High Accuracy One Step HIV Rapid Diagnostic test Cassette Certified Whole Blood/Serum/Plasma Specim

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High Accuracy One Step HIV Rapid Diagnostic test Cassette Certified Whole Blood/Serum/Plasma Specimen Product Name: HIV 1+2 Test Device (Cassette) INTENDED USE: The HIV 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 and type 2 in whole blood, serum or plasma to aid in the diagnosis of HIV infection.Any reactive specimen with the HIV Ab Rapid Test must be confirmed with alternative testing method(s) and clinical findings. This test is intended for screening purposes only. 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 1. Bring the pouched test device to room temperature(15-30) prior to testing. Do not open the pouch until ready to perform the assay. 2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface. 3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well. 4. Hold the buffer bottle vertically and add 1-2 drops to the sample well./ If using a pipette, change a new one to avoid cross-contamination. Draw and transfer 2-3 drops of buffer to the sample well. 5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes. Caution: The above interpreting time is based on room temperature range of 15 - 30C. If your room temperature is significantly lower than 15, then the interpreting time should be properly increased to 30 minutes. 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.). 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%. - - - - Method | | | | ELISA | | | | | | | | Total Result | | Results | | Positive | | Negative | | | | | HIV 1.2 Rapid Test Dipstick | | | | | | | Positive | | 108 | | 1 | 109 | (Whole Blood/Serum/Plasma) | | | | | | | | | | | | | | | | | Negative | | 0 | | 925 | 925 | | | | | | | | Total Result | | | 108 | | 926 | 1034 | | | | | | | | Relative Sensitivity: 99.9% (97.3%100%)* | | | | | | Relatively Specificity: 99.9% (99.4%100%)* | | | | | | Accuracy: 99.9% (99.5%100%) * | | *95% Confidence Intervals | | - - - - 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. NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

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Oriental New Life Medical Device Technology Co.,Ltd.

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