Antibody tests for COVID-19

Figures & data

Figure 1. Commercially available COVID-19 diagnostic antibody tests.

Table 1. SARS-CoV-2 antibody test types*

Type of test	Time to results	Antibodies
Rapid diagnostic test	10–30 minutes	IgG and IgM
Enzyme-linked immunosorbent assay	2–5 hours	IgG and IgM
Neutralization assay	3–5 days	N/A
Chemiluminescent immunoassay	1–2 hours	IgG, IgM, and IgA

* Source: The Johns Hopkins Center for Health.¹²

Table 2. Sensitivity and specificity of different antibody tests conducted globally*

Source	Antibody test	Sensitivity	Specificity
South America
Castro et al^14	Meta-analysis	IgM, 82%; IgG, 97%	IgM, 97%; IgG, 98%
Austria
Bundschuh et al^15	EDI	5–10 days: IgM, 37.1%; IgG, 37.1% >5–10 days: IgM, 76.4%; IgG, 82.4%	–
Egger et al^16	Elecsys and IgM/IgG EDI	94%−100%	–
Traugott et al^17	ELISA and RDT	80%	IgA, 83%; IgG, 98%; IgM, 97%
France
Tuaillon et al^18	RDT and ELISA	1–7 days: 50% >14 days: 80%–100%	–
Demey et al^19	RDT	>10 days: 60%–80% >14 days: 100%	–
Nicol et al^20	Abbott Architect, Euroimmun, and LFIA	>14 days: 80%	–
Germany
Kohmer et al^21	Abbott Architect, Roche Cobas, LIAISON XL, VIRCLIA	66.7%–89%	–
Haselmann et al^22	Roche, Euroimmun, and Epitope	92.3%–100%	84%–100%
Finland
Jääskeläinen et al^23	Abbott Architect, Diasorin Liaison, Euroimmun, Acro Biotech, and Xiamen Biotime Biotechnology	68.3%–97.5%	43.8%–81.3%
Belgium
Montesinos et al^24	Maglumi, Euroimmun, and RDT	64.3%–94%	–
Meschi et al^25	Abbott Architect	7 days: 8.3%–58.3%; 14 days: 61.9%–85.7%; >14 days: 100%	–
Bonelli et al^26	LIAISON	5 days: 91.3%; 15 days: 95.7%	–
Spain
Serrano et al^27	Euroimmun, Hangzhou Alltest Biotech, Wuhan UNscience Biotechnology and Guangzhou Wondfo Biotech	81.2%–100%	80.6%–100%
Pérez-García et al^28	AllTest	>14 days: 88%	–
China
Zhang et al^29	SARS-CoV-2 envelope nucleocapsid proteins	52%	–
Shen et al^30	Colloidal gold immunochromatography (RDT)	71%	96.2%
Taiwan and Singapore
Wu et al^31	Alltest, Dynamiker, ASK, and Wondfo	>21 days: 100%	>21 days: 100%
Chew et al^32	Abbott Architect	6 days: 8.6%; 7–14 days: 84%; 14–20 days: 84.4%	–

* Positive controls were COVID-19 patients with varying clinical severity in symptoms.

Table 3. Commercially available COVID-19 antibody diagnostic tests by continent*

Antibody test and company	Country	Sensitivity	Specificity	Days measured
North America
RDT – Cellex	US	93.8%	95.6%	–
RDT – ChemBio	US	–	–	–
ELISA – Mount Sinai Laboratory	US	–	–	–
CI – Ortho-Clinical Diagnostics	US	–	–	–
RDT – Autobio Diagnostics	US	IgM, 95.7%; IgG, 99%	IgM, 99%; IgG, 99%	–
ELISA – DiaSorin	US	90%–97%	90%	5–15
CI – Abbott Laboratories	US	–	–	–
ELISA – Bio-Rad	US	98%	99%	–
Microsphere immunoassay – Wadsworth Center	US	–	93–100%	–
Electro-CI – Roche	US	0–6 days, 65.5%; 7–13 days, 88.1%; >14 days, 100%	99.8%	0–14
ELISA – Euroimmun AG	US	0–10 days, 13.9%; 11–20 days, 61.1%; <21 days, 100%	100%	0–21
RDT – Healgen Scientific	US	IgM, 86.7%; IgG, 96.7%; IgM and IgG, 96.7%	IgM, 99%; IgG, 98%; IgM/IgG, 97%	–
CI – Siemens Health care Diagnostics	US	0–6 days, 60.7%; 7–13 days, 97.5%; >14 days, 100%	99.8%	0–14
CI – Siemens Health care Diagnostics	US	0–6 days, 65.1%; 7–13 days, 97.5%; >14 days, 100%	99.8%	0–14
Electro-CI – Roche Diagnostics	US	84%	63%	–
CI – Vibrant America Clinical Labs	US	98.1%	98.6%	–
CI – Babson Diagnostics	US	8–14 days, 66.7%; >15 days, 100%	100%	–
CI – Beckman Coulter	US	0–7 days, 75%; 8–14 days, 95.3%; >15 days, 96.8%	100%	–
ELISA – InBios International	US	92.5%	98.5%	0–12
CI – Diazyme Laboratories	US	91.7%	97.4%	–
ELISA – Mayo Clinic/Univ Minnesota	US	–	–	–
RDT – Advaite	US	89%	100%	–
RDT – Kabla Clinical Diagnostics	Mexico	IgM, 85%; IgG, 99.9%	IgM, 96%; IgG, 98%	–
Europe
Multiplexed Immuno Refractive Assay – Quotient	Switzerland	100%	99.8%	–
RDT – Edinburgh Genetics	UK	100%	98.7%	–
ELISA – Euroimmun AG	Germany	0–10 days, 13.9%; 11–20 days, 61.1%; >21 days, 100%	100%	0–21
Asia
NA – Singapore/ Wang Lab	Singapore	90%	–	–
RDT – Aytu Biosciences/Orient Gene Biotech	China	IgM, 87.9%; IgG, 97.2%	IgM, 100%; IgG, 100%	–
Proprietary – ScanWell Health/INNOVITA	China	87.3%	100%	–
RDT – Ringbio	China	IgM, 89.4%; IgG, 97.9%	IgM, 97.7%; IgG, 97.7%	–
RDT – Cellex	China	93.8%	95.6%	–
RDT – Healgen Scientific	China	IgM, 86.7%; IgG, 96.7%; IgM/IgG, 96.7%	IgM, 99%; IgG, 98%; IgM/IgG, 97%	–
RDT – Hangzhou Biotest Biotech	China	IgM, 92.5%; IgG, 91.56%	IgM, 98.1%; IgG, 99.52%	0–14
RDT – Biohit Health care (Heifei)	China	1–7 days: IgM, 33%; 8–14 days: IgM, 83%; IgG, 56.6%; >15 days, IgM, 97.7%; IgM, 96.2%	IgM, 99.46%; IgG,100%	0–15
RDT – Hangzhou Laihe Biotech	China	0–6 days: IgM, 100%; IgG, 0%; 7–14 days: IgM, 85.7%; IgG, 76%; >14 days: IgM, 99.3%; IgG, 98.5%	99.4%	0–14
RDT – Assure Biotech (Hangzhou)	China	95.1%	100%	–
RDT – Beijing Wantai Biological Pharmacy Enterprise	China	94.7%	98.9%	–

* Source: The Johns Hopkins Center for Health.¹² Positive controls were COVID-19 patients with varying clinical severity in symptoms.

CI indicates chemiluminescent immunoassay; ELISA, enzyme-linked immunosorbent assay; NA, neutralization assay; RDT, rapid diagnostic test.

Table 4. Society recommendations for SARS-CoV-2 antibody testing*

Categories	Recommendations
Antibody tests	Use antibody test with high sensitivity Use antibody tests with IgG, IgM, IgG, or total antibody; avoid using antibody kits measuring IgA Use orthogonal testing algorithms (two independent tests in sequence when the first test yields a positive result) Administer antibody tests 1 to 3 weeks after symptom onset
Patients to screen	Patients with a previous COVID-19 infection Patients exposed to an individual diagnosed with COVID-19
Limitations of antibody tests	Antibody tests are unable to reveal the following: Duration of antibody protection Potential for SARS-CoV-2 infection Kinetics of antibody response Ability of antibodies to protect from repeat infections Protective titer required to prevent infection A false-positive is possible due to cross-reactive antibodies from previous coronavirus infection

* Sources: The Johns Hopkins Center for Health Security,⁸ European Commission,³⁴ Centers for Disease Control and Prevention,³⁵ American Association for Clinical Chemistry,³⁶ Infectious Diseases Society of America.³⁷

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