MEDsan® SARS-Cov-2 AG Duo Home, approved corona antigen test, nasal swab in 15 min, rapid test, self-test, lay test
Product number:
T00601
Packunit:
Testset
Product information "MEDsan® SARS-Cov-2 AG Duo Home, approved corona antigen test, nasal swab in 15 min, rapid test, self-test, lay test"
The MEDsan® SARS-CoV-2 Ag Duo Home is a rapid test for the qualitative detection of the nucleocapsid antigen of SARS-CoV-2 (coronavirus) in human nasal swab specimens.
The test is intended for self-testing by persons 18 years of age and older.
Tests for persons under 18 years of age should be performed under adult supervision.
- Temporary special approval for self-testing according to §11 Abs. 1 MPG in Germany (BfArM GZ: 5640-S-167/21)
- Evaluated according to the guidelines of the RKI and the Paul Ehrlich Institute
- Easy handling (anterior nasal swab)
- Reliable result after only 15 minutes
- Only low viral load required for detection
- Infected persons can thus be detected even before they develop symptoms
- Sensitivity: 96.7% [95% CI: 91.7%, 98.7%]
- Specificity: 100% [95% CI: 99.2%, 100%]
- Limit of detection ( LoD): 14.4 TCID50/mL
- Quantity: 1 test set
Scope of delivery:
- MEDsan SARS-CoV-2 Ag Duo Home
- Includes test cassette, extraction buffer, extraction tube with dispensing cap, sample preparation swab, and instructions for use
Manufacturer's Note:
The currently circulating variants of concern (VOC) - Alpha (B.1.1.7), Beta (B1.351), Gamma (P.1), Delta (B.1.617.2) and Omicron (B.1.1.529) - have, according to current knowledge, no effect on the results of sanaGroup's in vitro diagnostics for the detection of SARS-CoV-2 or COVID-19. This applies to both the rapid tests and the Ultra PCR solutions.
Please read the instructions for use in detail before using the MEDsan® SARS-CoV-2 Ag Duo Home Rapid Test.
The test is intended for self-testing by persons 18 years of age and older.
Tests for persons under 18 years of age should be performed under adult supervision.
- Temporary special approval for self-testing according to §11 Abs. 1 MPG in Germany (BfArM GZ: 5640-S-167/21)
- Evaluated according to the guidelines of the RKI and the Paul Ehrlich Institute
- Easy handling (anterior nasal swab)
- Reliable result after only 15 minutes
- Only low viral load required for detection
- Infected persons can thus be detected even before they develop symptoms
- Sensitivity: 96.7% [95% CI: 91.7%, 98.7%]
- Specificity: 100% [95% CI: 99.2%, 100%]
- Limit of detection ( LoD): 14.4 TCID50/mL
- Quantity: 1 test set
Scope of delivery:
- MEDsan SARS-CoV-2 Ag Duo Home
- Includes test cassette, extraction buffer, extraction tube with dispensing cap, sample preparation swab, and instructions for use
Manufacturer's Note:
The currently circulating variants of concern (VOC) - Alpha (B.1.1.7), Beta (B1.351), Gamma (P.1), Delta (B.1.617.2) and Omicron (B.1.1.529) - have, according to current knowledge, no effect on the results of sanaGroup's in vitro diagnostics for the detection of SARS-CoV-2 or COVID-19. This applies to both the rapid tests and the Ultra PCR solutions.
Please read the instructions for use in detail before using the MEDsan® SARS-CoV-2 Ag Duo Home Rapid Test.
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