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)
|Product Name||Sample Type||Storage Temperature||Packaging Size|
|COVID-19 Antigen Rapid|
Test Kit (ADS)
swab sample / blood
|Store at 2°C – 30°C||25 Tests / Kit|
Shelf life: 12 month
Order Number: S-CoV-2-ADRT (Kit with 25 tests)
Price: From 4,70€ per test
|1||Instructions For Use||1 copy|
|2||Test Cassette||25 cassettes|
|4||Extraction buffer (4ml)||1|
|5||Extrction Vials / Caps||25/25|
Take out the test cassette and sample to be tested and let it reach room temperature.
Tear open the aluminium foil bag, take out the test cassette and place it on a horizontal surface.
Write the sample number on the test cassette.
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.
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.
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.
Serum samples from patients with severe jaundice or serious contamination may lead to false results.
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.
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 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