Clinical performance assessment of five human papillomavirus DNA tests using liquid-based cytology samples.

AIM: To evaluate the performance of five HPV tests (Hybrid Capture 2, Linear Array [LA], DNA chip, type-specific polymerase chain reaction [PCR], and sequencing) in detecting high-risk (HR) HPV DNA and high-grade cervical intraepithelial neoplasia (CIN) and cancer.

MATERIAL AND

METHODS

A total of 137 women with abnormal cytologies were prospectively enrolled. The diagnostic accuracy of five HPV DNA tests in detecting high-grade CIN and cancer was assessed, and the concordance among HPV genotyping tests was evaluated. All specimens were obtained from cervical swab samples preserved in residual PreservCyt solution that were originally collected for ThinPrep Pap test.

RESULTS

The sensitivities of all five HPV tests did not differ significantly among the five HPV tests. The overall concordance level was excellent between LA and sequencing (98.2%, Kappa = 0.9) and was substantial between DNA chip and sequencing (96.4%, Kappa = 0.8). The concordance levels for detecting vaccine-type (HPV 16 and 18) of LA in comparison with DNA chip, type-specific PCR, and sequencing were substantial (Kappa = 0.67, 0.64, and 0.65, respectively). The sensitivities for all five HPV tests were >90% for the detection of CIN2 or higher. No statistically significant differences in sensitivity occurred between any of the tests.

CONCLUSION

All five HPV tests showed reliable results in detecting HR HPVs, high-grade CIN, and cancer. Both LA and DNA chip tests may be useful in identifying HR HPV, especially when multiple genotypes are present.