FDA authorises first COVID-19 diagnostic test using at-home collection of saliva sample

The FDA announced Friday that it issued an emergency-use authorisation (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory-developed test (LDT) to permit testing of samples self-collected by patients at home using Spectrum Solutions' SDNA-1000 saliva collection device. According to the agency, this marks the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing.

"Authorising additional diagnostic tests with the option of at-home sample collection will continue to increase patient access to testing for COVID-19…without traveling to a doctor's office, hospital or testing site," said FDA commissioner Stephen Hahn.

The prescription-only test had been previously added to the high complexity molecular-based LDT "umbrella" EUA. According to the FDA, this latest approval builds on last month's EUA for Laboratory Corporation of America's COVID-19 RT-PCR test, the first diagnostic test with a home-collection option, which uses a sample collected from the patient's nose with a nasal swab and saline.

For the Rutgers molecular test, once a saliva sample is collected using the designated self-collection kit, the FDA said patients return it to the Rutgers Clinical Genomics Laboratory in a sealed package for testing. The agency noted that the Rutgers test is currently the only authorised COVID-19 diagnostic test that uses saliva samples to test for SARS-CoV-2.

Here is a non-exhaustive list of the regulatory status of some COVID-19 tests:

Company Test Status
Rutgers Clinical Genomics Lab Rutgers Clinical Genomics Laboratory TaqPath SARS-CoV-2-Assay FDA EAU
Zymo Research Corporation Quick SARS-CoV-2rRT-PCR Kit FDA EAU
OPTI Medical Systems OPTI SARS-CoV-2 RT PCR Test FDA EAU
Sherlock BioSciences Sherlock CRISPR SARS-CoV-2 Kit FDA EAU
BioMérieux SARS-COV-2 R-GENE FDA EAU
Biomerica COVID-19 IgG/IgM rapid test CE mark
EUROIMMUN US Anti-SARS-CoV-2 ELISA (IgG) FDA EAU
Roche Diagnostics Elecsys Anti-SARS-CoV-2 FDA EAU
BioFire Diagnostics BioFire Respiratory Panel 2.1 (RP2.1) FDA EAU
Wadsworth Center, NYSDOH New York SARS-CoV Microsphere Immunoassay for Antibody Detection FDA EAU
QuantuMDX SARS-CoV-2 assay Launching in US; awaiting CE mark
LabGenomics LabGun COVID-10 RT-PCR kit FDA EUA
Rheonix Rheonix COVID-19 MDx assay FDA EUA
Bio-Rad Laboratories Platelia SARS-CoV-2 Total Ab assay FDA EUA; CE mark
SEASUN Biomaterials U-TOP COVID-19 detection kit FDA EUA
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack FDA EAU
DiaSorin LIAISON SARS-CoV-2 S1/S2 IgG FDA EAU
Autobio Diagnostics Anti-SARS-CoV-2 Rapid Test FDA EAU
Abbott SARS-CoV-2 IgG assay FDA EAU
SD Biosensor STANDARD M nCoV Real-Time Detection Kit FDA EUA
Siemens Healthineers COVID-19 total antibody test In development
Zeus Scientific Lateral flow SARS-COV-2 IgG IgM test Launched in US
Trividia Health SARS-CoV-2 Antibody Test Kit Launched in US
Beckman Coulter Access SARS-CoV-2 IgG test In development
Gold Standard Diagnostics COVID-19 IgA, IgG, and IgM assays Launched in US
ThermoGenesis SARS-CoV-2 (COVID-19) IgM/IgG Antibody Fast Detection Kit Launched in US
Vela Diagnostics ViroKey SARS-CoV-2 RT-PCR Test Provisional Singapore HSA approval
FYR Diagnostics ALRT rapid COVID-19 test In development
Quidel Lyra DIRECT SARS-CoV-2 assay Launched in US
Biocartis Idylla SARS-CoV-2 test In development
MedMira Reveal COVID-10 total antibody test Launched in US
Seegene Allplex 2019-nCoV Assay FDA EUA
altona Diagnostics RealStar SARS-CoV02 RT-PCR Kits US FDA EUA
MobiDiag Novodiag COVID-19 assay Finland EUA
LabCorp Pixel by LabCorp COVID-19 Test FDA EUA
Trax Management Services PhoenixDx 2019-CoV FDA EAU
OSANG Healthcare GeneFinder COVID-19 Plus RealAmp Kit FDA EAU
Fosun Pharma Fosun COVID-19 RT-PCR Detection Kit FDA EAU
KorvaLabs Curative-Korva SARS-Cov-2 Assay FDA EAU
GenoSensor GS COVID-19 RT-PCR KIT FDA EAU
Maccura Biotechnology SARS-CoV-2 Fluorescent PCR Kit FDA EAU
Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test FDA EAU
Abbott SARS-CoV-2 IgG test Launched in US
Chembio Diagnostic System DPP COVID-19 IgM/IgG System CE mark, FDA EUA
MobiDiag AmpliDiag COVID-19 test Finland EUA
Atila Biosystesm iAMP COVID-19 Detection kit FDA EUA
DiaCarta QuantiVirus SARS-CoV-2 test kit FDA EUA
Becton Dickinson BD SARS-COv-2 reagents for BD MAX system FDA EUA
Biodesix SARS-CoV-2 Droplet Digital PCR Launched in US
InBios International Smart Detect SARS-CoV-2 rRT-PCR Kit FDA EUA
Gnomegen Gnomegen COVID-19 RT-Digital PCR Detection Kit FDA EUA
Biolidics Novel Coronavirus 2019 IgG/IgM test CE mark
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack. FDA EUA
Menarini VitaPCR SARS-CoV-2 assay kit CE marked
ScienCell Research Laboratories ScienCell SARS-CoV-2 Coronavirus Real-time RT-PCR (RT-qPCR) Detection Kit FDA EUA
Co Diagnostics Logix Smart COVID-19 test FDA EUA, CE marked
BD, BioGX BioGX SARS-CoV-2 Reagents FDA EAU
Cellex qSARS-CoV-2 IgG/IgM Rapid Test FDA EUA
BD, BioMedomics COVID-19 antibody test Launched in US
Chembio DPP COVID-19 IgM/IgG System Launched in US
Bodysphere COVID-19 IgG/IgM Rapid Test Cassette Launched in US
Molecule Holding COVID Care COVID-19 IgG and IgM Rapid Test Launched in US
NeuMoDx Molecular, Inc. euMoDx SARS-CoV-2 Assay FDA EUA
Qiagen QIAstat-Dx Respiratory 2019-nCoV Panel FDA EUA, CE marked
Luminex ARIES SARS CoV2 Assay FDA EUA
Siemens Healthineers Fast Track Diagnostics SARS-CoV-2 test kit FDA EAU, CE mark
Luminex NxTAG CoV Extended Panel Assay FDA EUA
Abbott ID NOW COVID-19 Test FDA EUA
Sysmex 2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit (BGI Genomics' test) Approved in Japan
Avellino AvellinoCoV2 test FDA EAU
Perkin Elmer PerkinElmer New Coronavirus Nucleic Acid Detection Kit FDA EUA
Mesa Biotech Accula SARS-CoV-2 test FDA EAU
BioFire Defense (bioMerieux) BioFire COVID-19 test FDA EAU
Abbott RealTime SARS-CoV-2 assay FDA EUA
Quest Diagnostics Quest SARS-CoV-2 rRT-PCR FDA EUA
Quidel Lyra SARS-CoV-2 Assay FDA EUA
LabCorp COVID-19 T-PCR test FDA EAU
Hologic Panther Fusion SARS-COV-2 Assay FDA EUA
Centers for Disease Control and Prevention 2019-nCoV RT-PCR Diagnostic Panel FDA EUA
Wadsworth Center, NYSDOH New York SARS-CoV-2 RT-PCR Diagnostic Panel FDA EUA
Roche cobas SARS-CoV-2 FDA EUA
Thermo Fisher TaqPath COVID-19 Combo Kit FDA EUA
BD/BioGX BD MAX COVID-19 Test FDA EUA
Fulgent/MedScan COVID-19 NGS Test Awaiting EUA
Diatherix Eurofins COVID-19 Panel Awaiting EUA
Stanford Medicine COVID-19 RT-PCR test In-house LDT
UC San Diego Health System COVID-19 Test In-house LDT
Diasorin Simplexa COVID-19 Direct Assay FDA EUA
Opko Health COVID-19 test In development
CerTest Biotec Viasure COVID-19 test CE marked
Genomica CLART COVID-19 test CE marked
Novacyt COVID-19 test FDA EUA, CE marked
BGI Genomics RT-PCR test CE marked, FDA EUA, Chinese NMPA approval
GenMark ePlex SARS_CoV-2 test FDA EUA
Cepheid Xpert Xpress SARS-CoV-2 FDA EUA
Aytu Biosciences COVID-19 IgG/IgM Rapid Test Awaiting FDA approval, CE marked
20/20 BioResponse CoronaCheck COVID-19 Rapid Antibody Test Kit Awaiting FDA approval
Corona Diagnostics Colloidal Gold COVID-19 POC screening test kit CE marked
Solgent DiaPlexQ Novel Coronavirus (2019-nCoV) Detection assay CE marked/EUA in Korea, Philippines
Veredus Labs VereCoV MDx Singapore HSA provisional authorisation
CoSara Diagnostics RT-PCR COVID-19 test India CDSCO authorisation

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