> The test kit has not been FDA cleared or approved, however distribution and use of the test kits follows the U.S. Food and Drug Administration (FDA) February 4, 2020, issuance of an Emergency Use Authorization (EUA). The tests are being shipped through the International Reagent Resource (IRR), a CDC-established mechanism that distributes laboratory reagents domestically and globally.
> Is this purely a regulatory bottleneck?
That seems likely. It needs to be shipped through a particular resource, under particular constraints that lie outside the norm:
> The CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel was developed for qualified domestic public health laboratories to detect SARS-CoV-2. The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on February 4, 2020, to enable emergency use of the test kit in the United States. CDC has produced EUA and Research Use Only (RUO) test kits that are now available to order by domestic and international public health partners through IRR.
> Is this purely a regulatory bottleneck?
That seems likely. It needs to be shipped through a particular resource, under particular constraints that lie outside the norm:
> The CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel was developed for qualified domestic public health laboratories to detect SARS-CoV-2. The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on February 4, 2020, to enable emergency use of the test kit in the United States. CDC has produced EUA and Research Use Only (RUO) test kits that are now available to order by domestic and international public health partners through IRR.