Description
The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2,influenza A and influenza B viral nucleoprotein antigens in nasopharyngeal swab from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is intended for the detection and differentiation of SARS-CoV-2, influenza A and influenza B viral nucleoprotein antigens. Antigens are generally detectable in nasopharyngeal specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.Negative results do not rule out SARS-CoV-2, influenza A or influenza B infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results must be combined with clinical observations, patient history and epidemiological information, and confirmed with a molecular assay, if necessary for patient management. The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.
Test Procedure:Note: Allow the test devices, reagents and specimens to equilibrate to room temperature (15-30℃ or 59-86℉) prior to testing.
1.Put an extraction tube on the work station.
2.Unscrew the lid of an extraction reagent. Add all of the extraction reagent into
an extraction tube.
3.Sampling refer to section ‘Specimen Collection’.
4.Insert the swab specimen into the extraction tube which contains extraction reagent. Roll the swab at least 5 times while pressing the head against the bottom and side of the extraction tube. Leave the swab in the extraction tube for one minute.
5.Remove the swab while squeezing the sides of the tube to extract the liquid
from the swab. The extracted solution will be used as test sample.
6.Cover the extraction tube with a dropper tip tightly.
7.Remove the test cassette from the sealed pouch.
8.Reverse the specimen extraction tube, holding the specimen extraction tube upright, transfer 3 drops (approximately 100μL) to each specimen well (S) of the test cassette, then start the timer. See illustration below.
9.Wait for colored lines to appear. Interpret the test results at 15 minutes. Do
not read results after 20 minutes.
Limitations：
1.The product is limited to provide a qualitative detection. The intensity of the test line does not necessarily correlate to the concentration of the antigens in the specimens.
2.Negative results are presumptive. Negative test results do not preclude infection and should not be used as the sole basis for treatment or other patient management decisions, including infection control decisions, particularly in the presence of clinical signs and symptoms consistent with COVID-19, or in those who have been in contact with the virus. It is recommended that these results be confirmed by a molecular testing method, if necessary, for patient management.
3.A physician must interpret the results in conjunction with the patient’s history, physical findings, and other diagnostic procedures.
4.A negative result can occur if the quantity of antigens present in the specimen is below the detection threshold of the assay, or the virus has undergone minor amino acid mutation(s) in the target epitope region recognized by the monoclonal antibodies utilized in the test.
Specification：25T
