High Accuracy Home Testing Kits , Blood Rapid HIV Home Test Kit CE Certificated

Certified, High Accuracy HIV Home Test kit , Whole Blood/Serum/Plasma Specimen, Home self test use, quick and easily

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INTENDED USE:

HIV Home Test kit is a single-use, qualitative immunoassay to detect antibodies to Human Immunodeficiency Virus Type 1 (HIV-1 and HIV-2) in fingerstick whole blood specimens. The Test is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi test algorithms designed for statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms.

SUMMARY AND EXPLANATION OF THE TEST

Acquired Immune Deficiency Syndrome (AIDS), AIDS related complex (ARC) and pre-AIDS are thought to be caused by the Human Immunodeficiency Virus (HIV). The first AIDS-related virus, HIV-1 (also known as HTLV-III, LAV-1 and ARV) has been isolated from patients with AIDS and from healthy persons at high risk for AIDS.1,2 Genetic analysis of HIV-1 isolates has documented the existence of subtypes. To date, eight HIV-1 subtypes (A through H), designated as Group M, have been identified world-wide in addition to the highly divergent HIV-1 isolates from AIDS patients in Cameroon, designated as Group O.3 A closely related but distinct second type of pathogenic human immunodeficiency retrovirus, designated HIV-2 (formerly LAV -2), has been isolated from West African patients with AIDS. HIV-2 has been shown to share a number of conserved sequences with HIV-1, but serological cross-reactivity between HIV-1 and HIV-2 has been shown to be highly variable from sample to sample.

HIV is known to be transmitted by sexual contact, by exposure to blood (including sharing contaminated needles and syringes) or by contaminated blood products, or it may be transmitted from an infected mother to her fetus during the prenatal period. Individuals infected with HIV produce antibodies against the HIV viral proteins. Testing for the presence of antibodies to HIV in bodily fluids (e.g., blood, oral fluid, and urine) is an accurate aid in the diagnosis of HIV infection. However, the implications of seropositivity must be considered in a clinical context. For example, in neonates, the presence of antibodies to HIV is indicative of exposure to HIV, but not necessarily of HIV infection, due to the acquisition of maternal antibodies that may persist for up to six months. Conversely, absence of antibody to HIV cannot be taken as absolute proof that an individual is free of HIV infection or incapable of transmitting the virus. An antibody response to a recent exposure may take several months to reach detectable levels. HIV has been isolated from asymptomatic, seronegative individuals presumably before seroconversion following exposure.

The standard laboratory HIV testing algorithm used in the United States consists of screening with an enzyme immunoassay (EIA) and confirmation of repeatedly reactive EIAs using a Western blot test. Results are typically reported within 48 hours to 2 weeks, making these standard screening and supplemental tests inadequate to meet the need for rapid HIV diagnosis.

Test Principle

The HIV 1.2 Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibodies to HIV 1.2 in whole blood, serum or plasma. The membrane is pre-coated with recombinant HIV antigens. During testing, the whole blood, serum or plasma specimen reacts with HIV antigen coated particles in the test Dipstick. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with recombinant HIV antigen on the membrane in the test line region. If the specimen contains antibodies to HIV 1 and/or HIV 2, a colored line will appear in the test line region, indicating a positive result. If the specimen does not contain HIV 1 and/or HIV 2 antibodies, a colored line will not appear in the test line region, indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

The assay test strip, which can be viewed through the test device result window, contains synthetic peptides representing the HIV envelope region and a goat anti-human IgG procedural control immobilized onto a nitrocellulose membrane in the Test (T) zone and the Control (C) zone, respectively.

A fingerstick whole blood specimen is collected and transferred into the vial of developer solution, followed by the insertion of the test device. The developer solution facilitates the flow of the specimen into the device and onto the test strip. As the diluted specimen flows through the device, it rehydrates the protein-A gold colorimetric reagent contained in the device. As the specimen continues to migrate up the strip, it encounters the T zone. If the specimen contains antibodies that react with the antigens immobilized on the nitrocellulose membrane, a reddish-purple line will appear, qualitatively indicating the presence of antibodies to HIV-1 and HIV-2in the specimen. The intensity of the line color is not directly proportional to the amount of antibody present in the specimen.

Further up the assay strip, the sample will encounter the C zone. This built-in procedural control serves to demonstrate that a specimen was added to the vial and that the fluid has migrated adequately through the test device. A reddish-purple line will appear in the C zone during the performance of all valid tests, whether or not the sample is positive or negative for antibodies to HIV-1 and HIV-2 (refer to the Interpretation of Results section below).

The test results are interpreted after 20 minutes but not more than 60 minutes after the introduction of the test device into the developer solution containing the test specimen. No precision pipeting, predilutions, or specialized instrumentation are required to perform the Rapid HIV-1 and HIV-2 Antibody Test.

INTERPRETATION OF RESULTS

Negative: The presence of only one line in the control region indicates a negative result (Figure 1).

HIV-1 Positive: The control line and HIV-1 line (T1) are visible in the result window. The test is positive for HIV-1.

HIV-2 Positive: The control line and HIV-2 line (T2) are visible in the result window. The test is positive for HIV-2.

HIV-1 and HIV-2 Positive: The control line, HIV-1 (T1) and HIV-2 (T2) lines are visible in the result window. The test is positive for HIV-1and HIV-2.

Regarding the positive results for both HIV-1 and HIV-2 in one patient, it is possible for reasons as follows:

1.  There is the homology in the amino acid sequence of HIV type-1 and type-2. So, it is possible that the test
results show the positive results for HIV-1 and HIV-2 in one patient, simultaneously.
2.  Provisionally, you can conclude virus type according to the line density. If the line density of type-1 is darker
than that of type-2 in the result window, you can read as HIV-1 positive. If the line density of type-2 is darker
than that of type-1 in the result window, you can read as HIV-2 positive. If you want to determine virus type or co-infection exactly, you should perform the confirmatory assay (e.g Western blot etc.).

Invalid: If the pink color line in C region is not visible, the result is considered invalid (Figure 3) regardless of the presence or absence of the test line(s).

PERFORMANCE STUDY

The HIV 1.2 Rapid Test cassette (Whole Blood/Serum/Plasma) has correctly identified specimens of seroconversion panel and has been compared to a leading commercial ELISA HIV test using clinical specimens. The results show that the relative sensitivity of the HIV 1.2 Rapid Test cassette (Whole Blood/Serum/Plasma) is >99.9% and the relative specificity is 99.9%.

Conclusion:

The sample correlation results show that the relative sensitivity of the HIV 1.2 Rapid Test cassette is >99.9%, and the relative specificity is 99.9% and the overall accuracy is 99.9% to be compared with a commercial available HIV ELISA test.