H1N1 Rapid Test,qualitative detection of influenza type A (H1N1) antigen
A rapid test for the qualitative detection of Influenza type A (H1N1) antigen in nasopharyngeal swab or throat swab specimens.
For professional in vitro diagnostic use only.
The H1N1 Antigen Rapid Test Cassette (Swab) is a rapid chromatographic immunoassay for the qualitative detection of influenza type A (H1N1) antigen in nasopharyngeal swab or throat swab specimens.
Results are for the detection of Influenza type A (H1N1) Antigen. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude Influenza type A (H1N1) infection and should not be used as the sole basis for treatment or patient management decisions.
The H1N1 Antigen Rapid Test is intended to be used by trained clinical laboratory personnel.
Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of the respiratory tract. It is a communicable disease easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus.1 Influenza outbreaks occur each year during the fall and winter months. Influenza type A virus antigens easily mutate and form new subtypes, causing a worldwide pandemic.
Of the various influenza serotypes, H1N1 has been regarded as one of the most severe pathogen due to its high pathogenicity and mortality rates of infected individuals.H1N1 was the etiological agent for human influenza outbreak in 2009 and is associated with many epidemics including the 1918 flu pandemic.
The H1N1 Antigen Rapid Test Cassette (Swab) is a qualitative, lateral flow immunoassay for the detection of Influenza type A (H1N1) nucleoproteins in nasopharyngeal swab or throat swab specimens. In this test, antibodies specific to the Influenza type A (H1N1) nucleoproteins is separately coated on the test line region of the test cassette. During testing, the extracted specimen reacts with the antibodies to Influenza type A (H1N1) that are coated onto particles.
The mixture migrates up the membrane to react with the antibodies to Influenza type A (H1N1) on the membrane and generate one colored line in the test region. The presence of this colored line in the test region indicates a positive result. To serve as a procedural control, a colored line will always appear in the control region if the test has performed properly.
SPECIMEN COLLECTION AND PREPARATION
• Nasopharyngeal swab sample
1.Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx.
2.Swab over the surface of the posterior nasopharynx 5-10 times.
• Throat swab sample
Insert a sterilized swab into pharynx and collect mucoepidermoid mainly wiping flare region of post-pharyngeal wall and palatine tonsil several times, and be careful not to make saliva attach to the swab.
*NOTE: Samples should be tested as soon as possible after collection. If swabs are not been processed immediately, it should be placed into a dry, sterile, and tightly sealed plastic tube for storage, it was stable for up to 8 hours at room temperature and 24 hours at 2-8°C.
DIRECTIONS FOR USE
Allow the test, specimen, extraction buffer and/or control to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it within one hour. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2. Remove the cover on the specimen collection tube. See illustration 1.
3. Place the swab specimen in the specimen collection tube. Rotate the swab for approximately 10 seconds while pressing the head against the inside of the tube to release the antigen in the swab. See illustration 2.
4. Remove the swab while squeezing the swab head against the inside of the specimen collection tube as you remove it to expel as much liquid as possible from the swab. Discard the swab in accordance with your biohazard waste disposal protocol. See illustration 3.
Note: The extracted specimen is stable for 8 hours at room temperature, 48 hours at 2-8°C and 12 months at -20°C.
5. Tighten the cap onto the specimen collection tube. Hold the specimen collection tube upright then unscrew the small cap of the specimen collection tube. See illustration 4.
6. Invert the specimen collection tube and add 3 drops of the solution (approx.120μl) to the specimen well(S) and then start the timer.
7. Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not interpret the result after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration)
POSITIVE:* Two colored lines appear. One colored line should be in the control region (C) and another colored line should be in the test region (T). A positive result in the test region indicates that H1N1 antigen was detected in the sample.
*NOTE: The intensity of the color in the test line region will vary based on the amount of H1N1 antigen present in the sample. So any shade of color in the test region should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line region.
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 kit immediately and contact your local distributor.
|H1N1 Rapid Test Cassette