Statement attributable to:
Carmen L. Wiley, PhD
President, American Association for Clinical Chemistry
“We share the FDA’s goal of expanding access to critical COVID-19 testing and encourage the agency to continue using its full authority to ensure laboratories are able to increase capacity as quickly as possible to flatten the curve of the pandemic. However, the FDA’s authorization of LabCorp’s home test collection kit for COVID-19 on April 20, 2020 raises questions for scientific accuracy and public health. FDA’s authorization means consumers literally will take their health into their own hands by using swabs to collect specimens from their own nasal passages and then by returning these swabs to a laboratory for testing. We are confident in LabCorp’s ability to perform the testing of the samples once they reach their laboratories. But we are concerned that consumers will not carefully follow directions, which could lead to incorrect sample collection.
“AACC recommends that the FDA recognize the preanalytical problems with this type of home collection and consider issuing a warning about its use for COVID-19 testing. False negative test results could give false reassurance to concerned members of the public, and may soften their adherence to social distancing guidelines.”
To speak to Dr. Wiley about this issue, please contact Molly Polen, AACC Senior Director of Communications & PR, at [email protected] or 202-420-7612.
Dedicated to achieving better health through laboratory medicine, AACC brings together more than 50,000 clinical laboratory professionals, physicians, research scientists, and business leaders from around the world focused on clinical chemistry, molecular diagnostics, mass spectrometry, translational medicine, lab management, and other areas of progressing laboratory science. Since 1948, AACC has worked to advance the common interests of the field, providing programs that advance scientific collaboration, knowledge, expertise, and innovation. For more information, visit www.aacc.org.