Abstract:
Objective
To examine the test performance of careHPV, Hybrid Capture2 (HC2) and visual inspection
with acetic acid (VIA) for detection of cytologically diagnosed high-grade cervical lesions or
cancer (HSIL+).
Design
Cross-sectional study.
Setting
Ocean Road Cancer Institute (ORCI) and Kilimanjaro Christian Medical Center (KCMC),
Tanzania.
Population
Women attending routine cervical cancer screening.
Method
We enrolled 4080 women (25–60 years) in the study. The women were interviewed on lifestyle
habits, and tested for HIV. A cervical specimen for careHPV testing (performed at
ORCI and KCMC), and a liquid-based cytology sample for HPV DNA detection using HC2
(performed at Tuebingen University Hospital, Germany) and for cytology assessment (performed
at Vejle Hospital, Denmark) were obtained at a gynecological examination.
Subsequently, VIA was performed. With cytology as gold standard, the sensitivity and specificity
of careHPV, HC2, and VIA for detection of HSIL+ were calculated.
Results
Altogether, 23.6% had a positive careHPV test, 19.1% had positive HC2 test, and 6.3% had
a positive VIA test. The sensitivity/specificity was 88.9%/78.9% for careHPV and 91.1%/
83.7%, for HC2. VIA showed a low sensitivity of 31.1% but a high specificity (94.6%) for
detection of HSIL+. The sensitivity of careHPV, HC2 and VIA was higher among younger
women, and among HIV positive women. VIA triage of careHPV positive women improved
specificity, but sensitivity dropped to 27%.
Conclusion
Our results confirm the low sensitivity of VIA for detection of HSIL+ and further document
that careHPV test is promising as a primary screening method for cervical-cancer prevention
in low-resource regions. A suitable triage test has to be identified.
