PAP Smear + High Risk HPV (Cytology)

The cobas® 4800 HPV Test is a qualitative in vitro test for the detection of HPV in patient specimens, The test utilises amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridisation for the detection of 14 HR HPV types in a single analysis. The test specifically identifies HPV 16 and HPV 18 while concurrently detecting the other high-risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) at clinically relevant infection levels.

HPV16 and/or HPV18 and/or Other HR HPV Detected Not Detected Invalid.

Limitations of the test:

The cobas® 4800 HPV Test detects DNA of the high-risk types 16, 18, 31, 33,

35, 39, 45, 51, 52, 56, 58, 59, 66 and 68. This test does not detect DNA 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.

• The cobas® 4800 HPV Test for detection of human papillomavirus types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68 is not recommended for evaluation of suspected sexual abuse.
• The performance of the cobas® 4800 HPV Test has not been adequately established for HPV vaccinated individuals.
• 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.
• Infection with HPV is not an indicator of cytologic HSIL or underlying highgrade CIN, nor does it imply that CIN2-3 or cancer will develop. Most women infected with one or more high-risk HPV types do not develop CIN2-3 or cancer.
• A negative high-risk HPV result does not exclude the possibility of future cytologic HSIL or underlying CIN2-3 or cancer.
• Detection of high-risk HPV 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.
• Reliable results are dependent on adequate specimen collection, transport, storage and processing. Follow the procedures in the Package Insert.
• The effects of other potential variables such as vaginal discharge, use of tampons, douching, etc. and specimen collection variables have not been evaluated.
• Though rare, mutations within the highly conserved regions of the genomic DNA of Human papillomavirus covered by the cobas® 4800 HPV Test’s primers and/or probes may result in failure to detect the presence of the viral DNA.
• The presence of PCR inhibitors may cause false negative or invalid results.
• Cervical specimens often show visibly detectable levels of whole blood as a pink or light brown coloration. These specimens are processed normally on the cobas® 4800 System. If concentrations of whole blood exceed 2% (dark red or brown coloration) in PreservCyt® Solution, there is a likelihood of obtaining a false-negative result
• Use of the RepHresh® vaginal hygiene products has been associated with false-negative results in PreservCyt® Solution

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