Bio Breeders Inc.

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.

Cervical cancer is the second most frequent female malignancy worldwide. High-risk human papillomavirus (HPV) is the main cause of cervical cancer, affecting nearly 500,000 women around the world every year and killing more than 270,000. About 80% of these women live in developing countries that do not have adequate cervical cancer screening or treatment programs¹. Most developing countries have insufficient infrastructure for cytology-based screening and lack well-trained cytopathologists. In these countries, only a minority of women receive effective screening and treatment for cervical cancer². Using cytology as the main method of screening is not feasible in developing countries, thus new screening methods are sought and are being evaluated, for example, visual inspection with acetic acid (VIA) and HPV-DNA testing³.

Persistent infection with HPV is the leading cause of cervical cancer and precancerous cervical lesions⁴. Infection with HPV is very common in young women after the onset of sexual activity. When infection persists, HPV viral oncoproteins disrupt cell-cycle controls, resulting in cervical intraepithelial neoplasia (CIN)⁵. Therefore, the high-risk HPV test is an effective cervical cancer screening tool. A large sample study in North America and Europe indicated that the sensitivity of the conventional Pap cytology smear for detecting cervical cancer or cancerous lesions of greater or equal seriousness to CIN 2 is only 53%. This contrasts with the Digene HC2 High-Risk HPV DNA Test (HC2) which has a sensitivity of 96.1%. The specificity of the two methods is 96.3% and 90.7%, respectively⁶. The Digene HC2 assay is a commercially available test for HPV DNA detection and is approved by the United States Food and Drug Administration (FDA). The HC2 assay can detect 13 types of high-risk HPV associated with cervical cancer: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 and 68. However, the HC2 assay is expensive and requires laboratory equipment, so it is not commonly available in developing countries. An international research project, supported by the Bill & Melinda Gates foundation in China and India from 2003–2007, worked towards developing a new, rapid and economical method of cervical cancer screening. One of the methods developed is a high-risk HPV nucleic acid detection kit (using hybrid capture-chemiluminescence technology) known as the careHPV test, developed by Qiagen (Gaithersburg, MD, USA)⁷.

The careHPV test is a powerful, rapid and precise HPV-DNA detection method in which antibodies bind to magnetic beads, rapidly capturing specific target HPV nucleic acid sequences, which are then detected using a chemiluminescence signal. This method can detect 14 types of high-risk HPV (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) and more than 80 specimens can be processed in 2.5 hours. This allows screening and follow-up to be completed in one day.

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.