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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).
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
CEPHIA Evaluation Panel (N=2500)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Known HIV1 positives | Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay |
| |
| Known AIDS | Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay |
| |
| Low risk (negatives) | Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Geenius HIV1/2 Supplemental Assay | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 9 months |
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Inclusion Criteria for HIV1 positives and AIDS positive populations:
Exclusion Criteria for HIV1 positives and AIDS positive populations:
Inclusion Criteria for Low Risk population:
Exclusion criteria for Low Risk Population:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Scott Dennis, BS | Bio-Rad Laboratories | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HIV/AIDS Division, San Fransisco General Hospital | San Francisco | California | 94110 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9521191 | Background | 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. | |
| 6189183 | Background | Barre-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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Known HIV1 Positives | Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). |
| FG001 | Known AIDS | Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). |
| FG002 | Low Risk (Negatives) | Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Known HIV1 Positives | Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | 95% Confidence Interval | Percentage of True Results | Up to 9 months |
|
The period in which adverse event data were collected was 1 year (April 2013- April 2014).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Known HIV1 Positives | Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Bhend | Bio-Rad Laboratories | 425 498 1758 | david_bhend@bio-rad.com |
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Serum and plasma samples
| Blood Systems Research Institute |
| San Francisco |
| California |
| 94118 |
| United States |
| Center for Disease Control and Prevention | Atlanta | Georgia | 30333 | United States |
| Clinical Trials Center, Walter Reed Army Institute of Research | Silver Spring | Maryland | 20910 | United States |
| University Of Washington AIDS Clinical Trials Unit, Harborview Medical Center | Seattle | Washington | 98104-2499 | United States |
| 6200936 | Background | Gallo 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. |
| 3010128 | Background | Coffin 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. |
| 2425430 | Background | Clavel 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. |
| 3472076 | Background | Clavel 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. |
| 3122008 | Background | Centers 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. |
| 1578597 | Background | O'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. |
| 9531953 | Background | Sullivan 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. |
| 2879971 | Background | Brun-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. |
| 2467206 | Background | Quinn 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. |
| 3031510 | Background | Guyader 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. |
| 9143601 | Background | Janssens 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. |
| 7975221 | Background | Charneau 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. |
| 9734396 | Background | Simon 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. |
| 15507630 | Background | Meloni ST, Kim B, Sankale JL, Hamel DJ, Tovanabutra S, Mboup S, McCutchan FE, Kanki PJ. Distinct human immunodeficiency virus type 1 subtype A virus circulating in West Africa: sub-subtype A3. J Virol. 2004 Nov;78(22):12438-45. doi: 10.1128/JVI.78.22.12438-12445.2004. |
| 19648927 | Background | Plantier JC, Leoz M, Dickerson JE, De Oliveira F, Cordonnier F, Lemee V, Damond F, Robertson DL, Simon F. A new human immunodeficiency virus derived from gorillas. Nat Med. 2009 Aug;15(8):871-2. doi: 10.1038/nm.2016. Epub 2009 Aug 2. |
| 7933127 | Background | Gao F, Yue L, Robertson DL, Hill SC, Hui H, Biggar RJ, Neequaye AE, Whelan TM, Ho DD, Shaw GM, et al. Genetic diversity of human immunodeficiency virus type 2: evidence for distinct sequence subtypes with differences in virus biology. J Virol. 1994 Nov;68(11):7433-47. doi: 10.1128/JVI.68.11.7433-7447.1994. |
| 2350452 | Background | George JR, Rayfield MA, Phillips S, Heyward WL, Krebs JW, Odehouri K, Soudre R, De Cock KM, Schochetman G. Efficacies of US Food and Drug Administration-licensed HIV-1-screening enzyme immunoassays for detecting antibodies to HIV-2. AIDS. 1990 Apr;4(4):321-6. doi: 10.1097/00002030-199004000-00006. |
| 7910884 | Background | Loussert-Ajaka I, Ly TD, Chaix ML, Ingrand D, Saragosti S, Courouce AM, Brun-Vezinet F, Simon F. HIV-1/HIV-2 seronegativity in HIV-1 subtype O infected patients. Lancet. 1994 Jun 4;343(8910):1393-4. doi: 10.1016/s0140-6736(94)92524-0. |
| 7968029 | Background | Schable C, Zekeng L, Pau CP, Hu D, Kaptue L, Gurtler L, Dondero T, Tsague JM, Schochetman G, Jaffe H, et al. Sensitivity of United States HIV antibody tests for detection of HIV-1 group O infections. Lancet. 1994 Nov 12;344(8933):1333-4. doi: 10.1016/s0140-6736(94)90695-5. |
| 2419594 | Background | Resnick L, Veren K, Salahuddin SZ, Tondreau S, Markham PD. Stability and inactivation of HTLV-III/LAV under clinical and laboratory environments. JAMA. 1986 Apr 11;255(14):1887-91. |
| 6630443 | Background | Bond WW, Favero MS, Petersen NJ, Ebert JW. Inactivation of hepatitis B virus by intermediate-to-high-level disinfectant chemicals. J Clin Microbiol. 1983 Sep;18(3):535-8. doi: 10.1128/jcm.18.3.535-538.1983. |
| 7316505 | Background | Sehulster LM, Hollinger FB, Dreesman GR, Melnick JL. Immunological and biophysical alteration of hepatitis B virus antigens by sodium hypochlorite disinfection. Appl Environ Microbiol. 1981 Nov;42(5):762-7. doi: 10.1128/aem.42.5.762-767.1981. |
| 16195697 | Background | Panlilio AL, Cardo DM, Grohskopf LA, Heneine W, Ross CS; U.S. Public Health Service. Updated U.S. Public Health Service guidelines for the management of occupational exposures to HIV and recommendations for postexposure prophylaxis. MMWR Recomm Rep. 2005 Sep 30;54(RR-9):1-17. |
| BG001 |
| Known AIDS |
Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). |
| BG002 | Low Risk (Negatives) | Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Known AIDS | Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). |
| OG002 | Low Risk (Negatives) | Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). |
|
|
| 0 |
| 87 |
| 0 |
| 87 |
| EG001 | Known AIDS | Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). | 0 | 212 | 0 | 212 |
| EG002 | Low Risk (Negatives) | Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay Geenius HIV1/2 Supplemental Assay: 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). | 0 | 120 | 0 | 120 |
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a five year period from the time of the non-disclosure agreement execution.