Flu AB + COVID-19 Antigen Combo Test

Directions For Use:

1.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 solution to the Extraction Tube.

2.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. 3.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.

4.Cover the tube with cap,then add 3 drops of the sample into the left sample hole vertically and add another 3 drops of the sample into the right sample hole vertically.

5.Read the result after 15 minutes. If left unread for 20 minutes or more the results are invalid and a repeat test is recommended.

Product Description:

The test is intended for use in the simultaneous rapid in vitro detection and differentiation of influenza A virus, influenza B virus, and COVID-19 virus nucleocapsid protein antigen , but does not differentiate, between SARS-CoV and COVID-19 viruses and is not intended to detect influenza C antigens. Performance characteristics may vary against other emerging influenza viruses. Influenza A, influenza B, and COVID-19 viral antigens are generally detectable in upper respiratory 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. The agent detected may not be the definite cause of disease. Negative COVID-19 results, from patients with symptom onset beyond five days, should be treated as presumptive and confirmation with a molecular assay, if necessary, for patient management, may be performed. Negative results do not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Negative results do not preclude influenza virus infections and should not be used as the sole basis for treatment or other patient management decisions.

Application:

The Flu A/B + COVID-19 Antigen Combo Test is a rapid diagnostic tool designed to simultaneously detect and differentiate between influenza A virus, influenza B virus, and COVID-19 virus nucleocapsid protein antigen in upper respiratory specimens. It provides a quick means for healthcare professionals to identify multiple viral infections, aiding in the determination of appropriate treatment plans and infection control measures. However, it must be used in conjunction with patient history and additional diagnostic information due to its limitations in ruling out bacterial infections or other co-infections, and negative results should not solely dictate treatment decisions. This test is especially useful in situations where both flu and COVID-19 are circulating, streamlining the diagnostic process and potentially saving time and resources.

Storage: 4-30°C

Executive Standards: International Standard.