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Influenza A+B & COVID-19 Ag Combo Test
Influenza A+B & COVID-19 Ag Combo Test
CorDx’s Influenza A+B & COVID-19 Ag Combo Test is an in vitro immuno-chromatographic assay for the qualitative and differential detection of nucleocapsid protein antigen from influenza A (including the subtype H1N1), influenza B, and SARS-CoV-2 in nasopharyngeal (NP) swab specimens. The test provides clinicians with preliminary qualitative results of a COVID-19 or influenza infection present in a patient. This test provides only a preliminary test result. Any reactive specimen with the influenza A+B and COVID-19 Ag Combo Test must be confirmed with alternative testing methods and clinical findings.
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产品参数
Accessories:
1. Influenza A+B & COVID-19 Ag Combo Test cassette
2. Instruction for use
3. Sample collection tube containing processing solution
4. Nasopharyngeal swab (Optional equipment)

Principle of Test:
Immunochromatographic assay

Intended Use:
The Influenza A+B & COVID-19 Ag Combo Test is an in vitro immuno-chromatographic assay for the qualitative and differential detection of nucleocapsid protein antigen from influenza A (including the subtype H1N1), influenza B and/or SARS-CoV-2 in nasopharyngeal (NP) swab specimens. It is intended to aid in the rapid diagnosis of influenza A, influenza B and/or SARS-CoV-2 infections. However, this test provides only a preliminary result. Therefore, any reactive specimen with the Influenza A+B & COVID-19 Ag Combo Test must be confirmed with alternative testing methods and clinical findings.

Instructions for Use:
Specimen Preparation:
Remove a nasopharyngeal swab from the pouch (see Fig. 1).
Place the swab into one of patient’s nostrils until it reaches the posterior nasopharynx (see Fig. 2).
Slowly rotate the swab 3–5 times over the surface of the posterior nasopharynx (see Fig. 3).
Remove the swab from the nasal cavity (see Fig. 4).
Sample processing: insert the swab in the collection tube to the bottom. Rotate and squeeze the swab 10 times (see Fig. 5).
Leave the swab in the collection tube for one (1) minute (see Fig. 6).
Rotate and squeeze the swab three (3) times (see Fig. 7).
Remove and discard the swab (see Fig. 8). The retained liquids will be tested with the Influenza A+B & COVID-19 Ag Combo Test.

Notes:
Use swab for specimen collection.
To avoid contamination, collect the specimen while wearing safety gloves.
Do not touch the tip (specimen collection area) of the swab.
Collect the sample as soon as possible after onset of symptoms.
Treat the sample immediately after collection. The sample can be stored at 2–8°C for 72 hours, and it needs to be frozen at -20°C for long-term storage. Avoid repeated freezing and thawing.

Interpreting the Results:
For Flu A+B Antigen Test
POSITIVE:
Flu A Positive: The presence of two lines as control line (C) and A test line within the result window indicates a positive result for Influenza A viral antigen.
Flu B Positive: The presence of two lines as control line (C) and B test line within the result window indicates a positive result for Influenza B viral antigen.
Flu A+B Positive: The presence of three lines as control line (C), A test line and B test line within the result window indicates a positive result for Influenza A and Influenza B viral antigen.
NEGATIVE:
The presence of only control band (C) within the result window indicates a negative result.
INVALID:
If the control band (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
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