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CorDx influenza test A + B, COVID-19, RSV, combination test 4in1, 1 ST

Product information "CorDx influenza test A + B, COVID-19, RSV, combination test 4in1"

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The CorDx Influenza A + B, COVID-19, RSV 4-in-1 Combination Test is an antigen test. Using a simple nasal swab, COVID-19, influenza A/B and RSV can be detected within 15 minutes.

The combined test for Influenza A, Influenza B, COVID-19 and RSV (respiratory syncytial virus) is an immunochromatographic in vitro assay for the qualitative and differentiated detection of nucleocapsid protein antigens of influenza A (including the H1N1 subtype), Influenza B, respiratory syncytial virus and/or SARS-CoV-2 in nasal swab samples from individuals with or without symptoms, or where there are other epidemiological grounds for suspecting the presence of Influenza A, Influenza B, RSV and/or COVID-19 infections. This Covid Influenza RSV Combination Test is intended for in vitro diagnostics and self-testing.

Advantages of the CorDx Covid Influenza RSV Combination Test

The CorDx Covid Influenza RSV Combination Test is a qualitative test capable of detecting Covid-19, RSV, Influenza A and B with a high sensitivity of over 96% and a specificity of over 99%. It is quick and easy to use and is suitable for both staff and members of the public seeking certainty in the event of illness.

  • Quick to carry out: The test can be completed within a few minutes.
  • 4-in-1 combination test: Covid, influenza A/B and RSV
  • Results available after 15 minutes
  • Easy to use: The test is straightforward to carry out. Simple nasal swab.
  • Storage at 2–30 °C CE certified Clinically tested
  • Includes all necessary supplies

Clinical performance

The clinical performance characteristics of the CorDx Influenza A/B, COVID-19, RSV Combo Ag Test were evaluated in clinical trials. A total of 452 symptomatic or asymptomatic participants were recruited for the clinical trial of the Influenza A/B and RSV test. In addition, a trial was conducted involving 560 symptomatic or asymptomatic individuals suspected of having COVID-19.

The test results are as follows:

  • Influenza A: For the detection of the Influenza A antigen, the positive concordance rate is 100.00 per cent, the negative concordance rate is 99.34 per cent and the overall concordance rate is 99.43 per cent.
  • Influenza B: For Influenza B antigen detection, the positive concordance rate is 96.00 per cent, the negative concordance rate is 99.67 per cent and the overall concordance rate is 99.15 per cent.
  • RSV: For RSV antigen detection, the positive concordance rate is 98.98 per cent, the negative concordance rate is 99.21 per cent and the overall concordance rate is 99.14 per cent.
  • COVID-19: For COVID-19 antigen detection, the positive concordance rate is 89.09%, i.e. 98.67% for Ct ≤ 25, 93.00% for Ct ≤ 30; the negative concordance rate is 100.00% and the overall concordance rate is 97.86%.

Detection limit (analytical sensitivity)

  • Influenza A: 1.5×10⁴ TCID₅₀/mL
  • Influenza B: 1.5×10⁵ TCID₅₀/mL
  • COVID-19: 200 TCID₅₀/mL
  • RSV: 1.0×10⁴ TCID₅₀/mL

Test principle of the CorDx Influenza Test A + B, COVID-19, RSV, 4-in-1 combination self-test

Influenza A and Influenza B

  • The Influenza A and Influenza B antigen test strip utilises monoclonal mouse anti-influenza A antibodies (T1), monoclonal mouse anti-influenza B antibodies (T2) and polyclonal goat anti-mouse IgG antibodies (C), each of which is immobilised on a nitrocellulose membrane. The test uses colloidal gold to label the monoclonal mouse anti-influenza A antibodies and the monoclonal mouse anti-influenza B antibodies. It utilises nanocolloidal gold technology and relies on highly specific antibody-antigen reactions, as well as the principle of immunochromatographic analysis. During testing, the influenza A antigens in the sample combine with the colloidal gold-labelled monoclonal mouse anti-influenzaA antibodies to form a complex, which then binds during chromatography to the monoclonal mouse anti-influenza A antibodies coated on the T1 test line, forming a red line in the T1 line.
  • During testing, the influenza B antigens in the sample bind, in combination with the colloidal gold-labelled monoclonal mouse anti-influenzaB antibodies to form a complex, which then binds during chromatography to the monoclonal mouse anti-influenza B antibodies coated on the T2 test line, producing a red line in the T2 line. If the samples do not contain influenza type A or B antigens, no red lines will appear in the T1 and T2 regions. Regardless of the presence of influenza type A or B antigens in the sample, a red line should always appear in the quality control region (C) where possible. The red line in the quality control area (C) serves to verify that 1. a sufficient sample volume has been added, 2. an adequate flow rate has been achieved, 3. and acts as a quality control for the reagents.

COVID-19

  • The COVID-19, RSV Antigen Test Strip utilises monoclonal mouse anti-COVID-19 antibodies (T2), monoclonal mouse anti-RSV antibodies (T1) and polyclonal goat anti-mouse IgG antibodies (C), each of which is immobilised on a nitrocellulose membrane. It uses colloidal gold to label the monoclonal mouse anti-COVID-19 antibody and the monoclonal mouse anti-RSV antibody. This utilises nanocolloidal gold technology and employs highly specific antibody-antigen reactions, as well as the principle of immunochromatographic analysis technology. During testing, the COVID-19 antigen in the sample binds to the colloidal gold-labelled monoclonal mouse anti-COVID-19 antibody to form a complex, which is then combined with the monoclonal mouse anti-COVID-19 antibody, which was applied to the T2 test line during chromatography; at this point, a red line appears in the T2 area (the test is positive).

RSV

  • The RSV antigen in the sample binds to the colloidal gold-labelled monoclonal RSV antibody to form a complex, which is then bound to the monoclonal mouse anti-RSV antibody, which was coated onto the T1 test line during chromatography; at this point, a red line appears in the T1 region (the test is positive). If the samples do not contain COVID-19 or RSV antigens, no red lines appear in the T1 and T2 regions (the test is negative). Regardless of the presence of COVID-19 or RSV viral antigens in the sample, a red line always forms in the quality control region (C). The red line in the quality control zone (C) serves to verify that 1. a sufficient sample volume has been added, 2. proper flow has been achieved, and 3. as a quality control for the reagents. If this line does not appear, the test must not be interpreted.

General information on the CorDx Influenza A + B, COVID-19, RSV, 4-in-1 Combination Self-Test

The test is intended to aid in the rapid diagnosis of infections with influenza A, influenza B, respiratory syncytial virus and/or SARS-CoV-2. This test is intended for over-the-counter home use with self-collected nasal swabs from individuals aged 14 and over who have symptoms of influenza A, influenza B, RSV and/or COVID-19 within the first 7 days of symptom onset. This test is also intended for use with nasal swabs taken by adults from individuals aged 2 years and over who have symptoms of influenza A, influenza B, RSV and/or COVID-19 within the first 7 days of symptom onset. In individuals without COVID-19 symptoms and/or those living in areas with a low number of COVID-19 infections and no known exposure to COVID-19, a higher number of false-positive results may occur. People without symptoms should only be tested if they are close contacts of confirmed or probable cases, or if there are other epidemiological reasons to suspect an influenza A/B or RSV/COVID-19 infection. In addition, a confirmatory test using a molecular test (e.g. PCR) should be carried out.

This test provides only preliminary results. Therefore, all positive results from this combined antigen test for influenza A, influenza B, COVID-19 and/or RSV must be confirmed by alternative testing methods and clinical findings.


Form of supply
The test kit for the combined antigen test for influenza A/B, COVID-19 and RSV contains the following components for carrying out the test: 1 test cassette, 1 instruction leaflet, 1 sample collection tube with sample processing solution, 1 swab for sample collection, 1 tube rack, 1 collection bag.

Use
Please refer to the package leaflet.
Piece: 1
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Warnings - CorDx influenza test A + B, COVID-19, RSV, combination test 4in1

Instructions for use

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