Three basic test types are the focus here, and it’s these we will need to have mass-produced and distributed to a significant percentage of the population. Anything less risks prolonging lockdown or making the relaxing of lockdown a gamble. The gamble may pay off, but it may also end up with a death toll in the millions.
Whether you back “gamble!” or “don’t risk lives!” – and where this preference changes, along the infection + fatality + recovery progress line – it’s a question for individuals and its answer is more about your own personality and outlook than any objective data. Some are more gung-ho about life’s ups and downs (everything is a risk, get living). Others are more socially minded about doing the best for the most (all in it together, we’ll beat this if we unite). Whatever.
Here’s the data. Three test types. A bunch of approved, clinical trial and in the pipeline tests. Best thing we can all do, gung-ho or group-first, is keep a close eye on the facts – not just the numbers but the medical supply chains, testing most of all – and hold to account anyone presuming to take authority (be it the President, State Governors, City Mayors, federal, state and city officials). Keep an eye on where the money is going. Keep an eye on where the supply chains aren’t working. Keep an eye on where the institutions are working and where they’re failing. Get loud about any incompetence, corruption, grift, bullshit misdirection, bogus propaganda, etc.
Stay safe.
APRIL 18th 2020
| Type of test | Time to results | What it tells us | What it cannot tell us | Figure |
| Rapid diagnostic test (RDT) | 10-30 minutes | The presence or absence (qualitative) of antibodies against the virus present in patient serum. | The quantifiable amount of antibodies in the patient serum, or if these antibodies are able to protect against future infection | RDT figure |
| Enzyme linked immunosorbent assay (ELISA) | 1-5 hours | The presence or absence (quantitative) of antibodies against the virus present in patient serum. | If the antibodies are able to protect against future infection. | ELISA figure |
| Neutralization assay | 3-5 days | The presence of active antibodies in patient serum that are able to inhibit virus growth ex vivo, in a cell culture system. Indicates if the patient is protected against future infection. | It may miss antibodies to viral proteins that are not involved in replication. | PRNT figure |
Tests approved in the United States
| Country of development | US/China |
| Type of Serological Test | RDT |
| Authors/Company | Cellex Inc. |
| Description | RDT, lateral flow assay, which detects IgM and IgG to the nucelocapside protein of SARS-CoV-2. The sensitivity is 93.8% and specificity is 95.6%, when tested at 2 Chinese hospitals in a total of 128 COVID19 positive patients, and 250 COVID19 negative patients (as detected by RT-qPCR). |
| Phase of development | Approved by FDA for EUA on diagnostics, has CE approval |
| Proposed release | available for purchase by research labs/healthcare providers (product number 5513) |
| Date | April 1, 2020 |
| Country of development | USA |
| Type of Serological Test | RDT |
| Authors/Company | ChemBio |
| Description | This test detects IgM and IgG antibodies to the nucleocapsid (N) protein of SARS-CoV-2. Sensitivity and specificity values were not released. |
| Phase of development | Approved for EUA by the FDA |
| Proposed release | April 14, 2020 |
| Date | April 15, 2020 |
| Country of development | USA |
| Type of Serological Test | Modified ELISA |
| Authors/Company | VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack/Total Calibrator (Ortho Clinical Diagnostics) |
| Description | This test is a proprietary ELISA, and detects total IgM and IgG, but does not discern between the two. The target antigen is SARS-CoV-2 spike protein. Sensitivity was 83% when tested in 36 samples known positive, and sensitivity was 100% out of 400 known SARS-CoV-2 negative samples. Sensitivity increases as day from symptom onset increases. This must be used on the platform VITROS® XT 7600 Integrated System, the VITROS® 3600 Immunodiagnostic System, the VITROS® 5600 Integrated System and VITROS® ECi/ECiQ Immunodiagnostic systems. |
| Phase of development | Approved for EUA by the FDA |
| Proposed release | April 14, 2020 |
| Date | April 15, 2020 |
| Country of development | USA |
| Type of Serological Test | ELISA |
| Authors/Company | Mount Sinai Laboratory COVID-19 ELISA IgG Antibody Test |
| Description | This test detects, qualitatively, IgG present in the serum of patients. The ELISA based method uses a 1:50 dilution of human serum that is flowed over a plate coated with the spike protein receptor binding domain (RBD). Sensitivity and specificity are not yet available. |
| Phase of development | Approved for EUA by the FDA |
| Proposed release | April 15, 2020 |
| Date | April 16, 2020 |
Tests approved outside the United States
| Country of development | US/China |
| Type of Serological Test | RDT, solid phase immunochromatographic assay |
| Authors/Company | Aytu Biosciences/Orient Gene Biotech |
| Description | The (COVID-19) IgG/IgM Rapid Test will assay patient antibodies to SARS-CoV-2 from blood or plasma samples. The sensitivity is 87.9% and specificity is 100% for IgG, and for IgM it is 97.2% and 100%, respectively. |
| Phase of development | CE approved, used in China in clinical settings, awaiting FDA approval |
| Proposed release | Shipments should be ready by early April |
| Date | March 10, 2020 |
| Country of development | US/China |
| Type of Serological Test | Proprietary |
| Authors/Company | ScanWell Health/INNOVITA |
| Description | This kit is for detection of IgG and IgM for SARS-CoV-2 in the blood, taking only 15 minutes, and is an at-home test. The test has 87.3% sensitivity and 100% specificity. |
| Phase of development | Cleared by China’s National Medical Products Administration (NMPA), and pending approval by US FDA |
| Proposed release | 6-8 weeks (May 1 to May 15), depending on FDA approval date |
| Date | March 20, 2020 |
| Country of development | Singapore |
| Type of Serological Test | Not explicity stated, though their “gold standard” is a neutralization assay |
| Authors/Company | Singapore/ Wang Lab |
| Description | The Wang lab developed two tests. One, which has about 90% sensitivity, is rapid and uses recombinant viral proteins to detect reactive antibodies. The second is their “gold standard” and utilizes a viral neutralization assay but takes 3-5 days. |
| Phase of development | Deployed in Singapore |
| Proposed release | Not stated |
| Date | March 1, 2020 |
| Country of development | China |
| Type of Serological Test | Lateral flow assay (RDT) |
| Authors/Company | Guangzhou Wondfo Biotech Co Ltd |
| Description | Wondfo SARS-CoV-2 Antibody Test, which is a lateral flow assay that assays patient IgG and IgM. The article did not specify target antigens, sensitivity, or specificity |
| Phase of development | CE/IVD, approved by NMPA in China for point of care testing |
| Proposed release | CE/IVD in the EU |
| Date | Feb. 22, 2020 |
| Country of development | China |
| Type of Serological Test | RDT (colloidal gold lateral flow assay) |
| Authors/Company | Guangdong Hecin-Scientific |
| Description | Tests for IgM against SARS-CoV-2. |
| Phase of development | Cleared by China’s National Medical Products Administration (NMPA) |
| Proposed release | Approved for use in China |
| Date | Feb. 22, 2020 |
| Country of development | China |
| Type of Serological Test | RDT |
| Authors/Company | Dynamiker |
| Description | The test, DNK-1419-1, assays for patient IgG and IgM with 92% accuracy. |
| Phase of development | The NMPA has approved it in the 7th edition of Diagnostic and treatment protocol of COVID-19 |
| Proposed release | Used in China, no other approvals to date |
| Date | Date not given |
| Country of development | The Republic of Korea |
| Type of Serological Test | RDT |
| Authors/Company | SD Biosensor |
| Description | US supplier Henry Schein will distribute the test for IVD use only |
| Phase of development | Approved for diagnostic us outside the US, Research use only in US |
| Proposed release | 2-3 weeks |
| Date | March 26, 2020 |
| Country of development | US |
| Type of Serological Test | ELISA |
| Authors/Company | MayoClinic/University of Minnesota |
| Description | MayoClinic is developing an ELISA to test for antibodies to SARS-CoV-2. The types of antibodies are not stated, nor is sensitivity or specificity. |
| Phase of development | Clinical |
| Proposed release | April 6, 2020 |
| Date | April 1, 2020 |
| Country of development | USA |
| Type of Serological Test | RDT |
| Authors/Company | Advaite |
| Description | RapCov Rapid COVID-19 Test is an in vitro diagnostic test for IgM and IgG antibodies. In a study with 18 healthy and 18 COVID-19 positive patients, the sensitivity was 89% and specificity was 100%. It should be noted that “specificity” was only performed on healthy patient samples, not patient samples from related viruses. Further testing is necessary to validate the test. It is currently being used to study community prevalence in Chester County, PA. https://advaite.com/press-release/advaite-deploys-covid-19-rapid-antibody-test-kits-to-chester-county-and-collaborates-with-pennsylvania-companies-to-scale-up-manufacturing/ |
| Phase of development | Research use only (IVD), not approved for diagnostic use. This company was not found on any FDA categorization of tests |
| Proposed release | April 2020 |
| Date | April 6, 2020 |
Tests approved for research or surveillance purposes
| Country of development | US |
| Type of Serological Test | ELISA |
| Authors/Company | Epitope Diagnostics, Ltd |
| Description | KT-1032 tests for IgG to SARS-CoV-2, while KT-1033 tests for IgM to SARS-CoV-2. The kits do not state the antigens of interest. |
| Phase of development | Approved by FDA, for clinical use only and for research use. Not for at home testing. The test itself has not been evaluated by the FDA |
| Proposed release | Ongoing |
| Date | March 3, 2020 |
| Country of development | US |
| Type of Serological Test | RDT |
| Authors/Company | CTK Biotech |
| Description | The test, COVID-19 IgG/IgM Rapid Test, tests for patient IgG and IgM in a lateral flow assay. |
| Phase of development | Not approved for use in the US, but available for purchase by research labs/healthcare providers |
| Proposed release | available for purchase by research labs/healthcare providers and export out of the US |
| Date | March 12, 2020 |
| Country of development | US |
| Type of Serological Test | RDT (colloidal gold lateral flow assay) |
| Authors/Company | BioMedomics |
| Description | This assay detects patient antibodies, IgG and IgM, on a lateral flow assay. It uses a recombinant viral antigen, though it does not state the specific antigen. The test is a 3 line read-out, one line for a control, one line to detect IgM, and one to detect IgG. Three lines indicates the patient has both IgG and IgM. |
| Phase of development | CE/IVD, approved by FDA but only for research use |
| Proposed release | CE/IVD, available for purchase by research labs/healthcare providers in the US, but only for research use |
| Date | March 16, 2020 |
| Country of development | US |
| Type of Serological Test | RDT |
| Authors/Company | Ray Biotech |
| Description | This test, the Coronavirus (COVID-19) IgM/IgG Rapid Test Kit, detects patient IgM and IgG to SARS-CoV-2 in patient blood samples. It detects antibodies against the viral N protein. |
| Phase of development | CE/IVD, approved for research use only in the US. Approved for research use under FDA EUA. |
| Proposed release | available for purchase by research labs/healthcare providers, CE/IVD approved |
| Date | March 19, 2020 |
| Country of development | US |
| Type of Serological Test | ELISA |
| Authors/Company | Creative Diagnostics |
| Description | Kit DEIASL019 detects patient IgG for SARS-CoV-2, and uses the whole virus lysate as the antibody binding target. The reported sensitivity and specificity are 100% (from 16 and 30 samples, respectively). The DEIA2020 kit only tests for patient IgG that reacts to N protein. |
| Phase of development | Not approved for diagnostic use; for research use only |
| Proposed release | available for purchase by research labs/healthcare providers, but not for diagnostic use |
| Date | March 20, 2020 |
| Country of development | US |
| Type of Serological Test | ELISA |
| Authors/Company | Eagle Biosciences |
| Description | This company has two kits, one (KTR-1032) which targets patient IgG, and one (KTR-1033) that targets IgM. The target antigen is an “HRP-labeled-COVID-19 antigen.” They did not list sensitivity or specificity |
| Phase of development | Research use only, CE/IVD outside the US |
| Proposed release | available for purchase by research labs/healthcare providers, but not for diagnostic use |
| Date | Date not given |
| Country of development | China/US |
| Type of Serological Test | RDT |
| Authors/Company | Sure Biotech |
| Description | The Coronavirus Rapid Test assays for IgG and IgM antibody in blood or plasma samples, with 92-96% accuracy. |
| Phase of development | CE approved |
| Proposed release | available for purchase by research labs/healthcare providers, CE approved |
| Date | Feb. 2020 |
| Country of development | China/US |
| Type of Serological Test | RDT, immunofluorescence, colloidal gold |
| Authors/Company | BioEasy/Shenzhen BioEasy Biotechnology Co. |
| Description | There are three tests: 1) the 2019 nCoV Ag test, which assays sputum or nasal swabs for SARS-CoV-2 antigens and gives a fluorometric read out, 2) the 2019-nCoV Ag GICA test, which uses colloidal gold, and 3) the 2019 nCoV IgG/IgM GICA rapid test which assays for patient antibodies to the virus from blood samples |
| Phase of development | CE/IVD approved |
| Proposed release | available for purchase by research labs/healthcare providers, CE/IVD approved |
| Date | Date not given |
| Country of development | The Republic of Korea |
| Type of Serological Test | RDT (colloidal gold lateral flow assay) |
| Authors/Company | Sugentech |
| Description | This test is a colloidal gold lateral flow assay that can be read in 10 minutes, and measures presence of patient IgG and IgM. |
| Phase of development | CE/IVD approved |
| Proposed release | available for purchase by research labs/healthcare providers, CE/IVD approved |
| Date | Date not given |
| Country of development | The Republic of Korea |
| Type of Serological Test | RDT |
| Authors/Company | SD Biosensor |
| Description | This company currently offers 3 tests. 1) The Standard Q COVID-19 IgM/IgG Duo which tests for both IgG and IgM patient antibodies to SARS-CoV-2. Sensitivity was 82% and specificity was 97% (based on data from 30 healthy donors and 33 COVID-19 positive individuals. 2) Standard Q COVID-19 Ag, which detects virus antigen from nasopharyngeal swabs, and 3) Standard F COVID-19 Ag FIA, which detects viral N protein present in nasopharyngeal swabs in a fluorescence based assay. |
| Phase of development | Korea EUA approved |
| Proposed release | available for purchase by research labs/healthcare providers, but not for diagnostic use |
| Date | Date not given |
| Country of development | Singapore |
| Type of Serological Test | RDT, prescreen step |
| Authors/Company | Sensing self |
| Description | This is a pre-screening, at home test (though not authorized for at-home use yet). It tests for IgG and IgM antibodies, and is reported to be 92% accurate. |
| Phase of development | CE certified awaiting FDA EUA. |
| Proposed release | available for purchase by research labs/healthcare providers, CE/IVD approved |
| Date | Date not given |
| Country of development | Germany |
| Type of Serological Test | ELISAs |
| Authors/Company | Euroimmun AG |
| Description | This company has two tests, including EI 2606-9601 A, which tests for patient IgA, and EI 2606-9601 G, which tests for patient IgG. The target antigens were not stated, nor were specificity or sensitivity of tests. |
| Phase of development | Research use only, CE/IVD in EU |
| Proposed release | CE/IVD in the EU |
| Date | March 12, 2020 |
| Country of development | Germany |
| Type of Serological Test | RDT, lateral flow assay |
| Authors/Company | PharmACT |
| Description | This RDT tests for IgM and IgG of patients, with 92-98% sensitivity in later stages of the infection (day 11-24) with 100% sensitivity. |
| Phase of development | Research use only |
| Proposed release | Appears available for purchase by research labs/healthcare providers, but no clear approvals |
| Date | Date not given |
| Country of development | China |
| Type of Serological Test | RDT (colloidal gold lateral flow assay) |
| Authors/Company | Liming Bio |
| Description | COVID-19 IgG/IgM Combo Rapid Test Device is an RDT that tests for patient IgG and IgM antibodies. The sensitivity and specificity for total antibodies were 93.1 and 100%, respectively. For IgG, sensitivity is 82% and specificity is 100%. For IgM, the sensitivity is 62% and specificity is 100%. |
| Phase of development | CE/IVD |
| Proposed release | CE/IVD |
| Date | Feb. 2020 |
| Country of development | China |
| Type of Serological Test | Not listed |
| Authors/Company | Snibe Co |
| Description | The company provides two tests the 2019-nCoV IgG , and 2019-nCoV IgM tests. The test is a chemiluminescent immunoassay (CLIA). It has been clinically tested in China, though the exact specificity and sensitivity was not stated. |
| Phase of development | CE/IVD approved |
| Proposed release | available for purchase by research labs/healthcare providers, CE/IVD approved |
| Date | Feb. 19, 2020 |
| Country of development | China |
| Type of Serological Test | ELISA |
| Authors/Company | Beijing Wantai |
| Description | They offer, 1. Wantai SARS-CoV-2 Ab Rapid Test Kit, 2. Wantai SARS-CoV-2 IgM ELISA kit, and 3. Wantai SARS-CoV-2 Ab ELISA kit. The kits do not state which antigens are used as targets. 93.1% sensitivity and 100% specificity. |
| Phase of development | Approved for Research use only, unclear if available in the US |
| Proposed release | Released in China |
| Date | Feb. 25, 2020 |
| Country of development | China |
| Type of Serological Test | ELISA |
| Authors/Company | Shenzhen Yhlo Biotech Company |
| Description | This company provides 2 tests, the iFlash-SARS-CoV-2-IgG and the iFlash-SARS-CoV-2-IgM, which test for patient antibodies to the virus. The target antigen is not specified. The sensitivity of the IgG assay is over 90%, and specificity is over 95%. For the IgM test, the sensitivity and specificity are both over 95%, based on assaying over 1200 Chinese patient samples. |
| Phase of development | CE/IVD approved |
| Proposed release | available for purchase by research labs/healthcare providers, CE/IVD approved |
| Date | Feb. 27, 2020 |
| Country of development | China |
| Type of Serological Test | RDT (colloidal gold lateral flow assay) |
| Authors/Company | Sanuo Biotech |
| Description | The SARS-Cov-2 Antibody Test strip tests for patient IgG and IgM. The press release did not disclose sensitivity or specificity of the test. |
| Phase of development | CE/IVD approved |
| Proposed release | available for purchase by research labs/healthcare providers, CE/IVD approved |
| Date | March 12, 2020 |
| Country of development | China |
| Type of Serological Test | RDT (colloidal gold lateral flow assay) |
| Authors/Company | BioTime |
| Description | The SARS-CoV-2 IgG/IgM kit tests for patient antibodies to the virus from blood or plasma samples. There is no reported sensitivity or specificity. |
| Phase of development | Only approved for in vitro diagnostic use |
| Proposed release | available for purchase by research labs/healthcare providers |
| Date | Date not given |
| Country of development | The Republic of Korea |
| Type of Serological Test | RDT |
| Authors/Company | GenBody |
| Description | GenBody FIA COVID-19 IgM/IgG (COVI025) |
| Phase of development | Research use only, CE/IVD in EU |
| Proposed release | CE/IVD in the EU |
| Date | March 2, 2020 |
| Country of development | United Kingdom |
| Type of Serological Test | RDT |
| Authors/Company | Mologic |
| Description | Seems to be an RDT (probably to IgM and IgG). No description was given, other than 3.5 million tests were ordered. |
| Phase of development | UK has purchased 3.5 million, they are validating now with Liverpool Trop Med and St. Georges, London |
| Proposed release | Date not given |
| Date | March 29, 2020 |
| Country of development | China |
| Type of Serological Test | RDT |
| Authors/Company | Livzon Diagnostics |
| Description | RDT, lateral flow assay, which detects IgM and IgG to the nucelocapside protein of SARS-CoV-2. |
| Phase of development | Research use only, CE/IVD approved |
| Proposed release | available for purchase by research labs/healthcare providers |
| Date | Date not given |
| Country of development | USA |
| Type of Serological Test | Not stated, seems to be ELISA |
| Authors/Company | Emory University |
| Description | Emory University has developed a serological test for COVID-19. Details of the test, such as method, target antigen, and antibody type are not listed. The Clinical Immunology section of Emory Medical Laboratories (EML) plans to begin testing 300 people per day, scaling up to 5000 tests per day by June. They state that it will take one vial of blood. |
| Phase of development | Research use only, approved under FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 Section IV.A |
| Proposed release | April 2020 |
| Date | April 13, 2020 |
| Country of development | USA |
| Type of Serological Test | RDT |
| Authors/Company | Confirm Biosciences |
| Description | This RDT detects IgM and IgG, though the target antigen is unclear. Sensitivity appears to be 93.8%, and sensitivity is 99.1%, in 704 samples tested. The location of the trial was not disclosed. |
| Phase of development | Research use only, not approved by the FDA |
| Proposed release | Available for purchase by research labs/healthcare providers |
| Date | April 15, 2020 |
| Country of development | USA |
| Type of Serological Test | ELISA |
| Authors/Company | Abbott |
| Description | This test detects IgG to SARS-CoV-2, and must be used on the ARCHITECT® i1000SR and i2000SR laboratory instruments. Sensitivity and specificity are not yet disclosed |
| Phase of development | Not approved by the FDA, appears to be under Section IV.C. Set for distribution in mid-April 2020. |
| Proposed release | April 17, 2020 |
| Date | April 16, 2020 |
| Country of development | USA |
| Type of Serological Test | ELISA (not stated) |
| Authors/Company | Roche Elecsys® Anti-SARS-CoV-2 serology test |
| Description | This tests detects antibodies, including IgG, to SARS-CoV-2 using the cobas e analysers. The sensitivity and specificity have not yet been disclosed. |
| Phase of development | Not approved by the FDA, applying for EUA |
| Proposed release | Mid-May in countries accepting the CE mark |
| Date | April 17, 2020 |
Tests that are still in development
| Country of development | US |
| Type of Serological Test | CRISPR-based lateral flow assay |
| Authors/Company | Broughton et al (Mammoth Biosciences) |
| Description | Using a CRISPR-Cas12 based method, they can specifically detect virus RNA for the E and N genes. This is called the DETECTR assay, and does not assay for patient antibodies, but the presence of viral RNA. The CRISPR-Cas12 RNA targeting is followed by isothermal amplification of the target, resulting in a visual readout with a fluorophore.This was 90% sensitive and 100% specific. |
| Phase of development | Pre-clinical |
| Proposed release | In development |
| Date | March 10, 2020 |
| Country of development | US |
| Type of Serological Test | Not stated |
| Authors/Company | CDC |
| Description | They are now beginning testing in specific populations, 1) people who have not been diagnosed but live in a COVID-19 hotspot, 2) a later national survey, and 3) populations like healthcare workers. |
| Phase of development | Clinical |
| Proposed release | Not given |
| Date | April 4, 2020 |
| Country of developmentU | US |
| Type of Serological Test | ELISA |
| Authors/Company | Amanat et al. |
| Description | An ELISA based method using recombinant receptor binding domain (RBD) regions of the spike protein or the full length spike protein. COVID-19 patient sera was most reactive to the full length spike protein, while non-COVID-19 patient sera did not react to either protein above background |
| Phase of development | Pre-clinical |
| Proposed release | Not stated |
| Date | March 18, 2020 |
| Country of development | US |
| Type of Serological Test | Proprietary |
| Authors/Company | United Biomedical (UBI)/ c19 |
| Description | This kit is being tested in a small community in Colorado, in partnership with the Public Health Department of San Miguel County, to test all residents for a SARS-Cov-2 antibody. The assay is testing for antibodies to recombinant fragments of the S, N, and M proteins. So far, the test has 100% sensitivity and specificity after day 10 of symptoms, according to their website. This has not been approved by the FDA. They also state that “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” |
| Phase of development | In testing in San Miguel, CO |
| Proposed release | Ongoing trials in Colorado, no stated release date |
| Date | March 19, 2020 |
| Country of development | Netherlands |
| Type of Serological Test | ELISA |
| Authors/Company | Okba et al |
| Description | Modifying existing beta version ELISA kits (EUROIMMUN Medizinische Labordiagnostika AG) for IgG or IgA, and an in-house ELISA kit, they coated plates with recombinant S1 domain of the spike protein. The commercially available kits are not yet approved for use. They found that the kits were sensitive and specific for the S1 region of SARS-CoV-2, looking at 45 samples overall. |
| Phase of development | Pre-clinical |
| Proposed release | Not stated |
| Date | March 20, 2020 |
| Country of development | China |
| Type of Serological Test | RDT |
| Authors/Company | Jiangsu bioPerfectus technologies |
| Description | This company has two tests, the PerfectPOC Novel Corona Virus (SARS-CoV-2) IgM/IgG Rapid Test Kit and the PerfectPOC Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit. The IgM/IgG test assays for patient antibodies to the virus from a blood sample, while the Ag Rapid test assays for SARS-CoV-2 antigen from nasal swab samples. |
| Phase of development | Developed, awaiting approval |
| Proposed release | Appears available for purchase by research labs/healthcare providers in China, but no clear approvals |
| Date | March 3, 2020 |
| Country of development | China |
| Type of Serological Test | RDT |
| Authors/Company | Wuhan EasyDiagnosis Biomedicine Ltd |
| Description | The SARS-CoV-2 IgM/IgG Antibody test kit uses blood or plasma samples to detect patient antibodies. There is no listed sensitivity or specificity |
| Phase of development | No clear approvals |
| Proposed release | available for purchase by research labs/healthcare providers, but no clear CE or FDA approvals |
| Date | Date not given |
| Country of development | Belgium |
| Type of Serological Test | Dipstick (lateral flow assay) |
| Authors/Company | Coris Bioconcept |
| Description | This lateral flow assay detects SARS-CoV-2 antigen in nasal mucus samples. The sensitivity was approximately 60% when tested in two different hospitals. |
| Phase of development | Clinically testing |
| Proposed release | available for purchase by research labs/healthcare providers, does not appear to have any approvals |
| Date | March 24, 2020 |
| Country of development | US |
| Type of Serological Test | ELISA |
| Authors/Company | Vitalant/UCSF |
| Description | It appears that Vitalant (a blood donation company) and UCSF have teamed up to make an in-house antibody test for SARS-CoV-2. It is an ELISA based assay, though they have not disclosed which antibodies are detected. |
| Phase of development | In development |
| Proposed release | Date not given |
| Date | March 31, 2020 |
| Country of development | US |
| Type of Serological Test | ELISA |
| Authors/Company | Klein lab, JHSPH |
| Description | They have adapted an ELISA, based on Amanat et al 2020, that tests for IgG and IgM to the full length Spike protien and to the receptor binding domain (RBD). They are now working to get a mucosal IgA ELISA working. So far, they are using the kit to test samples from Johns Hopkins Hospital. |
| Phase of development | Pre-clinical |
| Proposed release | Not given, but being used for research use |
| Date | April 6, 2020 |
| Country of development | China |
| Type of Serological Test | ELISA |
| Authors/Company | Zhang et al |
| Description | This group developed an in-house ELISA testing for patient antibodies (IgM and IgG) to the SARSr-CoV Rp3 nucleocapside (N) protein. They found that on day 5, 81% of patients were positive for IgM and 100% were positive for IgG (of 16 COVID-19 positive patients). |
| Phase of development | Pre-clinical |
| Proposed release | Not given |
| Date | February 17, 2020 |