BOSON Rapid SARS-CoV-2 Antigen Test Card is the first antigen self-test to be authorized for sale throughout the EU. This is also the reason that this product has a CE mark with four digits from the notified body, in this case, 0123 from TÜV SÜD. For this reason, this product may be sold without temporary waivers from the local authorities of each country that currently covers most of the testing on the market.
INTENDED USE :
The SARS-CoV-2 Antigen Rapid Assay is an immunochromatography-based, single-stage in vitro assay. It is designed for the rapid, qualitative determination of SARS-CoV-2 virus antigen in anterior nasal swabs (in front of the nose) within the first seven days of symptom onset in individuals with suspected COVID-19. The SARS-CoV-2 antigen rapid test should not be used as the sole basis for the diagnosis or exclusion of SARS-CoV-2 infection. Children under the age of 14 must be assisted by an adult.
The new coronaviruses belong to the genus. COVID-19 is a contagious and acute respiratory disease. People are generally susceptible. Currently, patients infected with the new coronavirus are the largest source of infection, and asymptomatically infected persons can also be a source of infection. Based on current epidemiological studies, the incubation period is 1 to 14 days, but in most cases 3 to 7 days. The main symptoms include fever, fatigue, loss of smell and/or taste and dry cough. In some cases, symptoms such as stuffy nose, runny nose, sore throat, muscle aches and diarrhoea have also been shown.
5 X individually packaged test vomit where each test kit consists of:
PERFORMANCE (SENSITIVITY AND SPECIFICITY) The Rapid SARS-CoV-2 Antigen Test Card was compared to the confirmed clinical diagnosis. 156 cases were tested in the study.
Sensitivity: 96.77% Specificity: 99.20% Accuracy: 98.72%
A feasibility study showed the following results:
- 99.10% of the non-professional users successfully performed the test independently. - 97.87% of the different types of results were interpreted correctly.
None of the following substances in the concentration tested interfered with the test:
Whole Blood: 1% Phenylephrine: 15% Menthol: 0.15% Fluticasone Propionate: 5% Oseltamivir Phosphate: 0.5% Biotin: 1200 ng/mL, Alkalol: 10% Thrombramycin: 0.00004% Cromolyn: 15% Mupirocin: 0.25% Sodium Chloride: 5%, Mucin: 2% Oxymetazoline: 15% Benzocaine: 0.15% Zicam Nasal Spray: 5% Human Anti-Mouse Antibody (HAMA): 60 ng/mL
IMPORTANT INFORMATION BEFORE IMPLEMENTATION
1. Read this manual carefully.
2. Do not use the product after the expiration date.
3. Do not use the product if the bag is damaged or the seal is broken.
4. Store the test between 4 and 30°C in the original sealed bag. Do not freeze.
5. The product should be used at room temperature (15°C to 30°C). When the product has been stored in a cooler area (less than 15°C), leave it at normal room temperature for 30 minutes before use.
6. Treat all trials as potentially infectious.
7. Inadequate or inaccurate sample collection, storage and transportation may lead to inaccurate test results.
8. Use the cotton swabs included in the test kit to perform the test optimally.
9. The correct test administration is the most important step in the execution of the test. Make sure that you collect enough test material (nasal mucus) with the cotton swab, especially during the nasalis anterior (in front of the nose) test.
10. Blow the nose several times before taking the test.
11. The tests should be examined as soon as possible after collection.
12. Place the test sample drops in the test well (S) only.
13. Too many or too few drops of the extraction solution can cause an invalid or incorrect test result.
14. Children under the age of 14 must be assisted by an adult.
1. The test is to be used only for the qualitative evidence of SARS-CoV-2 virus antigen in anterior nasalis (anterior nose) swab tests. The precise concentration of SARS-CoV-2 virus antigen cannot be determined in this test.
2. Professional test administration is of decisive importance. Ignoring this procedure may lead to inaccurate test results. Improper collection, storage or freezing and thawing of the test may lead to inaccurate test results.
3. When the virus load of the test is below the limit of evidence of the test, the test may give a negative result.
4. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of just one test but should be made by the physician after the analysis of all clinical and laboratory results.
5. Except for SARS-CoV-2, a negative result does not exclude viral infection and should be confirmed by molecular diagnostic methods when COVID-19 is suspected.
6. A positive result does not exclude co-infection with other pathogens.
7. The SARS-CoV-2 Antigen Rapid Test can detect both viable and non-viable SARS-CoV-2 material. The performance of the SARS-CoV-2 rapid test is virus load-dependent and may not correlate with other diagnostic methods performed on the same test.
8. Users should test the samples as soon as possible after the test administration and in any case within two hours after the test administration.
9. Sensitivity with nasal or oropharyngeal swabs may be lower than with nasopharyngeal swabs. It is advisable to have the nasopharyngeal swab method performed by healthcare professionals.
10. Monoclonal antibodies showing some amino acid changes in the target epitope region may not detect SARS-CoV-2 viruses or may have low sensitivity.
11. The amount of antigen in a test may decrease with increasing disease duration. Tests taken after the 5th to 7th day of illness are – compared with an RT-PCR analysis – tested negative with a higher probability.
12. The kit has been validated with the included swab swabs. Using other swabs may lead to false-negative results. 13. The validity of the SARS-CoV-2 antigen rapid test has not been established for the purpose of identification/confirmation of tissue culture isolates and should not be used for this purpose. 14. The cross-reactivity of the test cassette has been assessed by testing for viruses and other microorganisms. The final test concentrations of the viruses and other microorganisms are documented in the Cross-Reactivity study. With the exception of human SARS coronavirus, the viruses and other microorganisms listed therein do not affect the test results of the test cassette. Positive test results do not exclude co-infection with other pathogens. Positive results may occur in case of infection with SARS-CoV.