COVID-19 And Influenza A+B Antigen Infectious Disease Testing

The COVID-19 and Influenza A+B Antigen Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2, Influenza A and Influenza B virus antigens in nasopharyngeal swab specimens.

【SUMMARY】

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an
infectious source. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

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. 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. 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.

【SPECIMEN COLLECTION】

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.
3. Withdraw the sterile swab from the nasal cavity.

【SPECIMEN PREPARATION】
Only the extraction buffer and specimen collection tube provided in the kit is to be used for swab specimen preparation.
1. Unscrew the cap of the specimen collection tube.
2. Insert the swab specimen into the specimen collection tube. Press against the inner wall of the tube and stir the swab for approximately 10 seconds while pressing theswab head against the inner wall of the tube to release the antigens in the collection
tube.
3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
4. Tighten the cap onto the specimen collection tube.

【DIRECTIONS FOR USE】

Allow the test, extracted specimen and/or controls 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 resultswill be obtained if the test is performed immediately after opening the foil pouch.
2. Invert the specimen collection tube and add 3 drops of the extracted specimen (approx.75μl) to each of the specimen well(S) respectively and then start the timer.
3. 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】

POSITIVE COVID-19:* Two distinct colored lines appear in the left window. One colored line should be in the control region (C) and another colored line should be in the Test region (T). Positive result in the Test region indicates detection of COVID-19 antigens in the sample.
POSITIVE Influenza A:* Two distinct colored lines appear in the right window. 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 in the right window. 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 in the right window. 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 region (T) will vary based on the amount of COVID-19 antigen, Flu A and/or B antigen present in the sample. So any shade of color in the test region (T/B/A) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the test line region (T/B/A).
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.