COVID Flu (A+B) Combo Antigen rapid test

Cat.No.:HCOFLU021G

The Sars-CoV-2 & Influenza A+B Combo Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of Sars-CoV-2 and Influenza A/B antigens in human nasopharyngeal swab, or oropharyngeal swab specimen in individuals who are suspected of respiratory viral infection consistent with COVID-19 and/or flu. 

SUMMARY

The Sars-CoV-2 virus belong to the β genus coronaviruses and the cause of COVID-19 which is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the Sars-CoV-2 virus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is mostly 3 to 7 days, and could be up to 14 days in some individuals. 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 viruses are the pathogens that cause influenza. Influenza is an acute respiratory infection caused by influenza A, B viruses, which is highly contagious and spread fast, short incubation period, high incidence. Influenza A virus often appears in an epidemic form, which can cause a worldwide influenza pandemic. Influenza B virus often causes local outbreaks and does not cause a worldwide pandemic of influenza.

The Sars-CoV-2 & Influenza A+B Combo Rapid Test is designed as a simple tool in detection of Sars-CoV-2. influenza A and influenza B for regular clinical diagnosis.

PRINCIPLE-Lateral Flow (Qualitative)

The Sars-CoV-2 & Influenza A+B Combo Rapid Test is consist with two test strips which could be observed in the two windows of the rapid test cassette. Both of the two strips are based on sandwich method immunochromatographic assay. The nucleocapsid protein of Sars-CoV-2, generic Influenza A antigen, and Influenza B antigen are targeted individually.

In the test strip of Sars-CoV-2, anti-SARS-CoV-2 monoclonal antibodies are coated in the test line and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-SARS-CoV-2 antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with another Anti-SARS-CoV-2 monoclonal antibodies in the test region. The complex is captured and forming a colored line in the Test line region.

In the test strip of Influenza A+B, anti-influenza A monoclonal antibodies and anti-influenza B monoclonal antibodies are coated in the test lines and conjugated with the colloidal gold. During testing, the specimen reacts with the anti-Influenza A&B antibodies conjugate in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the pre-coated Influenza A & B monoclonal antibodies in the test regions.

To serve as a procedural control, a colored line will always appear at the control line regions(C) indicating that proper volume of specimen has been added and membrane wicking has occurred.

MATERIALS

Materials Provided

1) Foil pouches, each contains one test cassette, and one desiccant bag

2) Assay buffer tubes (0.5ml each) and tips

3) Sterile swabs (each bag contains one nasopharyngeal swab and one oropharyngeal swab)

4) Paper tube holder

5) Instruction for use

Materials Required But Not Provided

1) Timer

TEST PROCEDURE

Allow the rapid test, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the rapid test cassette from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.

See illustration below

INTERPRETATION OF RESULTS

Positive (+):

Sars-CoV-2 Positive: Both of the C line and T line appear in the left window of the rapid test cassette.

Influenza A Positive: Both C line and A line appear in the right window of the rapid test cassette.

Influenza B Positive: Both C line and B line appear in the right window of the rapid test cassette.

*NOTE: The intensity of the color in the test line regions may vary depending on the concentration of the virus present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such.

Negative (-): One colored line appears in the control line region (C). No line appears in the T line, A line, or B line region.

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