SG Diagnostics

SG Diagnostics Influenza A+B and COVID-19 Antigen Rapid Test Kit

The SG Diagnostics Influenza A/B + COVID-19 Antigen Rapid Test Kit (Colloidal Gold-Based) is a lateral flow immunoassay intended for the qualitative detection of COVID-19, and flu A and B antigens in direct nasal swabs from individuals suspected of respiratory viral infection consistent with COVID-19 and/or flu by their healthcare provider.

 It is intended for use by medical professionals or trained operators who are proficient in performing rapid lateral flow tests.

  • Product Information
  • Specification
  • Instruction For Use
  • Related Products

COVID-19 and flu are both contagious respiratory illnesses, but they are caused by different viruses. COVID-19 is caused by the infection with a new coronavirus, SARS-CoV-2 while flu is caused by the infection with influenza viruses. Among the influenza viruses, influenza A and B viruses that routinely spread in people are responsible for seasonal flu epidemics each year.

The SG Diagnostics Influenza A/B + COVID-19 Antigen Rapid Test Kit is an immunochromatographic membrane assay that uses highly sensitive antibodies to detect COVID-19, and flu A and B antigens from nasal swab specimens via the double antibody sandwich method. After loading, the sample will diffuse upwards from the charging end by capillary action, and then the COVID-19, and flu A and B antigens in the sample will combine with the respective antibody in the marker pad to form colloidal gold antibody-antigen complex; the complex continues to diffuse upwards to the nitrocellulose membrane with the sample, and then blocked by the respective Test (T) Line packed with antibody to form colloidal gold labeled antibody-antigen-immune complex. The rest unblocked colloidal gold complex continues to move upwards and combine with the Control (C) line (quality control line), indicating that the reaction is completed.

  • The assay time is shorter (within 10 minutes as compared to around 24 hours for enzyme-linked immunosorbent assay (ELISA))
  • The cost is cheaper than ELISA
  • The test can be carried out at the point-of-care
  • Test or multiple infection at a time
  • It is a one-step assay that requires no special skills or instrumentation to achieve the result(s)
  • It has a long shelf life and assay reagents do not require refrigeration or freezer storage
  • The samples do not need to be pre-treated before applying to the assay

Note: The test cassette must be at room temperature before use, and the test must be operated at room temperature.

  1. Place and soak the Patient Swab in the Sample Eluent for 10 seconds and then stir well by rotating the swab against the side of the vial 5 times.
  2. Remove the Patient Swab while squeezing the middle of the Sample Eluent Vial to remove the liquid from the swab. Discard the swab in biohazard waste.
  3. Firmly attach Dropper Lid to the top of the Sample Eluent Vial.
  4. Gently invert the Sample Eluent Vial five times just before applying the sample to the Test Cassette.
  5. Apply the extracted sample from the Sample Eluent Vial onto the charging hole of the Test Cassette. To do this, gently press the sides of the Sample Eluent Vial to add 4 drops (about 80μL) of extracted sample to the charging hole of the Test Cassette. The sample will then be drawn by capillary action into the Test Strip.
  6. Start and timer and read the results after 10 minutes. The result is invalid after 15 minutes.
  7. Dispose the Swab, Sample Eluent Vial and Test Cassette in the appropriate biohazard waste.

Note: In a valid, tested device, a red line appears at the Control Line position, confirming that the sample has flowed through the test strip and the reagents are working.

The test results are analyzed as follows:
Positive
A positive specimen will give two or more red colored lines. Red Test Line 1, 2 or 3 means that COVID-19 antigen, flu A or B antigen is detected, respectively. Specimens with low levels of antigen may give a faint Test Line. Any visible red colored Test Line is positive.

Negative
A negative specimen will give a single red colored Control Line in the top half of the window, indicating a negative result. This means that the detection part of the test is done correctly, but no COVID-19 antigen, flu A antigen or flu B antigen is detected.

Invalid
If no lines are seen, if just the red Test Line 1, 2 or 3 is seen, if just the red Test Line 1 and 2, 2 and 3, 1 and 3, and 1, 2 and 3 are seen, or if the red Control Line is not seen, the assay is invalid. Invalid tests should be repeated.

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Test Kit Specifications Materials Provided

Test Cassettes (20)
A test cassette consists of a test strip, packed individually in a sealed desiccant foil pouch.
Disposable Swabs
Sterile nasal swabs for use with test cassettes
Sample Eluent (20)
0.5mL of phosphate buffer with surfactant
Product Insert (1)

Test Kit Characteristics

Assay format
Lateral flow test / immunochromatographic
Instrument
No
Testing Time
10 -15 mins
Specificity
Sensitivity
Type of analyte
Spike protein antigen and Nucleocapsid protein antigen of SARS-CoV-2,
Sample material
Nasal, Oropharyngeal or Nasopharyngeal Swab Specimen

External Clinical Evaluation

Coming soon

For more information, you can download the file below.