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SARS-CoV-2 Rapid Antibody Test 2.0

IVD

Antibody check with a finger prick

Fast and improved detection of antibodies to SARS-CoV-2. Broader use in both recovered and now vaccinated individuals with the convenient capillary blood sampling possibility in point of care settings.

The SARS-CoV-2 Rapid Antibody Test 2.0 is intended for the qualitative in vitro detection of IgG antibodies to SARS-CoV-2 spike protein present in human serum, plasma or whole blood. The test can be used as an aid in the determination of an adaptive immune reaction to SARS-CoV-2, indicating recent or prior infection or vaccination and is intended for professional environments.

Key benefits

Detection of IgG antibodies to SARS-CoV-2 spike protein after natural infection or vaccination¹
Improved composition of the test device, optimized to detect antibodies against several dominant variants of the SARS-CoV-2 virus¹
Enhanced performance: 95.83% PPA and 100.00 % NPA (For non-vaccinated patients after infection) and for vaccinated patients 98.67% PPA (after 2nd vaccination) and 100.00% PPA (after booster shot)¹
Easy handling with an improved capillary tube system
Only needing a very small capillary sample of 20μl
Access to testing in areas where laboratory testing is not available, or when a venous blood draw is not suitable
Data matrix code on each test device for facilitated result sharing

Performing a test*

A) Performing a test with capillary whole blood

Sample collection

Using a 20 μL capillary tube from the easy sample collector bag, collect capillary whole blood to completely fill the collector as shown above.

Sample application

To apply the collected capillary whole blood to the specimen well of the test device, place the bottom end of the easy sample collector on the specimen well and press down lighty.

Dropping buffer

Add 3 drops (90 μL) of buffer vertically into the specimen well of the test device. Do not touch the surface of the specimen well with the tip of the bottle.

Read the results

Read the results at 10-15 minutes.

WARNING! Risk of incorrect results. Do not read test result before 10 or after 15 minutes.

B) Performing a test with serum, plasma, or venous whole blood

Sample collection

Using a micropipette, collect 10 μL of serum or plasma (A, B) or 20 μL of venous whole blood (C).

Sample application

Apply the collected 10 μL of serum or plasma (A, B) or 20 μL of venous whole blood (C) to the specimen well of the test device.

Dropping buffer

Add 3 drops (90 μL) of buffer vertically into the specimen well of the test device. Do not touch the surface of the specimen well with the tip of the bottle.

Read the results

Read the results at 10-15 minutes.

WARNING! Risk of incorrect results. Do not read test result before 10 or after 15 minutes.

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

Interpreting the results

A colored line appears in the top section of the result window to show that the test is working properly. This is the control line (C). Even if the control line is faint or not uniform, the test should be considered to have been performed properly. If the IgG antibody test is positive, a colored line will appear in the lower section of the result window. This line is the test line of IgG (T). Even if the line is very faint or not uniform, the test result should be interpreted as a positive result.

Positive results

If the test is positive, both the control line (C) and IgG test line (T) are visible.

Negative test result

If the test is negative, only the control line (C) is visible.

Invalid test result

If no control line (C) is visible, the test is invalid.

Test kit information

The kit is ready for use and contains all equipment needed to perform a test, with the exception of a pricking device (lancet), which is not included.

A pricking device (lancet) is needed if a blood sample is taken from the finger or ear. Roche recommends to use the “Accu-Chek Safe T Pro Uno or Plus” which can be ordered through the usual channels. Any other pricking device that is able to produce a sample of 20 microliters can be used too.

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

Test device (individually in a foil pouch with desiccant)
Buffer bottle
Easy sample collector (20 ul)
Instructions For Use
Quick Reference Guide

Digital connectivity

The SARS-CoV-2 Rapid Antibody 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.

Data Matrix Code

The 2D data 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.