Antigen Rapid Test Kit (ADS)

COVID-19 Antigen Rapid Test Kit (ADS)

Product characteristics

The ADS COVID-19 rapid antigen is used for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen (hereinafter referred to as SARS-CoV-2 N-antigen) in human serum and nasopharyngeal swab and/or oropharyngeal swab samples.
Listed on the list of the BfArM (AT 015/20) (Federal Institute for Drugs and Medical Devices)

Refundable under the test regulation – High specificity (> 99.6%)
High sensitivity with high viral load: 97.65% (ct value: 20-30)
Easy handling
Reliable result after only 15 minutes
May only be used by healthcare professionals
Only low viral load required for detection
Infected people can be identified before they develop symptoms
CE IVD certified test

Test Pinciple

This rapid kit uses a fluorescence immunochromatography method to detect SARSCoV- 2 N antigen. The sample to be tested is applied to the sample well of the test cassette. The SARS-CoV-2 N-antigen within the sample forms a complex with an antibody labelled with fluorescently-tagged microspheres. This complex then migrates along the membrane from the sample well to reach the test region (T-line) where it then binds to a second imbedded antibody to the SARS-CoV-2 N-antigen. Any unbound fluorescently-tagged microspheres continue to migrate along the membrane to the control region (C-line) and are bound there by the control region antibody. The test result (T-Line) in the test window is illuminated with a UV lamp of wavelength 365 nm. If both, the T-line and the C-line fluoresce, the test result is SARS-CoV-2 N-anti-gen positive; if only the C-line fluoresces and no T-line becomes visible, the test result is SARS-CoV-2 N-antigen negative. When no C-line becomes visible, the test result is invalid, and the sample must be retested with a new test cassette.

Indication for Testing

To detect infection after contact with COV-2 infected persons
At or before onset of symptoms in addition to PCR test.
As a precaution before meeting third party
If no PCR test is accessible.
As a precaution in case of uncertainty if infection took place.
As a follow up after being PCR positive tested, to monitor the status if potentially still infective.

Specifications

Sensitivity 96,12%
Specificity 99,49%

Product Name	Sample Type	Storage Temperature	Packaging Size
COVID-19 Antigen Rapid Test Kit (ADS)	Nasopharyngeal swab sample / blood	Store at 2°C – 30°C	25 Tests / Kit

Shelf life: 12 month
Order Number: S-CoV-2-YIG-NS-2501 (Kit with 25 tests)
Price: From 1,10€ per test

No	Content	Quantity
1	Instructions For Use	1 copy
2	Test Cassette	25 cassettes
3	Sterilized Swab	25
4	Extraction buffer (4ml)	1
5	Extrction Vials / Caps	25/25

Test Procedure For Swab Samples

The test can be performed according to the standard nasopharyngeal swab or oropharyngeal swab sample collection procedure.
Nasopharyngeal swab sample collection: Tilt back the head of the patient 70 degrees. Insert swab into nostril (swab should reach depth equal to the distance from nostrils to outer opening of the ear). Leave swab in place for several seconds to absorb secretions. Slowly remove swab while rotating it.
Oropharyngeal swab sample collection: Insert swab into the posterior pharynx and tonsillar areas. Rub swab over both tonsils and posterior oropharynx and avoid touching the tongue, teeth and gums.
It is recommended that the sample is tested immediately following sample collection.

Test Procedure For Serum Samples

Step 1:
Take out the test cassette and sample to be tested and let it reach room temperature.

Step 2:
Tear open the aluminium foil bag, take out the test cassette and place it on a horizontal surface.

Step 3:
Write the sample number on the test cassette.

Step 4:
Pipette 80 μL (3 drops with the included pipette) of the sample to be tested and apply it to the sample well on the test cassette. Ensure that there is no air bubble formation during the operation.

Interpretation of the Results

Under the UV flashlight,if a visible red fluorescent band appears in the detection area(T) and the control region (C) at the same time, the test is SARS-CoV-2-N-protein positive; if a red fluorescent band becomes visible in the control region(C) , and no visible red fluorescent band in the detection area(T), the test is SARS-CoV-2-N-protein is negative; if there is no visible red fluorescent band in the control region(C),regardless of whether there is a red fluorescent band visible in the detection area(T), the test result is invalid and the sample needs to be tested again with a new test cassette.

Due to the complex structure of bioactive substances in samples and the difference of antigen antibody specificity, the possibility of false positive results cannot be completely ruled out when using this kit. If the test results are inconsistent with the clinical indications, other appropriate test methods should be used for confirmation.

If the SARS-CoV-2 N-protein is positive, it is an indicator of SARS-CoV-2 infection. A negative result of SARS-CoV-2 N-antigen cannot completely rule out a SARS-CoV-2 infection. A negative result can be caused if the sample is below the detection limit or if the anti-N-antigen antibodies have been produced and are present in the serum which decreases the N-antigen.

The test results of this kit are only used as the basis of auxiliary diagnosis. Clinical diagnosis should be combined with clinical symptoms and other diagnostic methods.

Limitation of the Procedures

13.1.
Hyperlipidemia, hemolysis samples, samples contaminated with microorganisms, repeated freezing and thawing (more than 3 times) or use of serum samples after heat inactivation may affect the accuracy of the detection and may lead to erroneous results.

13.2.
Serum samples from patients with severe jaundice or serious contamination may lead to false results.

13.3.
The accuracy of the test depends on the sample collection process. Improper sample collection, improper sample storage or repeated freezing and thawing of the sample may affect the test result.

Performance characteristics

Detection limit
The detection limit (LoD) for serum samples was determined with negative serum samples added with recombinant N-antigen; the test was repeated 60 times, 3.5 pg/ml has been determined as the LoD. The LoD for negative swab samples was determined with swab samples added with recombinant N-antigen; the test was repeated 60 times, 7.0 pg/ml has been determined as the LoD.

Virus Detection Limit
Novel coronavirus stock solution (2.0×104 TCID50/mL) (IVCAS 6.7512), that has been inactivated at 56℃ for 30 minutes has been diluted to 200 TCID50/mL, 100 TCID50/mL, 40 TCID50/mL, 20 TCID50/ mL, 10 TCID50/mL, 5 TCID50/mL samples. Each sample was tested 3 times.

Test Concentration (TCID50/mL)	Test cycles	Test Result Serum Samples	Test Result Swab Specimen
20000	3	3/3 Positive	3/3 Positive
200	3	3/3 Positive	3/3 Positive
100	3	3/3 Positive	3/3 Positive
40	3	3/3 Positive	3/3 Positive
20	3	3/3 Positive	1/3 Positive
10	3	1/3 Positive	0/3 Positive
5	3	0/3 Positive	0/3 Positive

The limit of detection for serum samples is determined at 20 TCID50 /mL and the limit of detection for swab samples was determined at 40 TCID50 /mL.

Cross-reactivity Studies
Cross-reactivity was evaluated by testing a panel of microbials that could potentially crossreact with the SARS-CoV-2 Antigen rapid test in serum and swab samples. The results do not show any cross reactivity with the below listed microbial substances.

For detailed data have a look to the Instructions for Use