NINGBO® COVID-19 / SARS-COV-2 Antigen Rapid Test / Lollipop Test PZN: 16879141 – Bfarm: AT153/20 – BfArM Listing (reimbursable) (20 tests per box)

SARS-CoV-2 Antigen Combination Test Kit NINGBO(R) by Saliva (Bfarm: AT153/20, PZN: 16879141)

The NINGBO(R) COVID-19 / SARS-CoV-2 antigen rapid test meets two essential criteria. First, it is simple to perform. Second, it belongs to a new generation of rapid tests. This means that, unlike previous models, it can detect asymptomatic infections with (still) low viral loads. This enables their early detection and thus preventive action against emerging chains of infection.

How the test kit works

This rapid test is a lolly test. This is used to detect N/S antigen using a saliva sample. This eliminates the need for the classic nasopharyngeal swab, such as is often used in a pharmacist’s test.

The individually packaged test cassettes do not require a separate buffer solution for evaluating the saliva sample. This is because the test kit consists of only one piece and thus offers sampling and evaluation in one. By sucking, the saliva gets onto the test piece. The result is available after 15 minutes.

Due to the simple handling, the product is also suitable for carrying out multiple tests. Thus, it can be integrated into comprehensive hygiene and protection concepts of companies. In addition, there is no age restriction, which expands the application possibilities.

The product’s sensitivity is 89.2 percent, and its specificity is 100 percent. It meets the minimum criteria for antigen testing set by the German Federal Institute for Vaccines and Biomedical Products, the Paul Ehrlich Institute (PEI).

Important sales and use information

The test belongs to the list of the BfArM (Federal Institute for Drugs and Medical Devices). The product can be stored at temperatures from 4 to 30 degrees Celsius. The shelf life is 12 months. Please note the instructions for this purpose on the products.

Attention! For this product is no lay approval. According to the Medical Devices Tax Ordinance § 3 is therefore also no sale to private individuals. However, a change existing since 02.02.2021 takes into account certain companies and facilities to purchase and use antigen tests with approval. These include those that provide utility services to the general public and thus must ensure unrestricted operations. However, even in this case, the tests are not intended for use by lay persons. The handling of the testing procedures is to be based on advice from the company medical service or the employers’ liability insurance association.

The sales regulation of PSA Partner

In principle, the products available from PSA-Partner are not sold to private individuals, but exclusively to commercial persons. For antigen tests, this means sales are made to purchasers, not end users. This also applies when it comes to home tests with special approval. Therefore, a minimum order quantity also applies to the purchase of individual products. For wholesale orders, please submit a separate request. In order to handle the larger order quantities, there is permanent availability for the range. In addition, all products are certified and fairly priced.

Please note:

This offer for a Corona rapid test is intended exclusively for commercial customers (physicians, healthcare professionals, companies) with appropriate professional staff. This product is not a layman’s test that may be ordered by private individuals – the purchase of this Corona rapid test is strictly defined according to the Medical Devices Dispensing Ordinance §3.

!!! You confirm with your purchase that you are placing the order for commercial/medical purposes and you are handing over the products to appropriate qualified personnel. Therefore, each order will be carefully checked! Please understand that we unfortunately have to cancel your order if you can not provide proof that you are an authorized person according to MPAV !!!

Note for companies

As a result of an amendment to the Medical Devices Dispensing Ordinance (MPAV), as of Feb. 2, 2021, companies and facilities that provide a service to the general public, the failure or impairment of which would lead to significant supply shortages or endanger public safety, may also obtain and use rapid antigen tests for the detection of the SARS-CoV-2 coronavirus.

This means, specifically, that these companies and facilities may offer regular testing for their employees and visitors and make these tests part of their hygiene and health care services.

In concrete terms, this means that these companies and facilities can offer regular testing for their employees and visitors and make these tests part of their hygiene and protection concept, ideally with advice from the respective company medical service or the employers’ liability insurance association.

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