Aesku Rapid covid 19 self test kit

AESKU.RAPID SARS-CoV-2 Rapid Test

The AESKU.RAPID SARS-CoV-2 Rapid Test is based on immunochromatographic polymer technology combined with the sandwich principle for the qualitative detection of the nucleocapsid protein antigen in human nasal swab specimens. The specimen is placed in the test device’s specimen well with colored polymer-labeled monoclonal SARS-CoV-2 antibody 1 and mixed along the nitrocellulose membrane chromatographed. If SARS-CoV-2 antigens are present in the sample, they bind to the SARS-CoV-2 antibody 1.The mixture then binds to the immobilized SARS-CoV-2 antibody 2 on the nitrocellulose membrane. The resulting complex of antibody 1, antigen, and antibody 2 forms the colored test line. The test device’s control line is coated with secondary antibodies, which, under normal test procedure, a colored strip is drawn.

ESfEQA Evaluation Study: AESKU SARS-CoV-2 Antigen Rapid Test

Sensitivity	100% Ct -Value ≤ 30.0 (95% Cl 92% – 100%)
Specificity	98% (95% CI 95% – 99%)

RT-PCR

The samples were tested in parallel with the RT-PCR test of a leading European manufacturer.
Positive test results confirm the presence of viral antigens
Negative test results do not completely rule out COVID-19
However, a clinical history of the patient is still necessary to determine the infection status

Positive	Negative	Total
101	4	105
4	218	222
105	222	327