VioOne HIV Profile Supplemental Assay

VioOne™ HIV Profile™ Supplemental Assay

Assessment of the sensitivity, specificity and reproducibility of the VioOne HIV Profile Supplemental Assay

Study Overview

• Status: Completed
• Conditions: HIV Infections
• Intervention / Treatment: Device: VioOne HIV Profile Supplemental Assay

Detailed Description

Specificity A total of 280 serum samples and 300 plasma samples from a low-risk population (e.g. blood donors) will be collected at Houston Gulf Coast Regional Blood Center (Houston, TX). All serum and plasma specimens will be previously screened and found non-reactive with FDA licensed or approved HIV-1/2 assays (a population of samples that would not normally be tested with the Avioq VioOne™ HIV Profile™ Supplemental Assay). The number of serum samples will be supplemented up to 300 with the inclusion of 20 pediatric samples; 10 from children aged 2 - 11 and 10 from children aged 12-18 for a total of 600 samples for specificity testing. Samples will be tested with one of three validation kit lots of the Avioq VioOne TM HIV Profile™ Supplemental Assay manufactured at Avioq.

The samples will be tested at 3 external sites in proportions based on the manufacturing size of the individual validation lots. At Site 1 the samples will be further divided approximately 70% I 30% between Validation lots 1 & 2. At Site 2 the samples will be divided approximately 70% / 30%, between Validation lots 2 and 3. At site 3 the samples will be tested entirely with Validation lot 3. The study design calls for the use of at least one lot in common at all 3 clinical sites based on a request from the FDA.

For the Specificity Study, any indeterminate or reactive samples will be tested with either the FDA approved Bio-Rad Geenius assay or Western Blot to determine the true classification. Specificity and 95% confidence intervals will be calculated.

Sensitivity Serum or plasma (n= 757) repository samples from individuals infected with HIV will be tested at four external sites and at Avioq with up to four validation kit lots. The samples will be tested at all sites in proportions based on the manufacturing size of the individual validation lots. At Site 1 the samples will be further divided approximately 75% I 25% between Validation lots 1 & 2. At Site 2 the samples will be divided approximately 75% / 25%, between Validation lots 2 and 3. At sites 3 and 4 the samples will be tested entirely with Validation lot 3. A fourth lot (Validation lot 5) will be used to test a few HIV-1 Group O samples at Avioq. The study design calls for the use of at least one lot in common at all 4 clinical sites based on a request from the FDA.

The sensitivity samples will consist of 400 HIV positives, a minimum of 200 HIV-2 positives, 50 AIDS positive, 40 pediatric HIV positive, a minimum of 15 HIV-O positives, 10 HIV-1/HIV-2 coinfected positives and a minimum of 27 samples from pregnant females (samples from all three trimesters) infected with HIV.

All specimens are expected to be positive for HIV-1 and/or HIV-2 antibody representing the types of specimens expected to be tested with the Avioq VioOne™ HIV Profile™ Supplemental Assay. Samples with VioOne™ HIV Profile™ assay results discordant from this expectation will be resolved by testing the same samples in FDA approved confirmatory assays such as the BioRad Geenius or Western Blot.

• Study Type: Interventional
• Enrollment (Actual): 757
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Research Triangle Park, North Carolina, United States, 27712
      • Avioq Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Specificity = 280 Serum Samples and 300 Plasma Samples
• An additional 20 Serum pediatric samples
• From low risk population (e.g. blood donors)

• Sensitivity = 757 Total Samples

  • 400 HIV positive,
  • 200 HIV-2 positive
  • 50 AIDS positive
  • 40 Pediatric
  • 15 HIV-O positive
  • 10 HIV-1/HIV-2 co-infected positive
  • 27 samples from pregnant females with HIV

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: VioOne HIV Profile; HIV Profile™ is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. It is intended as an additional, more specific test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens repeatedly reactive in diagnosis or screening procedures, including pediatric patients (ages 2-20).

Device: VioOne HIV Profile Supplemental Assay; The VioOne™ HIV Profile™ Supplemental Assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of Human Immunodeficiency Virus Type 1 (HIV-1 Group M & Group O) and Type 2 (HIV-2) in human serum or plasma. The HIV Profile™ is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical specificity and sensitivity of HIV Infection	Clinical Specificity and 95% CI of the Profile Assay Clinical Sensitivity and 95% CI of the Profile Assay	9 months

Collaborators and Investigators

• Sponsor: Avioq, Inc.
• Collaborators: Duke Clinical Research Institute; University of North Carolina; Clinical Reference Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): April 11, 2018
• Study Completion (Actual): April 11, 2018

Study Registration Dates

• First Submitted: October 25, 2018
• First Submitted That Met QC Criteria: October 31, 2018
• First Posted (Actual): November 1, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; HIV Infections
• Other Study ID Numbers: 100004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes