A systematic review and meta-analysis of studies evaluating the performance of point-of-care tests for human papillomavirus screening

Abstract

SummaryBackground High-risk human papillomavirus (HPV) is a necessary cause of high-grade cervical intraepithelial neoplasia (grade 2 or higher, CIN2+). Simplified and rapid HPV DNA assays designed for use in resourcelimited settings have recently become available. methods We performed a systematic review and metaanalysis by searching Medline, Embase, Global Health and CINAHL databases for studies from 1 January 2004 to 25 February 2017 that reported the performance of careHPV or OncoE6 for the detection of histological CIN2+ in cervical cancer screening. We used bivariate models to estimate pooled sensitivity and specificity for CIN2+ and CIN3+. results A total of 29 657 women were included from seven studies evaluating the performance of careHPV for the detection of CIN2+ and four studies among 27 845 women for the detection of CIN3+. The pooled prevalence for CIN2+ and CIN3+ was 2.3% and 1.1%, respectively. careHPV had sensitivity and specificity of 88.1% (95% CI 81.4 to 92.7) and 83.7% (95% CI 74.9 to 89.8), respectively, for CIN2+ and 90.3% (95% CI 83.4 to 94.5) and 85.3% (95% CI 73.1 to 92.5), respectively, for CIN3+, using clinician-collected cervical specimen. The corresponding pooled estimates using self-collected vaginal swabs were 73.6% (95% CI 64.9 to 80.8) and 88.0% (95% CI 79.1 to 93.5) for CIN2+ and 75.2% (95% CI 66.8 to 82.0) and 90.6% (95% CI 83.4 to 94.9) for CIN3+. Two studies using OncoE6 reported sensitivity and specificity ranging from 31.3% to 42.4% and 99.1%-99.4% for CIN2+, and 53.5% and 98.9% for CIN3+ for one study. Conclusion CareHPV has good sensitivity and specificity for the detection of CIN2+ and CIN3+, but sensitivity was lower using self-collected vaginal samples. The specificity is lower in high HPV prevalence populations such as women living with HIV. OncoE6 assay warrants further evaluation.

Selecting human papillomavirus genotypes to optimize the performance of screening tests among South African women

“…[2][3][4] Point-of-care tests are conducted in the clinic setting with non-physician providers and produce results within the same day, alleviating the burden of limited laboratory infrastructure and personnel. 5 Furthermore, HPV DNA testing has been demonstrated to be considerably more sensitive than cytology 6,7 and is more sensitive, specific, and reproducible than the visual inspection with acetic acid (VIA). 8 The low sensitivity of cytology necessitates frequent, repeated screening to be effective, making it susceptible to high attrition and costly follow-up.…”

“…2 VIA is a subjective, visual skill that requires intensive quality assurance monitoring and frequent refresher courses to ensure test performance does not fluctuate by provider. 3,5,8 Although advantageous in many regards, HPV DNA testing has the trade-off of having relatively low specificity, 7,[9][10][11] particularly in women living with HIV. 5,12 In the screen-and-treat model, now widely recommended as the most appropriate approach for low-resource settings, the relatively low specificity of HPV DNA testing means that sizable numbers of women may be overtreated for transient infections that will ultimately regress.…”

The cooperation between professional societies contributes to the capacity building and system development for prevention and control of cancer in low- and middle-income countries: the practice of Cervical Cancer Prevention and Control Project in Cambodia

“…In parallel with health education, cervical cancer screening was offered on site to minimize the geographic access barrier to screening. The HPV test (careHPV ® , QIAGEN) was used because of its higher accuracy, more objective endpoint, and limited pathological capacity in the country (7,11). With no reliable data on HPV infection in Cambodia, the eligibility criteria for screening were determined to be those who attended the health education program, who were over age 25 years old, who had ever had a sexual partner and who were not pregnant.…”

Reproducibility of a Rapid Human Papillomavirus Test at Different Levels of the Healthcare System in Tanzania: The AISHA Study

“…One of them, careHPV (QIA-GEN) based on the Hybrid Capture 2 (HC2) signal amplification technology, has recently been prequalified by WHO. careHPV detects 14 oncogenic HPV types, can be performed in less than 3 hours, requires less training and laboratory equipment than HC2, and is, to our knowledge, the least expensive validated HPV test currently available (5)(6)(7)(8)(9).…”