RAPID TEST COVID-19 Ag (PRE-FILLED BUFFER) 25T AMP DIAGNOSTICS

EOF product registration number: 2830000672611

The Rapid Test COVID-19 Ag 25T AMP DIAGNOSTICS is proposed by the European Union Health Security Committee and is included in the list issued on May 10, 2021.

Approved for home use by the German Institute for Drugs and Medical Devices.

It has CE quality certification

Rapid Test to limit the spread of SARS-CoV-2 and COVID – 19

Extreme sensitivity & specialty …
Naso- or oropharyngeal or anterior nasal swab

Rapid immunochromatographic test for the qualitative detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) nucleocapsid protein antigen in human naso- and oropharyngeal, as well as anterior nasal swab samples as an aid in rapid diagnosis of
Coronavirus (Covid-19) infection.

PROVIDED MATERIALS

• 25 Individual aluminum packages each containing a Test cassette and a desiccant
• 25 extraction tubes prefilled with buffer
• 25 Sterile swabs
• 25 sample collection tubes with the corresponding dropper tips
• 1 tube holder

PRINCIPLE

The test is performed by applying the extracted sample to the sample well (S) of the cassette and observing the formation of colored lines.
Nucleocapsid protein antigen to SARS-CoV-2 are detected by utilizing highly sensitive monoclonal antibodies.
The sample migrates by capillary effect along the membrane. If present in the sample, SARS-CoV-2 antigen react with monoclonal
antibody conjugated colloid-gold particles and are captured by secondary monoclonal antibodies immobilized in the Test (T) region.
A colored line will form in the Test (T) region. The presence of this colored line indicates a positive result, while its absence indicates a negative result.
As a procedure control a coloured line has to appear in the Control (C) region confirming that sufficient sample has been absorbed.

TEST PROCEDURE

PERFORMANCE
Detection limit (LOD):
The minimum detectable concentration of SARS-CoV-2 Ag is 1.15 x 10² TCID₅₀/mL.

Sensitivity and specificity:
AMP Rapid Test SARS-CoV-2 Ag has been evaluated with clinical patient samples using a commercial molecular assay (RT PCR) as a reference method. Sensitivity, specificity and overall relative accuracy have been found to be as following:

Test sensitivity:          97.3%    (95% CI: 90.0% – 99.8%)

Test specificity:         100.0%    (95% CI: 96.6% – 100%)

Relative accuracy:    98.8%    (95% CI: 91.8% – 99.9%)

Interferences
The following substances did not show any interference:
Human blood (EDTA), anti-viral drugs, antibiotics/anti-bacterial drugs, nasal sprays or nose drops, nasal corticosteroids.

Available in a package of 25 tests