visual inspection of the cervix with acetic acid is used to control the burden of cervical cancer in low and middle-income countries. This method has some limitations and HPV DNA testing may be an alternative, but it is expensive and requires a laboratory setup. A cheaper and faster HPV tests have been developed. This study describe the agreement between a fast HPV test (careHPV) and hybrid capture 2 (HC2) in detection of high-risk HPV among Tanzanian women.
study involving women attending routine cervical cancer screening at Ocean Road Cancer Institute and Kilimanjaro Christian Medical Centre in Tanzania. They were offered HIV testing. Two cervical samples were subsequently obtained, the 1 sample was processed at the clinics by using careHPV and the 2 sample was transported to Denmark and Germany for cytology and hc2 analysis, respectively. Kappa statistic was calculated to assess the agreement between careHPV and HC2. The sensitivity, specificity and predictive values of careHPV was calculated using HC2 as reference. The analyses were done for the overall study population and stratified by testing site and HIV status.
A total of 4080 women were enrolled with 437 being excluded due to invalid information, lack of careHPV or hc2 results. Overall agreement between the tests was substantial with a kappa value of 0.69 (95% CI: 0.66-0.72), sensitivity and specificity of careHPV was 90.7% (95%CI: 89.6 – 91.8) and 84.2% (95% CI: 81.2 – 86.8) respectively. the agreement was similar in the stratified analyses where the kappa values were 0.75 (95% CI:0.70-0.79) in women aged 25-34, 0.66 (95% CI:0.62-0.70) in women aged 35-60, 0.73 (95% CI: 0.70-0.77) at Ocean Road Cancer Institute, 0.64 (95% CI: 0.60-0.69) at Kilimanjaro Christian Medical Centre, 0.73 (95% CI: 0.68-0.79) in HIV positive and 0.66 (95% CI: 0.63-0.70) in HIV negative women. The kappa value of 0.64 (95% CI: 0.39 – 0.88) for cervical high-grade lesions indicates a substantial agreement between careHPV and HC2 in detecting HPV among women with cervical high-grade lesions.
a substantial agreement was found between careHPV and HC2 in detecting HPV overall as well as detecting HPV among women with cervical high-grade lesions. However, given the limited resources available in low and middle-income countries, the HPV testing assay should be weighed against the cost effectiveness of the test.