High-risk HPV nucleic acid detection kit-the careHPV test -a new detection method for screening.

ABSTRACT

This study assessed the clinical accuracy of the correlation between the careHPV test and the HC2 test, as well as the correlation between the careHPV test and the HPV-PCR test. From September 21 to December 31, 2009, 419 cervical specimens from women, 30-49 years, were collected. All women were assessed by Digene HC2 High-Risk HPV DNA Test (HC2), careHPV test, and HPV-PCR. The concordance rate between careHPV and HC2 was 93.81% and between careHPV and HPV-PCR 88.12%. The sensitivity and specificity of the careHPV test to detect cancers of equal or greater severity than CIN 2 were 85.71% and 83.15% respectively. Results from careHPV, HC2, and HPV-PCR were highly consistent. The careHPV test has good sensitivity and specificity for the detection of HPV infection and is a promising primary screening method for cervical cancer in low-resource regions.