NEW YORK – Roche has inked a deal with the German government allowing the order of up to 10.5 million SARS-CoV-2 Rapid Antigen Nasal Tests by German states for self-testing that will be delivered starting Wednesday.
Under the agreement, German states were able to order a specific number of self-tests determined by their population sizes up until midday Tuesday. The tests could be ordered directly from Roche via the federal government's starter package, a Roche spokesperson said.
Roche said it will start delivering the tests on Wednesday. The company confirmed German news reports saying each test costs €4.50 ($5.36) not including value-added tax but including shipping. For orders of 1 million tests or more, it costs €4.
Roche's antigen test received special approval for at-home self-testing with a nasal swab from the German Federal Institute for Drugs and Medical Devices and CE marking last month. The rapid chromatographic immunoassay returns results in 15 minutes and will be available at German pharmacies without a prescription.
The test was developed in partnership with Korean diagnostic company SD Biosensor and qualitatively detects the nucleocapsid protein of SARS-CoV-2. A self-testing clinical study showed the assay had a sensitivity of nearly 83 percent and a specificity of 100 percent when compared to RT-PCR testing, and sensitivity for samples with a high viral load was 91 percent.