A systematic and meta-analysis review on the diagnostic accuracy of antibodies in the serological diagnosis of COVID-19

Vengesai, Arthur; Midzi, Herald; Kasambala, Maritha; Mutandadzi, Hamlet; Mduluza-Jokonya, Tariro L.; Rusakaniko, Simbarashe; Mutapi, Francisca; Naicker, Thajasvarie; Mduluza, Takafira

doi:10.1186/s13643-021-01689-3

Systematic Reviews

Table 1 The general characteristics of the studies included in the review

From: A systematic and meta-analysis review on the diagnostic accuracy of antibodies in the serological diagnosis of COVID-19

Study ID	Country	Antibody type	Antigen type	Commercial	Reference standard	Index test	Control group/comparison group
Kai-Wang To [27] ^{P, CS}	China	IgG and IgM	S and N	Inhouse	rRT-PCR	ELISA	No control
Cassaniti [28] ^{P, CS}	Italy	IgG, IgM and IgG-IgM	S	Commercial	rRT-PCR	POC LFIA	Patients with fever and respiratory syndrome/RT-PCR negative
Duchuan Lin [29]	China	IgG, IgM and IgG-IgM	N	Inhouse	Epidemiological risk/clinical features/rRT-PCR	CLIA	Healthy individuals and tuberculosis patients
Jie Xiang [30]	China	IgG, IgM and IgG-IgM		Commercial	rRT-PCR	ELISA and POC LFIA	Healthy individuals
Li Guo [13] ^P	China	IgM	N	Inhouse	Deep sequencing and rRT-PCR	ELISA	Adult patients with acute lower respiratory tract infections (ALRTIs)
Rui Liu [31] ^CS	China	IgM	N	Inhouse	rRT-PCR		COVID-19 rRT-PCR negative patients
Wanbing Liu [32] ^P	China	IgG, IgM and IgG-IgM	S and N	Commercial	rRT-PCR	ELISA	Healthy individuals
Xuefei Cai [33]	China	IgG, IgM and IgG-IgM	S	Inhouse	rRT-PCR	Peptide-based magnetic CLIA	Mixed diseases and healthy controls
Yu bao Pan [34] ^CS	China	IgG, IgM and IgG-IgM		Commercial	rRT-PCR	POC LFIA	COVID-19 rRT-PCR negative patients
Yujiao Jin [35] ^P	China	IgG, IgM and IgG-IgM	S-N	Commercial	rRT-PCR	CLIA	Patients with suspected SARS-CoV-2 infection but with negative rRT-PCR results
Zhao [36] ^P	China	IgG and IgM	S	Commercial	Chest CT images/epidemiological history/clinical diagnosis/rRT-PCR	ELISA	Healthy individuals
Zhengtu Li [37] ^P	China	IgG, IgM and IgG-IgM	S	Commercial	rRT-PCR	POC LFIA	Healthy individuals
Rongqing Zhao [38]	China	IgG-IgM	S	Inhouse	Not clear but all cases were confirmed COVID-19 patients	ELISA	Healthy individuals (samples collected before and during the COVID-19 pandemic)
Pingping Zhang [39]	China	IgG-IgM	S	Inhouse	rRT-PCR	POC LFIA	COVID-19 rRT-PCR negative patients
Paradiso [40]	Italy	IgG-IgM	S	Commercial	rRT-PCR	POC LFIA	Patients with COVID-19 disease orienting-symptoms but rRT-PCR negative
Huan Ma [41]	China	IgA, IgG, IgM, IgG-IgM and Ab	S and N	Inhouse	rRT-PCR	CLIA	Healthy individuals, COVID-19 suspected individuals and mixed disease group
Qian [15]	China	IgG and IgM	S-N	Commercial	rRT-PCR	CLIA	Healthy individuals and hospitalised individuals
Ling Zhong [42] ^P	China	IgG and IgM		Inhouse	rRT-PCR	CLIA and ELISA	Healthy individuals
Jiajia Xie [43] ^{P, CS}	China	IgG and IgM	E-N	Commercial	Chest CT images/epidemiological history/clinical diagnosis/rRT-PCR	CLIA	Clinically confirmed COVID-19 rRT-PCR negative patients
Infantino [44] ^P	Italy	IgG and IgM	S-N	Commercial	rRT-PCR	CLIA	Mixed diseases patients and blood donors pre-COVID-19
Adams [45]	UK	IgG, IgM and IgG-IgM	S	Inhouse (ELISA) and Commercial (LFIA)	rRT-PCR	ELISA and POC LFIA	Healthy blood and ICU cerebral organ donors before the COVID-19 pandemic
Lassaunière [46]	Denmark	IgA, IgG and Ab	S	Commercial	rRT-PCR	ELISA and POC LFIA	Healthy individuals and mixed diseases patients (including acute respiratory tract infections caused by other corona viruses and non-corona viruses
Qiang Wang [47] ^P	China	IgG, IgM and IgG-IgM		Commercial	Chest CT images/epidemiological history/clinical diagnosis/rRT-PCR	ELISA and POC LFIA	COVID-19 clinical negative mixed diseases patients
Fei Xiang [30] ^P	China	IgG and IgM	N	Commercial	rRT-PCR	ELISA	Healthy blood donors or from patients with other disease hospitalised
Bin Lou [48]	China	IgG, IgM and Ab	S and N	Commercial	rRT-PCR	ELISA, CLIA and POC LFIA	Healthy Individuals
Lei Liu [49]	China	IgG-IgM	N	Commercial	rRT-PCR	ELISA	Randomly selected ordinary patients and healthy blood donors
Imai [50]	Japan	IgG, IgM and IgG-IgM		Commercial	rRT-PCR	POC LFIA	Non-COVID-19 patients (from April to October 2019
Pérez-García [51]	Spain	IgG, IgM and IgG-IgM		Commercial	rRT-PCR	POC LFIA	Healthy individuals (samples collected before the COVID-19 pandemic)
Zhenhua Chen [52] ^P	China	IgG	N	Inhouse	rRT-PCR	POC LFIA	Clinically suspicious for the presence of anti-SARS-CoV-2
Dohla [53] ^{P, CS}	German	IgG, IgM and IgG-IgM		Commercial	RT-qPCR	POC LFIA	COVID-19 RT-qPCR negative patients
Burbelo [54]	USA	Ab	S and N	Inhouse	RT-PCR	LIPS	Subjects with COVID-19-like symptoms or household contacts of persons with COVID-19 (not tested by PCR), and blood donors who donated samples before 2018.

Studies with P superscripts were published articles and without P superscripts were MedRxiv preprints
Studies with CS superscripts are cross sectional studies and without CS superscripts are case control studies
IgG-IgM means that either one of them or both were detected in serum
Ab means total antibodies

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ISSN: 2046-4053

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