Cassette Infectious Disease Testing For Qualitative Detection Of Influenza A And Influenza B Virus

CE certified Cassette Fast reading rapid test for the qualitative detection of Influenza A and Influenza B virus in nasal swab, throat swab or nasal aspirate specimens 

Applications:

The Influenza A+B Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of influenza A and B antigens in
nasopharyngeal swab, throat swab or nasal aspirate specimens. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections.

Description:

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. Type A viruses are typically more prevalent than type B viruses and are associated with most serious influenza epidemics, while type B infections are usually milder.
The gold standard of laboratory diagnosis is 14-day cell culture with one of a variety of cell lines that can support the growth of influenza virus. 2 Cell culture has limited clinical utility, as results are obtained too late in the clinical course for effective patient intervention. Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a newer method that is generally more sensitive than culture with improved detection rates over culture of 2-23%. 3 However, RT-PCR is expensive, complex and must be performed in specialized laboratories.
The Influenza A+B Rapid Test cassette (Swab/Nasal Aspirate) qualitatively detects the presence of Influenza A and/or Influenza B antigen in nasopharyngeal swab or throat swab or nasal aspirate specimens, providing results within 15 minutes. The test uses antibodies specific for Influenza A and Influenza B to selectively detect Influenza A and Influenza B antigen in nasopharyngeal swab, throat swab or nasal aspirate specimens.

How to use?

Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed immediately after opening the foil pouch.
2. Place the Extraction Tube in the workstation. Hold the extraction reagent bottle upside down vertically. Squeeze the bottle and let the solution drop into the extraction tube freely without touching the edge of the tube. Add 10 drops of extraction reagent (Approx. 400μL) to the Extraction Tube. See illustration 1.
3. Place the swab specimen in the Extraction 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 Extraction 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.
5. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface. See illustration 4.
6. Add three drops of the solution (approx.120μL) to the sample well 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 above)

POSITIVE Influenza A:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the Influenza A region (A). A positive result in the Influenza A region indicates that Influenza A antigen was detected in the sample.

POSITIVE Influenza B:* Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the Influenza B region (B). A positive result in the Influenza B region indicates that Influenza B antigen was detected in the sample.

POSITIVE Influenza A and Influenza B:* Three distinct colored lines appear. One colored line should be in the control region (C) and two colored line should be in the Influenza A region (A) and Influenza B region (B). A positive result in the Influenza A region and Influenza B region indicates that Influenza A antigen and Influenza B antigen were detected in the sample.

*NOTE: The intensity of the color in the test line regions (A or B) will vary based on the amount of Flu A or B antigen present in the sample. So any shade of color in the test regions (A or B) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line regions (A or B).

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 cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.