HIV AIDS home test kit
FOR THE QUALITATIVE ASSESSMENT OF HIV I&II ANTIBODIES IN HUMAN SERUM, PLASMA OR WHOLE BLOOD
Catalog Number: 1N01C2-3
For In Vitro Diagnostic Use Only
HomeScanTM HIV/AIDS Self Test Kit is a single use device, for qualitative detection of antibodies to Human Immunodeficiency Viruses I&II (HIV I&II) in human serum, plasma or whole blood. The Test Kit provides private at-home HIV testing with fast and reliable result, and at a time when you needed to know the most!
SUMMARY AND EXPLANATION
The Human Immunodeficiency Viruses type 1 and type 2 are etiological agents of the acquired immunodeficiency syndrome (AIDS). HIV has been isolated from patients with AIDS, AIDS related complex (ARC) and from healthy individuals at high risk for AIDS. Infection with HIV is followed by an acute flu-like illness. This phase may remain unnoticed and the relationship to HIV infection may not be clear in many cases. The acute phase is typically followed by an asymptomatic carrier state, which progresses to clinical AIDS in about 50% of infected individuals within 10 years after seroconversion.
Serological evidence of HIV infection may be obtained by testing for HIV antigens or antibodies in blood of individuals suspected of HIV infection. Antigen can generally be detected during the acute phase and during the symptomatic phase of AIDS only. Antibodies to HIV-1 and/or HIV-2 may be detected throughout virtually the total infection period, starting at or shortly after the acute phase and lasting until the end stage of AIDS. Therefore, the use of highly sensitive antibody assays is the primary approach in serodiagnosis of HIV infection.
PRINCIPLE OF THE ASSAY
HIV I&II Test Card employs chromatographic lateral flow device in a cassette format. Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HIV-1 gp120, gp41 and HIV-2 gp-36 are dry-immobilized at the end of nitrocellulose membrane strip. HIV 1+2 antigens are bond at the Test Zone (T) and rabbit anti-HIV 1+2 antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If there are HIV1 or HIV 2 antibodies in sample, they will bind with the gold conjugated antigens forming complexes. These complexes will continue to migrate along the strip to the Test Zone (T) zone where they are captured by the HIV 1+2 antigens generating a visible red line. If there are no HIV 1 or HIV 2 antibodies in sample, no red line is formed in the Test Zone (T).The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the rabbit anti-HIV 1+2 antibodies aggregating in a red line, which indicates the validity of the test.
1. HIV I&II Test Card:
Test Zone: contains recombinant HIV1+2 antigens
Control Zone: contains rabbit anti-HIV 1+2 antibodies
Conjugate Pad: contains colloid gold conjugated with recombinant HIV1+2 antigens
2. Alcohol Prep Pad.
3. Safety Lancet.
4. Transfer Pipet.
5. Sample Buffer.
6. Instructions for use
MATERIALS REQUIRED BUT NOT SUPPLIED
Clock or Timer, Biohazard Waste Container.
STORAGE AND STABILITY
Store the test device at 4 to 30°C. Do Not Freeze. The test device will be effective until the expiration date stated on the package. The product is humidity-sensitive and should be used immediately after being open. Any improperly sealed product should be discarded.
1. For in vitro diagnostic use only.
2. Do not use product beyond the expiration date.
3. Handle all specimens as potentially infectious.
The control zone is an internal reagent and procedural control. It will appear if the test has been performed correctly and the reagents are reactive.
INTERPRETATION OF RESULTS
If two colored bands are visible within 20 minutes, the test result is reactive or positive and valid. The test result can be read as soon as a distinct colored band appears in the test area.
If test area has no color band and the control area displays a colored band, the result is non-reactive or negative and valid.
The test result is invalid if a colored band does not form in the control region. The sample must be re-tested, using a new test device.
LIMITATIONS OF THE PROCEDURE
1. Negative results do not exclude the possibility of HIV exposure or infection. Infection through recent exposure (seroconversion) to HIV may not be detectable. For positive or reactive results, line intensity cannot be used to evaluate the anti-HIV antibody levels. A test giving an invalid result should be repeated. HIV (1+2) Test is not intended use for differentiation between recognition of HIV-1 antibodies and HIV-2 antibodies.
2. This kit is intended ONLY for testing of individual sample. Do not use it for testing of cadaver sample, saliva, urine or other body fluid, or pooled (mixed) blood.
3. This is a qualitative assay and the results cannot be use to measure antibodies concentrations.
In a clinical evaluation of the performance of HIV I&II Test Card using 2567 confirmed negative and 510 positive samples, sensitivity was 99.6% (508/510) and specificity was 99.7% (2560/2567). The overall agreement with the reference ELISA tests is 99.7%.
The precision of three lots tested with Chinese FDA QC panel showed 100% agreement.