ITB HOLDINGS LLC | 390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
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 Test Status Use
Agena Bioscience SA | MassArray RS-CoV-2 Panel FDA Authorized H
American BioSources Inc DBA Genomic Diagnostics | GDx GrandPerformance SARS-CoV-2 Detection Kit Not FDA Authorized H
AMSBIO Inc | A+CheQ COVID-19 High-Speed RT-qPCR Detection Kit Not FDA Authorized H
Baebies Inc | FINDER SARS-CoV-2 Test (used with FINDER 1.5 instrument) Not FDA Authorized H
BD BioGx | SARS-CoV-2 Reagents for BD MAX System FDA Authorized H, M
BGI Genomics Co Ltd FDA Authorized H
Bio Vision LLC | Bio Vision SARS-CoV-2 Rapid Molecular Test Not FDA Authorized H
Biocartis NV | Idylla™ SARS-CoV-2 Test Not FDA Authorized H
BioGenex Laboratories Inc | BGX COVID-19 RT-PCR Not FDA Authorized H
BioGX Inc | Xfree COVID-19 Direct RT-PCR FDA Authorized H
Biomeme Inc | Biomeme SARS-CoV-2 test kit FDA Authorized H
BIONEER Corporation | AccuPower SARS-CoV-2 Multiplex Real-Time RT-PCR Kit Not FDA Authorized H
Biopoa Co Ltd | Rapid COVID-19 PoaCheck Not FDA Authorized H
Biotrack BV | Escher BT-MED® COV19 Test Not FDA Authorized H
BioZentech Co Ltd | BZ QPCR COVID-19 Kit Not FDA Authorized H
Chai Inc | COVID-19 Saliva Dx Test Kit Not FDA Authorized H
ChromaCode Inc | HDPCR SARS-CoV-2 Assay FDA Authorized H
Clinomics USA Inc | TrioDx RT-PCR COVID-19 Test FDA Authorized H
Co-Diagnostics Inc | FDA Authorized H
Delphine Diagnostics Inc | Delphine PrecisQT™ COVID-19 Test Kit Not FDA Authorized H
Detectachem Inc | MD-Bio BCC19 FDA Authorized H
DiaSorin Inc | LIAISON SARS-CoV-2 Ag FDA Authorized H
DowGene Co Ltd | Dow QuickFinderTM 2019-nCov Real-Time PCR Kit Not FDA Authorized H
ELITechGroup MDx LLC | SARS-CoV-2 ELITe MGB Assay Not FDA Authorized H
Ender Diagnostics Ag | Ender LAB COVID-19 isothermal PCR detection kit Not FDA Authorized H
Enzo Life Sciences Inc | Enzo AMPIPROBE® SARS-CoV-2 Test System FDA Authorized H
Eryigit Medical Devices | Sentebiolab Senteligo SARS CoV-2 (COVID-19) Multiplex qPCR Detection Kit Not FDA Authorized H
Fluidigm Corporation | Advanta Dx SARS-CoV-2 RT-PCR Assay FDA Authorized H
Gencurix Inc | GenePro SARS-CoV-2 Test FDA Authorized H
Genedrive Diagnostics Ltd | Genedrive ®96 SARS-CoV2 kit Not FDA Authorized H
GeneOne Diagnostics Corporation | COVID-19 Nucleic Acid Diagnostic Kit Not FDA Authorized H
General Biologicals Corporation | GB SARS-CoV-2 Real-Time RT-PCR Not FDA Authorized H
GeneReach Biotechnology Corporation | POCKIT Central SARS-CoV-2 Not FDA Authorized H
Genetic Signatures Limited | EasyScreen™ SARS-CoV-2 Detection Kit (RP011 and RP012) Not FDA Authorized H
GenMark Diagnostics Inc | ePlex Respiratory Pathogen Panel 2 (ePlex RP2 Panel) FDA Authorized H, M
Genomictree Inc | AccuraDTect SARS-CoV-2-qPCR Kit Not FDA Authorized H
Genrui Biotech Inc | Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (RT-PCR) Not FDA Authorized H
Gerbion GmbH & Co. KG | Gerbion virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0 Not FDA Authorized H
GK Pharmaceuticals Contract Manufacturing Operations | ACCU-RIGHT SARS-COV-2 RT-PCR KIT FDA Authorized H
GreenRoads Diagnostics LLC | GreenRoads Dx SARS-CoV-2™ Test Not FDA Authorized H
Grifols Diagnostic Solutions Inc | Procleix SARS-CoV-2 Assay FDA Authorized H
GUANGDONG ARDENT BIOMED Co Ltd | Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (PCR-fluorescent Probe) Not FDA Authorized H
Hologic Aptima | SARS-CoV-2 Assay Pooled Samples Workflow FDA Authorized H
Hologic Panther Fusion | SARS-CoV-2 Assay Pooled Samples Workflow FDA Authorized H
Hologic Inc | Aptima SARS-CoV-2 assay FDA Authorized H
iCubate Inc | iC-COVID-19 Assay Not FDA Authorized H
Illucidx Inc | Illucidx COVID-19 Dx RT-LAMP Not FDA Authorized H
İDİL BİOTECH ARAŞTIRMA SAN. VE TİC. LTD. ŞTİ | RevoDx SARS-CoV-2 qPCR Kit v2.2 Not FDA Authorized H
Jiangsu Code Biomedical Technology Co Ltd | CodeCheckSARS-CoV-2 RT-PCR Kit Not FDA Authorized H
LabGenomics Co Ltd | LabGun™ COVID-19 Assay kit FDA Authorized H
LG CHEM Ltd | AdvanSure™ One-Stop COVID-19 Kit Not FDA Authorized H
LGC Biosearch Technologies | SARS-CoV-2 Real-Time and End-Point RT-PCR Test FDA Authorized H
LMSI LLC d/b/a Lighthouse Lab Services | CovidNow SARS-CoV-2 Assay Kit Not FDA Authorized H
LMSI LLC d/b/a Lighthouse Lab Services | SalivaNow SARS-CoV-2 Assay Kit Not FDA Authorized H
LuminUltra Technologies Ltd | GeneCount® COVID-19 RT-qPCR Assay Kit Not FDA Authorized H
Merlin Biomedical (Xiamen) Co Ltd | Novel Coronavirus (COVID-19) RT-PCR Kit Not FDA Authorized H
MiCo BioMed Co Ltd | Veri-Q COVID-19 Multiplex Detection Kit Not FDA Authorized H
MiRXES Pte Ltd | MiRXES Fortitude Kit 3.0 COVID-19 RT-PCR Test Not FDA Authorized H
Nanjing Liming Bio-Products Co Ltd | StrongStep® Novel Coronavirus (SARS-CoV-2) Multiplex Real-Time PCR Kit Not FDA Authorized H
OPTOLANE Technologies Inc | Kaira 2019-nCoV Detection Kit FDA Authorized H
Ortho Clinical Diagnostics VITROS Immunodiagnostic Products | SARS-CoV-2 Ag Assay (Reagent Pack / Calibrators) FDA Authorized H, M
OSANG Healthcare Co Ltd | GeneFinder COVID-19 Plus RealAmp Kit FDA Authorized H
ProteomeTech Inc | GENEdania COVID-19 qRT-PCR Not FDA Authorized H
QIAGEN GmbH | artus® SARS-CoV-2 Prep&Amp UM Kit Not FDA Authorized H
QIAGEN QIAstat-Dx Respiratory | SARS-CoV-2 Panel Assay FDA Authorized H, M
Roche Molecular Systems Pooling Sample Workflow for the cobas® SARS-CoV-2 for use on the cobas® 6800/8800 Systems FDA Authorized H, M
RTA Laboratuvarlari Biyolojik Urunler Ilac ve Makine San. Tic. A.S | Diagnovital SARS-CoV-2 Multiplex Not FDA Authorized H
RTA Labs DIAGNOVITAL | SARS-CoV-2 FDA Authorized H
Sacace Biotechnologies srl | SARS-CoV-2 Real-TM Not FDA Authorized H
Sanigen Co Ltd | Genelix™ COVID-19 Real-Time PCR Kit Not FDA Authorized H
Shimadzu Corporation | 2019 Novel Coronavirus Detection Kit Not FDA Authorized H
SML GENETREE Co Ltd | Ezplex SARS-CoV-2 G Kit FDA Authorized H
Solgent Co Ltd | COVID-19 DiaplexQ Diagnostic Kit FDA Authorized H
Suzhou PreciGenome Ltd Co | Fastplex Triplex SARS-CoV-2 Detection Kit (RT-PCR) Not FDA Authorized H
T2Biosystems Inc | T2SARS-CoV-2 Panel FDA Authorized H
Taigen Bioscience Corporation | LabTurbo AIO COVID-19 RNA Testing kit Not FDA Authorized H
TCM Bioscience | TCM-Q Corona III test Not FDA Authorized H
Tetracore Inc | EZ-SARS-CoV-2 Real-Time RT-PCR Not FDA Authorized H
Thermo Fisher Scientific Inc ( Life Technologies) | TaqPath™ COVID-19 RNase P Combo Kit 2.0 Not FDA Authorized H
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 Authorized H
Todos Medical USA Inc | TODOS 2019-nCoV RT-qPCR Detection Kit Not FDA Authorized H
UStar Biotechnologies (Hangzhou) Ltd | EasyNAT® Diagnostic Kit for Novel-Coronavirus (COVID-19) RNA (Isothermal Amplification-Real Time Fluorescence Assay) Not FDA Authorized H
Vela Operations Singapore Pte Ltd | ViroKey SARS-CoV-2 RT-PCR Test v2.0 FDA Authorized H
VelaDx ViroKey™ SARS-CoV-2 RT-PCR Test FDA Authorized H
YD Diagnostics Corp | MolecuTech Real-Time COVID-19 Not FDA Authorized H
ZhuHai Sinochips Bioscience Co Ltd | COVID-19 Real-time PCR Test Kit FDA Authorized H

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.
Days
Hours
Minutes
Seconds
CONTACT ITB HOLDINGS LLC