Human papilloma virus IVDs

Intended purpose

The Aptima HPV assay is a target amplification nucleic acid probe test for the in vitro qualitative detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk HPV types of human papillomavirus (HPV) (16/18/31/33/35/39/45/51/52/56/58/59/66/68). The Aptima HPV assay does not discriminate between the 14 high-risk types. 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) from human papillomavirus (HPV) high-risk types 16, 18, and 45 in samples from women with positive Aptima HPV assay results.