SARS-CoV-2 Laboratory Diagnostic Test Timeline
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Friday, January 24: Full genome sequence of 2019-nCoV identified in U.S.
made publicly available on NCBI/Genbank.
Friday, January 24
o CDC publicly posted its assay for 2019-nCoV reverse transcriptase realtime PCR (RT-PCR). This allows the global community to develop their own
assays using the CDC design.
o CDC announced it is putting the test into a kit format for eventual
distribution through the International Reagent Resource (IRR).
Sunday, February 2: CDC completes EUA package for submission to FDA. 400
test kits (200 EUA kits for domestic use and 200 RUO kits for international use)
shipped to American Type Culture Collection (ATCC) for distribution through
International Reagent Resource (IRR).
Monday, February 3: CDC submitted an EUA package to FDA in order to
expedite FDA-permitted use of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic
Panel in the U.S.
Tuesday, February 4: FDA issued EUA to enable emergency use of the CDC
2019-nCoV Real-Time RT-PCR Diagnostic Panel.
Tuesday, February 4: CDC shipped the viral isolate to BEI for distribution.
Tuesday, February 4: CDC and FDA post Instructions for Use for Real-Time RTPCR Panel for Detection of 2019-Novel Coronavirus.
Thursday and Friday, February 6 and 7: 90 test kits were shipped from IRR
to qualified laboratories including 50 US state laboratories, DC and DoD as well
as repatriation sites and funneling sites.
Saturday, February 8: CDC became aware of issues with assay kits reported
by a number of laboratories when trying to validate the test as part of
preparation for testing clinical samples. Specifically, some laboratories found
sporadic reactivity in the negative control. This sporadic activity resulted in an
inconclusive test result.
Friday, February 14: CDC completed testing of 1,776 specimens from
approximately 757 persons for SARS-CoV-19.
Tuesday, February 18: CDC stood up new surge laboratory to support testing
for COVID-19; throughput expanded to 350 samples/day.
Thursday, February 20: CDC completed contracts with 2 large commercial
manufacturers to ensure reagent availability for the public health laboratories.
Wednesday, February 26: CDC, in conjunction with FDA, determined how to
move forward and shared this information immediately with public health labs
through APHL:
o CDC is remanufacturing the test kits to ensure that laboratories have
effective and reliable kits. The new kits will only include the two
components (e.g., reagents) that are specific to novel coronavirus.
o In the meantime, before new test kits are available:
 States that were able to validate all three assays should continue to
test in this manner.
 States that were able to validate the other two assays (N1 and N2)
can test using these two assays. We anticipate this will increase
testing capacity to about 40 state and local health departments.

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FDA granted CDC “enforcement discretion,” which means that testing in
this manner can move forward while an updated EUA is officially
completed.
CDC distributed updated instructions for use through APHL.

Thursday, February 27: CDC distributed new test kits to 7 laboratories to
serve as evaluation sites to ensure these health departments are able to verify
the assay; the sites will be required to provide feedback to us within 24 hours to
ensure that the test works as intended. An additional 40 test kits were hand
carried to IRR for repackaging and distribution to additional public health labs.
Friday, February 28: IRR will begin to distribute new test kits to an additional
40 laboratories.

Saturday, February 29: 31 public-health labs now up and running with CDC
assay. 10 additional laboratories are verifying the assay. By end of the first week of
March, 2020, CDC estimates that the public health system will be able to test up to
75,000 people.