Table III.
EUAs for RT-PCR tests
Date EUA issued | Laboratory | Primers | Positive human gene control |
---|---|---|---|
April 24, 2020 | AIT Laboratories | ORF1ab, N, S | None |
April 24, 2020 | Ultimate Dx Laboratory | ORF1ab | β-actin |
April 23, 2020 | Southwest Regional PCR Laboratory LLC. dba MicroGen DX | N1, N2, N3 | RNaseP gene |
April 22, 2020 | Diatherix Eurofins Laboratory | S | None |
April 20, 2020 | Mayo Clinic Laboratories, Rochester, Minn | None | |
April 15, 2020 | CirrusDx Laboratories | E, N, RdRp | None |
April 15, 2020 | Hackensack University Medical Center Molecular Pathology Laboratory | N2, E | RNaseP gene |
April 14, 2020 | Exact Sciences Laboratories | E, N, RdRp | NA |
April 14, 2020 | Infectious Diseases Diagnostics Laboratory, Boston Children’s Hospital | S | None |
April 13, 2020 | Pathology/Laboratory Medicine Lab of Baptist Hospital Miami | N2 | RNase P |
April 13, 2020 | Integrity Laboratories | N1, N2 | RNase P |
April 10, 2020 | Specialty Diagnostic (SDI) Laboratories | ORF1ab | β-actin |
April 10, 2020 | Rutgers Clinical Genomics Laboratory-Rutgers University | N, S, ORF1ab | None |
April 10, 2020 | Orig3n, Inc | N1, N2, N3 | RNase P |
April 10, 2020 | University of North Carolina Medical Center | E | None |
April 8, 2020 | Stanford Health Care Clinical Virology Laboratory | E | RNase P |
April 6, 2020 | Viracor Eurofins Clinical Diagnostics | N1, N2 | None |
April 3, 2020 | Massachusetts General Hospital | N1, N2 | RNase P |
April 2, 2020 | Diagnostic Molecular Laboratory – Northwestern Medicine | N1 | RNase P |
April 2, 2020 | Infectious Disease Diagnostics Laboratory, Children’s Hospital of Philadelphia | N2 | β-actin |
March 31, 2020 | Yale New Haven Hospital, Clinical Virology Laboratory | N1, N2 | RNase P |
Tests are authorized for use in the single laboratory that developed the single authorized test and that is certified under Clinical Laboratory Improvement Amendments, to perform high-complexity tests.
E, Envelope; NA, not available; ORF, Open Reading Frame; RdRp, RNA-dependent RNA polymerase.