Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 13 - Any |
| Updated: | 4/13/2015 |
| Start Date: | July 2014 |
| End Date: | December 2014 |
Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test for the Detection of HIV-1 Antibodies in Fingerstick and Venous Whole Blood Samples
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and
fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test
will be determined by comparing the results with patient infected status for HIV-1 (human
immunodeficiency virus type 1).
The study will consist of a single one-hour visit, at which time blood samples will be
collected and tested with the investigational device (Reveal G4) and FDA approved comparator
assays for detection of HIV-1 antibodies.
fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test
will be determined by comparing the results with patient infected status for HIV-1 (human
immunodeficiency virus type 1).
The study will consist of a single one-hour visit, at which time blood samples will be
collected and tested with the investigational device (Reveal G4) and FDA approved comparator
assays for detection of HIV-1 antibodies.
This clinical trial is a multi-center study to assess the performance characteristics of a
rapid in vitro diagnostic assay, the Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4).
Specifically, the objective of this study is to determine the sensitivity and specificity of
Reveal G4 in finger stick and venous whole blood, relative to FDA approved reference assays
for the detection of HIV-1 antibodies.
Approximately 1500-2000 subjects in total will be enrolled in the study across all sites,
into three different study populations. Population 1 will be comprised of at least 500
subjects from a population at risk of infection with HIV. Population 2 will be comprised of
at least 500 subjects that are known HIV positive individuals. Population 3 will be
comprised of at least 500 subjects from a population at low risk of HIV infection. Reveal G4
will be used to test fingerstick whole blood and venous whole blood samples from all study
subjects. For enrolled subjects in Populations 1 and 3, who are of unknown HIV antibody
status, a plasma sample prepared from the venous whole blood sample will also be tested with
an algorithm of FDA-approved assays for the detection of HIV-1 antibodies. For Population 2
subjects who are known HIV-positive individuals, results of previous HIV tests will be
obtained from the subjects' medical records. The sensitivity and specificity of Reveal G4
will be determined in fingerstick and venous whole blood relative to HIV-1 antibody status
as determined by an algorithm of FDA-approved assays.
The primary analysis will involve comparison of Reveal G4 results for anti-HIV-1 in each
sample matrix (fingerstick whole blood and venous whole blood) with the subject's HIV-1
antibody status as determined by FDA-approved assays. Based on the above, the sensitivity
and specificity of Reveal G4 will be determined with corresponding two-sided 95% confidence
intervals for both fingerstick and venous whole blood.
rapid in vitro diagnostic assay, the Reveal G4 Rapid HIV-1 Antibody Test (Reveal G4).
Specifically, the objective of this study is to determine the sensitivity and specificity of
Reveal G4 in finger stick and venous whole blood, relative to FDA approved reference assays
for the detection of HIV-1 antibodies.
Approximately 1500-2000 subjects in total will be enrolled in the study across all sites,
into three different study populations. Population 1 will be comprised of at least 500
subjects from a population at risk of infection with HIV. Population 2 will be comprised of
at least 500 subjects that are known HIV positive individuals. Population 3 will be
comprised of at least 500 subjects from a population at low risk of HIV infection. Reveal G4
will be used to test fingerstick whole blood and venous whole blood samples from all study
subjects. For enrolled subjects in Populations 1 and 3, who are of unknown HIV antibody
status, a plasma sample prepared from the venous whole blood sample will also be tested with
an algorithm of FDA-approved assays for the detection of HIV-1 antibodies. For Population 2
subjects who are known HIV-positive individuals, results of previous HIV tests will be
obtained from the subjects' medical records. The sensitivity and specificity of Reveal G4
will be determined in fingerstick and venous whole blood relative to HIV-1 antibody status
as determined by an algorithm of FDA-approved assays.
The primary analysis will involve comparison of Reveal G4 results for anti-HIV-1 in each
sample matrix (fingerstick whole blood and venous whole blood) with the subject's HIV-1
antibody status as determined by FDA-approved assays. Based on the above, the sensitivity
and specificity of Reveal G4 will be determined with corresponding two-sided 95% confidence
intervals for both fingerstick and venous whole blood.
Inclusion Criteria:
- All subjects must be at least 18 years of age, able to sign consent form, complete
the risk assessment questionnaire, and provide the required blood samples:
fingerstick sample (1 drop), venous whole blood sample (1 K2 EDTA tube).
- Population 1 - Individuals at risk of HIV infection (n ≥ 500) Subjects must meet
have at least one risk factor for infection with HIV
- Population 2 - Known HIV-1 positive individuals (n ≥ 500) Subjects must be a
known HIV-positive individual (previous positive HIV test result)
- Population 3 - Individuals at low risk of HIV infection (n ≥ 500) Subjects must
not have any risk factors for infection with HIV
Exclusion Criteria:
- Subjects do not meet inclusion criteria
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