HIVNCT02401555
Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
An observational study of HIV, run by Bio-Rad Laboratories at 5 sites in United States.
Trial summary
The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV 1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- Geenius HIV1/2 Supplemental Assay
- Type of treatment
- Medical device
- How many people
- 419 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2013to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: HIV1 Positives: Individuals with confirmed HIV1 positive records AIDS Positives: Individuals with proved CDC stage 3 (AIDS) Low Risk patients: Low Risk individuals including potential military recruits, soldiers and civilians who have not reported any high risk behavior for HIV infection.
Who may be able to join
- Able to provide Informed consent
- Must be greater than or equal to 18 years of age.
- Subject does not report any high risk behaviors for HIV infection.
- Of unknown HIV status.
Who cannot join
- Unable to provide informed consent.
- Individuals with one or more high risk behaviors with HIV infection within the previous 6 months.
- Self reported history of HIV infection
- Prior receipt of HIV infection
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Center for Disease Control and Prevention
Atlanta, Georgia, 30333
HIV/AIDS Division, San Fransisco General Hospital
San Francisco, California, 94110
Blood Systems Research Institute
San Francisco, California, 94118
University Of Washington AIDS Clinical Trials Unit, Harborview Medical Center
Seattle, Washington, 98104-2499
Clinical Trials Center, Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910
About this study
The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV 1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma samples (EDTA, heparin, and sodium citrate).
Read the detailed description
Prospectively collected matched sample types, including fingerstick (capillary blood), serum, plasma, and whole venous blood were obtained from subjects at three clinical trial sites within the United States. Informed consent was used to enroll subjects at low risk for HIV (N=120 subjects) and from subjects pre-diagnosed as HIV positive (N=299 subjects).
The fingerstick samples were tested with Geenius HIV 1/2 Supplemental Assay at the collection site, while the remaining matched sample types, (serum, plasma, and whole venous blood) were sent to a clinical lab to be tested on the Geenius HIV 1/2 Supplemental Assay. Results of the Geenius HIV 1/2 Supplemental Assay on each of 4 matched sample were compared to the serum result on the Bio-Rad GS HIV 1/HIV 2 PLUS O EIA, Bio-Rad HIV-1 Western blot, and the Bio-Rad Multispot HIV 1/HIV-2 Rapid Test (reference methods).
Retrospective specimens from repositories or specimens purchased from commercial vendors were also included in the study. In addition to the Geenius HIV 1/2 Supplemental Assay, the GS HIV 1/HIV 2 PLUS O EIA, Bio-Rad HIV-1 Western blot, and the Bio-Rad Multispot HIV 1/HIV-2 Rapid Test were utilized as reference methods. Historical data, when available, was also used. All samples were identified with a unique study number and included the following populations/panels:
- HIV-1/HIV-2 False Reactive Samples (N=100)
- Unrelated Medical Conditions (N=40).
- Normal Pediatric Patients (N=10)
- HIV-1 Positive Pediatric Patients (N=40)
- HIV-1 Non B Group M Subtypes (N=136)
- HIV-1 Group O Antibody Positive (N=15)
- Known HIV-2 Positive Population (N=200)
- HIV Performance Panels
- Anti-HIV-1/2 Combo Performance Panel: PRZ208 (N=15)
- HIV-1 Low Titer Panel: PRB109 (N=20)
- HIV-1 Incidence / Prevalence Panel: PRB601 (N=15)
- HIV-1 Seroconversion Panels (26 Panels, N=230)
- CEPHIA Evaluation Panel (N=2500)
- Conditions
- HIV
- Being tested
- Geenius HIV1/2 Supplemental Assay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geenius HIV1/2 Supplemental AssayDevice
The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate).
| Study group | Role | What they receive |
|---|---|---|
| Known HIV1 positives | Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay Receives: Device: Geenius HIV1/2 Supplemental Assay | |
| Known AIDS | Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay Receives: Device: Geenius HIV1/2 Supplemental Assay | |
| Low risk (negatives) | Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay Receives: Device: Geenius HIV1/2 Supplemental Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis
The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma (EDTA, heparin and sodium citrate). The Accuracy analysis on the serum samples is a proportion of results that are correctly identified as such.
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startApr 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 419 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Rad Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Dennis, BS, Study director, Bio-Rad Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401555
- Sponsor's protocol ID
- RP.BVD.GEHIV.02
- Status last verified
- Feb 2017
- First submitted
- 16 Mar 2015
- Last updated
- 28 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Delmonico FL, Snydman DR. Organ donor screening for infectious diseases: review of practice and implications for transplantation. Transplantation. 1998 Mar 15;65(5):603-10. doi: 10.1097/00007890-199803150-00001. No abstract available.
PubMed 9521191Barre-Sinoussi F, Chermann JC, Rey F, Nugeyre MT, Chamaret S, Gruest J, Dauguet C, Axler-Blin C, Vezinet-Brun F, Rouzioux C, Rozenbaum W, Montagnier L. Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immune deficiency syndrome (AIDS). Science. 1983 May 20;220(4599):868-71. doi: 10.1126/science.6189183.
PubMed 6189183Gallo RC, Salahuddin SZ, Popovic M, Shearer GM, Kaplan M, Haynes BF, Palker TJ, Redfield R, Oleske J, Safai B, et al. Frequent detection and isolation of cytopathic retroviruses (HTLV-III) from patients with AIDS and at risk for AIDS. Science. 1984 May 4;224(4648):500-3. doi: 10.1126/science.6200936.
PubMed 6200936Coffin J, Haase A, Levy JA, Montagnier L, Oroszlan S, Teich N, Temin H, Toyoshima K, Varmus H, Vogt P, et al. What to call the AIDS virus? Nature. 1986 May 1-7;321(6065):10. doi: 10.1038/321010a0. No abstract available.
PubMed 3010128Clavel F, Guetard D, Brun-Vezinet F, Chamaret S, Rey MA, Santos-Ferreira MO, Laurent AG, Dauguet C, Katlama C, Rouzioux C, et al. Isolation of a new human retrovirus from West African patients with AIDS. Science. 1986 Jul 18;233(4761):343-6. doi: 10.1126/science.2425430.
PubMed 2425430Clavel F, Mansinho K, Chamaret S, Guetard D, Favier V, Nina J, Santos-Ferreira MO, Champalimaud JL, Montagnier L. Human immunodeficiency virus type 2 infection associated with AIDS in West Africa. N Engl J Med. 1987 May 7;316(19):1180-5. doi: 10.1056/NEJM198705073161903.
PubMed 3472076Centers for Disease Control (CDC). AIDS due to HIV-2 infection--New Jersey. MMWR Morb Mortal Wkly Rep. 1988 Jan 29;37(3):33-5. No abstract available.
PubMed 3122008O'Brien TR, George JR, Holmberg SD. Human immunodeficiency virus type 2 infection in the United States. Epidemiology, diagnosis, and public health implications. JAMA. 1992 May 27;267(20):2775-9. No abstract available.
PubMed 1578597Sullivan MT, Guido EA, Metler RP, Schable CA, Williams AE, Stramer SL. Identification and characterization of an HIV-2 antibody-positive blood donor in the United States. Transfusion. 1998 Feb;38(2):189-93. doi: 10.1046/j.1537-2995.1998.38298193104.x.
PubMed 9531953Brun-Vezinet F, Rey MA, Katlama C, Girard PM, Roulot D, Yeni P, Lenoble L, Clavel F, Alizon M, Gadelle S, et al. Lymphadenopathy-associated virus type 2 in AIDS and AIDS-related complex. Clinical and virological features in four patients. Lancet. 1987 Jan 17;1(8525):128-32. doi: 10.1016/s0140-6736(87)91967-2.
PubMed 2879971Quinn TC, Zacarias FR, St John RK. AIDS in the Americas: an emerging public health crises. N Engl J Med. 1989 Apr 13;320(15):1005-7. doi: 10.1056/NEJM198904133201509. No abstract available.
PubMed 2467206Guyader M, Emerman M, Sonigo P, Clavel F, Montagnier L, Alizon M. Genome organization and transactivation of the human immunodeficiency virus type 2. Nature. 1987 Apr 16-22;326(6114):662-9. doi: 10.1038/326662a0.
PubMed 3031510Janssens W, Buve A, Nkengasong JN. The puzzle of HIV-1 subtypes in Africa. AIDS. 1997 May;11(6):705-12. doi: 10.1097/00002030-199706000-00002. No abstract available.
PubMed 9143601Charneau P, Borman AM, Quillent C, Guetard D, Chamaret S, Cohen J, Remy G, Montagnier L, Clavel F. Isolation and envelope sequence of a highly divergent HIV-1 isolate: definition of a new HIV-1 group. Virology. 1994 Nov 15;205(1):247-53. doi: 10.1006/viro.1994.1640.
PubMed 7975221Simon F, Mauclere P, Roques P, Loussert-Ajaka I, Muller-Trutwin MC, Saragosti S, Georges-Courbot MC, Barre-Sinoussi F, Brun-Vezinet F. Identification of a new human immunodeficiency virus type 1 distinct from group M and group O. Nat Med. 1998 Sep;4(9):1032-7. doi: 10.1038/2017.
PubMed 9734396
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of the Bio-Rad Geenius HIV1/2 Supplemental Assay
- ClinicalTrials.gov ID
- NCT02401555
- Acronym / sponsor ID
- RP.BVD.GEHIV.02
- Conditions
- HIV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 419 participants (actual)
- Lead sponsor
- Bio-Rad LaboratoriesIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Mar 2015 (estimated)
- Results
- Posted 28 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV 1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma samples (EDTA, heparin, and sodium citrate).
Detailed description
Prospectively collected matched sample types, including fingerstick (capillary blood), serum, plasma, and whole venous blood were obtained from subjects at three clinical trial sites within the United States. Informed consent was used to enroll subjects at low risk for HIV (N=120 subjects) and from subjects pre-diagnosed as HIV positive (N=299 subjects).
The fingerstick samples were tested with Geenius HIV 1/2 Supplemental Assay at the collection site, while the remaining matched sample types, (serum, plasma, and whole venous blood) were sent to a clinical lab to be tested on the Geenius HIV 1/2 Supplemental Assay. Results of the Geenius HIV 1/2 Supplemental Assay on each of 4 matched sample were compared to the serum result on the Bio-Rad GS HIV 1/HIV 2 PLUS O EIA, Bio-Rad HIV-1 Western blot, and the Bio-Rad Multispot HIV 1/HIV-2 Rapid Test (reference methods).
Retrospective specimens from repositories or specimens purchased from commercial vendors were also included in the study. In addition to the Geenius HIV 1/2 Supplemental Assay, the GS HIV 1/HIV 2 PLUS O EIA, Bio-Rad HIV-1 Western blot, and the Bio-Rad Multispot HIV 1/HIV-2 Rapid Test were utilized as reference methods. Historical data, when available, was also used. All samples were identified with a unique study number and included the following populations/panels:
- HIV-1/HIV-2 False Reactive Samples (N=100)
- Unrelated Medical Conditions (N=40).
- Normal Pediatric Patients (N=10)
- HIV-1 Positive Pediatric Patients (N=40)
- HIV-1 Non B Group M Subtypes (N=136)
- HIV-1 Group O Antibody Positive (N=15)
- Known HIV-2 Positive Population (N=200)
- HIV Performance Panels
- Anti-HIV-1/2 Combo Performance Panel: PRZ208 (N=15)
- HIV-1 Low Titer Panel: PRB109 (N=20)
- HIV-1 Incidence / Prevalence Panel: PRB601 (N=15)
- HIV-1 Seroconversion Panels (26 Panels, N=230)
- CEPHIA Evaluation Panel (N=2500)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Known HIV1 positives | – | Device: Geenius HIV1/2 Supplemental AssayIndividuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay |
| Known AIDS | – | Device: Geenius HIV1/2 Supplemental AssayIndividuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay |
| Low risk (negatives) | – | Device: Geenius HIV1/2 Supplemental AssayIndividuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- HIV1 Positives: Individuals with confirmed HIV1 positive records AIDS Positives: Individuals with proved CDC stage 3 (AIDS) Low Risk patients: Low Risk individuals including potential military recruits, soldiers and civilians who have not reported any high risk behavior for HIV infection.
Key inclusion criteria (4 listed)
- Able to provide Informed consent
- Must be greater than or equal to 18 years of age.
- Subject does not report any high risk behaviors for HIV infection.
- Of unknown HIV status.
Key exclusion criteria (4 listed)
- Unable to provide informed consent.
- Individuals with one or more high risk behaviors with HIV infection within the previous 6 months.
- Self reported history of HIV infection
- Prior receipt of HIV infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Geenius HIV1/2 Supplemental AssayThe purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate). | Device | Known AIDS, Known HIV1 positives, Low risk (negatives) |
Primary outcome
Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis
Time frame: Up to 9 months
The purpose of this study was to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay, a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma (EDTA, heparin and sodium citrate). The Accuracy analysis on the serum samples is a proportion of results that are correctly identified as such.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9521191Delmonico FL, Snydman DR. Organ donor screening for infectious diseases: review of practice and implications for transplantation. Transplantation. 1998 Mar 15;65(5):603-10. doi: 10.1097/00007890-199803150-00001. No abstract available.
- Background: PubMed 6189183Barre-Sinoussi F, Chermann JC, Rey F, Nugeyre MT, Chamaret S, Gruest J, Dauguet C, Axler-Blin C, Vezinet-Brun F, Rouzioux C, Rozenbaum W, Montagnier L. Isolation of a T-lymphotropic retrovirus from a patient at risk for acquired immune deficiency syndrome (AIDS). Science. 1983 May 20;220(4599):868-71. doi: 10.1126/science.6189183.
- Background: PubMed 6200936Gallo RC, Salahuddin SZ, Popovic M, Shearer GM, Kaplan M, Haynes BF, Palker TJ, Redfield R, Oleske J, Safai B, et al. Frequent detection and isolation of cytopathic retroviruses (HTLV-III) from patients with AIDS and at risk for AIDS. Science. 1984 May 4;224(4648):500-3. doi: 10.1126/science.6200936.
- Background: PubMed 3010128Coffin J, Haase A, Levy JA, Montagnier L, Oroszlan S, Teich N, Temin H, Toyoshima K, Varmus H, Vogt P, et al. What to call the AIDS virus? Nature. 1986 May 1-7;321(6065):10. doi: 10.1038/321010a0. No abstract available.
- Background: PubMed 2425430Clavel F, Guetard D, Brun-Vezinet F, Chamaret S, Rey MA, Santos-Ferreira MO, Laurent AG, Dauguet C, Katlama C, Rouzioux C, et al. Isolation of a new human retrovirus from West African patients with AIDS. Science. 1986 Jul 18;233(4761):343-6. doi: 10.1126/science.2425430.
- Background: PubMed 3472076Clavel F, Mansinho K, Chamaret S, Guetard D, Favier V, Nina J, Santos-Ferreira MO, Champalimaud JL, Montagnier L. Human immunodeficiency virus type 2 infection associated with AIDS in West Africa. N Engl J Med. 1987 May 7;316(19):1180-5. doi: 10.1056/NEJM198705073161903.
- Background: PubMed 3122008Centers for Disease Control (CDC). AIDS due to HIV-2 infection--New Jersey. MMWR Morb Mortal Wkly Rep. 1988 Jan 29;37(3):33-5. No abstract available.
- Background: PubMed 1578597O'Brien TR, George JR, Holmberg SD. Human immunodeficiency virus type 2 infection in the United States. Epidemiology, diagnosis, and public health implications. JAMA. 1992 May 27;267(20):2775-9. No abstract available.
- Background: PubMed 9531953Sullivan MT, Guido EA, Metler RP, Schable CA, Williams AE, Stramer SL. Identification and characterization of an HIV-2 antibody-positive blood donor in the United States. Transfusion. 1998 Feb;38(2):189-93. doi: 10.1046/j.1537-2995.1998.38298193104.x.
- Background: PubMed 2879971Brun-Vezinet F, Rey MA, Katlama C, Girard PM, Roulot D, Yeni P, Lenoble L, Clavel F, Alizon M, Gadelle S, et al. Lymphadenopathy-associated virus type 2 in AIDS and AIDS-related complex. Clinical and virological features in four patients. Lancet. 1987 Jan 17;1(8525):128-32. doi: 10.1016/s0140-6736(87)91967-2.
- Background: PubMed 2467206Quinn TC, Zacarias FR, St John RK. AIDS in the Americas: an emerging public health crises. N Engl J Med. 1989 Apr 13;320(15):1005-7. doi: 10.1056/NEJM198904133201509. No abstract available.
- Background: PubMed 3031510Guyader M, Emerman M, Sonigo P, Clavel F, Montagnier L, Alizon M. Genome organization and transactivation of the human immunodeficiency virus type 2. Nature. 1987 Apr 16-22;326(6114):662-9. doi: 10.1038/326662a0.
Related trials for HIV
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Dennis, BS study director
Bio-Rad Laboratories
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Bio-Rad Laboratories at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Result of Assay (Bio-Rad Geenius HIV 1/2 Supplemental Assay) From Accuracy Analysis (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02401555, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.