Lack of materials needed to conduct tests gave labs a slow start
Testing the right person is a crucial aspect in any pandemic. Apart from saving lives, widespread testing can provide important data required to model the course of the outbreak. Reagents are a critical component of testing. Unfortunately, many US labs have struggled to procure the reagents needed to perform large batches of coronavirus diagnostic testing.
COVID-19 testing in the US
In the US, the CDC provides the test kits for public health laboratories (PHLs) to perform real-time RT-polymerase chain reaction (rRT-PCR) detection of the novel coronavirus. The CDC received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for use of its rRT-PCR test on February 4.
The CDC test kits are available through the International Reagent Resource (IRR), which is a special unit established by the CDC to provide registered users with reagents, tools and information for studying and detecting pathogens, such as the virus causing COVID-19. The purpose of centralizing these functions within the IRR is to ensure that use and access of the reagents is monitored and quality control assured.
The FDA specifies that clinical and commercial laboratories conducting coronavirus testing can access test reagents from commercial reagent manufacturers which have received EUA from the FDA.
Public health laboratories in the US performing the test receive the following reagents from the CDC’s International Reagent Resource (IRR):

Reagent
- Equipment and extraction kits used in the preparation of specimens, including kits from QIAGEN and Roche
- rRT-PCR test kits, which include vials of test reagents that detect the virus that causes COVID-19
- Master mix kits from Thermo Fisher that contain the enzymes and other components needed to run the PCR test
- Human specimen control
- EUA positive control
- CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel (CDC)
- New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel (Wadsworth Center, NYSDOH)
- cobas SARS-CoV-2 (Roche Molecular Systems, Inc.)
- TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, Inc.)
- Panther Fusion SARS-CoV-2 (Hologic, Inc.)
- COVID-19 RT-PCR Test (Laboratory Corporation of America)
- Lyra SARS-CoV-2 Assay (Quidel Corp.)
- Quest SARS-CoV-2 rRT-PCR (Quest Diagnostics Infectious Disease, Inc.)
- Abbott RealTime SARS-CoV-2 assay (Abbott Molecular)
- Simplexa COVID-19 Direct (DiaSorin Molecular LLC)
- ePlex SARS-CoV-2 Test (GenMark Diagnostics, Inc.)
- Primerdesign Ltd COVID-19 genesig Real-Time PCR assay (Primerdesign Ltd)
- Xpert Xpress SARS-CoV-2 test (Cepheid)