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

Completed

• Conditions: Human Papillomavirus Infection

• Registration Number: NCT01384370
• Lead Sponsor: Gen-Probe, Incorporated

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2011-02-18
• Study Start: 2011-06
• Study First Submitted QC: 2011-06-27
• Study First Posted: 2011-06-29
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-04
• Last Update Posted: 2011-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1260

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of the assay to detect HPV genotypes 16, 18 and/or 45	6 months	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
Specificity of the assay to give a positive signal only in HPV 16, 18 and/or 45 positive samples	6 months	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

Trial Locations

Locations (3)

North Shore LIJ Health System Laboratories; 🇺🇸 Lake Success, New York, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Laboratory Corporation of America; 🇺🇸 Burlington, North Carolina, United States