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FDA COVID-19
Test Kits
Companies Marketing Coronavirus (COVID-19) Diagnostic or Antibody Test Kits

The U.S. Food and Drug Administration (FDA) has authorized several diagnostic COVID-19 tests for use with at-home collection of samples from the nose or saliva, that can then be sent to a lab for processing and reporting.

Antibody tests, also called serological tests, detect antibodies to SARS-CoV-2 (originally called 2019 Novel Coronavirus or 2019 nCoV), which can help identify individuals who have developed an adaptive immune response to the virus, as part of either an active infection or a prior infection.

In vitro diagnostic (IVD) devices are tests performed on samples taken from the human body, such as swabs of mucus from inside the nose or back of the throat, or blood taken from a vein or fingerstick. IVDs can detect diseases or other conditions and can be used to monitor a person’s overall health to help cure, treat, or prevent diseases. There are several types of SARS-CoV-2 and COVID-19 related IVDs:

  • Diagnostic Tests: detect parts of the SARS-CoV-2 virus and can be used to diagnose infection with the SARS-CoV-2 virus. These include molecular tests and antigen tests
  • Serology or Antibody Tests: detect antibodies (IgM, IgG) to the SARS-CoV-2 virus. They cannot be used to diagnose a current infection
  • Tests for Management of COVID-19 Patients: beyond tests that diagnose or detect SARS-CoV-2 virus or antibodies, there are also tests that are authorized for use in the management of patients with COVID-19, such as to detect biomarkers related to inflammation. Once patients are diagnosed with COVID-19 disease, these additional tests can be used to inform patient management decisions

The assays are intended for use by qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic products. They are only for use under the Food and Drug Administration’s Emergency Use Authorization (EUA) .

Emergency Use Authorization (EUA)

These EUAs are issued for each individual test with certain conditions of authorization required of the manufacturer and authorized laboratories. An EUA is revoked, when FDA determines that it is not reasonable to believe the product may be effective in diagnosing infection or detecting antibodies against SARS-CoV-2, or that the known and potential benefits of the device when used for this purpose outweigh its known and potential risks. Therefore, false test results could justify revocation to protect the public health or safety.

Manufacturers and authorized distributor(s) will collect information on the performance of the products, and report to FDA any suspected occurrence of false positive and false negative results and significant deviations from the established performance characteristics of the product of which they become aware.

Products must comply with the following labeling requirements under FDA regulations: the intended use statement, adequate, directions for use, any appropriate limitations on the use, and any available information regarding performance of the device.

  • Diagnostic or Antibody Test Kits have not been FDA cleared or approved
  • They are authorized for use by Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified laboratories
  • Tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19, unless the authorization is terminated or revoked sooner.

Current good manufacturing practice (GMP) requirements, including the quality system with respect to the design, manufacture, packaging, labeling, storage, and distribution of these products, are usually waived.

Manufacturer and TestStatusUse
Agena Bioscience SA | MassArray RS-CoV-2 PanelFDA AuthorizedH
American BioSources Inc DBA Genomic Diagnostics | GDx GrandPerformance SARS-CoV-2 Detection KitNot FDA AuthorizedH
AMSBIO Inc | A+CheQ COVID-19 High-Speed RT-qPCR Detection KitNot FDA AuthorizedH
Baebies Inc | FINDER SARS-CoV-2 Test (used with FINDER 1.5 instrument)Not FDA AuthorizedH
BD BioGx | SARS-CoV-2 Reagents for BD MAX SystemFDA AuthorizedH, M
BGI Genomics Co LtdFDA AuthorizedH
Bio Vision LLC | Bio Vision SARS-CoV-2 Rapid Molecular TestNot FDA AuthorizedH
Biocartis NV | Idylla™ SARS-CoV-2 TestNot FDA AuthorizedH
BioGenex Laboratories Inc | BGX COVID-19 RT-PCRNot FDA AuthorizedH
BioGX Inc | Xfree COVID-19 Direct RT-PCRFDA AuthorizedH
Biomeme Inc | Biomeme SARS-CoV-2 test kitFDA AuthorizedH
BIONEER Corporation | AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR KitNot FDA AuthorizedH
Biopoa Co Ltd | Rapid COVID-19 PoaCheckNot FDA AuthorizedH
Biotrack BV | Escher BT-MED® COV19 TestNot FDA AuthorizedH
BioZentech Co Ltd | BZ QPCR COVID-19 KitNot FDA AuthorizedH
Chai Inc | COVID-19 Saliva Dx Test KitNot FDA AuthorizedH
ChromaCode Inc | HDPCR SARS-CoV-2 AssayFDA AuthorizedH
Clinomics USA Inc | TrioDx RT-PCR COVID-19 TestFDA AuthorizedH
Co-Diagnostics Inc |FDA AuthorizedH
Delphine Diagnostics Inc | Delphine PrecisQT™ COVID-19 Test KitNot FDA AuthorizedH
Detectachem Inc | MD-Bio BCC19FDA AuthorizedH
DiaSorin Inc | LIAISON SARS-CoV-2 AgFDA AuthorizedH
DowGene Co Ltd | Dow QuickFinderTM 2019-nCov Real-Time PCR KitNot FDA AuthorizedH
ELITechGroup MDx LLC | SARS-CoV-2 ELITe MGB AssayNot FDA AuthorizedH
Ender Diagnostics Ag | Ender LAB COVID-19 isothermal PCR detection kitNot FDA AuthorizedH
Enzo Life Sciences Inc | Enzo AMPIPROBE® SARS-CoV-2 Test SystemFDA AuthorizedH
Eryigit Medical Devices | Sentebiolab Senteligo SARS CoV-2 (COVID-19) Multiplex qPCR Detection KitNot FDA AuthorizedH
Fluidigm Corporation | Advanta Dx SARS-CoV-2 RT-PCR AssayFDA AuthorizedH
Gencurix Inc | GenePro SARS-CoV-2 TestFDA AuthorizedH
Genedrive Diagnostics Ltd | Genedrive ®96 SARS-CoV2 kitNot FDA AuthorizedH
GeneOne Diagnostics Corporation | COVID-19 Nucleic Acid Diagnostic KitNot FDA AuthorizedH
General Biologicals Corporation | GB SARS-CoV-2 Real-Time RT-PCRNot FDA AuthorizedH
GeneReach Biotechnology Corporation | POCKIT Central SARS-CoV-2Not FDA AuthorizedH
Genetic Signatures Limited | EasyScreen™ SARS-CoV-2 Detection Kit (RP011 and RP012)Not FDA AuthorizedH
GenMark Diagnostics Inc | ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel)FDA AuthorizedH, M
Genomictree Inc | AccuraDTect SARS-CoV-2-qPCR KitNot FDA AuthorizedH
Genrui Biotech Inc | Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR)Not FDA AuthorizedH
Gerbion GmbH & Co. KG | Gerbion virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0Not FDA AuthorizedH
GK Pharmaceuticals Contract Manufacturing Operations | ACCU-RIGHT SARS-COV-2 RT-PCR KITFDA AuthorizedH
GreenRoads Diagnostics LLC | GreenRoads Dx SARS-CoV-2™ TestNot FDA AuthorizedH
Grifols Diagnostic Solutions Inc | Procleix SARS-CoV-2 AssayFDA AuthorizedH
GUANGDONG ARDENT BIOMED Co Ltd | Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (PCR-fluorescent Probe)Not FDA AuthorizedH
Hologic Aptima | SARS-CoV-2 Assay Pooled Samples WorkflowFDA AuthorizedH
Hologic Panther Fusion | SARS-CoV-2 Assay Pooled Samples WorkflowFDA AuthorizedH
Hologic Inc | Aptima SARS-CoV-2 assayFDA AuthorizedH
iCubate Inc | iC-COVID-19 AssayNot FDA AuthorizedH
Illucidx Inc | Illucidx COVID-19 Dx RT-LAMPNot FDA AuthorizedH
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ | RevoDx SARS-CoV-2 qPCR Kit v2.2Not FDA AuthorizedH
Jiangsu Code Biomedical Technology Co Ltd | CodeCheckSARS-CoV-2 RT-PCR KitNot FDA AuthorizedH
LabGenomics Co Ltd | LabGun™ COVID-19 Assay kitFDA AuthorizedH
LG CHEM Ltd | AdvanSure™ One-Stop COVID-19 KitNot FDA AuthorizedH
LGC Biosearch Technologies | SARS-CoV-2 Real-Time and End-Point RT-PCR TestFDA AuthorizedH
LMSI LLC d/b/a Lighthouse Lab Services | CovidNow SARS-CoV-2 Assay KitNot FDA AuthorizedH
LMSI LLC d/b/a Lighthouse Lab Services | SalivaNow SARS-CoV-2 Assay KitNot FDA AuthorizedH
LuminUltra Technologies Ltd | GeneCount® COVID-19 RT-qPCR Assay KitNot FDA AuthorizedH
Merlin Biomedical (Xiamen) Co Ltd | Novel Coronavirus (COVID-19) RT-PCR KitNot FDA AuthorizedH
MiCo BioMed Co Ltd | Veri-Q COVID-19 Multiplex Detection KitNot FDA AuthorizedH
MiRXES Pte Ltd | MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR TestNot FDA AuthorizedH
Nanjing Liming Bio-Products Co Ltd | StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR KitNot FDA AuthorizedH
OPTOLANE Technologies Inc | Kaira 2019-nCoV Detection KitFDA AuthorizedH
Ortho Clinical Diagnostics VITROS Immunodiagnostic Products | SARS-CoV-2 Ag Assay (Reagent Pack / Calibrators)FDA AuthorizedH, M
OSANG Healthcare Co Ltd | GeneFinder COVID-19 Plus RealAmp KitFDA AuthorizedH
ProteomeTech Inc | GENEdania COVID-19 qRT-PCRNot FDA AuthorizedH
QIAGEN GmbH | artus® SARS-CoV-2 Prep&Amp UM KitNot FDA AuthorizedH
QIAGEN QIAstat-Dx Respiratory | SARS-CoV-2 Panel AssayFDA AuthorizedH, M
Roche Molecular Systems Pooling Sample Workflow for the cobas® SARS-CoV-2 for use on the cobas® 6800/8800 SystemsFDA AuthorizedH, M
RTA Laboratuvarlari Biyolojik Urunler Ilac ve Makine San. Tic. A.S | Diagnovital SARS-CoV-2 MultiplexNot FDA AuthorizedH
RTA Labs DIAGNOVITAL | SARS-CoV-2FDA AuthorizedH
Sacace Biotechnologies srl | SARS-CoV-2 Real-TMNot FDA AuthorizedH
Sanigen Co Ltd | Genelix™ COVID-19 Real-Time PCR KitNot FDA AuthorizedH
Shimadzu Corporation | 2019 Novel Coronavirus Detection KitNot FDA AuthorizedH
SML GENETREE Co Ltd | Ezplex SARS-CoV-2 G KitFDA AuthorizedH
Solgent Co Ltd | COVID-19 DiaplexQ Diagnostic KitFDA AuthorizedH
Suzhou PreciGenome Ltd Co | Fastplex Triplex SARS-CoV-2 Detection Kit (RT-PCR)Not FDA AuthorizedH
T2Biosystems Inc | T2SARS-CoV-2 PanelFDA AuthorizedH
Taigen Bioscience Corporation | LabTurbo AIO COVID-19 RNA Testing kitNot FDA AuthorizedH
TCM Bioscience | TCM-Q Corona III testNot FDA AuthorizedH
Tetracore Inc | EZ-SARS-CoV-2 Real-Time RT-PCRNot FDA AuthorizedH
Thermo Fisher Scientific Inc ( Life Technologies) | TaqPath™ COVID-19 RNase P Combo Kit 2.0Not FDA AuthorizedH
Thermo Fisher Scientific | TaqPath™ COVID 19 High Throughput Combo Kit (also called “The Amplitude™ Solution with the TaqPath™ COVID 19 High Throughput Combo Kit”)FDA AuthorizedH
Todos Medical USA Inc | TODOS 2019-nCoV RT-qPCR Detection KitNot FDA AuthorizedH
UStar Biotechnologies (Hangzhou) Ltd | EasyNAT® Diagnostic Kit for Novel-Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay)Not FDA AuthorizedH
Vela Operations Singapore Pte Ltd | ViroKey SARS-CoV-2 RT-PCR Test v2.0FDA AuthorizedH
VelaDx ViroKey™ SARS-CoV-2 RT-PCR TestFDA AuthorizedH
YD Diagnostics Corp | MolecuTech Real-Time COVID-19Not FDA AuthorizedH
ZhuHai Sinochips Bioscience Co Ltd | COVID-19 Real-time PCR Test KitFDA AuthorizedH

Settings for use include the following:

  • H – Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
  • M – Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate complexity tests.
  • W – Patient care settings operating under a CLIA Certificate of Waiver.
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