APTIMA HPV 16 18/45 Genotype Assay on the TIGRIS DTS System in Women With ASC-US or Negative Pap Test Results

Gen-Probe, Incorporated1,260 enrolled

Overview

In both the ASC-US Study and Adjunct Study populations, the objectives are to: * evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and * evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.

The APTIMA HPV 16 18/45 Genotype Assay (AHPV-GT 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 from women with positive results in the APTIMA HPV Assay. The AHPV-GT Assay can differentiate between samples positive for HPV 16 from those positive for HPV 18 and/or 45, but does not differentiate between HPV 18-positive samples and HPV 45-positive samples. Cervical specimens collected in ThinPrep Pap Test vials containing PreservCyt Solution (Hologic, Inc., Marlborough, Massachusetts) with commercially available collection devices (broom-type collection device or cytobrush/spatula combination) may be tested with the AHPV-GT Assay either pre- or post-Pap processing. The assay is used with the TIGRIS DTS (TIGRIS) System. In both the ASC-US Study and Adjunct Study populations, the objectives are to: * evaluate the performance characteristics of the AHPV-GT Assay for detecting cervical disease in women with APTIMA HPV Assay positive results and * evaluate the ability of the AHPV-GT Assay to detect HPV high-risk types 16, 18, and 45 in women with APTIMA HPV Assay positive results.

Study Type

OBSERVATIONAL

Enrollment

1,260

Conditions

Human Papillomavirus Infection

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * • the subject attended a colposcopy visit, and * the referral Pap sample had a valid APTIMA HPV Assay result, and * the sample had an APTIMA HPV Assay positive result, or * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of cervical intraepithelial neoplasia (CIN) grade 2 \[CIN2\] or more severe (eg, CIN2, CIN grade 3 \[CIN3\], or cervical cancer; "CIN2+"), or * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of normal or CIN grade 1 (\<CIN2) and was randomly selected for inclusion. the referral Pap sample had a valid APTIMA HPV Assay result, and * the sample had an APTIMA HPV Assay positive result, or * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of CIN2+, or * the sample had an APTIMA HPV Assay negative result and the subject had a consensus histology result of \<CIN2 and was randomly selected for inclusion. Exclusion Criteria: * Samples from evaluable subjects meeting the sample inclusion criteria will not be tested with the AHPV-GT Assay if there is insufficient volume for AHPV-GT Assay testing or the sample was deemed unsuitable for testing (eg, stored under unacceptable conditions).

Locations (3)

North Shore LIJ Health System Laboratories

Lake Success, New York, United States

Laboratory Corporation of America

Burlington, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45

Sensitivity (%) = TP/(TP + FN) x 100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status \<CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status \<CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay

Time frame: 6 months

Specificity of the assay to give a positive signal only in HPV 16, 18 and/or 45 positive samples

Specificity (%) = TN/(TN + FP) x100: True Negative (TN): AHPVGT=Negative, Cervical Disease Status \<CIN2; True Positive (TP): AHPVGT=Positive, Cervical Disease Status CIN2+; False Positive (FP): AHPVGT=Positive, Cervical Disease Status \<CIN2; False Negative (FN): AHPVGT=Negative, Cervical Disease Status CIN2+; Indeterminate: AHPVGT= Invalid, Cervical Disease Status Any; AHPVGT = APTIMA HPV 16 18/45 Genotype Assay

Time frame: 6 months

Data from ClinicalTrials.gov

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