CorDx

Influenza A+B & COVID-19 Ag Combo Test

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 influen-za A, influenza B and/or SARS-CoV-2 infections. This test provides only a preliminary test result. Therefore, any reactive specimen with the Influenza A+B & COVID-19 Ag Combo Test must be confirmed with alternative testing method(s) and clinical findings.

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 influen-za A, influenza B and/or SARS-CoV-2 infections. This test provides only a preliminary test result. Therefore, any reactive specimen with the Influenza A+B & COVID-19 Ag Combo Test must be confirmed with alternative testing method(s) and clinical findings.

 

INTRODUCTION

Influenza is a highly contagious, acute viral infection of the respiratory tract with symptoms such as headache, chills, dry cough, body aches or fever. It is a communicable disease that is easily transmitted through aerosolized droplets containing live virus from coughing and sneezing. The causative agents of the disease are immunologically diverse single strand RNA viruses known as influenza viruses. Influenza type A viruses are typically more prevalent than influenza type B viruses and are associated with most senous influenza epidemics, while influenza type B infections are usually milder. Diagnosis is difficult because the initial symptoms are similar to those caused by other infectious agents.Accurate diagnosis and prompt treatment of patients can have a positive effect on public health. Rapid and accurate diagnosis of influenza viral infection can also help reduce the inappropriate use of antibiotics and gives the physician the opportunity to prescribe appropriate antiviral medications.CoV is mainly transmitted through direct contact with secretions or through aerosols and droplets. Evidence suggests transmission via fecal-oral route.7 kinds of HCoVs caused human,s respiratory diseases are found by now: HCoV-229E, CoV-OC43,SARS-CoV,H-CoV-NL63,HCoV-HKU1,MERS-CoV and 2019-nCoV which are the serious pathogens for human’ s respiratory diseases.Its clinical mani-festation are fever, enervate and systemic symptom, with dry cough, difficult breathing etc. and it may aggravate to severe pneumonia, respiratory failure, acute respiratory distress syndrome ,septic shock, multiple organ failure, severe acid-base metabolic disorders etc and even life threatening rapidly.

 

SPECIMEN PREPARATION

  1. The collection method of nasopharyngeal swab is shown in Figure 1 to 4.Figure 1. Remove a nasopharyngeal swab from the pouch.Figure 2. Place the swab into one of patient,s nostrils until reach-es the posterior nasopharynx.Figure 3. Slowly rotate the swab 3-5 times over the surface of the posterior nasophanynx.Figure 4. Remove the swab from the nasal cavity.
  2. Sample processing: Figure 5. Insert the swab in collection tube to the bottom, rotate and squeeze the swab 10 times. Figure 6. Leave the swab in the collection tube for 1 minute. Figure 7. Rotate and squeeze the swab 3 times. Figure 8. Take out and discard the swab. The retained liquids will be tested with Influenza A+B & COVID-19 Ag Combo Test.

NOTE: 

  1. Please use swab for specimen collection.
  2. It is highly recommended to collect specimen with wearing a pair of safety gloves to avoid contamination.
  3. Do not touch the tip(specimen collection area) of the swab.
  4. Collect sample as soon as after onset of symptoms.
  5. It is recommended to treat the sample immediately after collec-tion.The sample can be stored at 2°C~8°C for 72 hours, and it needs to be frozen at -20°C for long-term storage, avoiding repeated freezing and thawing.

TEST PROCEDURE

Read the instruction first prior to testing. Bring the pouched test to room temperature prior to testing. Do not open the pouch until ready to begin testing.

  1. Remove the test from the sealed pouch.Lay it on a flat, clean and dry surface.
  2. Place the test cassette on a flat and clean surface. Using the provided pipette, add 3 drops retained solution to each of the sample well.
  3. Read results within 10-15 minutes.

INTERPRETATION OF RESULTS

For Flu A+B Antigen Test

1. POSITIVE:

1.1 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.

1.2 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.

1.3 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.

2. NEGATIVE:

The presence of only control band (C) within the result window indicates a negative result.

3. 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 because of 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.For COVID-19 Antigen Test1. POSITIVE:The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.2. NEGATIVE:The presence of only control line (C) within the result window indicates a negative result.3. INVALID:If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of 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.

For COVID-19 Antigen Test

1. POSITIVE:

The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.

2. NEGATIVE:

The presence of only control line (C) within the result window indicates a negative result.

3. INVALID:

If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of 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.

NOTE: 

  1. The intensity of color in the test line region (T) may vary depend-ing on the concentration of analyses present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive. Please note that this is a qualitative test only, and cannot determine the concentration of analytes in the speci-men.
  2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely reasons for control band failure.