Reveal HIV 1 Rapid Test
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- 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 testsare 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
Product and ordering information
USA details
Sale of Reveal ™ G4 in the USA is restricted to clinical laboratories that have an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met and where there is assurance that operators will receive and use the instructional materials.
There are three formats of the Reveal ™ G4 HIV test: :
Point-of-Care: (NOT FOR SALE in the United States)
This format includes a test tray in each pouch and is ideally suited to testing at the point of patient care, settings such as mobile clinics requiring a portable and all-in-one testing solution.
FDA cleared HIV-1
CE-marked
Qty. 20 tests per box
LAB+:This format maximizes customer flexibility in for testing serum, plasma, and whole blood specimens.
FDA cleared HIV-1
CE-marked
Qty. 50 tests per box
LAB S/P:This format is ideally suited for laboratories using serum and plasma specimens, and batch testing.
FDA cleared HIV-1
CE-marked
Qty. 50 tests per box
Minimum Order Quantity: 100 tests or 20 sets
Regulatory approval information
FDA cleared. Made in Canada at an ISO 13485 facility.
Additionally, research demonstrates that MedMira’s rapid HIV test detects early infection better than other rapid tests and closely matches the performance of much more complicated enzyme immunoassay tests. Reveal ™ G4 has delivered clinical performance in rigorous evaluations and achieved approval from the U.S. Food and Drug Administration (FDA) in October of 2015.
FAQ:
When do you use a MedMira Rapid test for HIV?
Rapid tests are used when a result is needed right away and the patient or the provider can not wait for results to be returned overnight or over a few days.
Reveal ™ G4 is not approved for use to screen donors of blood, plasma, cells or tissues. (The Miriad line of tests by the same manufacturer is the right solution for tissue banks.)
How do you use a MedMira Rapid test for HIV?
Reveal ™ G4 is used to look for antibodies in a sample of a patient’s blood. Once you decide to have the Reveal ™ G4 test, your healthcare provider will take a tube of blood from your vein or a fingerstick sample, perform the test while you wait and give you the test results within the same visit.
What specimen do you use to perform the MedMira Rapid test for HIV?
The United States Food and Drug Administration has approved this test for use with human whole blood (venipuncture and fingerstick), serum, and plasma specimens only.
What’s the difference between plasma, serum, blood?
Blood, serum, and plasma are three components of the blood, each with distinct characteristics and functions. Here's the difference between them:
Test Results and Interpretation of Results
What does a positive test mean?
A reactive test result on Reveal™ G4 means that the patient’s blood may contain HIV antibodies. In most health care settings, this result is confirmed by another test and is part of a formal algorithm of tests.
How do you read the test? What does the ‘readout’ of the Reveal G4 test mean?
The Reveal ™G4 test has a unique readout which is clearer than lateral flow tests. A pink DOT next to the word ‘HIV-1’ signifies that the test has identified antibodies to HIV-1 and thus is read as ‘positive for HIV-1.’
A pink line next to C or ‘Control’ means that the built-in control is working well.
Is there enough evidence for the effectiveness of MedMira’ Reveal G4 Rapid test for HIV?
Research demonstrates that MedMira’s rapid HIV test detects early infection better than other rapid tests and closely matches the performance of much more complicated enzyme immunoassay tests. The FDA approved this test in 2015 and an independent CDC analysis found the test to be highly sensitive and specific.
Citations:
Independent review by the U.S.CDC:
MedMira's G4 HIV (FDA approved) rapid test - an independent evaluation by the CDC
Where is the price?
Pricing is based on shipping location and the number of units ordered. To request a price, please use the Request a Quote button below. A sales representative will respond to you quickly.
- 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 testsare 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
Product and ordering information
USA details
Sale of Reveal ™ G4 in the USA is restricted to clinical laboratories that have an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met and where there is assurance that operators will receive and use the instructional materials.
There are three formats of the Reveal ™ G4 HIV test: :
Point-of-Care: (NOT FOR SALE in the United States)
This format includes a test tray in each pouch and is ideally suited to testing at the point of patient care, settings such as mobile clinics requiring a portable and all-in-one testing solution.
FDA cleared HIV-1
CE-marked
Qty. 20 tests per box
LAB+:This format maximizes customer flexibility in for testing serum, plasma, and whole blood specimens.
FDA cleared HIV-1
CE-marked
Qty. 50 tests per box
LAB S/P:This format is ideally suited for laboratories using serum and plasma specimens, and batch testing.
FDA cleared HIV-1
CE-marked
Qty. 50 tests per box
Minimum Order Quantity: 100 tests or 20 sets
Regulatory approval information
FDA cleared. Made in Canada at an ISO 13485 facility.
Additionally, research demonstrates that MedMira’s rapid HIV test detects early infection better than other rapid tests and closely matches the performance of much more complicated enzyme immunoassay tests. Reveal ™ G4 has delivered clinical performance in rigorous evaluations and achieved approval from the U.S. Food and Drug Administration (FDA) in October of 2015.
FAQ:
When do you use a MedMira Rapid test for HIV?
Rapid tests are used when a result is needed right away and the patient or the provider can not wait for results to be returned overnight or over a few days.
Reveal ™ G4 is not approved for use to screen donors of blood, plasma, cells or tissues. (The Miriad line of tests by the same manufacturer is the right solution for tissue banks.)
How do you use a MedMira Rapid test for HIV?
Reveal ™ G4 is used to look for antibodies in a sample of a patient’s blood. Once you decide to have the Reveal ™ G4 test, your healthcare provider will take a tube of blood from your vein or a fingerstick sample, perform the test while you wait and give you the test results within the same visit.
What specimen do you use to perform the MedMira Rapid test for HIV?
The United States Food and Drug Administration has approved this test for use with human whole blood (venipuncture and fingerstick), serum, and plasma specimens only.
What’s the difference between plasma, serum, blood?
Blood, serum, and plasma are three components of the blood, each with distinct characteristics and functions. Here's the difference between them:
Test Results and Interpretation of Results
What does a positive test mean?
A reactive test result on Reveal™ G4 means that the patient’s blood may contain HIV antibodies. In most health care settings, this result is confirmed by another test and is part of a formal algorithm of tests.
How do you read the test? What does the ‘readout’ of the Reveal G4 test mean?
The Reveal ™G4 test has a unique readout which is clearer than lateral flow tests. A pink DOT next to the word ‘HIV-1’ signifies that the test has identified antibodies to HIV-1 and thus is read as ‘positive for HIV-1.’
A pink line next to C or ‘Control’ means that the built-in control is working well.
Is there enough evidence for the effectiveness of MedMira’ Reveal G4 Rapid test for HIV?
Research demonstrates that MedMira’s rapid HIV test detects early infection better than other rapid tests and closely matches the performance of much more complicated enzyme immunoassay tests. The FDA approved this test in 2015 and an independent CDC analysis found the test to be highly sensitive and specific.
Citations:
Independent review by the U.S.CDC:
MedMira's G4 HIV (FDA approved) rapid test - an independent evaluation by the CDC
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