Clinical validation of the PCR-reverse dot blot human papillomavirus genotyping test in cervical lesions from Chinese women in the Fujian province: a hospital-based population study

Abstract

ObjectiveTo determine the clinical significance of the polymerase chain reaction (PCR)-reverse dot blot (RDB) human papillomavirus (HPV) genotyping assay in cervical cancer screening.MethodsA total of 10,442 women attending the Fujian Provincial Maternity and Children's Health Hospital were evaluated using the liquid-based cytology (thinprep cytologic test [TCT]) and the PCR-RDB HPV test. Women with HPV infection and/or abnormal cytology were referred for colposcopy and biopsy. For HPV DNA sequencing, 120 specimens were randomly selected. Pathological diagnosis was used as the gold standard.ResultsUsing the PCR-RDB HPV test, overall HPV prevalence was 20.57% (2,148/10,442) and that of high-risk (HR)-HPV infection was 18.68% (1,951/10,442). There was 99.2% concordance between HPV PCR-RDB testing and sequencing. In this studied population, the most common HR-HPV types were HPV-16, -52, -58, -18, -53, -33, and -51, rank from high to low. HPV-16, -18, -58, -59, and -33 were the top 5 prevalent genotypes in cervical cancer but HPV-16, -18, -59, -45, and -33 were the top 5 highest risk factors for cancer (odds ratio [OR]=34.964, 7.278, 6.728, 6.101, and 3.658; all p<0.05, respectively). Among 10,442 cases, 1,278 had abnormal cytology results, of which, the HR-HPV positivity rate was 83.02% (1,061/1,278). To screen for cervical cancer by PCR-RDB HPV testing, when using CIN2+, CIN3+, and cancer as observed endpoints, the sensitivity was 90.43%, 92.61%, and 94.78% and the negative predictive value (NPV) was 99.06%, 99.42%, and 99.78%, respectively. PCR-RDB HPV and TCT co-testing achieved the highest sensitivity and NPV.ConclusionFor cervical cancer screening, the PCR-RDB HPV test can provide a reliable and sensitive clinical reference.

Cervical cancer screening using the Cervista high-risk human papillomavirus test: opportunistic screening of a hospital-based population in Fujian province, China

“… 7 In our previous study, HPV-16 was the most prevalent genotype in the HR-HPV-positive women, followed by, from highest to lowest, HPV-52, -58, -18, -53, -33, -51, -56, -59, -68, -31, -66, -39, -35, and -45. 29 The data implied that the A9 pool (HPV-16, -31, -33, -35, -52, and -58) involved approximately 77% HPV positive genotypes and were the major HPV group in CIN2+ cases, compared to the A7 pool (HPV-18, -39, -45, and -59) at 14% and the A5/A6 pool (HPV-51, -56, and -66) at 6%. Based on the A9 pool, which is a major species in Fujian, we also evaluated HR-HPV primary screening for A9 pool as a triage approach to explore the Cervista test role in a primary screen.…”

“…The clinical performance characteristics of PCR-reverse dot blot (PCR-RDB) assays among 10,442 women in FCLSCs were evaluated previously; the results suggested that PCR-RDB can provide a reliable and sensitive clinical reference for cervical cancer screening. 29 In the current study, patient data were derived from that for FCLSCs using the Cervista test since 2012; moreover, the population eligible for this cohort study involved two arms, one consisting of healthy patients undergoing routine physical examinations, and another consisting of patients visiting the outpatient clinic for any gynecologic conditions except cancer. The total infection rate of HR-HPV tested using the Cervista HR-HPV test was estimated at 16.49%, which is in accordance to our previous report 29 and other epidemiological studies regarding HPV in China.…”

“… 29 In the current study, patient data were derived from that for FCLSCs using the Cervista test since 2012; moreover, the population eligible for this cohort study involved two arms, one consisting of healthy patients undergoing routine physical examinations, and another consisting of patients visiting the outpatient clinic for any gynecologic conditions except cancer. The total infection rate of HR-HPV tested using the Cervista HR-HPV test was estimated at 16.49%, which is in accordance to our previous report 29 and other epidemiological studies regarding HPV in China. 30 We also found that 10.15% women with CIN3+ were cytology-negative.…”

<p>Evaluation of PCR-Reverse Dot Blot Human Papillomavirus Genotyping Test in Predicting Residual/Recurrent CIN 2+ in Posttreatment Patients in China</p>

“…However, the above methods are inconvenient and may cause large economic burden, which is not suitable for resource-limited countries. In our previous study, 8 stated that the PCR-RDB HPV genotyping test could be applied in cervical cancer primary screening for hospitalbased opportunistic screening. However, there is no adequate research on whether the PCR-RDB HPV test is suitable for the posttreatment of high-grade cervical lesions.…”

The role of human papillomavirus genotyping for detecting high-grade intraepithelial neoplasia or cancer in HPV-positive women with normal cytology: a study from a hospital in northeastern China

“…Moreover, previous population-based screening results have demonstrated that the overall prevalence of hrHPV varies from 9.9-27.5% across China [22]. A previous study suggested possible reasons for this inconsistency, such as, different study populations, geographical prevalence, and differences in detection methods [23]. The HPV GenoArray test was a PCR-based kit that detected individual HPV genotypes.…”