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Confidence in COVID-19 testing results helps free us all to focus on the great things in life. PCR-based tests are designed to enable early virus detection, even in asymptomatic cases, and help deliver reliable answers.
The virus spread around the world in a few short months, and its variants continue to sweep the globe. The good news is that a robust testing program as part of an organization’s SARS-CoV-2 response can help mitigate the spread of the disease. Diagnostic testing can identify active coronavirus infection and inform proactive next steps, like quarantining, to protect the infected individual and close contacts.
As testing is critical to diagnose and contain the spread of the virus, there are multiple methodologies available to yield a coronavirus testing result. The two types of diagnostic tests discussed here are molecular lab-based PCR, which detects viral RNA, rapid PCR testing, and antigen-based testing, which detects viral proteins (the antigen). PCR and antigen testing are described more fully below to help make strategic decisions regarding community testing, planning, and implementation.
There are different types of technologies used to test for SARS-CoV-2:
“Lab-based PCR” molecular diagnostic testing uses well-established lab processes that are run in a laboratory by trained technicians.
“Rapid PCR” tests use relatively new technology that simplifies the testing process by allowing it to be performed at the site of sample collection, or point of care (POC).
Lab-based PCR tests are ideal for high-volume processing, supporting local and national-level testing such as in schools and corporations.
Rapid PCR POC tests are ideal for evaluating high-risk congregate settings such as emergency rooms, clinics, hospitals, and nursing homes.
Accuracy of a PCR test takes into account the sensitivity and specificity of how correctly the test can identify whether a sample is infected with SARS-CoV-2 viral RNA. Both lab-based and rapid PCR tests have high sensitivity and high specificity,* meaning that either test will correctly detect the presence of SARS-CoV-2 RNA in samples from patients who have COVID-19. Diagnostic PCR tests are considered the gold standard for viral detection and provide accurate results with high confidence. |
A PCR instrument is capable of running thousands of samples per day
Most lab-based PCR tests can accommodate 96 to 384 samples (including controls) simultaneously on a single test plate, which is considered high throughput.
Most rapid PCR tests can process one sample at a time, which is considered low throughput. The number of patient samples that can be run simultaneously is determined by the availability of instruments and staff at the testing site.
It can take as little as 24 hours to get results
Lab-based PCR tests are ideal for high-volume processing, supporting localand national-level testing such as in schools and corporations.
Rapid PCR POC tests are ideal for evaluating high-risk congregate settings such as emergency rooms, clinics, hospitals, and nursing homes.
It can take up to 30 minutes to report out each individual result, especially if the result is negative
For the latest guidelines, please refer to:
The CDC:
https://www.cdc.gov/coronavirus/2019-ncov/lab/testing.html
https://www.cdc.gov/coronavirus/2019-ncov/lab/resources/antigen-tests-guidelines.html
The European CDC:
https://www.ecdc.europa.eu/en/publications-data/options-use-rapid-antigen-tests-covid-19-eueea-and-uk
The World Health Organization:
https://www.who.int/publications/i/item/antigen-detection-in-the-diagnosis-of-sars-cov-2infection-using-rapid-immunoassays
The decision to include PCR and antigen technologies in a testing program depends on the unique needs of the community. Importantly, community leaders should consider the organization's tolerance of an incorrect answer and the acceptability of that risk: what are the potential downstream effects of allowing an infected individual into the community because of a false negative result? Does convenience outweigh accuracy?
A clear understanding of the testing options is the first step in designing a testing program that will help keep the community safe. PCR tests, the gold standard for SARS-CoV-2 testing, provide high accuracy and therefore high confidence in the test results. Antigen tests are convenient when only a few results are needed, which may be advantageous in the point-of-care setting.