Comparison of APTIMA HPV E6/E7 mRNA and Hybrid Capture 2 Assays using Wet and Dry Self-Collected Flocked Vaginal Swabs and PreservCyt L-Pap Samples

Abstract

 Background: Performance of HPV assays on less invasive specimens can be assessed through agreement of assays and specimen types as well as the ability to identify patients with precancerous lesions.

Objectives: To compare the APTIMA HPV (AHPV) E6/E7 mRNA assay to the HC2 DNA test for high risk (HR) HPV performed on PreservCyt L-Pap cervical specimens and flocked self-collected vaginal swabs (SCVS) transported to the laboratory wet or dry.

Results: Testing specimens from 100 women attending a colposcopy clinic showed 90.7% (k=0.81) agreement between HC2 and AHPV assays for PreservCyt specimens. Agreement was 80.2% (K=0.80) to 88.0% (K=0.76) between L-Pap and wet and dry SCVS respectively and 89.2% (K=0.77) between the 2 SCVS by AHPV testing. For HC2, the agreement was 90.6% (k=0.81) to 89.2% (k=0.78) between L-Pap and the 2 swabs and 96.0% (k=0.90) between wet and dry swabs. Using pathology (CIN2+) as the reference standard, SCVS tested by AHPV demonstrated sensitivities of 88.8% for dry and 90% for wet SCVS, compared to 86.4% for L-Pap samples. HC2 testing of wet and dry SCVS was 70.8% sensitive compared to 94.4% for L-Pap samples.

Conclusion: SCVS collected with flocked nylon swabs transported wet or dry may serve as alternative specimens for HPV testing of women who are reluctant to have a pelvic examination.