The International Reagent Resource (IRR) is a centralized supply unit set up by the CDC to provide registered users (labs with CLIA certification to run the tests) with reagents, tools, and information for conducting COVID-19 testing. The IRR is the ONLY way for labs to order supplies. The IRR purchases from commercial suppliers across the globe and maintains strict quality controls before distributing them for use.

The CDC provides a good FAQ here for Laboratories ordering testing supplies.

Early shortages of lab reagents

The IRR provides COVID-19 testing centers with the following supplies:

  1. Equipment and extraction kits used in the preparation of specimens, including kits from QIAGEN and Roche
  2. rRT-PCR test kits, which include vials of test reagents that detect the virus that causes COVID-19
  3. Master mix kits from Thermo Fisher that contain the enzymes and other components needed to run the PCR test
  4. Human specimen control
  5. EUA positive control

Testing in the early, critical stages of March 2020 was delayed by a shortage of the RNA extractor, which is the FIRST step to conduct a coronavirus test. The other items are useless without this critical first reagent.

What led to the shortage?

  1. In the beginning of testing in the US, the CDC had the only approved test, and private labs were not granted EUA until later. At this time, the CDC initially recommended collecting two specimen swabs, which meant greater use of the reagent than was necessary. This was changed by the CDC on March 13, 2020.
  2. Criteria for who should be tested was adjusted:
    • Initially, only those who had a fever and/or lower respiratory infection AND had traveled to Wuhan, China or been in contact with someone who had coronavirus was tested.
    • In late February, a patient was infected with no known exposure, and the CDC modified the guideline to include anyone with a fever who was hospitalized with a respiratory illness.

As you can imagine, this led to a massive increase in testing demand – which was evidenced by the news and public concern around this time.

Current status of the IRR and testing availability

As the pandemic has worn on, testing supply deployment processes by the IRR have become more mature, and many of these hurdles have been overcome. The FDA has granted EUA to many companies supplying reagents and test kits; and approved some alternative reagents and tests if those are depleted. More data than ever before is available about accuracy of testing, and turnaround times are decreasing – which is all great news for patients.

The IRR has never met a challenge as big as COVID-19 and has certainly been through trial by fire.

The IRR has never met a challenge as big as COVID-19 and has certainly been through trial by fire. Important lessons have been learned about scaling testing quickly, and one can only hope this will lead to improved future protocols.