NCT02190305

Rapid Diagnostics for HIV and Hepatitis

Rapid Diagnostics for HIV and Hepatitis - Multiplo HBc/HIV/HCV and Reveal HBsAg

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: MedMira Laboratories Inc. · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood. The clinical performance of Multiplo HBc/HIV/HCV will be determined by comparing the results with patient infected status for HIV-1/2 (human immunodeficiency viruses 1 and 2), HBV (hepatitis B virus) and HCV (hepatitis C virus). The clinical performance of Reveal HBsAg will be determined by comparing the results with patient infected status for HBV. Subject participation in the study will consist of a single one-hour visit, at which time blood samples will be drawn for testing with the investigational devices and with approved comparator assays. The test results, which are the outcome of the study, will be obtained only once, at the time of this visit.

Detailed description

The objective of this study is to determine the performance characteristics of two rapid diagnostic tests. Approximately 3000-4500 subjects in total will be enrolled in the study into four different study populations. In Population 1, which is "at risk" group of about 2000-3000 subjects, roughly 2/3 will be individuals who are at risk of infection with HIV or hepatitis B or C, or who have signs or symptoms of hepatitis. Approximately 500 of these individuals are expected to be known HIV-positive individuals. The remaining three study populations will be comprised of individuals with known infection with HIV (Population 1A, \~500 individuals), HBV (Population 1B, \~500 individuals), and HCV (Population 1C, \~500 individuals). Both Multiplo HBc/HIV/HCV and Reveal HBsAg will be used to test finger stick whole blood, venous whole blood and plasma samples from each subject in Population 1. Plasma samples (repository or fresh) will be used to fulfill the requirements for Populations 1A, 1B, and 1C. For all enrolled subjects, the plasma sample will be tested with the following FDA-approved assays: EIA for anti-HIV-1/2, anti-HCV, anti-HBc total, anti-HBc IgM, anti-HBs, and HBsAg. The efficacy of Multiplo will be determined by comparing the results with patient infected status for HIV-1/2, HBV and HCV. The efficacy of Reveal will be determined by comparing the results with patient infected status for HBV. The primary analysis will involve comparison of Multiplo HBc/HIV/HCV and Reveal HBsAg results for each of the test markers (anti-HIV-1/2, anti-HCV, anti-HBc, and HBsAg), in each sample matrix (finger stick whole blood, venous whole blood and plasma) with the patient infected status as determined by separate algorithms for HIV, HBV, and HCV. The percent positive and percent negative agreement will be determined relative to patient infected status for each marker and sample type, with corresponding two-sided 95% confidence intervals.

Conditions

• HIV Infections
• Hepatitis B Infections
• Hepatitis C Infections

Interventions

Type	Name	Description
DEVICE	Multiplo HBc/HIV/HCV and Reveal HBsAg	All subjects tested with both investigational devices, plus with algorithms of approved assays for HIV and hepatitis B and C.

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-07-15
• Last updated: 2023-04-21

Locations

4 sites across 1 country: United States