COVID-19 Técnicas de ELISA / CLIA Disponibles

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.
Sensitivity
Specificity
Phase of  development Approved for EUA by the FDA
Proposed release April 15, 2020
Date April 16, 2020

 

Country of development USA
Type of Serological Test Chemiluminescent immunoassay
Authors/Company Ortho-Clinical Diagnostics, Inc.
Description This test detects IgG and is designed to be used with VITROS Immunodiagnostic Products and the VITROS ECi/ECiQ/3600 Immunodiagnostic System and the VITROS 5600/XT 7600 Integrated Systems. Sensitivity was approximately 87.5% and specificity is approximately 100%.
Sensitivity
Specificity
Phase of  development Approved for EUA by the FDA
Proposed release Current
Date April 24, 2020

 

Country of development USA
Type of Serological Test ELISA
Authors/Company DiaSorin Inc.
Description This test is designed to run on the LIAISON XL analyzer and detects IgG specific to recombinant spike protein subunits 1 and 2 (S1 and S2). Specificity was approximately 98%. Sensitivity was approximately 90% on samples obtained 5-15 days post-symptom onset. For samples taken greater than 15 days post-symptom onset, the sensitivity was approximately 97%.
Sensitivity 90-97%
Specificity 98%
Phase of  development Approved for EUA by the FDA
Proposed release Current
Date April 24, 2020

 

Country of development USA
Type of Serological Test Chemiluminescent microparticle immunoassay (CMIA)
Authors/Company Abbott Laboratories Inc.
Description This test detects IgG by measuring antibody-antigen binding in terms of relative light units (RLU). It is intended to be used with the ARCHITECT i1000SR and i2000SR systems.
Sensitivity
Specificity
Phase of  development Received EUA by the FDA
Proposed release Current
Date April 26, 2020

 

Country of development US
Type of Serological Test Modified ELISA
Authors/Company Bio-Rad
Description The Platelia SARS-CoV-2 Total Ab assay measures IgM, IgG, and IgA antibodies to SARS-CoV-2. The target antigen is recombinant nucleocapsid protein, coupled with peroxidase that provides the read-out. Human serum or plasma samples are required.The sensitivity and specificity are not yet known, though it appears the readout of the assay may be quantiative or qualitative.
Sensitivity 98%
Specificity 99%
Phase of  development Received EUA
Proposed release Current
Date April 29, 2020

 

Country of development US
Type of Serological Test Microsphere immunoassay
Authors/Company Wadsworth Center, New York State Department of Health
Description This test assays for total antibodies (IgG, IgM, and IgA) in human serum samples. The test uses full-length recombinant nucleocapsid protein from SARS-CoV-1 (it is stated that the sequence is similar enough to use the other virus’ N protein-90% homologous). The test should be run with a Luminex FlexMap dual laser cytometer.
Sensitivity Not stated
Specificity 93-100%
Phase of  development Received EUA, available for purchase by healthcare professionals and researchers.
Proposed release Current
Date April 30, 2020

 

Country of development US/Switzerland
Type of Serological Test electro-chemiluminescence immunoassay (ECLIA)
Authors/Company Roche
Description The test couples chemiluminescence immunoassay technology with an electric pulse that allows for rapid quantifiation of captured antigen-antibody complexes from patient serum samples. The target antigen is the viral N protein.The test assays for IgM and IgG, and takes about 18 minutes. The test should be run on the Elecsys Anti-SARS-CoV-2 on the cobas e 411, cobas e 601, cobas e 602, or cobas e 801 analyzers. Sensitivity was determined from 204 samples, and specificity from 5,272 negative samples.
Sensitivity From 0-6 days, 65.5%; from 7-13 days, 88.1%; from 14 days onward, 100%
Specificity 99.81%
Phase of  development Received EUA, available for purchase by healthcare professionals and researchers.
Proposed release Current
Date May 2, 2020

 

Country of development Germany
Type of Serological Test ELISA
Authors/Company Euroimmun AG
Description The Euroimmun AG IgG ELISA assay uses the viral S1 region of the spike protein to quantify IgG antibodies present in serum samples. Sensitivity and specificity were determined compared to onset of symptoms in PCR positive and negative samples. Sample sizes varied over time.
Sensitivity From 0-10 days, 13.9%; from 11-20 days, 61.1%; from 21 days onward, 100%. 90% by NCI validation
Specificity 100% by NCI validation
Phase of  development Received EUA, available for purchase by healthcare professionals and researchers.
Proposed release Current
Date May 4, 2020

 

Country of development US
Type of Serological Test CLIA
Authors/Company Siemens Healthcare Diagnostics Inc.
Description This CLIA based assay uses the Atellica platform to detect total antibody to the S1 receptor binding domain. The test is fully automated, all-in-one step sandwich chemiluminescent immunoassay. It uses streptavidin-biotin based capture. Sensitivity was from 250 clinical positive samples, with times since PCR positivity listed. Specificity was determined from 1091 samples, including 98 pregnant women.
Sensitivity 60.7% (0-6 days post PCR positive),97.5% (7-13 days post PCR positive), 100% (14+ days post PCR positive).
Specificity 99.82%%
Phase of  development Received EUA, available for purchase by healthcare professionals and researchers.
Proposed release Current, their website states that there are already over 20,000 analyzers installed, and there should be mass availability.
Date June 1, 2020

 

Country of development US
Type of Serological Test CLIA
Authors/Company Siemens Healthcare Diagnostics Inc.
Description This CLIA based assay uses the ADVIA Centaur platform to detect total antibody to the S1 receptor binding domain. The test is fully automated, all-in-one step sandwich chemiluminescent immunoassay. It uses streptavidin-biotin based capture. Sensitivity was determined using 262 clinical samples, with times listed post PCR postivity. Specificity was from 1589 people, including 100 pregnant women.
Sensitivity 65.1% (0-6 days post PCR positive),97.5% (7-13 days post PCR positive), 100% (14+ days post PCR positive).
Specificity 99.81%%
Phase of  development Received EUA, available for purchase by healthcare professionals and researchers.
Proposed release Current, their website states that there are already over 20,000 analyzers installed, and there should be mass availability.
Date June 1, 2020

 

Country of development US
Type of Serological Test ECLIA (electrochemiluminescence immunoassay)
Authors/Company Roche Diagnostics
Description Elecsys IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum and plasma. This assay is used to assist in identifying severe inflammatory response in patients with confirmed COVID-19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. The Elecsys IL-6 immunoassay is an electrochemiluminescence immunoassay “ECLIA” and is intended for use on cobas e immunoassay analyzers.
Sensitivity 84%
Specificity 63%
Phase of  development Received EUA and CE/IVD, available for purchase by healthcare professionals and researchers.
Proposed release Current
Date June 2, 2020

 

Country of development US
Type of Serological Test CLIA
Authors/Company Vibrant America Clinical Labs
Description The Vibrant COVID-19 Ab assay is a chemiluminescence immunoassay (CLIA) intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum or Dry Blood Spot (DBS) using fingerstick blood specimen collected by their health care provider.
Sensitivity 98.1%
Specificity 98.6%
Phase of  development Received EUA, available for purchase by healthcare professionals and researchers.
Proposed release Current
Date June 4, 2020

 

Country of development US
Type of Serological Test CLIA
Authors/Company Siemens Healthcare Diagnostics Inc.
Description The Dimension Vista COV2T assay is a chemiluminescent immunoassay used for the detection of total antibodies to SARS‑CoV‑2 in human serum and plasma from patients who may have been exposed to coronavirus disease (COVID‑19). The Dimension Vista COV2T assay is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI technology.
Sensitivity 97.3%
Specificity 99.8%
Phase of  development Received EUA, available for purchase by healthcare professionals and researchers.
Proposed release Current
Date June 8, 2020

 

Country of development US
Type of Serological Test CLIA
Authors/Company Siemens Healthcare Diagnostics Inc.
Description The Dimension EXL CV2T assay is a chemiluminescent immunoassay used for the detection of total antibodies to SARS‑CoV‑2 in human serum and plasma from patients who may have been exposed to coronavirus disease (COVID‑19). The Dimension EXL CV2T assay is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI technology. The LOCI reagents include two synthetic bead reagents and a biotinylated S1 RBD antigen.
Sensitivity 97.3%
Specificity 99.8%
Phase of  development Received EUA, available for purchase by healthcare professionals and researchers.
Proposed release Current
Date June 8, 2020

 

Country of development US
Type of Serological Test ELISA
Authors/Company InBios International, Inc.
Description The SCoV-2 Detect™ IgG ELISA is a qualitative immunoassay for the detection of IgG antibodies targeting SCoV-2 related antigens. Diluted serum specimens are added to antigencoated wells and incubated. After incubation and washing, human antibodies targeting SARS-CoV-2 antigens remain bound to the plate surface. Secondary antibody conjugated to horseradish peroxidase (HRP) targeting human IgG is then added to each well. After incubation, the ELISA wells are washed once again before a tetramethylbenzidine (TMB) substrate is added. An acidic stopping solution is finally used to stop the reaction and the degree of enzymatic turnover of the substrate is determined by absorbance measurement at 450 nanometers.
Sensitivity 97.8%
Specificity 98.9%
Phase of  development Received EUA, available for purchase by healthcare professionals and researchers.
Proposed release Current
Date June 10, 2020

 

Country of development US
Type of Serological Test ELISA
Authors/Company Emory University
Description This test detects IgG antibodies specific to a recombinant receptor binding domain (RBD) of the spike protein. It should be run on the BioTek 800 TS Absorbance Reader. Sensitivity was determined from 231 positive samples, and specificity from 388 negative samples–including samples taken prior to the pandemic and rRT-PCR negative health care workers during the pandemic. These results were stratified based on days post-positive rRT-PCR.
Sensitivity 73% (days 0-7), 100% (days 8-14), 100% (days 14+)
Specificity 97.7% (prior to pandemic), 94.4% (PCR negative HCW)
Phase of  development Received EUA by the FDA
Proposed release Current, Emergency use of this test is limited to the Emory Medical Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA)
Date June 15, 2020

 

Country of development US
Type of Serological Test Chemiluminescent immunoassay/indirect sandwich immunoassay
Authors/Company Babson Diagnostics
Description This test is a CLIA based assay that detects IgG antibodies. The target antigen is the S1 region of the spike protein. The test should be run on the Siemens Atellica IM platform. Sensitivity was determined from 34 positive samples, stratified by time post symptom onset and 2 of which were asymptomatic individuals. Specificity was determined from 100 individuals.
Sensitivity 66.7% (8-14 days), 100% (15+ days), 100% (asymptomatic)
Specificity 100%
Phase of  development Received EUA by the FDA
Proposed release Current, but only to be used at Babson Diagnostics
Date June 23, 2020

 

Country of development US
Type of Serological Test Chemiluminescent immunoassay
Authors/Company Beckman Coulter, Inc.
Description This is a two step CLIA that uses the target antigen of the receptor binding domain of S1 of the spike protein. It detects IgG in patient samples. Sensitivity was determined using 192 positive clinical samples, stratified by time since symptom onset. Specificity was determined from 1400 samples collected before December 2019.
Sensitivity 75% (0-7 days), 95.3% (8-14 days), 96.8% (15+ days)
Specificity 100%
Phase of  development Received EUA by the FDA
Proposed release Current
Date June 26, 2020

 

Country of development US
Type of Serological Test ELISA
Authors/Company InBios International, Inc.
Description This kit specifically tests for IgM present in patient serum. The target antigen is not stated. Samples for testing should only be taken between 7 days to 64 days post symptom onset. Samples taken before 12 days post-symptom onset that test negative should be re-tested using a second, molecular method. Samples, taken after 12 days post symptom onset, that are negative should also be tested for IgG. Sensitivity was determined from 120 positive clinical samples, and specificity from 95 negative samples. Sensitivity presented is overall sensitivity, but the company does list varied sensitivity stratified by time post symptom onset. In general, the greater number of days post symptom onset, the more sensitive the assay.
Sensitivity 92.5%
Specificity 98.5%
Phase of  development Received EUA
Proposed release Current
Date June 30, 2020

 

Country of development US
Type of Serological Test CLIA
Authors/Company Diazyme Laboratories, Inc.
Description The Diazyme DZ-Lite SARS-CoV-2 IgG CLIA Kit is an indirect chemiluminescence immunoassay. The light signal is measured by the DZ-lite 3000 Plus Chemiluminescence Analyzer as relative light units (RLUs), which is evaluated against the established cutoff to determine the final result. The product contains a Low and a High Calibrator to execute calibration operation.
Sensitivity 91.7%
Specificity 97.4%
Phase of  development Received EUA
Proposed release Current
Date 7/8/2020

 

 

Country of development US
Type of Serological Test Fluorescent microbead-based immunoassay (FMIA)
Authors/Company Luminex
Description This is a multiplexed, bead based assay that tests for antibodies against the nucleocapsid protein, the receptor binding domain of spike, and the S1 subunit of spike protein. The test should be run using the Luminex® xMAP technology and works with Luminex 200, MAGPIX, and FLEXMAP 3D System. This test is specific for IgG. Sensitivity was determined from 112 serum samples, stratified by time since symptom onset. Specificity was from 309 negative serum samples. They also tested plasma sensitivity, stratified by time (n=46). They validated sensitivity and specificity on all platforms suitable for the test.
Sensitivity Serum: 71% (days 0-7), 71.4% (8-14 days), 96.2% (14+ days); Plasma: 100% (0-7 days), 82% (8-14 days), 96.6% (14+ days)
Specificity Serum: 100%, Plasma: 99.2%
Phase of  development Received FDA EUA
Proposed release Current
Date July 16, 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.
Sensitivity
Specificity
Phase of  development Clinical
Proposed release April 6, 2020
Date April 1, 2020

 

Country of development Switzerland
Type of Serological Test MIRA – Multiplexed Immuno-Refractive Assay
Authors/Company Quotient
Description An antibody microarray running on the CE marked MosaiQ instrument. The test looks for both IgM and IgM. Time to initial results is 35 minutes and the machine can process 1000 microarrays in an eight hour shift.
Sensitivity 100%
Specificity 99.8%
Phase of  development CE/IVD; in process of applying for FDA EUA
Proposed release Currently available in Europe; manufacturing capacity of 30M per year rate in 2020, 60M per year within 18 months
Date May 1, 2020

 

Country of development Spain
Type of Serological Test Double Recognition ELISA
Authors/Company Ingenasa (via Gold Standard Diagnostics)
Description The INgezim COVID assays use the SARS-CoV-2 nucleoprotein (N protein) as the antigen for the detection of antibodies to SARS-CoV-2. This test can use serum or plasma samples. The test uses SARS-CoV-2 recombinant N protein as a coating and conjugate. Sensitivity and specificity were determined using 116 positive samples and 249 negative samples.
Sensitivity 98.3%
Specificity 99.2%
Phase of  development Received CE mark; undergoing FDA EUA review
Proposed release Current
Date

 

Country of development US
Type of Serological Test ELISA
Authors/Company Gold Standard Diagnostics
Description The GSD SARS-CoV-2 IgG / IgM / IgA ELISA kits are intended for the qualitative detection of antibodies to SARS-CoV-2 virus in human serum and plasma.
Sensitivity IgG: 100% (>12 days)
IgM: 44% (>12 days)
IgA: 88.9% (>12 days)
Specificity IgG: 100%
gM: 99%
IgA: 100%
Phase of  development Received CE mark; undergoing FDA EUA review
Proposed release Current
Date

 

Country of development Germany
Type of Serological Test ELISA
Authors/Company VIROTECH Diagnostics GmbH (via Gold Standard Diagnostics)
Description The VIROTECH SARS-CoV-2 IgG / IgM / IgA ELISA kits are intended for the qualitative detection of antibodies to SARS-CoV-2 virus in human serum.
Sensitivity IgG:100% (>12 days)
IgM: 77.8% (>12 days)
IgA: 77.8% (>12 days)
Specificity IgG: 100%
IgM: 100%
IgA: 100%
Phase of  development Recieved CE mark; undergoing FDA EUA review
Proposed release Current
Date

 

Country of development Germany
Type of Serological Test ELISA
Authors/Company NovaTec Immundiagnostica GmbH (via Gold Standard Diagnostics)
Description There are 3 NovaLisa tests for COVID-19 IgG, IgM, and IgA. The ELISA tests can use serum or plasma samples.
Sensitivity IgG: 100% (>12 days)
IgM: 40% (>12 days)
IgA: 88.9% (>12 days)
Specificity IgG: 99.3%
IgM: 100%
IgA: 98.3%
Phase of  development Recieved CE mark; undergoing FDA EUA review
Proposed release Current
Date

 

Country of development UK
Type of Serological Test ELISA
Authors/Company Erba Mannheim (IgG test)
Description The ErbaLisa COVID-19 IgG Enzyme Immunoassay (ELISA) kit for the detection of IgG antibodies to SARS-CoV-2 in human serum. The total incubation time is 50 min at room temperature with a simple one step serum dilution.
Sensitivity 98.3%
Specificity 98.1%
Phase of  development Received CE mark, FDA Notification status (not yet EUA)
Proposed release Current
Date

 

Country of development UK
Type of Serological Test ELISA
Authors/Company Erba Mannheim (IgM test)
Description The ErbaLisa COVID-19 IgM Enzyme Immunoassay (ELISA) kit for the detection of IgM antibodies to SARS-CoV-2 in human serum.The total incubation time is 50 min at room temperature with a simple one step serum dilution.
Sensitivity 100%
Specificity 90%
Phase of  development Received CE mark, FDA Notification status (not yet EUA)
Proposed release Current
Date

 

Country of development US
Type of Serological Test CLIA
Authors/Company PerkinElmer
Description The SuperFlex™ Anti-SARS-CoV-2 IgG kit product is an immunoassay intended for qualitative detection of anti-SARS-CoV-2 IgG in human serum, plasma (EDTA, sodium citrate) and venous whole blood on Automated chemiluminescence analyzer. The test is performed using superparamagnetic microparticles together with direct chemiluminescence technology to detect anti-SARS-CoV-2 IgG.
Sensitivity 90.3%
Specificity 100%
Phase of  development Received CE mark
Proposed release
Date Current

 

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.
Sensitivity 100%
Specificity 100%
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.» Sensitivity was determined from 30 positive patients, and specificity was determined from 54 negative patients.
Sensitivity 100%
Specificity 100%
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 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.
Sensitivity
Specificity
Phase of development Research use only, CE/IVD in EU
Proposed release CE/IVD in the EU
Date March 12, 2020

 

Country of development UK
Type of Serological Test ELISA
Authors/Company Adams et al (Liverpool School of Tropical Medicine and Hygiene)
Description The authors developed an in-house ELISA, with recombinant SARS-CoV-2 trimeric spike protein. They were testing for IgM and IgG, against RT-qPCR. They found, in 31 samples, there was 100% sensitivity for IgG after 10 days post symptom onset.
Sensitivity 100%
Specificity
Phase of  development Research use only
Proposed release Not stated
Date April 20 2020
Country of development US
Type of Serological Test Chemiluminescent immunoassay
Authors/Company BioCheck
Description The BioCheck MS-FAST system and SARS-CoV-2 chemiluminescence-based tests can process blood, serum, or plasma samples in 30 minutes to detect IgM and IgG antibodies.
Sensitivity
Specificity
Phase of  development Applying for FDA EUA
Proposed release Available for purchase by research labs/healthcare providers, but not for diagnostic use
Date April 15, 2020

 

Country of development US
Type of Serological Test Chemiluminescence immunoassay
Authors/Company Accelerate Diagnostics/BioCheck
Description The test is called BioCheck MS-FAST.This test is run on the BioCheck platform to rapidly detect IgM and IgG to SARS-CoV-2 in patient serum samples. The test takes about 30 minutes.
Sensitivity
Specificity
Phase of  development Under development, submitted for EUA
Proposed release
Date

 

Country of development US
Type of Serological Test ELISA
Authors/Company University of Kentucky
Description The University of Kentucky College of Medicine FCIM lab is developing an ELISA assay for detection of antibodies to SARS-CoV-2 in patient samples. The target antigen is the spike protein. While the sensitivity and specificity were unavailable, the researchers state that the test is accurately identifying positive COVD-19 cases and did not react to negative samples.
Sensitivity
Specificity
Phase of  development Under development
Proposed release
Date May 11, 2020

 

Country of development US
Type of Serological Test Single molecule array (Simoa)
Authors/Company Norman et al
Description This group used single molecule array assay to measure total antibodies to SARS-CoV-2. The Simoa protocol has shown, in other cases, 1000-fold improvement in sensitivity over standard ELISA, and it allows analysis of multiple types of antibodies and antigens at once. The target antigens are Spike Protein, S1 subunit, Receptor Binding Domain (RBD), and Nucleocapsid protein.
Sensitivity First week of infection, 86%; second week of infection and onward, 100%
Specificity 100%
Phase of  development Preclinical
Proposed release Not stated
Date May 5, 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.
Sensitivity
Specificity
Phase of  development In development
Proposed release Date not given
Date March 31, 2020

 

Country of development Spain
Type of Serological Test ELISA
Authors/Company Colavita et al./Diesse Diagnostica
Description Researchers developed an ELISA to detect IgA, IgG, and IgM from serum samples of patients. The test, ENZY-WELL SARS-CoV-2 ELISA, uses native viral protein (but does not specify which protein). Sensitivity and specificity were determined from 200 positive and 353 negative clinical samples. Sensitivity was optimal in samples obtained greater than 10 days after symptom onset.
Sensitivity 92.5% (IgG), 93.6% (IgA), 87% (IgM)
Specificity 91.7% (IgG) , 97.9% (IgA), 88% (IgM)
Phase of  development Research use only, CE/IVD approved
Proposed release
Date

 

Country of development US
Type of Serological Test Modified neutralization assay
Authors/Company Genscript
Description This test uses a pseudovirus expressing the RBD of the spike protein to assay the ability of antibodies to block virus interaction with ACE2 receptors. This is not a traditional neutralization assay, in that it does not require live cells. It is a «blocking ELISA» assay. Essentially, if there is an antibody that blocks interaction of the RBD with ACE2, then there is no color change. A lack of neutralizing antibodies results in a color change. Sensitivity was determined from 60 clinical samples, and specificity from 97 negative clinical samples.
Sensitivity 93%
Specificity 100%
Phase of  development Research use only; currently has CE/IVD approval (EU) and HSA approval (Singapore)
Proposed release
Date May 26, 2020

 

Country of development Republic of Korea
Type of Serological Test fluorescence immunoassay
Authors/Company Boditech Med Inc.
Description This test is intended to be used with the company’s accompanying AFIAS-6 or AFIAS-1 analyzer machine. Results from SARS-CoV-2 IgM and IgM can be read in 10 minutes. Blood can either be whole plasma or finger-stick specimens.
Sensitivity 95.8%
Specificity 96.7%
Phase of  development CE/IVD
Proposed release Currently licensed for use in Brazil in addition to CE/IVD status
Date March 30, 2020