Friday, April 3, 2020

New 2-Day Online Rapid Microbiological Methods Master Class - May 20-21, 2020

Due to an overwhelming request to repeat my online 2-Day Rapid Microbiological Methods Master Class, I have scheduled a new class for May 20 and 21, 2020. This will be a live event where you will learn about the current regulatory policies for implementation and submissions, the scientific principles for commercially-available rapid technologies, a comprehensive, step-by-step strategy for validation, rapid sterility testing for ATMPs (cell therapy), case studies on statistical analyses and how to develop a financial justification when purchasing a RMM system. For the complete agenda and information on how to register, please visit http://rapidmicromethods.com/events/masterclass-may2020.php.

Tuesday, March 24, 2020

Overview of Current COVID-19 Diagnostic Devices with FDA Emergency Use Authorization

Updated April 3, 2020 (added new EUA)

Please bookmark this page as I will continually update this information as additional EUA's are issued and new commercial diagnostic and serology kits are validated. 

Numerous COVID-19 in-vitro diagnostic devices have been submitted to FDA for Emergency Use Authorizations (EUA). The following table provides an up-to-date summary of all FDA EUA's.

There are also a number of SARS-CoV-2 diagnostic and serology tests that are in development or that have been distributed while manufacturers prepare an EUA submission for a test whose performance characteristics have already been validated. A current list of diagnostic and serology tests that fit into this category is provided after the EUA table. NOTE: the table should be viewed in landscape mode on smaller handheld devices.



Date EUA Issued
Supplier
Letter of Authorization
Fact Sheet 
for Healthcare Providers
Fact Sheet 
for Patients
Supplier Instructions or Package Insert
Other Info
04/02/2020
Becton, Dickinson & Company (BD)
None
04/01/2020
Ipsum Diagnostics, LLC
None
04/01/2020
Cellex Inc.
None
03/30/2020
QIAGEN GmbH
None
03/30/2020
NeuMoDx Molecular, Inc.
None
03/27/2020
Abbott Diagnostics Scarborough, Inc.
None
03/27/2020
Luminex Molecular Diagnostics, Inc.
None
03/26/2020
BGI Genomics Co. Ltd.
None
03/25/2020
Avellino Lab USA, Inc.
None
03/24/2020
PerkinElmer, Inc.
None
03/23/2020
Mesa Biotech Inc.
None
03/23/2020
BioFire Defense, LLC
None
03/20/2020
Cepheid
None
03/20/2020
Primerdesign Ltd.
None
03/19/2020
GenMark Diagnostics, Inc.
None
03/19/2020
DiaSorin Molecular LLC
IFU
None
03/18/2020
Abbott Molecular
None
03/17/2020
Quest Diagnostics Infectious Disease, Inc.
None
03/17/2020
Quidel Corporation
03/16/2020
Laboratory Corporation of America (LabCorp)
None
03/16/2020
Hologic, Inc.
None
03/13/2020
Thermo Fisher Scientific, Inc.
None
03/12/2020
Roche Molecular Systems, Inc. (RMS)
None
02/29/2020
Wadsworth Center, New York State Department of Public Health's (CDC)
02/04/2020
Centers for Disease Control and Prevention's (CDC)
None


As stated in Section IV.C of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to a commercial manufacturer's development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time after the manufacturer's validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test's performance characteristics on the manufacturer's website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users. As noted in the guidance, FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. This policy does not apply to at home testing.

The commercial manufacturers listed below have notified FDA that they have validated and are distributing test kits as set forth in Section IV.C of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. The FDA has not yet reviewed the validation of the tests of these manufacturers or issued EUAs for these manufacturers' tests and is including this list here to provide transparency regarding the notifications submitted to FDA.

        Co-Diagnostics, Inc.
        OSANG Healthcare Co., Ltd, GeneFinder COVID-19 Plus RealAmp Kit

As stated in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019, the FDA does not intend to object to the development and distribution by commercial manufacturers, or development and use by laboratories, of serology tests to identify antibodies to SARS-CoV-2, where the test has been validated, notification is provided to FDA, and information along the lines of the following is included in the test reports:

  • This test has not been reviewed by the FDA. 
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. 
  • Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. 
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. This policy does not apply to at home testing. 

The commercial manufacturers and laboratories listed below have notified FDA that they have validated and are offering serology tests as set forth in Section IV.D of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019. The FDA has not reviewed the validation of tests offered by these developers, who will not be pursuing EUAs, and is including this list here to provide transparency regarding the notifications submitted to FDA.

  • Assure Tech (Hangzhou) Co., Ltd.'s COVID-19 IgG/IgM Rapid Test Device
  • Autobio Diagnostics' Anti-SARS-CoV-2 Rapid Test
  • Beijing Decombio Biotechnology Co., Ltd. Novel Coronavirus IgM/IgG Combo Rapid Test-Cassette (Serum/Plasma/Whole blood)
  • Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG Antibody Determination Kit
  • Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgM Antibody Determination Kit
  • Beijing Diagreat Biotechnologies Co., Ltd. 2019-nCoV IgG/IgM Antibody Rapid Test Kit
  • Beijing Kewei Clinical Diagnostic Reagent Inc. Genonto RapidTest10 COVID-19 IgG/IgM Antibody Rapid Test Kit
  • Beijing O&D BIOTECH Co., LTD. Coronavirus disease(COVID-19) Total Antibody Rapid Test (Colloidal Gold)
  • Beroni Group SARS-CoV-2 IgG/IgM Antibody Detection Kit
  • BioMedomics, Inc. COVID-19 IgM-IgG Rapid Test
  • BTNX, Inc. Rapid Response™ COVID-19 IgG/IgM Test Cassette
  • Chembio Diagnostic Systems, Inc. DPP COVID-19 IgM/IgG System
  • Core Technology Co., Ltd. CoreTest COVID-19 IgM/IgG Ab Test
  • Coronacide™ COVID-19 IgM/IgG Rapid Test
  • Diazyme Laboratories, Inc. Diazyme DZ-LITE SARS-CoV-2 IgG CLIA Kit
  • Diazyme Laboratories, Inc. Diazyme DZ-Lite SARS-Cov-2 IgM CLIA Kit
  • Eachy Biopharmaceuticals Co., Ltd. AccuRapid™ SARS-CoV-2 IgM/IgG Test Kit (Lateral Flow Immunoassay)
  • EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgA)
  • EUROIMMUN AG Anti-SARS-CoV-2 ELISA (IgG)
  • Guangzhou Wondfo Biotech Co., Ltd. SARS-CoV-2 Antibody Test
  • Hangzhou AllTest Biotech Co., Ltd. AllTest 2019-nCoV IgG/IgM Rapid Test Cassette
  • Hangzhou AllTest Biotech Co., Ltd. AllTest COVID IgG/IgM Rapid Test Dipstick
  • Hangzhou Clongene Biotech Co., Ltd. Clungene COVID-19 IgM/IgG Rapid Test Cassette
  • Hangzhou Biotest Biotech's COVID-19 IgG/IgM Rapid Test Cassette
  • Hangzhou Realy Tech Co Ltd. 2019-nCOV IgG/IgM Rapid Test
  • Hangzhou Testsealabs Biotecnology Co., Ltd One Step SARS-CoV2 (COVID-19) IgG/IgM Test
  • Healgen Scientific, LLC. COVID-19 IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma)
  • INNOVITA (Tangshan) Biological Technology Co., Ltd. 2019-nCoV Ab Test (Colloidal Gold)
  • Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. SARS-CoV-2 IgM/IgG Rapid Assay Kit (Colloidal Gold)
  • Lifeassay Diagnostics (Pty) Ltd Test-it COVID-19 IgM/IgG Lateral Flow Assay
  • Medical Systems Biotechnology Co., Ltd. Coronavirus Disease 2019 Antibody (IgM/IgG) Combined Test Kit
  • Nanjing Liming Bio-products Co.,Ltd SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit
  • NanoResearch, Inc. NanoMedicina™ SARS-COV-2 IgM/IgG Antibody Rapid T
  • Nantong Diagnos Biotechnology Co., Ltd. (2019-nCoV) New coronavirus Antibody Test (Colloidal Gold)
  • Nirmidas Biotech, Inc. COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit
  • PCL Inc. COVID19 IgG/IgM Rapid Gold
  • Phamatech Inc. COVID19 IgG/IgM Rapid Test
  • Promedical COVID-19 Rapid Test {Wondfo SARS-CoV-2 Antibody Test (Lateral Flow Method)}
  • SD Biosensor STANDARD Q COVID-19 IgM/IgG Duo
  • Shanghai Eugene Biotech Co., Ltd. SARS-CoV2 (COVID-19) IgG/IgM Rapid Test
  • Shenzhen Landwind Medical Co., Ltd COVID-19 IgG/IgM Rapid Test Device
  • Sugentech, Inc. SGTi-flex COVID-19 IgM/IgG
  • Suzhou Kangheshun Medical Technology Co., Ltd SARS-CoV-2 IgG/IgM Rapid Test Cassette
  • Telepoint Medical Services SARS-CoV-2 IgG/IgM Rapid Qualitative Test
  • Tianjin Beroni Biotechnology Co. Ltd SARS-CoV-2 IgG/IgM Antibody Detection Kit
  • United Biomedical, Inc. UBI® SARS-CoV-2 ELISA
  • VivaChek Biotech (Hangzhou) Co., Ltd. VivaDiag COVID-19 IgM/IgG Rapid Test
  • Zhejiang Orient Gene Biotech, Co., Ltd. COVID-19 IgG/IgM Rapid Test Cassette
  • Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgG Antibody Rapid Test Kit (Colloidal Gold Immunochromatography method)
  • Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 IgM Antibody Rapid Test Kit (Colloidal Gold Immunochromatography method)
  • Zhengzhou Fortune Bioscience Co., Ltd. COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography method)
  • Zhongshan Bio-Tech Co. Ltd SARS-CoV-2 IgM/IgG (GICA)
  • Zhuhai Encode Medical Engineering Co., Ltd Novel Coronavirus (COVID-19) IgG/IgM Rapid Test Device
  • Zhuhai Livzon Diagnostics, Inc. Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2) (Colloidal Gold)