CAP elucidated its position on serology testing in a statement from President Dr. Patrick Godbey. Antibody tests have been drawing scrutiny with the entry of a large number of tests that had not been reviewed by the U.S. Food and Drug Administration (FDA). Questions have arisen about quality and validation. The agency recently revised its policies to provide more oversight over antibody tests.
CAP's statement noted that the accuracy of available antibody assays and the clinical significance of positive results are unclear.
"It is important for clinical laboratories to understand and communicate to providers that SARS-CoV-2 serology tests should not replace nucleic acid amplification tests for diagnosis of acute infection," Godbey stated.
Furthermore, antigen tests are now becoming available, but performance has not been studied yet, he noted.
"Often, direct antigen assays have lower sensitivity than nucleic acid amplification tests," Godbey said.
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