This assay is designed to enhance existing methods for the detection of cervical disease and should be used in conjunction with clinical information derived from other diagnostic and screening tests, physical examinations, and full medical history in accordance with appropriate patient management procedures.
Negative results are not intended to prevent women from proceeding to colposcopy.
Negative results indicate HPV E6/E7 mRNA was not detected.
Personal lubricants and anti-fungal agents may interfere with the performance of this assay.
ThinPrep® specimens can be used for HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis testing.
The use of this test has not been evaluated for the management of HPV vaccinated women, women with prior ablative or excisional therapy, hysterectomy, who are pregnant or who have other risk factors (e.g., HIV+, immunocompromised, history of sexual transmitted infection).