The U.S. Food and Drug Administration (FDA) previously permitted use of LabCorp COVID-19 RT-PCR tests only under limited conditions. These included a health provider having reason to suspect the subject person had the COVID-19 disease. And the laboratory running the test in isolation without sample pooling. However, on July 24, 2020 the FDA gave permission for diagnostic tests for people without symptoms.
More Upgrades to the Diagnostic Test for People without Symptoms
The LabCorp COVID-19 RT-PCR test still requires a medical prescription. However, the reissued license expands to allow diagnostic tests for asymptomatic people – those without symptoms – under these circumstances.
1… The subject person is not displaying any COVID-19 symptoms
2… The subject person has no reason to suspect COVID-19 infection
Moreover, as many as five individual samples, that healthcare professionals have taken, may pool and sample together. Sample pooling is a procedure allowing testing of several people simultaneously. If this ‘pool’ turns out positive, then each sample passes through a second test to identify the positive one(s).
The Benefits of These Changes by Food and Drug Administration
The revised method requires fewer laboratory tests overall, and ensures uninfected people get their clear results sooner. The FDA introduced the change after LabCorp COVID-19 proved its RT-PCR test detected SARS-CoV-2 in a general, asymptomatic population. Diagnostic tests for people without symptoms may enable reopening of workplaces and schools sooner, says FDA Commissioner Stephen M. Hahn.
Administration of LabCorp tests at home is still only permissible using Lab-Corp-authorized kits. Unless, that is a health provider takes the samples in which case these may pool for laboratory purposes. The core takeaways are a healthcare provider no longer needs consider exposure or community spread. And controlled tests may be pooled for faster processing.
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Preview Image: COVID-19 Laboratory Test Kit
