SARS-CoV-2 diagnostic pipeline
FIND is collating an overview of SARS-CoV-2 tests that are commercially available or in development for the diagnosis of COVID-19.
For all commercialized immunoassays and molecular tests, we have compiled a fully searchable directory. Manufacturer performance data (sensitivity and specificity) are included, where known, alongside data from independent evaluations conducted by FIND, where applicable.
COVID-19 TEST DIRECTORY (Immunoassays, MOLECULAR tests)
For all immunoassays and molecular tests in development, please refer to the list below. This pipeline tracker also has information on other diagnostic tools such as digital solutions and sample collection devices.
The list below was compiled from information submitted voluntarily by test suppliers and is not independently verified. If you have any queries or wish for us to make updates in this pipeline, please contact us.
To know more about the FIND evaluations of submitted SARS-CoV-2 tests, click here. ongoing test evaluations
- Abace Biotechnology Virus Sampling Kit (CE-IVD)
- Absea Biotechnology Ltd The non-invasive MEGA test of SARS-CoV-2 (mucosal swabs) (In development)
- Abwiz Bio RabWiz Ultra Sensitive COIV-19 Viral Antigen Test Kit (ELISA) (In development)
- Academia Sinica Anti-SARS-CoV-2 nucleocapsid protein human IgM/IgG rapid detection kit (In development)
- Actim Oy Actim ELISA SARS CoV-2 IgG/IgM (In development)
- Actim Oy Actim SARS CoV-2 (In development)
- Actim Oy Actim SARS CoV-2 IgG/IgM (In development)
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Advanced Biological Laboratories SA
DeepChek® 8-Plex CoV-2 Genotyping Assay (by NGS) (RUO)
- AIVD Biotech Inc. COVID-19 IgG/IgM Rapid Test (colloidal gold-based) (In development)
- AlphaBiolabs Coronavirus test kit - sample collection (CE-IVD)
- Applied Biological Materials Inc. Sample Collection and Viral Transport Solution (CE-IVD)
- Aptamer Group Ltd ADx SARS CoV-2 Virus Antigen Rapid Point of Care Test (In development)
- Ardent Biomed Guangdong Inc. Ardent Throat Swab Sampling Kit for SARS-CoV-2 (CE-IVD - )
- Ativa Medical Ativa Enhanced Screen (In development)
- Aura Biotechnologies Ltd Quick COVID-19 Colorimetric LAMP PCR (In development)
- Aura Biotechnologies Ltd Quick COVID-19 Realtime Multiplex PCR (In development)
- Aurora Biomed Inc. SARS-COV-2 Detection Kit for the VERSA Viral Detection workstation (In development)
- Baiya Phytopharm, Co, Ltd Baiya Rapid COVID-19 IgM/IgG test kit (In development)
- Beijing Beier Bioengineering Co., Ltd Multiple Real-time PCR kit for Detection of SARS-CoV-2 RNA (In development)
- Beijing Infervision Technology Co. Ltd InferRead CT Pneumonia (In development)
- BIOHIT HealthCare (Hefei) Co., Ltd SARS-CoV-2 Antigen assay kit (Colloidal Gold Method) (In development)
- Bright Line Research Rona 19 Screen Coronavirus (SARS-CoV-2) IgG/IgM Rapid Test (In development)
- BTS Consultores S.A.C. CavBio RT-PCR COVID-19 kit V1.0 (In development)
- Canary Health Technologies AiroStotleCV19 (Breath VOCs) (In development)
- Caspr Biotech Lyo-CRISPR SARS-CoV-2 Kit (In development)
- Caspr Biotech Phantom 1.0 Dx (near-POC) (In development)
- Clear Labs Inc. Clear Dx SARS-CoV-2 Test
- DART Diagnostics DART COVID-19 (manual) (In development)
- Denovo Biolabs Pvt Ltd DeQuanto SARS CoV-2 RTqPCR Kit (In development)
- DNA Software, Inc. Upper Respiratory Virus Panel, multiplex PCR, COVID-19, Influenza A B (In development)
- Edinburgh Genetics Limited Edinburgh Genetics Complete Whole Blood Collection Kit (RUO)
- Edinburgh Genetics Limited Edinburgh Genetics Virus Swab Sampling Kit (RUO)
- Eluceda Limited Eluceda Rapid RNA Covid-9 test (In development)
- En Carta En Carta SARS-CoV-2 (In development)
- ender diagnostics ag enderMOBILE (In development)
- FABPulous/DTwist BV DTwist
- FemtoDx COVID-19 Rapid Home Nucleic Acid Test (In development)
- Finbiosoft Results Manager (automatic PCR interpretation software) (RUO)
- Fjord Diagnostics SDN BHD SEDIPREP COVID-19 (CE-IVD)
- Fjord Diagnostics SDN BHD Fjord - Viral Transport Medium (VTM, alcohol formulation) (Malaysia MDA - CE-IVD)
- FluroTest LLC CompleTest (In development)
- Fluxergy LLC Fluxergy Sample-to-Answer SARS-CoV-2 RT-PCR (In development)
- GaDia Diagnostics SA COVIDia - Antigen (In development)
- General Biologicals Corporation GB Viral Transport Medium (VTM) Swab Kit (CE-IVD)
- GenoSUR LLC Sampling and transport device for SARS-CoV-2 and other respiratory viruses (Chile ISP)
- Genrui Biotech Inc. Disposable Viral Sampling Tube (CE-IVD)
- GENSPEED Biotech Covid-19 Ag xPOC (In development)
- GENSPEED Biotech Covid-19 Complete xPOC (In development)
- GNA Biosolutions GmbH SARS-CoV-2 Detection Kit on portable PCA Analyzer (In development)
- Guangdong Huayin Medicine Science Co,. Ltd Detection Kit for 2019-nCoV RNA (RT-PCR Fluorescence Probing) (Lyophilised) (In development)
- Guangzhou FulenGen Co., Ltd RT-qPCR based SARS-CoV-2 detection kit with SPRS (Spike-in Reference Standard) (In development)
- Guangzhou Hybribio Medicine Technology Ltd Respiratory Virus (IFVa/b + COVID-19) Real-Time PCR Kit (In development)
- Hangzhou Bigfish Bio-tech Co., Ltd The golden standard of SARS-CoV-2 viral nucleic acid detection (In development)
- Hangzhou Bigfish Bio-tech Co., Ltd LAMP kit for qualitative detection of SARS-CoV-2 (In development)
- Hangzhou Dan Wei Biotechnology Co.Ltd 2019-nCoV Direct RT-qPCR Kit (In development)
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd Extended ViralTrans, Extended EnteroTrans, Sampling & Transport System (CE-IVD)
- Hangzhou Genesis Biodetection & Biocontrol Co., Ltd Viral Transport Medium (CE-IVD)
- Hemcheck Sweden AB HELGE™: POC-test for rapid and objective detection of hemolysis in blood samples aimed for SARS-CoV-2 antibody testing for prevention of sample rejection in the laboratory (CE-IVD)
- Huwel Lifesciences Pvt. Ltd. Quantiplus CORONA Virus (2019nCoV) detection kit (In development)
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InActiv Blue Saliva Collection Tube
InActiv Blue Saliva Collection Kit (CE-IVD)
For molecular testing using manual/automated NAT, automated near-POC NAT & automated POC NAT. Contact
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InActiv Blue Swab Collection Tube
InActiv Blue Swab Collection Kit (CE-IVD)
For molecular testing using manual/automated NAT, automated near-POC NAT & automated POC NAT. Contact
- Ingenuity Diagnostics Inc. Viral Transport Medium - BGX (VTM)
- Ingenuity Diagnostics Inc. RT-PCR Direct with VTM (In development)
- Ingenuity Diagnostics Inc. Saliva Collection kit (In development)
- Ingenuity Diagnostics Inc. Flu SC2 Multiplex Assay (In development)
- Ingenuity Diagnostics Inc. Home Collection Kit (In development)
- Institute of Process Engineering, Chinese Academy of Sciences Coronavirus Disease 2019 (COVID-19) Nucleic Acid Testing Kit (CAMP-based) (In development)
- Integrated Nano Technologies Palladium System (In development)
- Intrasense SA Myrian Covid-19 (China NMPA EUA - CE-IVD)
- iNtRON Biotechnology Inc. LiliF™ COVID-19 Real-time RT-PCR Kit (In development)
- IVDbio Inc. Machine-Free, Fast and Accurate Nucleic Acid Diagnoses System for COVID-19 (In development)
- Jetware SRL LOMT - Pool Testing Management Software (In development)
- Kephera Diagnostics KDx SARS-CoV-2 IgG/IgM ELISA (In development)
- Kephera Diagnostics KDx Rapid SARS-CoV-2 Antigen Test (In development)
- Kephera Diagnostics KDx COVID-19 IgG/IgM Rapid Detection Test Kit (In development)
- L&H Biotech Limited COVID-19 Antigen Rapid Test (In development)
- L7 Informatics Enterprise Science Platform (CLIA)
- Landcent Europe B.V. Real time RT-PCR Kit for the detection of SARS-CoV-2 (In development)
- Leadgene Biomedical, Inc. Leadgene® SARS/SARS-CoV-2 IgG/IgM Rapid Test Kit (In development)
- Leadgene Biomedical, Inc. Leadgene® SARS/SARS-CoV-2 Antigen Rapid Test Kit (In development)
- LetsGetChecked LetsGetChecked Coronavirus (COVID-19) Test
- Luminostics, Inc. CLIP-COVID19 (smartphone-read out high sensivity antigen detection test) (In development)
- Mediclone Biotech Pvt Ltd @sight COVID-19 IgG/IgM Rapid Test Kit (In development)
- MedStar Medical Co., Ltd One-step Direct Realtime PCR Test Kit of 2019-nCoV Coronavirus (In development)
- MGI Tech Co., Ltd Fast SARS-CoV-2 NAT with CRISPR assay by digital microfluidics automation (In development)
- Mobidiag Novodiag® COVID-19 + InfA/B (lab-based & near-POC) (In development)
- Module Innovations Private Ltd nCoVSENSe: IgM/ IgG test for spike and N-protein of SARS-CoV 2 (manual) (In development)
- Mologic Ltd Mologic COVID-19 Rapid Test (In development)
- myPOLS Biotec GmbH Direct SARS-CoV-2 PCR detection kit w/o extraction (In development)
- Nanjing BioPoint Diagnostics BioPoint SARS-CoV-2 dIgA/total antibody rapid test (In development)
- Neurix SA Spike neutralization assay (In development)
- Orpheus Medica Inc. CoviSafe™ (In development)
- Pinpoint Science Inc. Pinpoint Covid-19 Screening Assay (In development)
- PlexBio Co., Ltd PlexBio CoVid19/SARS/Influenza A, B Detection kit (In development)
- Prantae Solutions Pte Ltd EyeRa-Covid (In development)
- Predigen Inc. HR-PreV (In development)
- Premier Medical Corporation Pvt. Ltd SureStatus COVID-19 (SARS-CoV-2) EIA Test (In development)
- Premier Medical Corporation Pvt. Ltd SureStatus COVID-19 (SARS-CoV-2) Card Test (In development)
- Quansys Biosciences SARS-CoV-2 Human IgG (4-Plex) (In development)
- QuantuMDx QPOC™ Point of Care NAT for SARS-CoV-2 (In development)
- RetroVirox Inc. SARS-CoV-2 Pseudovirus assay for Neutralizing Antibodies (RUO)
- Saturn Pass Saturn Pass Mobile App (MHRA UK - CE-IVD)
- Scope Fluidics SA PCR|COV (In development)
- Selfdiagnostics Deutschland GmbH Multitest (In development)
- SignalDT Biotechnologies (SZ), Inc. LyoDx® A Freeze-Dried Real-Time RT-PCR Detection Reagent for SARS-CoV-2 (In development)
- STILLA COVID-19 Multiplex Crystal Digital PCR detection kit (In development)
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SVS Industries
Nasal Flock Swab
(validated ICMR)
- Trinity Biotech Bartels FlexTrans™ Medium
- Trivitron Healthcare Pvt. Ltd ViSure transport kit (CE-IVD)
- Twist Bioscience NGS-based target capture for SARS-CoV-2 detection and screening (In development)
- University of Washington Tongue swab diagnosis of SARS-CoV-2 (In development)
- Visible Patient Visible Patient Service - numerical (medical image analysis, CT or MRI) (CE Class IIa)
- Vision Biotechnology Research & Development VISION COVID19 Easyprep Test Kit (In development)
- Wells Bio, Inc. careUS™ COVID-19 IgM/IgG (In development)
- Wuxi Shenrui Bio-pharmaceuticals Co. Ltd Covflu-SR, Coronavirus 2019-nCoV and influenza virus A/B nucleic acid detection (In development)
- Zalgen Labs, LLC ReSARS CoV-2 Antigen ELISA Kit (In development)
- Zalgen Labs, LLC ReSARS CoV-2 Antigen Rapid Test (In development)
- Zalgen Labs, LLC ReSARS CoV-2 IgM ELISA Kit (In development)
- Zalgen Labs, LLC ReSARS Pan-Corona Antigen ELISA Kit (In development)
- Zalgen Labs, LLC ReSARS Pan-Corona IgM ELISA Kit (In development)
- Zalgen Labs, LLC ReSARS Pan-Corona Rapid Test (In development)
- Zugotech Labs Ltd Zugotech COVID-19 IgM/IgG Rapid Test (In development)