Testing for the respiratory illness COVID-19 and the associated SARS-CoV-2 virus has gotten off to a rocky start and continues to see struggles related to the complexity of testing, availability of resources, and a need for clear communication. However, laboratories across the U.S., with our Public Health Laboratories (PHLs) taking the lead, are working diligently to collect and test for COVID-19 in a safe, accurate, and rapid manner to slow the spread of the virus.
Initial Steps: Testing at CDC Only
Initially in the U.S., laboratory testing for COVID-19 was only performed using the CDC’s 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel that is being distributed to public health labs. The CDC started sending out test kits to laboratories the first week of February, a month after China announced the outbreak; however, there were manufacturing issues causing inconclusive results during verification. Until March 2, state labs had to send their samples to the CDC. Now that states can perform their own tests, testing turnaround times are improving. In a rapidly changing scenario, as we move forward, laboratories that are properly equipped to perform biohazardous, highly complex molecular testing are working to quickly develop approved COVID-19 tests.
Fortunately, to speed up the process, the FDA decreased some regulatory roadblocks by enacting an Emergency Use Authorization (EUA) that essentially allows labs to start COVID-19 testing without going through the full FDA approval process.
Laboratories Working at a Rapid Pace
Despite shortages of supplies and workers, laboratories are rapidly working to combat the COVID-19 outbreak. Some examples of laboratories that were at the starting lines are below:
- Washington State Department of Health – capacity to test about 100 people per day; have quadrupled laboratory staff, added laboratory equipment, planning to increase testing capacity as quickly as possible
- University of Washington Department of Laboratory Medicine – began processing 100 tests a day in early March; expect to quickly expand testing capacity to more than 1,000 a day
- New York Department of Health Wadsworth Center – first state lab to begin COVID-19 testing with its own internally developed test
By March 8, 78 states and local PHLs in 50 states and the District of Columbia were successfully using COVID-19 diagnostic tests, alongside the two CDC laboratories.
Reference & Commercial Labs Joining In
Currently, Quest, LabCorp, Mayo, ARUP, and TriCore reference laboratories (with more likely to join) can test for COVID-19. Commercial and academic medical center laboratories are developing internal tests and there are now two commercial tests available from Roche and Thermo Fisher. These additional testing opportunities will allow testing to pick up speed and begin to meet the dire need.
Specific Criteria for Patient Testing
Patients who believe they need to be tested are running into a demand issue and roadblocks with receiving testing in a timely manner. Originally, testing was limited to people who traveled to China or who had been in close contact with someone known to have COVID-19. Now, anyone with a physician’s order can be tested for COVID-19, but providers must follow CDC guidelines before requesting a test. Considering clinical presentation, providers are advised by the CDC to order testing on patients who have: 1) COVID-19 signs and symptoms; 2) relevant travel and/or contact history; and 3) had other flu-like illnesses ruled out.
Drive-through Specimen Collection
Cleveland Clinic and University Hospitals (UH) are collaborating to offer drive-through COVID-19 specimen collection for their symptomatic patients who have obtained a doctor’s order via virtual visit. Patients stay in their cars as samples are collected, reducing others’ exposure. Testing takes place at UH and Cleveland Clinic laboratories with approximately a one day turnaround time.
Are Our Statistics Skewed Due to Delayed Testing?
As testing increases, expect a spike in the number of confirmed positive cases. The shortage of tests and the delay in correcting problems has caused frustration among providers and patients and the lag in identifying positive cases may have hidden the true spread of the virus. Once the demand for testing is met, we will gain a more accurate statistical picture of the effects of the COVID-19 virus.
Orchard is committed to assisting laboratories that are involved in collection and testing for COVID-19 by efficiently integrating software tools and providing customer service that promotes timely testing. As always, we intend to keep you informed and be a trusted resource you can turn to for industry-related education. Follow us on Twitter at @OrchardSoftware and feel free to respond to this post by emailing us at email@example.com.
- CDC. Coronavirus Disease 2019 (COVID-19). March 2020. Accessed at: www.cdc.gov/coronavirus/2019-nCoV/lab/index.html
- U.S. Food & Drug Administration. Emergency Use Authorizations. March 2020. Accessed at: www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
- Washington State Department of Health. March 2020. Accessed at: www.doh.wa.gov/Emergencies/NovelCoronavirusOutbreak2020/TestingforCOVID19
- Robinson, D. Coronavirus in New York: What to know about COVID-19 test priority rules, fed approval lag. Lohud. March 2020. Accessed at: www.lohud.com/story/news/health/2020/03/09/what-you-need-know-get-coronavirus-covid-19-test-new-york/5001885002/
- Barber, G. FDA Approves the First Commercial Coronavirus Tests in the US. Wired. March 2020. Accessed from: www.wired.com/story/fda-approves-the-first-commercial-coronavirus-tests-in-the-us/
- Cleveland Clinic Newsroom. University Hospitals and Cleveland Clinic Partner to Provide Drive-Through COVID-19 Testing. March 2020. Accessed at: https://newsroom.clevelandclinic.org/2020/03/13/university-hospitals-and-cleveland-clinic-partner-to-provide-drive-through-covid-19-testing/