SARS-CoV-2 Rapid Antigen Test 2.0

Accurate and fast detection of SARS-CoV-2 antigens. Test strip formula and buffer components have been optimized to increase clinical and analytical performance in symptomatic and asymptomatic patients with a nasopharyngeal sample without the need for a lab. 

Reliable, rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 specific nucleocapsid antigen present in the human nasopharynx.

• Enhanced performance compared to previous version: 99.00% relative sensitivity and 99.75% relative specificity¹
• Detection of SARS-CoV-2 infection in symptomatic and asymptomatic individuals¹
• Optimized composition to detect antigens against several dominant variants of the virus¹
• No instrument required
  
• Enables access to testing in areas where laboratory testing is not available
• Rapid answers in only 15 minutes
• Data matrix code on each test device for facilitated result sharing

Performing a test

Simple to perform and fast results within 15–30 min*

Tilt the patient’s head back slightly (approximately at a 70° angle). Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx. Rotate the swab 3-4 times against the nasopharyngeal surface.

Insert the swab into an extraction buffer tube. While squeezing the buffer tube, stir the swab at least 10 times. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. Press the nozzle cap tightly onto the tube.

Apply 4 drops of extracted specimen to the specimen well of the test device.

WARNING! Dispense the specimen at 90 degree angle to allow for free-falling drops drops and avoid bubbles.

Read the test at 15 to 30 minutes.

WARNING! Test results that are read before 15 minutes or after 30 minutes may be incorrect.

WARNING! Failure to squeeze the tube can lead to incorrect results.

*Before using the SARS-CoV-2 Rapid Antigen Test 2.0, carefully read the Instructions for Use and all included warnings and precautions.

Result interpretation

Test results are quick and easy to read.

If both colored lines C and T are visible, even if they are faint or not uniform, the test result is positive. This means the test detected the virus protein in the sample. The tested person is very likely infected with SARS-CoV-2.

Control line C: Indicates that the test is working correctly

Test line T: Visibile if SARS-CoV-2 antigen was detected

A visible control line C alone means the test worked correctly. The test result is negative. No virus protein could be detected in the sample. The tested person is unlikely infected with SARS-CoV-2.

If a control line (C) is not visible, or only the line marked with a T, the result must be considered invalid. The test is not working correctly and you should perform another test using a different test kit.

Each kit contains 25 individually packaged, ready-to-use tests.

The following components are needed for a test and included in the kit:

• Test device (individually in a foil pouch with desiccant)
• Extraction buffer tube and buffer tube rack
• Nozzle cap
• Sterile swab
• Instructions For Use and Quick Reference Guide

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 cata matrix code is unique to each test device. The following elements are encoded in a digitally readable format:

• Lot number
• Expiry date
• GTIN (Global Trade Item Number)
• Reference to source entity (i.e. production factory identification)
• Serial number (i.e. 6-digit ID printed on the test cassette - unique per lot range)

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.