Multispot hiv 1 hiv 2 rapid test

Manufactured by Bio-Rad

Sourced in Ireland

The Multispot HIV-1/HIV-2 Rapid Test is a qualitative immunoassay for the detection of antibodies to human immunodeficiency virus type 1 (HIV-1) and type 2 (HIV-2) in human serum or plasma specimens.

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5 protocols using multispot hiv 1 hiv 2 rapid test

Evaluation of HIV Rapid Test Kits

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Three conventional HIV rapid test kits were used: Capillus^™ HIV-1/HIV-2 Rapid Test (Trinity Biotech, Ireland), Multispot^™ HIV-1/HIV-2 Rapid Test (Bio-Rad, Hercules, CA), and Uni-Gold^™ Recombigen® HIV-1/2 kit (Trinity Biotech, Ireland). While the prevalence of clinical use for these tests varies considerably, all are certified (as of October 15, 2015) for deployment by the USAID (United States Agency for International Development) (USAID, 2015) . All reagents were used as received and test procedures were carried out under ambient conditions according to manufacturer instructions provided in package inserts.
Negative control human serum was purchased from Sigma (# H4522, St. Louis, MO). This serum was used for serial dilutions of positive control serum from various rapid test kits. Fresh negative and positive clinical serum samples were obtained from the University of Maryland Medical Center (UMMC, Baltimore, MD) and Innovative Research, Inc (Novi, MI). These samples were characterized for the presence of HIV antibodies by 3^rd generation ELISA (Genetic Systems HIV 1/2 Plus O EIA). All serum samples were stored at 2–8 °C prior to use.

Bystryak S, & Ossina N. (2017). A rapid ultrasound particle agglutination method for HIV antibody detection: Comparison with conventional rapid HIV tests. Journal of virological methods, 249, 38-47.

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Vaccine-Induced Seropositivity Monitoring

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VISR was assessed 2 weeks after the third and fourth vaccinations and at 9 and 12 months after enrollment using a diagnostic algorithm that includes 4 different enzyme immunoassays (EIAs): Abbott Architect HIV Ag/Ab Combo, Abbot Prism, Bio-Rad Genetic Systems HIV Combo Ag/Ab EIA, and Bio-Rad Multispot HIV-1/HIV-2 Rapid Test. For participants with a positive result in any of these assays, RNA PCR (Abbott m2000 HIV-1 Real-Time PCR) was performed to distinguish vaccine-induced responses from actual infection.

Rouphael N.G., Morgan C., Li S.S., Jensen R., Sanchez B., Karuna S., Swann E., Sobieszczyk M.E., Frank I., Wilson G.J., Tieu H.V., Maenza J., Norwood A., Kobie J., Sinangil F., Pantaleo G., Ding S., McElrath M.J., De Rosa S.C., Montefiori D.C., Ferrari G., Tomaras G.D, & Keefer M.C. (2019). DNA priming and gp120 boosting induces HIV-specific antibodies in a randomized clinical trial. The Journal of Clinical Investigation, 129(11), 4769-4785.

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Clinical Laboratory Studies Methodology

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Clinical laboratory studies were done in compliance with USAMRIID’s Clinical Laboratory procedures. Hematology was performed using an AcT10 Hematology Analyzer by Beckman Coulter, and urinalysis was done utilizing a Multistix 10 SG, by Siemens. Clinical chemistries were performed using a Piccolo Point of Care General Chemistry panel (ALB, ALP, ALT, AMY, AST, BUN, Ca, CRE, GGT, GLU, TBIL, TP) by Abaxis. HIV Ab were done at USAMRIID using the Clinical Laboratory’s routine HIV testing kit, Bio-Rad Laboratories Multispot HIV-1/HIV-2 Rapid Test. Throat swabs were done using routine daily clinical methodology.

Pittman P.R., Martin J.W., Kingebeni P.M., Tamfum J.J., Mwema G., Wan Q., Ewala P., Alonga J., Bilulu G., Reynolds M.G., Quinn X., Norris S., Townsend M.B., Satheshkumar P.S., Wadding J., Soltis B., Honko A., Güereña F.B., Korman L., Patterson K., Schwartz D.A, & Huggins J.W. (2023). Clinical characterization and placental pathology of mpox infection in hospitalized patients in the Democratic Republic of the Congo. PLOS Neglected Tropical Diseases, 17(4), e0010384.

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Comprehensive HIV Screening Protocol

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Samples were classified as HIV positive or HIV negative using the testing algorithm shown in Figure 1. This algorithm is similar to the current US CDC testing algorithm², but was modified to include two fourth-generation assays and two HIV RNA assays to maximize sensitivity for detecting HIV infection. The two fourth-generation assays were performed in parallel (Abbott Combo assay; and GS HIV Combo Ag/Ab EIA, Bio-Rad Laboratories, Redmond, WA; referred to below as the Bio-Rad Combo assay). If one or both assay was reactive, samples were tested using the Multispot HIV-1/HIV-2 Rapid Test (Bio-Rad Laboratories, Redmond, WA; referred to below as the discriminatory assay). If the discriminatory assay was negative or indeterminate, samples were tested using two HIV RNA assays (APTIMA HIV-1 RNA Qualitative Assay, Hologic Gen-Probe Inc., San Diego, CA, referred to below as the Aptima RNA assay; and Roche COBAS AMPLICOR HIV-1 MONITOR test, v1.5, Roche Diagnostics, Branchburg, NJ; referred to below as the Roche viral load assay). Samples were classified as HIV positive if they had any of the following test results: positive discriminatory test, positive Aptima RNA assay, or positive Roche viral load assay (Figure 1).

Fogel J.M., Piwowar-Manning E., Donohue K., Cummings V., Marzinke M.A., Clarke W., Breaud A., Fiamma A., Donnell D., Kulich M., Mbwambo J.K., Richter L., Gray G., Sweat M., Coates T.J, & Eshleman S.H. (2015). Determination of HIV status in African adults with discordant HIV rapid tests. Journal of acquired immune deficiency syndromes (1999), 69(4), 430-438.

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HIV Seroconversion Testing Protocol

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The HPTN Laboratory Center (LC) performed Quality Assurance testing using the Abbott Architect HIV 1/2 Combo test. Incident HIV infections were confirmed at the HPTN LC using a panel of assays that included the Bio‐Rad GS Combo Ag/Ab EIA test and the Bio‐Rad MultiSpot HIV‐1/HIV‐2 Rapid test. Qualitative HIV RNA testing was performed using the APTIMA HIV‐1 RNA Qualitative Assay to determine if the participant had acute HIV infection at the visit prior to HIV seroconversion. Viral load and CD4 cell count testing were performed at study sites for participants who acquired HIV infection during the study.

Wheeler D.P., Fields S.D., Beauchamp G., Chen Y.Q., Emel L.M., Hightow‐Weidman L., Hucks‐Ortiz C., Kuo I., Lucas J., Magnus M., Mayer K.H., Nelson L.E., Hendrix C.W., Piwowar‐Manning E., Shoptaw S., Watkins P., Watson C.C, & Wilton L. (2019). Pre‐exposure prophylaxis initiation and adherence among Black men who have sex with men (MSM) in three US cities: results from the HPTN 073 study. Journal of the International AIDS Society, 22(2), e25223.

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