The AridiaHPV 16/18 Real-Time PCR Test is based on the real-time amplification and detection of human papillomavirus types 16 and 18 in a one-step format.
The test is designed for specific and qualitative detection and differentiation of HPV types 16 and 18 in clinical specimens as an aid in the diagnosis of HPV infection alongside all available clinical and epidemiological data, patient history, and other laboratory test outcomes. The product is intended for use by professionals specifically trained in nucleic acid amplification techniques and in vitro diagnostic procedures.
Recommended for use:
Women exhibiting abnormal cellular changes in samples collected from the cervix, as observed during Pap smear testing. Women over 30 years of age are at particular risk for developing cervical cancer due to infection with HPV 16/18.
HPV 16/18 DNA is detectable in cells collected from the cervix of infected individuals and DNA testing can be performed after or in parallel with Pap smear testing. A positive PCR test is confirmatory of HPV 16/18 infection. A negative PCR test does not exclude infection and should be followed up with additional testing. All test results should be evaluated by a health care professional in the context of clinical symptoms, epidemiological information, patient history, and other diagnostic test results.
Limit of Detection: ≥50 HPV 16 copies are detected as positive ≥95% of the time and reactions containing ≥10 HPV 16 copies are detected as positive ≥85% of the time. PCR reactions containing ≥10 HPV 18 copies are detected as positive ≥95% of the time
Cross-Reactivity: no cross-reactivity with many common pathogens causing sexually transmitted diseases (see details in package insert)