The Role of Human Papilloma Virus Testing in Cervical Cancer Prevention

Molly C. Fey, FNP, MSN; Margaret W. Beal, CNM, PhD


J Midwifery Womens Health. 2004;49(1) 

In This Article

HPV-Testing Technology

The Hybrid Capture II (HC II) DNA assay (Digene Diagnostics Inc., Gaithersburg, MD) uses non-radioactive ribonucleic acid (RNA) probes in a modified enzyme-linked immunosorbent assay (ELISA) procedure to report the presence or absence of 13 strains of high-risk HPV DNA. The HC II was approved for use by the FDA in April 1995 and is currently the only HPV test available commercially.[1,11,40,45,48] It costs approximately $30 to $50, not including the price of the office visit. Generally, HPV testing requires less skilled technicians and is a more simple laboratory procedure than cytology screening.[19,42,49]

Specimens for the HC II can be obtained in two ways. Reflex testing uses the residual cell suspension from liquid-based cytology. The alternative, but less convenient method, is to obtain a sample via cytobrush or cervical swab that is then placed into transport medium in a separate tube for HPV testing. Either approach is acceptable for accurate results.[2]

One drawback of the HC II is that it cannot determine the specific HPV strain or strains found in the sample. Due to use of a mixture of probes, this test reports only the presence or absence of high-risk HPV DNA. Originally, the HC II was designed to give quantitative data reflecting the viral load of cervical specimens, with the hope of establishing a correlation between increased levels of HPV DNA and increased risk of cervical pathology.[1,48] This approach has proved to be unreliable thus far.[50,51]


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