- Patented vertical flow technology is 5 times faster than lateral flow
- Highly accurate results in 3 minutes or less
- FDA cleared; manufactured in Canada
- Works with fingerstick whole blood, serum, or plasma
- Simple procedure with instant, easy-to-interpret results
- Built-in procedural and reagent control line
- No reader needed
- No refrigeration required
- No timers or specialized equipment needed
Rapid Vertical Flow HIV-1 Test
HIV 1 is the most common type of HIV that is affecting around 95% people around the world who are living with HIV. The FDA-approved Reveal® G4 is the next generation of rapid testing for HIV using MedMira’s patented Rapid Vertical Flow (RVF) Technology.™ Reveal G4 is a rapid, flow-through diagnostic immunoassay developed to utilize the performance characteristics of a conventional diagnostic immunoassay while simplifying the test procedure to eliminate the requirement for expensive equipment and highly trained personnel and decrease turnaround time.
How does a MedMira Rapid test work?
The Reveal™ G4 HIV-1 tests are single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) in human serum or plasma. The Reveal™ G4 Rapid HIV-1 Antibody Test is intended for a lab setting within the United States and as a point-of-care test outside of the United States.
Reveal™ G4 is a manually performed, visually interpreted, rapid vertical flow immunoassay.
Following the application of the sample, captured anti-HIV-1 antibodies are visualized through a reaction with the InstantGold cap, a plastic cap housing a filter medium impregnated with a proprietary protein A colloidal gold conjugate which reacts to form color in the test and control regions so that the test result can be visualized.
Universal Buffer, a solution composed of Tris-buffered saline, lysing agents, synthetic polymers and antimicrobial agents (Preservative: 0.05% Proclin 950) is used in the test procedure.
A reactive test result occurs only when the Protein A of the conjugate binds to the captured antibodies, producing a distinctive red dot in the test (T) zone and a vertical red Control Line in the control (C) zone of the test membrane upon completion of the test procedure. In contrast, a non-reactive test result, due to the absence of the HIV-1 antibody/antigen complex, is indicated by the presence of only the vertical red Control Line on the test membrane.
If the vertical red Control Line is not present, or is incomplete, the test result is considered invalid and testing must be repeated with a new cartridge (refer to the Test Results and Interpretation section below). The test results can be read and interpreted immediately following completion of the test procedure. Precision pipetting or specialized equipment are not required to perform Reveal ™ G4.
Specifications:
- Methodology: Rapid Vertical Flow Immunoassay manually performed, visually interpreted
- Sample Size:1 drop
- Sample Type:blood, serum, or plasma
- Operating range: (2-30°C or 35-85°F)
- Shelf Life: 12 month shelf-life at 2 – 30° C
- Controls: External test controls available as an accessory
- Sensitivity: 99.1% in serum
- Specificity 98.6% in serum
DMTSTG4FSWB
Sensitivity with Fingerstick
Whole Blood specimens: 99.64%
Specificity with Fingerstick Whole Blood specimens: 99.71%
DMTSTG4SPV
Sensitivity
Venipuncture: 99.46%
Serum: 99.8%
Plasma: 99.8%
Specificity
Venipuncture: 99.90%
Serum: 99.1%
Plasma: 98.6%
DMTSTG4ABSP
Sensitivity
Serum: 99.8%
Plasma: 99.8%
Specificity
Serum: 99.1%
Plasma: 98.6%
DMCTLG4H1AB
For use only with
Reveal G4 products