RE: Germans waiting for a Affidx home test5 Jul 2021 21:36
Description of the procurement:
Framework agreement for the delivery of 550,000 COVID-19 rapid lay tests with the following characteristics:
Evaluated by the Paul Ehrlich Institute
- BfArM listed with proven CE certification (appropriate evidence must be attached),
- The test must be listed at the RKI,
- Clinical sensitivity:> 96.00%,
- Specificity:> 99.00%,
- For the front nasal area *,
- test tube contains buffer solution,
- Results in 15 to 30 minutes,
- Results are easy to read,
- storage at room temperature,
- Sample material: Anterio Nasal, anterior nasal area.
Included:
- 1x test cassette,
- 1x swab (fine plastic brush),
- 1x vial with extraction solution and dropper cap,
- 1x waste bag,
- 1x Instructions for Use Private Use.
Contents of a package: 1 COVID-19 antigen test cassette, 1 virus sample swab, 1 buffer vial à 3 ml, 1 sample bag, 1 instruction sheet DE.
This is an anterio-nasal self-test - the smear is taken in the anterior nasal cavity. The test is used for the qualitative in vitro determination of SARS-CoV-2 antigen in the human anterior nasal segment. It's not a spit test. Carrying out the corona antigen self-test is particularly easy and therefore predestined for personal use. All test materials required for this are included in the scope of delivery. A laboratory and other utensils are not required, which is why the test is also ideal for use at the so-called point-of-care. Store the test set at 4 to 30 degrees Celsius.
Shelf life at least 12 months or longer.
No cross-reactivity and interference with parainfluenza and influenza A and B viruses.