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Table 4 Serology tests with EUA from the U.S. FDA

From: Monoclonal antibodies for COVID-19 therapy and SARS-CoV-2 detection

Name

Company

Source

Target

Accuracy

Method

Alinity i SARS-CoV-2 IgG

Abbott

IgG

NP

IgG Sens

0–7 days: 49.3%

8–13 days: 80.4%

 ≥ 14 days: 98.1%,

IgG Spec: 99.6%

CLIA

Architect SARS-CoV-2 IgG

Abbott

IgG

NP

IgG Sens

0–7 days: 49.3%

8–14 days: 82.6%

 ≥ 15 days: 98.1%,

IgG Spec: 99.6%

CLIA

AdviseDx SARS-CoV-2 IgM (Architect)

Abbott

IgM

S

IgM Sens

0–7 days: 42.6%

8–14 days: 79%

 ≥ 15 days: 95%,

IgM Spec: 99.6%

CLIA

Babson Diagnostics aC19G1

Babson Diagnostics, Inc

IgG

S

IgG Sens

8–14 days: 66.7%

 ≥ 15 days: 100%

IgG Spec: 100%

CLIA

Access SARS-CoV-2 IgG

Beckman Coulter, Inc

IgG

S

IgG Sens

0–7 days: 75.8%

8–14 days: 95.3%

 ≥ 15 days: 96.8%,

IgG Spec: 99.6%

CLIA

Access SARS-CoV-2 IgM

Beckman Coulter, Inc

IgM

S

IgM Sens

0–7 days: 54.4%

8–14 days: 91.7%

 ≥ 15 days: 98.3%,

IgM Spec: 99.9%

CLIA

SARS-CoV-2 IgG and IgM Combo Test

BioCheck, Inc

IgM, IgG

S

IgM Sens

0–7 days: 100%

8–14 days: 93.8%

 ≥ 15 days: 88.9%,

IgM Spec: 97.2%

IgG Sens

0–7 days: 100%

8–14 days: 100%

 ≥ 15 days: 100%,

IgG Spec: 100%

CLIA

SARS-CoV-2 IgG Antibody Test Kit

BioCheck, Inc

IgG

S

IgG Sens

0–7 days: 100%

8–14 days: 100%

 ≥ 15 days: 100%,

IgG Spec: 100%

CLIA

SARS-CoV-2 IgM Antibody Test Kit

BioCheck, Inc

IgM

S

IgM Sens

0–7 days: 100%

8–14 days: 93.8%

 ≥ 15 days: 88.9%,

IgM Spec: 97.2%

CLIA

LIAISON SARS-CoV-2 IgM Assay

DiaSorin, Inc

IgM

S

IgM Sens

0–7 days: 64.4%

8–14 days: 90.2%

 ≥ 15 days: 92.6%,

IgM Spec: 99.3%

CLIA

LIAISON SARS-CoV-2 S1/S2 IgG

DiaSorin, Inc

IgG

S

IgG Sens

0–5 days: 25%

6–14 days: 89.8%

 ≥ 15 days: 97.55%,

IgG Spec: 99.3%

CLIA

LIAISON SARS-CoV-2 TrimericS IgG

DiaSorin, Inc

IgG

S

IgG Sens

0–7 days: 21.4%

8–14 days: 70.8%

 ≥ 15 days: 96.9%,

IgG Spec: 99.5%

CLIA

DZ-Lite SARS-CoV-2 IgG CLIA Kit

Diazyme Laboratories, Inc

IgG

S, NP

IgG Sens

0–7 days: 43.5%

8–14 days: 91.7%

 ≥ 15 days: 100%,

IgG Spec: 97.4%

CLIA

DZ-Lite SARS-CoV-2 IgM CLIA Kit

Diazyme Laboratories, Inc

IgM

S, NP

IgG Sens

0–7 days: 26.1%

8–14 days: 83.8%

 ≥ 15 days: 94.4%,

IgG Spec: 98.3%

CLIA

QUANTA Flash SARS-CoV-2 IgG

Inova Diagnostics, Inc

IgG

S, NP

IgG Sens

0–7 days: 66.7%

8–14 days: 61.5%

 ≥ 15 days: 100%,

IgG Spec: 99.9%

CLIA

VITROS Anti-SARS-CoV-2 IgG test

Ortho-Clinical Diagnostics, Inc

IgG

S

IgG Sens

12–15 days: 83.3%

 ≥ 16 days: 90%,

IgG Spec: 100%

CLIA

VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent

Ortho-Clinical Diagnostics, Inc

Pan-Ig

S

Pan-Ig Sens

0–7 days: 80%

 ≥ 8 days: 100%,

Pan-Ig Spec: 100%

CLIA

Q-Plex SARS-CoV-2 Human IgG (4 Plex)

Quansys Biosciences, Inc

IgG

S

IgG Sens

0–7 days: 100%

8–14 days: 100%

 ≥ 15 days: 95.2%,

IgG Spec: 99.7%

CLIA

MAGLUMI 2019-nCoV IgM/IgG

Shenzhen New Industries Biomedical Engineering Co., Ltd

IgM, IgG

S, NP

IgM Sens

0–7 days: 43.8%

8–14 days: 78.3%

 ≥ 15 days: 77.5%,

IgM Spec: 99.6%

IgG Sens

0–7 days: 31.3%

8–14 days: 90.6%

 ≥ 15 days: 100%,

IgG Spec: 99.1%

CLIA

ADVIA Centaur SARS-CoV-2 IgG (COV2G)

Siemens Healthcare Diagnostics

IgG

S

IgG Sens

0–6 days: 53.5%

7–13 days: 93.4%

 ≥ 14 days: 100%,

IgG Spec: 99.9%

CLIA

ADVIA Centaur SARS-CoV-2 Total (COV2T)

Siemens Healthcare Diagnostics

Pan-Ig

S

IgG Sens

0–6 days: 61.1%

7–13 days: 97.5%

 ≥ 14 days: 100%,

IgG Spec: 99.8%

CLIA

Atellica IM SARS-CoV-2 IgG (COV2G)

Siemens Healthcare Diagnostics

IgG

S

IgG Sens

0–6 days: 56%

7–13 days: 92.2%

 ≥ 14 days: 100%,

IgG Spec: 99.9%

CLIA

Atellica IM SARS-CoV-2 Total (COV2T)

Siemens Healthcare Diagnostics

Pan-Ig

S

Pan-Ig Sens

0–6 days: 60.7%

7–13 days: 97.5%

 ≥ 14 days: 100%,

Pan-Ig Spec: 99.8%

CLIA

Vibrant COVID-19 Ab Assay

Vibrant America Clinical Labs

Pan-Ig

S, NP

IgG/IgM Sens: 98.1%,

IgG/IgM Spec: 98.6%

CLIA

WANTAI SARS-CoV-2 Ab ELISA

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd

Pan-Ig

S

Pan-Ig Sens

0–7 days: 55.4%

8–14 days: 84.8%

 ≥ 15 days: 98.7%,

Pan-Ig Spec: 97.5%

ELISA

Platelia SARS-CoV-2 Total Ab

Bio-Rad Laboratories, Inc

Pan-Ig

NP

Pan-Ig Sens

0–7 days: 100%

8–14 days: 96%

 ≥ 15 days: 100%,

Pan-Ig Spec: 99.3%

ELISA

SARS-CoV-2 RBD IgG test

Emory Medical Laboratories

IgG

S

IgG Sens

0–7 days: 73%

8–14 days: 100%

 ≥ 15 days: 100%,

IgG Spec: 97.7%

ELISA

SARS-CoV-2 ELISA (IgG)

EUROIMMUN

IgG

S

IgG Sens

0–4 days: 21.7%

5–10 days: 69.4%

 ≥ 11 days: 81.1%,

IgG Spec: 100%

ELISA

cPass SARS-CoV-2 Neutralization Antibody Detection Kit

GenScript USA Inc

Pan-Ig

S

Pan-Ig Sens: 100%,

Pan-Ig Spec: 100%

ELISA

SCoV-2 Detect IgG ELISA

InBios International, Inc

IgG

S

IgG Sens

8–14 days: 100%

 ≥ 15 days: 95.5%,

IgG Spec: 100%

ELISA

SCoV-2 Detect IgM ELISA

InBios International, Inc

IgM

S

IgM Sens

0–7 days: 66.7%

8–14 days: 91.4%

 ≥ 15 days: 93.8%,

IgM Spec: 98.8%

ELISA

COVID-SeroKlir, Kantaro Semi-Quantitative SARS-CoV-2 IgG Antibody Kit

Kantaro Biosciences, LLC

IgG

S

IgG Sens

0–7 days: 100%

8–14 days: 100%

 ≥ 15 days: 93%,

IgG Spec: 99.6%

ELISA

Mt. Sinai Laboratory COVID-19 ELISA Antibody Test

Mount Sinai Hospital Clinical Laboratory

IgM, IgG

S

Combined Sens: 92.5%,

Combined Spec: 100%

ELISA

Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

Quanterix Corporation

IgG

S

IgG Sens

0–7 days: 45.2%

8–14 days: 87.5%

 ≥ 15 days: 100%,

IgG Spec: 99.2%

ELISA

Dimension Vista SARS-CoV-2 Total Ab assay (COV2T)

Siemens Healthcare Diagnostics

Pan-Ig

S

Pan-Ig Sens

0–6 days: 66.7%

7–13 days: 97.4%

 ≥ 14 days: 100%,

Pan-Ig Spec: 99.8%

ELISA

Dimension EXL SARS-CoV-2 Total Ab assay (CV2T)

Siemens Healthcare Diagnostics

Pan-Ig

S

Pan-Ig Sens

0–6 days: 68.8%

7–13 days: 97.4%

 ≥ 14 days: 100%,

Pan-Ig Spec: 99.9%

ELISA

COVID-19 self-collected Ab test system

Symbiotica, Inc

IgG

S

IgG Sens

8–14 days: 100%

 ≥ 15 days: 100%,

Pan-Ig Spec: 98.04%

ELISA

OmniPATH COVID-19 Total Antibody ELISA Test

Thermo Fisher Scientific

Pan-Ig

S

Pan-Ig Sens

0–7 days: 19%

8–14 days: 76.7%

 ≥ 15 days: 100%,

Pan-Ig Spec: 100%

ELISA

COVID-19 ELISA pan-Ig Antibody Test

University of Arizona Genetics Core for Clinical Services

Pan-Ig

S

Pan-Ig Sens

 ≥ 15 days: 97.5%,

Pan-Ig Spec: 99.1%

ELISA

ZEUS ELISA SARS-CoV-2 Total Test

ZEUS Scientific, Inc

Pan-Ig

S

Pan-Ig Sens: 93.3%,

Pan-Ig Spec: 100%

ELISA

ZEUS ELISA SARS-CoV-2 IgG Test System

ZEUS Scientific, Inc

IgG

S

IgG Sens

0–7 days: 100%

8–14 days: 100%

 ≥ 15 days: 100%,

IgG Spec: 99.1%

ELISA

CareStart COVID-19 IgM/IgG

Access Bio, Inc

IgM, IgG

S, NP

IgM Sens

8–14 days: 100%

 ≥ 15 days: 88.7%,

IgM Spec: 99.5%

IgG Sens

8–14 days: 100%

 ≥ 15 days: 96.8%,

IgG Spec: 99.5%

LFIA

Assure COVID-19 IgG/IgM Rapid Test Device

Assure Tech

IgM, IgG

S, NP

IgG/IgM Sens

0–7 days: 100%

8–14 days: 83.3%

 ≥ 15 days: 89.3%,

IgG/IgM Spec: 100%

LFIA

ACON SARS-CoV-2 IgG/IgM Rapid Test

ACON Laboratories, Inc

IgM, IgG

S, NP

IgG/IgM Sens

0–7 days: 100%

8–14 days: 100%

 ≥ 15 days: 100%,

IgG/IgM Spec: 95.9%

LFIA

RapCov Rapid COVID-19 Test

ADVAITE, Inc

IgG

NP

IgG Sens

 ≥ 15 days: 93.3%,

IgG Spec: 99.5%

LFIA

WANTAI SARS-CoV-2 Ab Rapid Test

Beijing Wantai Biological Pharmacy Enterprise Co., Ltd

Pan-Ig

S

Pan-Ig Sens: 100%,

Pan-Ig Spec: 98.8%

LFIA

Tell Me Fast Novel Coronavirus (COVID-19) IgG/IgM Antibody Test

Biocan Diagnostics Inc

IgM, IgG

S, NP

IgM Sens

8–14 days: 88.9%

 ≥ 15 days: 85.2%,

IgM Spec: 98.7%

IgG Sens

8–14 days: 100%

 ≥ 15 days: 100%,

IgG Spec: 96.2%

LFIA

Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit

Biohit Healthcare (Hefei)

IgM, IgG

NP

IgM Sens

0–7 days: 33.3%

8–14 days: 83%

 ≥ 15 days: 97.7%,

IgM Spec: 99.5%

IgG Sens

8–14 days: 56.6%

 ≥ 15 days: 96.2%,

IgG Spec: 100%

LFIA

qSARS-CoV-2 IgG/IgM Rapid Test

Cellex, Inc

IgM, IgG

S, NP

Combined Sens: 93.8%,

Combined Spec: 96%

LFIA

COvAb SARS-CoV-2 Ab Test

Diabetomics, Inc

Pan-Ig

S

Pan-Ig Sens

0–7 days: 41.6%

8–14 days: 84.2%

 ≥ 15 days: 97.6%,

Pan-Ig Spec: 98.78%

LFIA

RightSign COVID-19 IgG/IgM Rapid Test Cassette

Hangzhou Biotest Biotech

IgM, IgG

S

IgG/IgM Sens

0–7 days: 66.7%

8–14 days: 100%

 ≥ 15 days: 88.9%,

IgG/IgM Spec: 100%

LFIA

LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo

Hangzhou Laihe Biotech

IgM, IgG

S

IgM Sens

0–6 days: 100%

7–14 days: 85.7%

 ≥ 15 days: 99.3%,

IgM Spec: 99.4%

IgG Sens

7–14 days: 76.2%

 ≥ 15 days: 98.5%,

IgG Spec: 99.4%

LFIA

COVID-19 IgG/IgM Rapid Test Cassette

Healgen Scientific, LLC

IgM, IgG

S

IgM Sens: 100%,

IgM Spec: 100%

IgG Sens: 96.7%,

IgG Spec: 97.5%

Combined Sens: 100%,

Combined Spec: 97.5%

LFIA

Innovita 2019-nCoV Ab Test (Colloidal Gold)

Innovita (Tangshan) Biological Technology Co., Ltd

IgM, IgG

S, NP

IgG/IgM Sens

0–7 days: 87.9%

8–14 days: 96.6%

 ≥ 15 days: 100%,

IgG/IgM Spec: 98%

LFIA

SCoV-2 Detect IgG Rapid Test

InBios International, Inc

IgG

S

IgG Sens

0–7 days: 92.9%

8–14 days: 81.8%

 ≥ 15 days: 100%,

IgG Spec: 97.7%

LFIA

Orawell IgM/IgG Rapid Test

Jiangsu Well Biotech

IgM, IgG

S

IgG/IgM Sens

8–14 days: 98.2%

 ≥ 15 days: 100%,

IgG/IgM Spec: 98%

LFIA

Rapid COVID-19 IgM/IgG Combo Test Kit

Megna Health, Inc

IgM, IgG

NP

IgM Sens

0–7 days: 66.7%

8–14 days: 77.1%

 ≥ 15 days: 90.9%,

IgM Spec: 99.6%

IgG Sens

0–7 days: 62.3%

8–14 days: 85.7%

 ≥ 15 days: 90.9%,

IgG Spec: 99.3%

LFIA

Nirmidas COVID-19 (SARS-CoV-2) IgM/IgG Antibody Detection Kit

Nirmidas Biotech, Inc

IgM, IgG

S

IgG Sens

0–7 days: 27.8%

8–14 days: 76.5%

 ≥ 15 days: 100%,

IgM Sens

0–7 days: 27.8%

8–14 days: 82.4%

 ≥ 15 days: 97%,

IgM/IgG Spec: 84.8%

LFIA

ADEXUSDx COVID-19 Test

NOWDiagnostics, Inc

Pan-Ig

S

Pan-Ig Sens: 93.3%,

Pan-Ig Spec: 100%

LFIA

QIAreach Anti-SARS-CoV-2 Total Test

QIAGEN, GmbH

Pan-Ig

S

Pan-Ig Sens: 100%

Pan-Ig Spec: 97.5%

LFIA

Sienna-Clarity COVIBLOCK COVID-19 IgG/IgM Rapid Test Cassette

Salofa Oy

IgM, IgG

S

IgM Sens: 90%,

IgM Spec: 100%

IgG Sens: 93.3%,

IgG Spec: 98.8%

Combined Sens: 93.3%,

Combined Spec: 98.8%

LFIA

SGTi-flex COVID-19 IgG

Sugentech, Inc

IgG

S, NP

IgG Sens

0–7 days: 41.2%

8–14 days: 91.7%

 ≥ 15 days: 98.6%,

IgG Spec: 100%

LFIA

TBG SARS-CoV-2 IgG/IgM Rapid Test Kit

TBG Biotechnology Corp

IgM, IgG

S, NP

IgM/IgG Sens

 ≥ 15 days: 96.4%,

IgM/IgG Spec: 99.8%

LFIA

BIOTIME SARS-CoV-2 IgG/IgM Rapid Qualitative Test

Xiamen Biotime Biotechnology Co., Ltd

IgM, IgG

S

IgM Sens

0–7 days: 55.1%

8–14 days: 94.1%

 ≥ 15 days: 100%,

IgG Sens

0–7 days: 46.4%

8–14 days: 67.7%

 ≥ 15 days: 100%,

IgM/IgG Spec: 98.5%

LFIA

VIDAS SARS-CoV-2 IgG

BioMérieux SA

IgG

S

IgG Sens

0–7 days: 47.9%

8–14 days: 100%

 ≥ 15 days: 100%,

IgG Spec: 99.9%

ELFA

VIDAS SARS-CoV-2 IgM

BioMérieux SA

IgM

S

IgM Sens

0–7 days: 53.8%

8–14 days: 100%

 ≥ 15 days: 100%,

IgG Spec: 99.4%

ELFA

Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2

Genalyte, Inc

Pan-Ig

S, NP

Ig Sen

0–7 days: 66.7%

8–14 days: 90.9%

 ≥ 15 days: 96.1%,

Ig Spec: 97.7%

PRI

xMAP SARS-CoV-2 Multi-Antigen IgG Assay

Luminex Corporation

IgG

S, NP

IgG Sens

0–7 days: 71.1%

8–14 days: 71.4%

 ≥ 15 days: 96.2%,

IgG Spec: 100%

FMIA

BioPlex 2200 SARS-CoV-2 IgG

Bio-Rad Laboratories

IgG

S

IgG Sens

0–7 days: 81.3%

8–14 days: 96.3%

 ≥ 15 days: 93.9%,

IgG Spec: 99.9%

FIA

FREND COVID-19 total Ab

NanoEntek America, Inc

IgM, IgG

NP

Combined Sens: 96.7%,

Combined Spec: 98.8%

FIA

MosaiQ COVID-19 Antibody Magazine

Quotient Suisse SA

Pan-Ig

S

Ig Sens

0–7 days: 100%

8–14 days: 100%

 ≥ 15 days: 93%,

Ig Spec: 99.8%

PIA

Elecsys Anti-SARS-CoV-2

Roche Diagnostics, Inc

Pan-Ig

NP

Ig Sens

0–6 days: 60.2%

7–13 days: 85.3%

 ≥ 14 days: 99.5%,

Ig Spec.: 99.7%

ECLIA

Elecsys Anti-SARS-CoV-2 S

Roche Diagnostics, Inc

Pan-Ig

S

Ig Sens

0–7 days: 90.6%

8–14 days: 87%

 ≥ 15 days: 96.6%,

Ig Spec.: 100%

ECLIA

New York SARS-CoV Microsphere Immunoassay for Antibody

Wadsworth Center, New York State Department of Health

Pan-Ig

NP

Ig Sens

0–6 days: 17.9%

7–10 days: 31.3%

11–15 days: 48.9%

16–20 days: 49.2%

 > 20 days: 79.3%,

Ig Spec: 99.6%

MIA

  1. CLIA chemiluminescence immunoassay, ECLIA enzyme-enhanced chemiluminescence immunoassay, ELFA enzyme-linked fluorescence assay, FMIA fluorescent microsphere immunoassay, FIA fluorescence immunoassay, LFIA lateral flow immunoassay, MIA: magnetic immunoassay, NP nucleoprotein, PIA photometric immunoassay, PRI photonic ring immunoassay, S spike protein, Sens sensitivity (positive percent agreement), Spec specificity (negative percent agreement). The commercial kits granted EUA are updated based on the FDA. For each type of method, the products are listed in alphabetical order of the company names