Human Immunodeficiency Viruses
Conditions
Brief summary
To test blood specimens using a new investigational test that detects antigen and antibody to human immunodeficiency virus (HIV). Results will be compared to an approved HIV antibody test and supplemental testing performed to determine HIV status.
Detailed description
All specimens collected under separate specimen collection protocols or obtained from specimen suppliers will be provided to the clinical sites performing the investigational HIV test. This includes 6252 specimens collected from normal healthy individuals (7B5-02-05Z01-01: Collection of Specimens Used in Abbott Laboratories In Vitro Diagnostic HIV and Hepatitis Assays Clinical Studies)and from specimen suppliers. 588 specimens from HIV-infected pediatric subjects and 448 pregnant females at risk for HIV infection collected under protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay)and from specimen suppliers. All specimens were previously collected and frozen, except for a subset of 586 specimens from normal healthy population and 55 specimen from pregnant females at risk for HIV infection which were collected under separate specimen collection protocols and tested as fresh specimens during the study. In addition, 83 specimens that were HIV antigen positive, 1121 specimens that were HIV-1 antibody positive, 201 specimens that were HIV-2 antibody positive, and 1409 specimens from US at risk for HIV infection or from HIV-2 endemic area were all obtained from specimen suppliers, except for 11 pediatric specimens collected under a separate protocol (7B5-02-05Z01-02: Collection of Pediatric and Pregnant Female Specimens Used in the Abbott Laboratories In Vitro Diagnostic HIV Assay).
Interventions
DEVICEARCHITECT HIV Ag/Ab Combo
Test blood samples with investigational HIV assay. If results for specimens from the normal healthy population or pregnant female population at risk for HIV infection are reactive, samples will be tested with supplemental HIV assays. If all supplemental HIV assays are negative, subject will be asked to return for a follow-up blood draw.
Sponsors
Abbott Diagnostics Division
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
Normal Healthy Population: Inclusion Criteria: * Apparently healthy individual at the time of enrollment as affirmed by the subject
Exclusion criteria
* HIV infection as affirmed by the subject Pregnant Female Population at Risk for HIV Infection: Inclusion Criteria: * Subject is a pregnant female * Subject has risk factor for HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection | 3 months | HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. |
| Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens | 3 months | Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test. |
| Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population | 3 months | HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. |
| Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | 3 months | HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | 3 months | Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test. |
Countries
United States
Participant flow
Recruitment details
All specimens collected under separate collection protocols or obtained from specimen suppliers: human immunodeficiency virus (HIV) antigen positive samples, HIV-1 antibody positive, specimens collected from individuals at risk for HIV infection in the United States (US), HIV-2 antibody positive and specimens collected from HIV-2 endemic area.
Pre-assignment details
All subjects were assigned to one group. There was no pre-screening criteria for this study.
Participants by arm
| Arm | Count |
|---|---|
| Architect HIV Ag/Ab Combo Specificity Specimens collected from apparently healthy individuals under a separate specimen collection protocol (7B5-02-05Z01-01) or obtained from specimen vendors and were tested with investigational HIV test. | 6,252 |
| Architect HIV Ag/Ab Combo HIV-1 Antigen Sensitivity Specimens obtained from specimen vendors were tested with investigational HIV test. | 83 |
| Architect Ag/Ab Combo HIV-1 Antibody Sensitivity Specimens collected from HIV-1 infected individuals under a separate specimen collection protocol (pediatric subjects 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test. | 1,121 |
| Architect HIV Ag/Ab Combo HIV-2 Antibody Sensitivity Specimens obtained from specimen vendors were tested with investigational HIV test. | 201 |
| Architect HIV Ag/Ab Combo Reactivity Specimens collected from individuals at increased risk for HIV infection under a separate specimen collection protocol (pregant females 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test. | 1,409 |
| Total | 9,066 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| General Population From 16 to 89 Years | Did not meet criteria for analysis | 0 | 20 | 0 |
| Pregnant Females Between 16-44 Years | Specimens classified incorrectly | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Architect HIV Ag/Ab Combo Specificity | Architect HIV Ag/Ab Combo HIV-1 Antigen Sensitivity | Architect Ag/Ab Combo HIV-1 Antibody Sensitivity | Architect HIV Ag/Ab Combo HIV-2 Antibody Sensitivity | Architect HIV Ag/Ab Combo Reactivity |
|---|---|---|---|---|---|---|
| Age, Customized >= 21 years | 8024 participants | 5663 participants | 0 participants | 1057 participants | 0 participants | 1304 participants |
| Age, Customized between 2 and 21 years | 713 participants | 588 participants | 0 participants | 64 participants | 0 participants | 61 participants |
| Age, Customized Not collected | 329 participants | 1 participants | 83 participants | 0 participants | 201 participants | 44 participants |
| Region of Enrollment Cameroon | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Côte D'Ivoire | 714 Participants | 0 Participants | 0 Participants | 0 Participants | 201 Participants | 513 Participants |
| Region of Enrollment South Africa | 4 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 8347 Participants | 6252 Participants | 78 Participants | 1121 Participants | 0 Participants | 896 Participants |
| Sex/Gender, Customized Female | 4926 participants | 4165 participants | 0 participants | 231 participants | 0 participants | 530 participants |
| Sex/Gender, Customized Male | 3856 participants | 2087 participants | 0 participants | 890 participants | 0 participants | 879 participants |
| Sex/Gender, Customized Not collected | 284 participants | 0 participants | 83 participants | 0 participants | 201 participants | 0 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 586 | 0 / 0 | 0 / 55 |
| serious Total, serious adverse events | 0 / 586 | 0 / 0 | 0 / 55 |
Outcome results
Primary
Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens
Positive HIV status was determined by the results of the HIV-1 Western blot, HIV-2 Western blot, and/or HIV-1 ribonucleic acid (RNA) test.
Time frame: 3 months
Population: Sensitivity was determine using confirmed positive specimens/panels for HIV-1 Antigen (63 samples/panels/viral isolates), HIV-1 antibody (1003 US population) and HIV-2 antibody (201 endemic area of Ivory Coast) based on supplemental testing.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens | ARCHITECT HIV Ag/Ab Reactive | 63 Blood specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens | ARCHITECT HIV Ag/Ab Nonreactive | 0 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens | ARCHITECT HIV Ag/Ab Reactive | 1003 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens | ARCHITECT HIV Ag/Ab Nonreactive | 0 Blood specimens |
| HIV-2 Antibody Sensitivity | Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens | ARCHITECT HIV Ag/Ab Reactive | 201 Blood specimens |
| HIV-2 Antibody Sensitivity | Architect HIV Combo Test Data for Clinical Sensitivity in HIV Positive Specimens | ARCHITECT HIV Ag/Ab Nonreactive | 0 Blood specimens |
95% CI: [94.31, 100]Exact binomial
95% CI: [99.63, 100]Exact binomial
95% CI: [98.18, 100]Exact binomial
Primary
Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection
HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.
Time frame: 3 months
Population: Specificity determined from 6,164 specimens from apparently healthy individuals (low risk): includes 250 specimens from pregnant females in first trimester and 580 specimens from low risk population prospectively collected and tested fresh during study. Total of 37 confirmed HIV positives by supplemental testing were excluded from analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection | HIV Ag/Ab Combo Reactive, HIV status Positive | 37 Blood Specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection | HIV Ag/Ab Combo Reactive, HIV status Negative | 14 Blood Specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection | HIV Ag/Ab Combo Nonreactive HIV status Positive | 0 Blood Specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Clinical Specificity in Population at Low Risk for HIV Infection | HIV Ag/Ab Combo Nonreactive HIV status Negative | 6113 Blood Specimens |
95% CI: [99.62, 99.88]Exact binomial
Primary
Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age)
HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.
Time frame: 3 months
Population: Specificity determine from 588 specimens: 364 low risk, 95 increased risk, 47 increased risk (HIV-2 endemic area), 44 pregnant females low risk and 38 pregnant females increased risk with HIV negative status. Sensitivity determined from 65 specimens: 60 HIV-1 infected, 2 HIV-1 infected pregnant females, 2 HIV infected from HIV-2 endemic area.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | HIV Ag/Ab Combo Reactive HIV Status Positive | 0 Blood specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | HIV Ag/Ab Combo Reactive HIV Status Negative | 1 Blood specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | HIV Ag/Ab Combo Nonreactive HIV Status Positive | 0 Blood specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | HIV Ag/Ab Combo Nonreactive HIV Status Negative | 587 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | HIV Ag/Ab Combo Nonreactive HIV Status Negative | 0 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | HIV Ag/Ab Combo Reactive HIV Status Positive | 64 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | HIV Ag/Ab Combo Nonreactive HIV Status Positive | 0 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Specificity and Sensitivity in Pediatric Population (From 2 up to 21 Years of Age) | HIV Ag/Ab Combo Reactive HIV Status Negative | 0 Blood specimens |
95% CI: [99.06, 100]Exact binomial
95% CI: [94.4, 100]Exact binomial
Primary
Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population
HIV status was determined by the results of the HIV comparator assay, HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.
Time frame: 3 months
Population: HIV negative status determined for specimens reactive by investigational assay and/or comparator by supplemental testing algorithm including HIV-1 Western blot, HIV-2 enzyme immunoassay (EIA), HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot. Specimens from pregnant females.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population | Architect HIV Ag/Ab Reactive | 0 Blood specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population | Architect HIV Ag/Ab Nonreactive | 448 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population | Architect HIV Ag/Ab Reactive | 65 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Specificity and Sensitivity in Pregnant Female Population | Architect HIV Ag/Ab Nonreactive | 0 Blood specimens |
95% CI: [99.18, 100]Exact binomial
95% CI: [94.48, 100]Exact binomial
Secondary
Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations
Reactivity was determined by the results of the Architect HIV Ag/Ab Combo assay and supplemental testing by HIV-1 Western blot, HIV-2 Western blot, and HIV-1 ribonucleic acid (RNA) test.
Time frame: 3 months
Population: Final HIV status determined for specimens reactive by investigational assay and/or comparator by supplement testing algorithm. Supplemental testing involved HIV-1 Western blot, HIV-2 EIA, HIV-2 Western blot, HIV-1 p24 Antigen assay and HIV-1 RNA. HIV positive status determined by HIV-1 Western blot.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Reactive HIV Status Positive | 65 Blood specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Reactive HIV Status Negative | 6 Blood specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Nonreactive - HIV Status Positive | 0 Blood specimens |
| Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Nonreactive HIV Status Negative | 622 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Nonreactive HIV Status Negative | 424 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Reactive HIV Status Positive | 83 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Nonreactive - HIV Status Positive | 0 Blood specimens |
| HIV-1 Antibody Sensitivity | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Reactive HIV Status Negative | 6 Blood specimens |
| HIV-2 Antibody Sensitivity | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Nonreactive HIV Status Negative | 198 Blood specimens |
| HIV-2 Antibody Sensitivity | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Reactive HIV Status Negative | 0 Blood specimens |
| HIV-2 Antibody Sensitivity | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Nonreactive - HIV Status Positive | 0 Blood specimens |
| HIV-2 Antibody Sensitivity | Architect HIV Combo Test Data for Reactivity of Architect HIV Combo in Increased HIV Risk Populations | HIV Ag/Ab Combo Reactive HIV Status Positive | 5 Blood specimens |