inconsistencies in the reporting of the geographic prevalence of HPV types, especially in developing countries. Here, we compared results of the recently developed GenoFlow HPV array test, which detects 33 HPV genotypes, to those of the well-established reverse line blot (RLB) assay, which detects 23 HPV types.
 Methodology: In total, 608 cervical specimens with cytology results ranging from normal to cancer were collected using an endocervical brush from women attending outpatient clinics in Riyadh, Saudi Arabia.
 Results: Sixty-nine specimens (11%) were positive for HPV. HPV genotype detection using the GenoFlow test had a sensitivity of 62% and a specificity of 100%. Overall agreement between the two HPV genotyping methods was 97%, with a concordance rate of 95%. Among the GenoFlow test results, 2% indicated additional HPV types that were not detected in the RLB assay, whereas the GenoFlow test missed 0.3% of the HPV types that were detected by the RLB; however, both tests were in agreement in detecting all major HPV types.
 Conclusion: The GenoFlow test was reliable, with results comparable to the RLB test. However, because the GenoFlow test is less labor-intensive and takes less total time (3 hours), it is a promising, affordable alternative to the RLB for HPV diagnosis and screening programs.

Prognostic impact of human papillomavirus infection on cervical dysplasia, cancer, and patient survival in Saudi Arabia: A 10-year retrospective analysis

“…These data are consistent with previous studies reporting that HPV-16 is the most common type followed by HPV-18 where there was a significant association between the presence of HPV and cervical cancer. 20 …”

“…The procedure was carried as described in Alhamlan 2019. 20 The genotyping results were interpreted using the manufacturer's instructions as follows: a valid HPV-positive result was one that included visible signals at the universal, hybridization control, and amplification control probe spots; a valid HPV-negative result included signals at the hybridization control and amplification control probe spots.…”

Prognostic Impact of Human Papillomavirus Infection on Cervical Dysplasia, Cancer, and Patient Survival in Saudi Arabia: A 10-Year Retrospective Analysis

“…Our study also showed that the GenoFlow assay had less sensitivity than the qPCR assay. In studies in our laboratory, the specificity of the GenoFlow assay is 100%, but its sensitivity is considered low (62%) [21].…”

Genetic Variability in the E6, E7, and L1 Genes of Human Papillomavirus Types 16 and 18 among Women in Saudi Arabia

“…All specimens were collected between 2017 and 2019. Clinical and sociodemographic data, as well as the viral load data of the specimens, were obtained from previous studies [ 23 , 33 , 34 ]. Participant inclusion criteria for the present study were (1) being a Saudi woman (2) who was married, divorced, or widowed, (3) having definite histological or cytological results for collected cervical specimens, and (4) having an HPV genotype test result positive for HPV16 or HPV18 infection.…”