The Aptima HPV 16 18/45 genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16,18 and 45 in cervical specimens. The Aptima HPV 16 18/45 genotype assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45.

HPV Genotyping should be ordered within the Pap order as a reflex test. Current ASCCP HPV triage recommendations are based on reflexing for HPV Genotyping off of the Pap result, HPV result. and patient's age. Our lab staff triage for HPV Genotyping is based on your order request within the Pap order and the ASCCP criteria. See Pap and HPV Testing FAQ's.

See instructions for Cytology, ThinPrep Pap Test.

Place specimen inside a biohazard bag with the request form in the outside pocket of the bag. Transport specimen to Laboratory.

Failure to tighten the cap on the PreservCyt vial may cause loss of the specimen.

Report provides interpretation.

A Not Detected result does not exclude the possibility of infection with HPV 16, 18 or 45, or any other high risk HPV type (31,33,35,39,51,52,56,58,59,66,68).  False negative results may be due to low levels of HPV infected cells, inhibitory substances, inappropriate or inadequate sampling, or insufficient cellular material.  Inadequate specimen collection, processing and storage may invalidate test results. 

Virus quantitation is not possible due to the nature of the specimen.

This test should not be used as the only criterion to form a clinical conclusion; instead, results should be correlated with other test results, patient symptoms and clinical presentation. 

This test is approved by the U.S. Food and Drug Administration.