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.
| 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 |
| 9 | SD BIOSENSOR, Inc. | STANDARD Q COVID-19 IgM/IgG Duo 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 |