Reference Interval:
Effective July 18, 2011
Negative
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| Interpretive Data: |
This test detects HPV types 16 and 18 only. It does not detect high-risk types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68, which are also associated with cervical cancer and its precursor lesions. Cross-reactivity with high levels of the high-risk HPV type 31 has been observed and may result in an HPV 16-positive result.
This assay is not intended for use as a stand-alone assay. Results should be interpreted in conjunction with a high-risk HPV screening test, cervical cytology test results, clinical context and other risk factors. Sensitivity may be affected by specimen integrity and/or cellularity.
A negative result does not exclude the possibility of HPV 16 and/or HPV 18 infection because very low levels of infection or sampling error may cause false-negative results. False-negative result may be obtained with specimens that are contaminated with high levels of contraceptive jelly and/or antifungal creams.
The performance characteristics of this test were determined by ARUP Laboratories, Inc.
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| CPT Code(s): |
87621 x2
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Cross References: |
Cervista™ HPV 16/18 (Human Papillomavirus (HPV), Genotypes 16 and 18)
, Cervista™ HPV High Risk (Human Papillomavirus (HPV), Genotypes 16 and 18)
, HPV (Human Papillomavirus (HPV), Genotypes 16 and 18), Invader Human Papillomavirus (HPV), High-risk With Reflex to HPV Genotypes 16 and 18 (Human Papillomavirus (HPV), Genotypes 16 and 18)
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