Rapid detection and differentiation between SARS-CoV-2, Influenza A and B
The SARS-CoV-2 & Flu A/B Rapid Antigen Test helps healthcare professionals at the point of care to quickly detect and differentiate infections with any of the three respiratory viruses and aid in pursuing appropriate courses of action, including patient management decisions. Also, it enables scaling up test capacities during flu season to meet the need for extensive testing during peak periods.
Simple to perform and fast results within 15 – 30 min*
Insert a sterile swab into the nostril of the patient. Rotate the swab 3 – 4 times against the nasopharyngeal surface, then leave the swab in place for 10 seconds to absorb secretions. Withdraw the swab from the nasal cavity.
A. Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab at least 10 times.
B. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
C. Press the nozzle cap tightly onto the tube.
WARNING! Failure to squeeze the tube can lead to incorrect results due to excess buffer in the swab.
Place the test device on a flat surface and apply 4 drops of extracted sample at a 90° angle to the specimen well of the test device.
Read the test result at 15 to 30 minutes. Do not touch or move the test device until the result can be read.
WARNING! Test results that are read before 15 minutes or after 30 minutes may be incorrect.
* Before using the SARS-CoV-2 & Flu A/B Rapid Antigen Test, carefully read the instructions for use that are provided in the kit.
Positive results
Postive results co-infection
Note: Co‑infection with influenza A, B and/or SARS‑CoV‑2 is possible. Test results are not intended to rule in or rule out other infections.
Negative test result
Invalid test result
Each kit contains 25 individually packaged, ready-to-use tests.
The following components are needed for a test and included in the kit:
The SARS-CoV-2 Rapid Antigen Test 2.0 is equipped with a 2D data matrix code and a unique identifier printed on each test cassette. The 2D code is compliant with the common industry standard GS1 and thus can be read and interpreted by any IT system compatible with standard 2D data matrix codes.
The 2D data matrix code is unique to each test device.
The following elements are encoded in a digitally readable format:
The unique identification of each test device enables a one to one assignment of test results to individual persons. This facilitates storage of test results under the respective patient ID in Electronic Medical Records. A digital readout of the data matrix code can lead to more efficient processes, especially in testing environments
with a high throughput.
*Relative sensitivity and relative specificity are compared to RT-PCR.
References
