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Commercial Labs Step up Coronavirus Test Efforts After FDA Guidance

NEW YORK – Laboratory Corporation of America announced on Thursday that its test for the novel coronavirus is now available, becoming the first of the big national clinical labs to launch their own tests for SARS-CoV-2.

LabCorp's test, called LabCorp 2019 Novel Coronavirus (COVID-19), NAA test, became available for ordering by physicians or other authorized healthcare providers in the US as of 6:00 PM ET. It will soon be joined by Quest Diagnostics, which said on Thursday that it plans to launch its SARS-CoV-2 test on March 9 to aid in the "presumptive detection of nucleic acid in respiratory specimens of patients" who meet the US Centers for Disease Control and Prevention's criteria for testing. 

Opko Health's BioReference Laboratories also said on Thursday it expects to offer a test for SARS-CoV-2 starting next week. 

LabCorp's test is a qualitative assay that uses PCR technology and detects the presence of the SARS-CoV-2 coronavirus. It has been validated for use with respiratory samples, including nasopharyngeal (NP) or oropharyngeal (OP) aspirates or washes, NP or OP swabs, and broncheoalveolar lavage. It can be used with patients who meet current guidance for evaluation of infection with SARS-CoV-2.

LabCorp is not collecting specimens for the test. Instead, specimens should be collected at the healthcare facility where a patient who needs the test is being seen and where the test is ordered. Test results are available in three to four days.

The LabCorp 2019 Novel Coronavirus (COVID-19), NAA test, along with those that will be offered by Quest and BioReference, are being made available pursuant to US Food and Drug Administration guidance issued on Feb. 29 that allows high-complexity, CLIA-certified labs to immediately perform tests they've developed and validated for the SARS-CoV2 coronavirus while they are pursuing Emergency Use Authorization.

LabCorp said an independent review by the FDA of the validation of the test is pending, and the firm is pursuing Emergency Use Authorization for the test, joining a number of commercial firms that are developing or have developed their own test for SARS-CoV-2 and plan to pursue EUAs. Quest also said it will seek EUA for its tests. Opko did not address its plans for EUA in its announcement, but the FDA guidance issued on Feb. 29 stipulates that high-complexity commercial, academic, and government labs that develop and plan to use their SARS-CoV-2 tests must validate their tests and then notify FDA. They may then begin using the test, but must also submit a completed EUA request to the FDA within 15 days.

Burlington, North Carolina-based LabCorp added that it can also perform the CDC's real-time, real-time reverse transcriptase (RT-PCR) test if needed to meet testing demand.

Meantime, Quest said its test is a molecular-based assay that detects viral RNA in respiratory specimens. Opko did not provide details about its test. 

New York-based Enzo Biochem said Friday morning that its clinical lab is also developing a molecular COVID-19 test, which it expects to launch next week.