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AESKU.RAPID SARS-CoV-2 Antigen Rapid Test

The CE certified 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.

aeskurapid 5 20 small

  

AESKU.RAPID SARS-CoV-2  CE certified Rapid Test (5 Tests)

AESKU.RAPID SARS-CoV-2 is a patient-specific antigen rapid test for the direct detection of SARS-CoV-2 NP antigen in human nasal swab specimens.
REF 840003: 5 individually sealed test cassettes per kit box.
REF 840003E: 5 individually sealed test cassettes per kit box. Test for self-testing.
REF 840003K: 5 individually sealed test cassettes per kit box. Test for self-testing with child-friendly packaging and instructions.
AESKU.RAPID SARS-CoV-2  CE certified Rapid Test (20 Tests)

AESKU.RAPID SARS-CoV-2 is a patient-specific antigen rapid test for the direct detection of SARS-CoV-2 NP antigen in human nasal swab specimens.
REF 840001: 20 individually sealed test cassettes per kit box.
REF 840001E: 20 individually sealed test cassettes per kit box. Test for self-testing.
AESKU.RAPID SARS-CoV-2  CE certified Rapid Test (2 Tests)

AESKU.RAPID SARS-CoV-2 is a patient-specific antigen rapid test for the direct detection of SARS-CoV-2 NP antigen in human nasal swab specimens.
REF 840005: 2 individually sealed test cassettes per kit box.
REF 840005E: 2 individually sealed test cassettes per kit box. Test for self-testing.
REF 840005K: 2 individually sealed test cassettes per kit box. Test for self-testing with child-friendly packaging and instructions.

Test Kit Components

Test Kit Components

  • Test tubes
  • Extraction buffer
  • SARS-CoV-2 antigen test cassette (individually sealed)
  • Specimen swabs
  • Instructions for use
  • Quick guide

 

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

 
Sensitivity
Specificity
AESKU.RAPID SARS-CoV-2 Rapid Test
100% Ct Value ≤ 30.0
(95% Cl 97% - 100%)
98%
(95% Cl 95% - 99%)

 

ESfEQA Evaluation Study: AESKU SARS-CoV-2 Antigen Rapid Test vs. Realtime PCR

 
 RT-PCR Positive
RT-PCR Negative
Total 
 AESKU.RAPID Positive
136
2
138
 AESKU.RAPID Negative
4
323
327
Total
140
325
465

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. The samples were tested in parallel with the RT-PCR test of a leading European manufacturer.

 

 

AESKU.RAPID SARS-CoV-2 Product Highlights

 

  • Antigen rapid test for the direct detection of SARS-CoV-2 NP antigen
  • Rapid test result after 15 minutes
  • Lateral-Flow principle based
  • Test material: minimally invasive nasal swab (2.5 cm depth)
  • Very high sensitivity: 100% Ct-Value ≤ 29.9, 93% Ct-Value ≥ 30.0
  • Very high specificity 98%
  • Detection limit of 50 TCID50/ml
  • No cross-reactivity
  • The rapid antigen test is stable for up to 18 months at 4 - 30°C
  • Test performance at room temperature (15 - 30°C)
  • Each test individually in a sealed foil pouch
  • Pack sizes:5 Tests, including consumables or 20 Tests, including consumables
  • CE certified

Literature:
Lindner AK et al., Head-to-head comparison of SARS-CoV-2 antigen-detecting rapid test with self-collected anterior nasal swab versus professional-collected nasopharyngeal swab. Eur Respir J 2020. doi: 10.1183/13993003.03961-2020
https://www.cdc.gov/coronavirus/2019-ncov/testing/self-testing.html
Rozand, C. (2013). Paper-based analytical devices for point-of-care infectious disease testing. European Journal of Clinical Microbiology & Infectious Diseases, 33(2), 147–156. doi:10.1007/s10096-013-1945-2