The HIV1.2 Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) type 1 and type 2 in serum or plasma to aid in the diagnosis of HIV infection.
HIV is the etiologic agent of Acquired Immune Deficiency Syndrome (AIDS). The virion is surrounded by a lipid envelope that is derived from 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 2 has been isolated from West African AIDS patients and from seropositive asymptomatic individuals.2 Both HIV 1 and HIV 2 elicit immune response.3 Detection of HIV antibodies in serum, plasma 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 characteristics, serological activities and genome sequences, HIV 1 and HIV 2 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 Rapid Test Cassette (Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to HIV 1 and/or HIV 2 in serum or plasma specimen. The test utilizes latex conjugate and multiple recombinant HIV proteins to selectively detect antibodies to the HIV 1.2 in serum or plasma.
【DIRECTIONS FOR USE】
Allow the test, specimen, buffer and/or controls to reach room temperature
(15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25μL) to the specimen area, then add 1 drop of buffer (approximately 40μL),and start the timer, see illustration below.
3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of HIV antibodies present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).
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. If the problem persists, discontinue using the test cassette immediately and contact your local distributor.
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