Comparison of PCR- and Hybrid Capture-Based Human Papillomavirus Detection Systems Using Multiple Cervical Specimen Collection Strategies

Abstract

This study compared the performances of three human papillomavirus (HPV) detection tests with specimens collected by three alternative procedures. The HPV tests included the Hybrid Capture Tube test (HCT), the microplate-based Hybrid Capture II test (HC II), and the MY09-MY11 L1 consensus primer PCR-based assay. Initial cervical specimens were collected from study subjects with a broom device, and after Papanicolaou smears were made, residual specimens were placed into PreservCyt (PC), a liquid cytology medium. A second specimen was collected from each subject and placed into Digene Specimen Transport Medium (STM). The device for collection of the second specimen alternated with consecutive subjects between a conical cytology brush and a Dacron swab. At the 1.0-pg/ml cutoff, the results of the HC II agreed well with those of the PCR. Specifically, when PCR data were restricted to the types found by the HC II (HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68), there was greater than 90% agreement between the HC II and PCR results with both STM and PC. At a lower cutoff (0.2 pg/ml), HC II-positive results increased further, especially when the test was applied to the PC specimens. However, false-positive HC II results were more often observed at the 0.2-pg/ml cutoff. HC II yielded the highest HPV positivity with specimens placed into PC, followed by specimens collected with a conical brush and placed into STM and, last, by those collected with a Dacron swab and placed into STM. Our results demonstrate the utility of both the STM and PC specimen collection methods and show good agreement between the HC II and PCR.

Self‐collected Pap smears may provide an acceptable and effective method of cervical cancer screening

“…There have been few other devices like solopap, dacronswabs, and digene conical collection used for this test as well. 19,20,35,36 The cervibroom is already used for pap smears and comes at no extra cost; it is also easy to use. The most important difference is that with cervibroom-collected samples, a liquid-based cytology slide can be made if required.…”

Human papillomavirus testing and molecular markers of cervical dysplasia and carcinoma

“…20 Studies have found that specimens collected in PreservCyt have a higher level of nonspecific detection than samples collected in Specimen Transport Medium, although both can be used for this assay. 52,58 Results can be expressed as a ratio of the specimens signal strength in relative light units (RLU) to that of concurrently tested 1 pg/ mL HPV DNA controls (the FDA-approved threshold for a positive result). This can provide a semiquantitative measure of viral load relative to 1 pg/ml.…”

Can clinical tests help monitor human papillomavirus vaccine impact?

“…17,18 Of note, the HC-2 test includes probes for only 13 types yet is considered cross-reactive with HPV type 66. 19 The FDA-approved format was modified to accommodate DNA extracts from self-collected cervico-vaginal swabs. A 50 lL aliquot of extracted DNA was added to 200 lL physiological saline and 125 lL denaturing solution from the HC-2 kit.…”