Tri - Line HIV 1,2,O Home Testing Kits Blood Specimen 4mm Cassette Private Test

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INTENDED USE:


The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) type 1, type 2 and subtype O in whole blood, serum or plasma to aid in the diagnosis of HIV infection.


SUMMARY AND EXPLANATION OF THE TEST


HIV (Human Immunodeficiency Virus) is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from the host cell membrane. Several viral glycoproteins are on the envelope. Each virus contains two copies of positive-sense genomic RNAs. HIV-1 has been isolated from patients with AIDS and AIDS-related complex, and from healthy people with high potential risk for developing AIDS.1 HIV-1 consists of Subtype M and Subtype O. Highly divergent strains of HIV-1 were first recognized in 1990 and grouped provisionally as Subtype O as this variation has similar glycoprotein markers to HIV-1 but a slight variation to the protein marker. Although rarely compared to HIV-1 and HIV-2, infections caused by Subtype O have so far been identified in Africa (Cameroon), France and Germany. HIV-2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals.2 HIV-1, HIV-2, and Subtype O all elicit immune responses.3 Detection of HIV antibodies in serum, plasma or whole blood is the most efficient and common way to determine whether an individual has been exposed to HIV and to screen blood and blood products for HIV.4 Despite the differences in their biological characters, serological activities and genome sequences, HIV-1, HIV-2, and Subtype O show strong antigenic cross-reactivity.5,6 Most HIV-2 positive sera can be identified by using HIV-1 based serological tests. The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibodies to HIV type 1, type 2, and/or Subtype O in whole blood, serum or plasma specimen


Test Principle


The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibodies to HIV-1, HIV-2, and Subtype O in whole blood, serum or plasma. The membrane is pre-coated with recombinant HIV antigens in the test line regions, T1 and T2. The T1 test line is pre-coated with HIV-1 and Subtype O antigen and the T2 test line is pre-coated with HIV-2 antigen. During testing, the whole blood, serum or plasma specimen reacts with HIV antigen coated particles in the test strip. 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 Subtype O, or HIV-2, one colored line will appear in the test line region; if the specimen contains antibodies to HIV-1 and/or Subtype O, and HIV-2, two colored lines will appear in the test line region. Both indicate a positive result. If the specimen does not contain HIV-1, Subtype O, and/or HIV-2 antibodies, no colored line will 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.


INTERPRETATION OF RESULTS


POSITIVE: Two or three distinct colored lines appear. One line should always appear in the control line region (C), and another one or two apparent colored line(s) should appear in the test line region(s) (T1 and/or T2).

*NOTE: The intensity of the color in the test line region (T1 and T2) will vary depending on the concentration of HIV antibodies present in the specimen. Therefore, any shade of color in the test line region (T1 and/or T2) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No apparent colored lines appear in the test line regions (T1 and T2).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.


LIMITATION

1. The HIV 1.2.O Rapid Test Cassette (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of HIV antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in HIV antibodies can be determined by this qualitative test.
2. The HIV 1.2.O Rapid Test cassette(Whole Blood/Serum/Plasma) will only indicate the presence of HIV antibodies in the specimen and should not be used as the sole criteria for the diagnosis of HIV infection.
3. As with all rapid test cassettes, all results must be interpreted together with other clinical information available to the physician.
4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of HIV infection.

PERFORMANCE STUDY



The HIV 1.2.O 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.O Rapid Test cassette (Whole Blood/Serum/Plasma) is >99.9% and the relative specificity is 99.9%.