Rapid Diagnostics for HIV and Hepatitis

Withdrawn before enrolling · Not applicable

Conditions studied: HIV Infections, Hepatitis B Infections, Hepatitis C Infections

In brief

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.

Key facts

Study ID

NCT02190305

Run by

MedMira Laboratories Inc.

People needed

0

Starts

2014-05-01

Expected to finish

2015-08-01

Last updated by the study team

2023-04-21

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• All subjects:
• 13 years of age or older
• able to sign consent form (or parent/guardian sign consent plus subject sign assent for ages 13-18)
• willing to complete the risk assessment questionnaire, and
• willing to provide blood samples: finger stick sample (2 drops), 1 serum separator tube, 2 anticoagulant (K2 EDTA) tubes.
• Population 1 - Diagnostic Trial "At Risk" Group (n = 2000-3000)
• Subjects must meet one or more of the following inclusion criteria to be enrolled in Population 1:
• Have at least one risk factor for infection with hepatitis B or C,
• Have at least one risk factor for infection with HIV,
• Present with signs and symptoms of hepatitis,
• Be a known HIV-positive individual (previous positive HIV test result, may comprise up to 500 individuals)
• Population 1A - Additional known HIV-positive individuals (n = \~500)
• Subjects must:
• be a known HIV-positive individual (previous positive HIV test result).
• Population 1B - Additional known HBV-positive individuals (n = \~500)
• Subjects must:
• be known to have current or past HBV infection, as evidenced by HBV serology results.
• Population 1C - Additional known HCV-positive individuals (n = \~500)
• Subjects must:
• be known to be infected with HCV, as evidenced by previous positive HCV test results.

You may not qualify if…

• Subjects do not meet the inclusion criteria

Where it is running

• Keck School of Medicine - LAUSC — Los Angeles, California, United States
• SCFLD Hepatology Diagnostic Research Laboratory — Miami, Florida, United States
• Minneapolis Medical Research Foundation — Minneapolis, Minnesota, United States
• NYC Dept Health & Mental Hygiene — New York, New York, United States

Full record on ClinicalTrials.gov

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