Limitations

1. The performance of the APTIMA HPV Assay has not been evaluated for HPV vaccinated individuals.
2. The APTIMA HPV Assay has not been evaluated in cases of suspected abuse.
3. Prevalence of HPV infection in a population may affect performance. Positive predictive values decrease when testing populations with low prevalence or individuals with no risk of infection.
4. ThinPrep liquid cytology specimens containing less than 1 mL after ThinPrep Pap Test slide preparation are considered inadequate for the APTIMA HPV Assay.
5. APTIMA HPV Assay performance has not been evaluated with post-processed ThinPrep liquid cytology specimens using processors other than the ThinPrep 2000 System.
6. Test results may be affected by improper specimen collection, storage or specimen processing.
7. The Internal Control monitors the target capture, amplification, and detection steps of the assay, It is not intended to control for cervical sampling adequacy.
8. A negative APTIMA HPV Assay result does not exclude the possibility of cytologic abnormalities or of future or underlying CIN2, CIN3, or cancer.
9. Personal lubricants that contain Polyquaternium 15 may interfere with the performance of the assay when present at concentrations greater than 0.025% (v/v or w/v) of a test sample.
10. Anti-fungal medications that contain tioconazole may interfere with the performance of the assay when present at concentrations greater than 0.075% (w/v) of a test sample.
11. The APTIMA HPV Assay provides qualitative results. Analyte levels are not necessarily associated with S/CO values (i.e., the expression level of mRNA in a specimen is not necessarily correlated with the magnitude of a positive assay signal). High S/CO values may be observed in samples close to the detection limit of the assay and low S/CO values may be observed in samples above the detection limit. Performing multiple tests on a sample may yield different S/CO values.
12. The APTIMA HPV Assay detects E6/E7 viral messenger RNA (mRNA) of the high-risk HPV types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. This test does not detect E6/ E7 mRNA of HPV low-risk types (e.g. 6, 11, 42, 43, 44) since there is no clinical utility for testing of low-risk HPV types for cervical cancer screening purposes.
13. Detection of high-risk HPV mRNA is dependent on the number of copies present in the specimen and may be affected by specimen collection methods, patient factors, stage of infection and the presence of interfering substances.
14. Infection with HPV is not an indicator of cytologic HSIL or underlying high-grade CIN, nor does it imply that CIN2, CIN3, or cancer will develop. Most women infected with one or more high-risk HPV types do not develop CIN2, CIN3, or cancer.
15. The effects of other potential variables such as vaginal discharge, use of tampons, douching, etc. and specimen collection variables have not been evaluated.
16.  Use of this device must be limited to personnel trained in the use of the APTIMA HPV Assay.
17.  Cross-contamination of samples can cause false positive results. The carry-over rate of the APTIMA HPV Assay on the TIGRIS DTS System and the PANTHER System was 0.7% and 0.4% respectively, as determined in non-clinical studies.
18. The APTIMA HPV Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.
19. False positive results may occur with this test. In vitro transcripts from low-risk HPV genotypes 26, 67, 70, and 82 exhibited cross-reactivity with the APTIMA HPV Assay.
20. The positive control material (TIGRIS DTS System only) is not intended to monitor performance at the assay cutoff.