COVID-19 Antigen/FLU A+B Antigen Combo Rapid Test Cassette (Colloidal Gold Method)

For professional use.

COVID-19 Antigen/FLU A+B Antigen Combo Rapid Test Cassette (Colloidal Gold Method) is a rapid test for the qualitative detection of antigens to SARS-CoV-2 and influenza A+B in human saliva, throat swab, or nasal swab specimens.

This rapid test cassette is a 2nd generation Antigen rapid test, which also works with saliva samples or nasal swab specimens from the nose front. It is sufficient to penetrate the nose only about 2 cm deep with the swabs, which is much more comfortable than the first generation tests.

Our rapid test reliably detects the known SARS-CoV-2 mutations VOC-202012/01 (or B.1.1.7, N501Y.V1, or UK variant), N501Y.V2 (or B.1.351 or South African variant), and the Indian “double mutation” variant B.1.617. Please refer to the product manual or contact us for further information.

One of the main advantages of an antigen test is the test’s speed, which can provide results in minutes. We can potentially scale to test millions of people per day due to their simpler operation.
The antigen tests may not detect all active infections. Therefore the negative results from an antigen test may need to be confirmed with a PCR test or virus culture before making treatment decisions or to prevent the possible spread of the virus due to a false negative, the administration added.
The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient’s clinical manifestations and other laboratory tests. Laboratory testing of virus should meet the requirements of the “Technical Guidelines for Covid-19 Laboratory Testing” and “Testing Guidance for Clinicians When SARS-CoV-2 and Influenza Viruses are Co-circulating” to do a better biosafety job.

Components

• Test kits
  • Test cassette
  • Extraction reagent
  • Sterilized swab
  • Extraction tube
  • Dropper tip
• Package insert

Features

• Sample: saliva, nasopharyngeal, or oropharyngeal secretion samples
• Easy to collect samples, reduce the infection rate;
• 15 minutes to get results;
• Less sample, only 3 drops of samples are needed;
• Results are clearly visible;
• Suitable for large-scale rapid screening;
• No special requirements for carrying out the test;
• One kit is for antigen testing, save cost and test time, convenient

Clinical Performance

• Test size: 436 samples

SARS-CoV-2

• Sensitivity (PPA): 98.10% (95% confidence interval: 93.32% – 99.48%）
• Specificity (NPA): 99.40% (95% confidence interval: 97.82% – 99.83%）

Influenza A

• Sensitivity (PPA): 96.69% (95% confidence interval: 92.48% – 98.58%）
• Specificity (NPA): 98.95% (95% confidence interval: 96.95% – 99.64%）

Influenza B

• Sensitivity (PPA): 95.81% (95% confidence interval: 91.60% – 97.96%）
• Specificity (NPA): 98.88% (95% confidence interval: 96.77% – 99.62%）

For further details, please refer to the datasheet and product manual.

Certifications

• Our product is CE-IVD-certified.
• It has been accepted to the List of In Vitro Diagnostic Medical Devices for COVID-19 of the EU Commission’s Joint Research Centre.
• Furthermore, it is included in the list of Antigen tests for SARS-CoV-2 of the German Federal Institute for Drugs and Medical Devices under the registration number AT 009/21.

Packaging Unit

• Box with 20 test kits