Roche SARS-CoV-2 / Covid-19 Nasal Antigen Test Approval Private Use / Self-administration by Lay Persons – File Number Special Approval 5640-S-025/21 – BfArM Listing (reimbursable) (25 tests per box)

rapid test with nasal sampling – lien approval granted

because of large demand order now

product details

• *Orders accepted*
• Reliable, rapid chromatographic immunoassay for the qualitative detection of a specific SARS-CoV-2 antigen in human nasopharynx.
• For detection of acute SARS-CoV-2 infection
• To be performed with nasopharyngeal swabs
• Listed with the BfArM
• Specificity: > 99.68 %
• Sensitivity: 96.52 %
• ct value: 20 – 30
• 1 pack of 25 rapid antigen tests

Please note that Roche SARS-CoV-2 antigen rapid test is excluded from the right of return!

Product details:

• Roche SARS-CoV-2 Antigen Test
• Allows rapid identification of SARS-CoV-2 infected individuals
• On the list of the BfArM (Federal Institute for Drugs and Medical Devices)
• Evaluated by the Paul Ehrlich Institute PEI
• Ideal for implementation at the point-of-car
• Simplified test performance with fewer steps
• Very well suited for screening SARS-CoV-2 contacts
• For qualitative detection of SARS-CoV-2 antigens
• Sample material: nasopharyngeal swabs
• Very high sensitivity: 96.52% and specificity: 99.68%
• Fast test results within approximately 15 minutes (reading time: 15 – 30 minutes)
• Extremely easy test performance
• Storage at room temperature: 2 – 30°C
• Included in the scope of delivery are all materials required for test performance (except for a timer)
• 25 tests incl. consumables
• For use by medical professionals or with additional kid as a layman application!
• Excluded from the right of return

Roche SARS-CoV-2 / Covid-19 Nasal Antigen Test (25 tests per box) – lay approval granted

Roche’s SARS-CoV-2 antigen test is a rapid immunochromatographic test for the qualitative detection of Covid-19 infection in the nasopharynx. Thanks to an additional kit, it is also suitable as a rapid test for laypersons – a corresponding special approval by the BfArM is available. This makes Roche’s antigen test one of the first Covid 19 tests for laypersons that may be offered in Germany in the future as a pharmacist’s test or freely in stores.

Properties of the Roche SARS-CoV-2 Antigen Test

The Roche rapid test detects specific proteins (antigens) of the coronavirus in human nasal swabs. Acutely infected individuals are thus detected quickly and reliably. With a sensitivity of 96.52% (according to the manufacturer), the test is very reliable. This also applies to the currently known virus mutations. The specificity is 99.68 %, false positive results are therefore extremely unlikely.

There are two options for sample collection: In the “professional version,” the swab is taken from the posterior nasopharynx. This conventional test method should only be performed by healthcare professionals. In addition, the Roche antigen test now includes an add-on kit with swabs for swabbing the anterior nasal region. This test method is less invasive and can be performed independently by lay persons. In addition, the gentle sampling in the anterior nasal region is also a great relief for sensitive groups of people such as children or people with handicaps.

The Roche antigen test requires only a few steps and is very easy to use; the result is available within 15 minutes. This allows larger groups of people to be tested quickly and efficiently directly at the point-of-care. Because of its high reliability, the test is also suitable for screening contacts who may have contracted SARS-CoV-2.

New: Special approval as a lay test

The Roche SARS-CoV-2 Nasal Antigen Test has been evaluated by the renowned Paul Ehrlich Institute (PEI), has a valid CE certificate, and is on the list of the BfArM (Federal Institute for Drugs and Medical Devices). For the “layman version”, the BfArM has recently granted a special approval. The layman-approved test version additionally contains swabs for sampling the anterior nasal region as well as detailed, layman-friendly instructions for use.

Product details and scope of delivery

The test kit from Roche contains all necessary materials and reagents in ready-to-use form. There are 25 tests included per box. The scope of delivery includes:

• 25 test strips
• 25 dispenser caps
• 25 containers of extraction buffer solution
• 25 sterile swabs for nasopharyngeal swab
• Covering foil for test strips (recommended for outdoor use)
• Detailed instructions for use
• Short instructions
• Additional kit tests for laymen: swab for swabbing the anterior nasal cavity, layman-friendly instructions for use

How to handle and store

The test materials can be stored unrefrigerated at room temperature (2-30 °C). However, please note that the reagents and the test cassette should assume room temperature (15-30 °C) before performing the test! The result could otherwise be falsified. Detailed instructions for sample collection, test performance and evaluation can be found in the enclosed instructions for use.

Buy Covid-19 tests with lay approval wholesale

Covid-19 tests for home use are considered particularly low-threshold and therefore have great market potential. Currently, the demand for tests with approval for laypersons is very high. At PSA-Partner, we have a broad partner network and can therefore procure even larger quantities quickly and reliably. Please contact us if you have any specific questions or would like further advice!

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