CORONAVIRUS TESTS -WHAT’S AVAILABLE, WHAT’S COMING, WHAT’S IN TRIAL – JUST THE FACTS (APRIL 2020)

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 testTime to resultsWhat it tells usWhat it cannot tell usFigure
Rapid diagnostic test (RDT)10-30 minutesThe 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 infectionRDT figure
Enzyme linked immunosorbent assay (ELISA)1-5 hoursThe 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 assay3-5 daysThe 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 developmentUS/China
Type of Serological TestRDT
Authors/CompanyCellex Inc.
DescriptionRDT, 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 developmentApproved by FDA for EUA on diagnostics, has CE approval
Proposed releaseavailable for purchase by research labs/healthcare providers (product number 5513)
DateApril 1, 2020
Country of developmentUSA
Type of Serological TestRDT
Authors/CompanyChemBio
DescriptionThis test detects IgM and IgG antibodies to the nucleocapsid (N) protein of SARS-CoV-2. Sensitivity and specificity values were not released.
Phase of  developmentApproved for EUA by the FDA
Proposed releaseApril 14, 2020
DateApril 15, 2020
Country of developmentUSA
Type of Serological TestModified ELISA
Authors/CompanyVITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack/Total Calibrator (Ortho Clinical Diagnostics)
DescriptionThis 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  developmentApproved for EUA by the FDA
Proposed releaseApril 14, 2020
DateApril 15, 2020
Country of developmentUSA
Type of Serological TestELISA
Authors/CompanyMount Sinai Laboratory COVID-19 ELISA IgG Antibody Test
DescriptionThis 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  developmentApproved for EUA by the FDA
Proposed releaseApril 15, 2020
DateApril 16, 2020

Tests approved outside the United States

Country of developmentUS/China
Type of Serological TestRDT, solid phase immunochromatographic assay
Authors/CompanyAytu Biosciences/Orient Gene Biotech
DescriptionThe (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 developmentCE approved, used in China in clinical settings, awaiting FDA approval
Proposed releaseShipments should be ready by early April
DateMarch 10, 2020
Country of developmentUS/China
Type of Serological TestProprietary
Authors/CompanyScanWell Health/INNOVITA
DescriptionThis 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 developmentCleared by China’s National Medical Products Administration (NMPA), and pending approval by US FDA
Proposed release6-8 weeks (May 1 to May 15), depending on FDA approval date
DateMarch 20, 2020
Country of developmentSingapore
Type of Serological TestNot explicity stated, though their “gold standard” is a neutralization assay
Authors/CompanySingapore/ Wang Lab
DescriptionThe 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 developmentDeployed in Singapore
Proposed releaseNot stated
DateMarch 1, 2020
Country of developmentChina
Type of Serological TestLateral flow assay (RDT)
Authors/CompanyGuangzhou Wondfo Biotech Co Ltd
DescriptionWondfo 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 developmentCE/IVD, approved by NMPA in China for point of care testing
Proposed releaseCE/IVD in the EU
DateFeb. 22, 2020
Country of developmentChina
Type of Serological TestRDT (colloidal gold lateral flow assay)
Authors/CompanyGuangdong Hecin-Scientific
DescriptionTests for IgM against SARS-CoV-2.
Phase of developmentCleared by China’s National Medical Products Administration (NMPA)
Proposed releaseApproved for use in China
DateFeb. 22, 2020
Country of developmentChina
Type of Serological TestRDT
Authors/CompanyDynamiker
DescriptionThe test, DNK-1419-1, assays for patient IgG and IgM with 92% accuracy.
Phase of developmentThe NMPA has approved it in the 7th edition of Diagnostic and treatment protocol of COVID-19
Proposed releaseUsed in China, no other approvals to date
DateDate not given
Country of developmentThe Republic of Korea
Type of Serological TestRDT
Authors/CompanySD Biosensor
DescriptionUS supplier Henry Schein will distribute the test for IVD use only
Phase of  developmentApproved for diagnostic us outside the US, Research use only in US
Proposed release2-3 weeks
DateMarch 26, 2020
Country of developmentUS
Type of Serological TestELISA
Authors/CompanyMayoClinic/University of Minnesota
DescriptionMayoClinic 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  developmentClinical
Proposed releaseApril 6, 2020
DateApril 1, 2020
Country of developmentUSA
Type of Serological TestRDT
Authors/CompanyAdvaite
DescriptionRapCov 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  developmentResearch use only (IVD), not approved for diagnostic use. This company was not found on any FDA categorization of tests
Proposed releaseApril 2020
DateApril 6, 2020

Tests approved for research or surveillance purposes

Country of developmentUS
Type of Serological TestELISA
Authors/CompanyEpitope Diagnostics, Ltd
DescriptionKT-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 developmentApproved 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 releaseOngoing
DateMarch 3, 2020
Country of developmentUS
Type of Serological TestRDT
Authors/CompanyCTK Biotech
DescriptionThe test, COVID-19 IgG/IgM Rapid Test, tests for patient IgG and IgM in a lateral flow assay.
Phase of developmentNot approved for use in the US, but available for purchase by research labs/healthcare providers
Proposed releaseavailable for purchase by research labs/healthcare providers and export out of the US
DateMarch 12, 2020
Country of developmentUS
Type of Serological TestRDT (colloidal gold lateral flow assay)
Authors/CompanyBioMedomics
DescriptionThis 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 developmentCE/IVD, approved by FDA but only for research use
Proposed releaseCE/IVD, available for purchase by research labs/healthcare providers in the US, but only for research use
DateMarch 16, 2020
Country of developmentUS
Type of Serological TestRDT
Authors/CompanyRay Biotech
DescriptionThis 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 developmentCE/IVD, approved for research use only in the US. Approved for research use under FDA EUA.
Proposed releaseavailable for purchase by research labs/healthcare providers, CE/IVD approved
DateMarch 19, 2020
Country of developmentUS
Type of Serological TestELISA
Authors/CompanyCreative Diagnostics
DescriptionKit 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 developmentNot approved for diagnostic use; for research use only
Proposed releaseavailable for purchase by research labs/healthcare providers, but not for diagnostic use
DateMarch 20, 2020
Country of developmentUS
Type of Serological TestELISA
Authors/CompanyEagle Biosciences
DescriptionThis 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 developmentResearch use only, CE/IVD outside the US
Proposed releaseavailable for purchase by research labs/healthcare providers, but not for diagnostic use
DateDate not given
Country of developmentChina/US
Type of Serological TestRDT
Authors/CompanySure Biotech
DescriptionThe Coronavirus Rapid Test assays for IgG and IgM antibody in blood or plasma samples, with 92-96% accuracy.
Phase of developmentCE approved
Proposed releaseavailable for purchase by research labs/healthcare providers, CE approved
DateFeb. 2020
Country of developmentChina/US
Type of Serological TestRDT, immunofluorescence, colloidal gold
Authors/CompanyBioEasy/Shenzhen BioEasy Biotechnology Co.
DescriptionThere 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 developmentCE/IVD approved
Proposed releaseavailable for purchase by research labs/healthcare providers, CE/IVD approved
DateDate not given
Country of developmentThe Republic of Korea
Type of Serological TestRDT (colloidal gold lateral flow assay)
Authors/CompanySugentech
DescriptionThis 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 developmentCE/IVD approved
Proposed releaseavailable for purchase by research labs/healthcare providers, CE/IVD approved
DateDate not given
Country of developmentThe Republic of Korea
Type of Serological TestRDT
Authors/CompanySD Biosensor
DescriptionThis 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 developmentKorea EUA approved
Proposed releaseavailable for purchase by research labs/healthcare providers, but not for diagnostic use
DateDate not given
Country of developmentSingapore
Type of Serological TestRDT, prescreen step
Authors/CompanySensing self
DescriptionThis 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 developmentCE certified awaiting FDA EUA.
Proposed releaseavailable for purchase by research labs/healthcare providers, CE/IVD approved
DateDate not given
Country of developmentGermany
Type of Serological TestELISAs
Authors/CompanyEuroimmun AG
DescriptionThis 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 developmentResearch use only, CE/IVD in EU
Proposed releaseCE/IVD in the EU
DateMarch 12, 2020
Country of developmentGermany
Type of Serological TestRDT, lateral flow assay
Authors/CompanyPharmACT
DescriptionThis 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 developmentResearch use only
Proposed releaseAppears available for purchase by research labs/healthcare providers, but no clear approvals
DateDate not given
Country of developmentChina
Type of Serological TestRDT (colloidal gold lateral flow assay)
Authors/CompanyLiming Bio
DescriptionCOVID-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 developmentCE/IVD
Proposed releaseCE/IVD
DateFeb. 2020
Country of developmentChina
Type of Serological TestNot listed
Authors/CompanySnibe Co
DescriptionThe 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 developmentCE/IVD approved
Proposed releaseavailable for purchase by research labs/healthcare providers, CE/IVD approved
DateFeb. 19, 2020
Country of developmentChina
Type of Serological TestELISA
Authors/CompanyBeijing Wantai
DescriptionThey 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 developmentApproved for Research use only, unclear if available in the US
Proposed releaseReleased in China
DateFeb. 25, 2020
Country of developmentChina
Type of Serological TestELISA
Authors/CompanyShenzhen Yhlo Biotech Company
DescriptionThis 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 developmentCE/IVD approved
Proposed releaseavailable for purchase by research labs/healthcare providers, CE/IVD approved
DateFeb. 27, 2020
Country of developmentChina
Type of Serological TestRDT (colloidal gold lateral flow assay)
Authors/CompanySanuo Biotech
DescriptionThe 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 developmentCE/IVD approved
Proposed releaseavailable for purchase by research labs/healthcare providers, CE/IVD approved
DateMarch 12, 2020
Country of developmentChina
Type of Serological TestRDT (colloidal gold lateral flow assay)
Authors/CompanyBioTime
DescriptionThe 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 developmentOnly approved for in vitro diagnostic use
Proposed releaseavailable for purchase by research labs/healthcare providers
DateDate not given
Country of developmentThe Republic of Korea
Type of Serological TestRDT
Authors/CompanyGenBody
DescriptionGenBody FIA COVID-19 IgM/IgG (COVI025)
Phase of developmentResearch use only, CE/IVD in EU
Proposed releaseCE/IVD in the EU
DateMarch 2, 2020
Country of developmentUnited Kingdom
Type of Serological TestRDT
Authors/CompanyMologic
DescriptionSeems to be an RDT (probably to IgM and IgG). No description was given, other than 3.5 million tests were ordered.
Phase of  developmentUK has purchased 3.5 million, they are validating now with Liverpool Trop Med and St. Georges, London
Proposed releaseDate not given
DateMarch 29, 2020
Country of developmentChina
Type of Serological TestRDT
Authors/CompanyLivzon Diagnostics
DescriptionRDT, lateral flow assay, which detects IgM and IgG to the nucelocapside protein of SARS-CoV-2.
Phase of  developmentResearch use only, CE/IVD approved
Proposed releaseavailable for purchase by research labs/healthcare providers
DateDate not given
Country of developmentUSA
Type of Serological TestNot stated, seems to be ELISA
Authors/CompanyEmory University
DescriptionEmory 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  developmentResearch use only, approved under FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 Section IV.A
Proposed releaseApril 2020
DateApril 13, 2020
Country of developmentUSA
Type of Serological TestRDT
Authors/CompanyConfirm Biosciences
DescriptionThis 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  developmentResearch use only, not approved by the FDA
Proposed releaseAvailable for purchase by research labs/healthcare providers
DateApril 15, 2020
Country of developmentUSA
Type of Serological TestELISA
Authors/CompanyAbbott
DescriptionThis 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  developmentNot approved by the FDA, appears to be under Section IV.C. Set for distribution in mid-April 2020.
Proposed releaseApril 17, 2020
DateApril 16, 2020
Country of developmentUSA
Type of Serological TestELISA (not stated)
Authors/CompanyRoche Elecsys® Anti-SARS-CoV-2 serology test
DescriptionThis 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  developmentNot approved by the FDA, applying for EUA
Proposed releaseMid-May in countries accepting the CE mark
DateApril 17, 2020

Tests that are still in development

Country of developmentUS
Type of Serological TestCRISPR-based lateral flow assay
Authors/CompanyBroughton et al (Mammoth Biosciences)
DescriptionUsing 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 developmentPre-clinical
Proposed releaseIn development
DateMarch 10, 2020
Country of developmentUS
Type of Serological TestNot stated
Authors/CompanyCDC
DescriptionThey 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 developmentClinical
Proposed releaseNot given
DateApril 4, 2020
Country of developmentUUS
Type of Serological TestELISA
Authors/CompanyAmanat et al.
DescriptionAn 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 developmentPre-clinical
Proposed releaseNot stated
DateMarch 18, 2020
Country of developmentUS
Type of Serological TestProprietary
Authors/CompanyUnited Biomedical (UBI)/ c19
DescriptionThis 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 developmentIn testing in San Miguel, CO
Proposed releaseOngoing trials in Colorado, no stated release date
DateMarch 19, 2020
Country of developmentNetherlands
Type of Serological TestELISA
Authors/CompanyOkba et al
DescriptionModifying 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 developmentPre-clinical
Proposed releaseNot stated
DateMarch 20, 2020
Country of developmentChina
Type of Serological TestRDT
Authors/CompanyJiangsu bioPerfectus technologies
DescriptionThis 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 developmentDeveloped, awaiting approval
Proposed releaseAppears available for purchase by research labs/healthcare providers in China, but no clear approvals
DateMarch 3, 2020
Country of developmentChina
Type of Serological TestRDT
Authors/CompanyWuhan EasyDiagnosis Biomedicine Ltd
DescriptionThe 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 developmentNo clear approvals
Proposed releaseavailable for purchase by research labs/healthcare providers, but no clear CE or FDA approvals
DateDate not given
Country of developmentBelgium
Type of Serological TestDipstick (lateral flow assay)
Authors/CompanyCoris Bioconcept
DescriptionThis 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 developmentClinically testing
Proposed releaseavailable for purchase by research labs/healthcare providers, does not appear to have any approvals
DateMarch 24, 2020
Country of developmentUS
Type of Serological TestELISA
Authors/CompanyVitalant/UCSF
DescriptionIt 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  developmentIn development
Proposed releaseDate not given
DateMarch 31, 2020
Country of developmentUS
Type of Serological TestELISA
Authors/CompanyKlein lab, JHSPH
DescriptionThey 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  developmentPre-clinical
Proposed releaseNot given, but being used for research use
DateApril 6, 2020
Country of developmentChina
Type of Serological TestELISA
Authors/CompanyZhang et al
DescriptionThis 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  developmentPre-clinical
Proposed releaseNot given
DateFebruary 17, 2020