Sero diagnosis: IgG1, IgG2, IgG3, IgG4 , IgM & IgA antibodies
The NANO HIV 1 & 2 is a rapid immunochromatographic screening test for the detection of antibodies to HIV 1 & 2 in human serum, plasma or whole blood. The test device contains test strip immobilized with recombinant antigens of HIV1 at test line (1), HIV 2 recombinant antigen at test line (2) and control line reagent at (C) on nitrocellulose membrane and dried gold conjugate sensitized with HIV antigens and anti control line.
The specimen is applied to the sample well followed by addition of running buffer. The buffer facilitates the lateral flow of the sample and gold conjugate as well as promoting the immunologic binding of antibodies and antigen, if present in patient’s specimen. The HIV antibodies present in the patient’s specimen binds to the gold conjugate and make a immune complex. The complex migrates on the nitrocellulose membrane and is captured by the antigens immobilized in the Test line zone (1 & 2) and produces pink/purple band with varying intensity, proportional to the HIV 1& 2 antibodies in the sample. In the absence of HIV 1/2 antibodies, there is no pink/purple band in the TEST line zone (1&2). The liquid continues to migrate along the membrane and produces another pink/purple band in the CONTROL line zone (C), demonstrating that the reagents are functioning properly and validates the result.
Immobilization of proteins on nitro cellulose membrane
- GP-41, GP 120 & p24 on test line 1 for capturing of HIV-1 antibodies.
- GP-36 on test line 2 for capturing of HIV-2 antibodies.
Packaging include: 1 feather blood lancet, 1 alcohol swab, 1 pipette, 1 Nano HIV 1/2 Test Kit, 1 package insert, 1 clear plastic glove,
- Allow the kit components & test specimen to come at room temperature if stored in refrigerator.
- Remove as many as test devices required for the testing from pouch by tearing along notch provided.
- Lay down the test device on flat surface and mention patient’s ID number.
- Dispense one drop (20µl) of serum, plasma or whole blood using provided dropper or micro pipette into sample well (S).
- Add 2-3 drops of running buffer using provided dropper bottle or dropper into sample well (S).
- Read the result in result window within 5-20 minutes of specimen and running buffer addition.
Note: Used test devices, droppers, gloves, blood / serum collection tubes, swab, lancets etc. should be discarded as per norms of Biomedical waste management.
Positive: The appearance of pink/purple line at ‘1’ in addition to control line at ‘C’ indicates that specimen contains antibodies of HIV-1. The appearance of test line at ‘2’ in addition to control line at ‘C’ indicates that specimen contains antibodies of HIV-2. The appearance of test line at ‘1’ & ‘2’ in addition to control line at ‘C’ indicates that specimen contains antibodies of HIV-1 & 2. The intensity of lines at ‘1’, ‘2’ and ‘C’ may vary with each other.
Negative: The appearance of no pink/purple lines at ‘1’ & ‘2’ and only one pink/purple line at ‘C’ indicates that specimen does not contain antibodies of HIV 1 & 2 and specimen should be considered negative. A negative result after 20 minutes of incubation indicates that there is no detectable level of antibodies in patient’s specimen.
Invalid: If there is no distinct pink/purple line visible at ‘C’, the test is invalid and it is recommended to repeat the test again.
Company’s manufacturing facility in Amritsar – Punjab.
Certification: GMP, ISO-9001-2000