Life Assay manufactures the Test‐it™ range of lateral flow assays for serodiagnosis of various diseases in humans. Test‐it™ HIV nano range of HIV tests are ultra-modern 3rd and 4th generation qualitative immunoassays utilising the latest cutting edge technology to detect Human Immunodeficiency Virus types 1 and 2 (HIV‐1 and HIV‐2).
Human immunodeficiency virus type 1 and 2 (HIV 1+2) are enveloped single strand RNA virus that cause acquired immunodeficiency syndrome (AIDS). HIV‐1 has been isolated from patients with AIDS and AIDS‐related complex, and from healthy individuals with high risk for developing AIDS. HIV‐2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals. Both HIV‐1 and HIV‐2 virus elicit strong immune responses, including the production of anti‐virus antibodies. Presence of specific anti HIV‐1 and/or anti HIV‐2 virus antibodies in blood, serum, or plasma indicates exposure of an individual to the HIV‐1 and/or HIV‐2 virus, and is of great value in clinical diagnosis. HIV nano and nano triline provides an indirect measure for infection through the detection of antibodies to HIV infection. In addition to recombinant antigens, HIV nano24 also employs a highly specific p24 antibody to detect HIV virus (HIV -1 groups M and O, and HIV-2) directly. HIV nano, nano triline and nano24 do not require any special training, equipment, or electricity.
The HIV nano tests are all immunoassays. The tests are ultra-sensitive and take only 5 minutes to yield results. Test results are read visually. The main reactive components are a new class of recombinant HIV‐1 antigen (gp 41) and recombinant HIV‐2 antigen (gp36) working in combination. HIV nano24 also combines p24 monoclonal antibody to detect very early infections. Internal control lines in the nano test range visually indicate that sufficient sample and reagent have been used.
Assays should be stored at +4°C to +30°C, in a dry place and protected from direct exposure to sunlight for optimal performance. The assays may be stored up to +45°C for short periods.
The expiry date is printed on the outer packaging. When stored properly the shelf life is two (2) years from the date of manufacturing.
Interpretation of Test Results
Negative Result: A red line forms at the control zone (C). No red line forms at the test zone (T).
Positive Result: A red line forms at the test zone (T) and a second red line forms at the control zone (C).
Note: The intensity of the Test line (T) or Control line (C) can vary and does not indicate a poor test result.
- measures IgM
- uses whole blood or serum
- 95.7% agreement with Rose Bengal
- >92.9% sensitive for 7-9 days fever
- 100% sensitive for >9 days fever
- >98% specific
- better performance than Widal
- ideal for field use
- on-the-spot results in 15 minutes
- no equipment or training required
(Point‐of‐Care Technologies) Developing rapid mobile POC systems ‐ Part 1: Devices and applications for
lateral‐flow immunodiagnostics (IVDT archive, Jul 07)
Transfer pipettes, alcohol swabs and lancets may be included, depending on packaging specification.[/info_list_item][info_list_item list_title=”Manufacturer’s Warranty: ” list_icon=”Defaults-thumbs-o-up”]Product replacements on faulty/non-performing product as per Life Assay’s quality control check procedures on retainer samples.[/info_list_item][/info_list]
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