Aptima HPV 16 18/45 Genotype Assay

Aptima HPV 16 18/45 Genotype Assay

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Hologic’s Aptima HPV 16 18/45 Genotype Assay, the Aptima HPV 16 18/45 Genotype Assay is an in vitro nucleic acid amplification test for the qualitative detection of human papillomavirus E6/E7 viral messenger RNA (mRNA) (HPV) types 16, 18, and 45 in cervical specimens from women who tested positive in the Aptima HPV Assay.

Description

Hologic’s Aptima HPV 16 18/45 Genotype Assay, the Aptima HPV 16 18/45 Genotype Assay is an in vitro nucleic acid amplification test for the qualitative detection of human papillomavirus E6/E7 viral messenger RNA (mRNA) (HPV) types 16, 18, and 45 in cervical specimens from women who tested positive in the Aptima HPV Assay.

The Aptima HPV 16 18/45 Genotyping Assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but doesn’t differentiate between HPV 18 and HPV 45

This test is directed for:

Women who are 21 or older with atypical squamous cells of undetermined significance (ASC-US), the Aptima HPV 16 18/45 Genotyping Assay can be used to test samples from women who test positive on the Aptima HPV Assay for the presence or absence of high-risk HPV genotypes 16, 18, and/or or 45.
For women who are 30 or older, the Aptima HPV 16 18/45 Genotyping Assay can be used to test specimens from women who have positive Aptima HPV Assay results. The assay’s results will be used in combination with cervical cytology to assess the presence or absence of high-risk HPV genotypes 16, 18, and/or 45.