COVID-19 is an emerging, rapidly evolving situation


Non-availability of SARS-CoV-2 diagnostic tests has remained a continuous problem globally. The low resourced hospital systems generally cannot utilize a Real Time Polymerase Chain Reaction (PCR) based assay for routine screening. There is clinical need of making the Point of Care Rapid Tests for COVID19 available globally. In this article, I tabulated a list of such fifteen (15) low cost, low turn around time rapid tests. There are more in pipeline while this list is based on simple google search coupled with website visit of the companies to obtain IgG/IgM based rapid test information. Majority of these are CE-IVD marked and under current FDA guidelines on COVID-19 emergency can be used by certified laboratory professional. The table can be used as guide by stakeholders, governments and hospital leaders around the world to fight the global pandemic of COVID-19 in low resource setting where PCR based assays are either not available or high cost makes them unaffordable. The table excludes molecular assays that are also getting approved as point of care test because those still need a costly machine to use.

FAED will continue to update the list
Table : Point of Care Rapid Test for detection of IgG/IgM COVID-19 antibodies. Prepared for public dissemination of information by the Foundation for Advancement of Essential Diagnostics

Sl. No Company Brief description of the test Current status
1 BioMedomics Test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick (capillary) or venous whole blood, serum, and plasma samples. Takes 10-15 minutes per test. US FDA- EUA under review. Under certified health professional the test can used under latest FDA notifications during the emergency period.
2 BTNX Inc. This is also a qualitative test for the detection of anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood, serum, or plasm samples. US FDA- EUA under review. Under certified health professional the test can used under latest FDA notifications during the emergency period.
3 Cellex Cellex qSARS-COV-2 IgG/IgM Rapid Test CE Mark EEA
4 VivaChek Biotech (Hangzhou) Co., Ltd VivaDiag™ COVID-19 IgM/IgG Rapid Test CE Mark EEA
5 CTK Biotech, Inc. OnSite COVID-19 IgG/IgM Rapid Test. 10 minutes assay. They claim 96.9% sensitivity and 99.4% specificity CE Mark EEA
6 Dynamiker Biotechnology (Tianjin) Co., Ltd. 2019 nCOV IgG/IgM Rapid Test. 10 minutes assay CE Mark EEA
7 GeneBody Inc GenBody COVID-19 IgM/IgG Rapid Test. CE Mark EEA
8 Liming Bio-Products Co., Ltd StrongStep® COVID-19 IgG/IgM Combo Rapid Test CE Mark EEA
10 SensingSelf, Pte, Ltd, Singapore EDR COVID 19 Rapid Test Kit (IgM/IgG) CE Mark EEA
11 Shenzhen Bioeasy Biotechnology Bioeasy Novel Coronavirus (2019-nCoV) Test Kits Rapid Colloidal Gold Antigen Test and IgG-IgM detection kit CE Mark EEA
12 Xiamen Biotime Biotechnology Co., Ltd. Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test Kit
13 Guangzhou Wondfo Biotech Rapid IgG-IgM 15-minute immunoassay directed against SARS-CoV-2 CE Mark EEA
14 Pharmact Rapid 20-minute test for detecting SARS-CoV-2 IgG and IgM antibodies CE Mark EEA
15 Ray Biotech Coronavirus (COVID-19) IgM/IgG Rapid Test Kit CE Mark EEA, FDA- EUA under review