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. 2022 Nov 17;2022(11):CD013652. doi: 10.1002/14651858.CD013652.pub2
    IgG IgM IgG or IgM
Test brand Test name Evaluations (TP/TP + FN) Sensitivity (95% CI) Evaluations (TP/TP + FN) Sensitivity (95% CI) Evaluations (TP/TP + FN) Sensitivity (95% CI)
Lateral flow assays
AAZ‐LM
CGIA
Covid‐Duo test rapid Covid‐19 IgG/IgM         1 (22/22) 100a (84.6, 100)**
AccuBiotech
CGIA
Accu‐Tell COVID‐19 IgG/IgM Cassette         1 (27/28) 96.4a (81.7, 99.9)*
ACON Laboratories SARS‐COV‐2 IgG/IgM Rapid Test 1 (34/37) 91.9a (78.1, 98.3)* 1 (143/146) 97.9a (94.1, 99.6)* 1 (34/37) 91.9a (78.1, 98.3)*
Alfa Scientific CLARITY COVID‐19 IgG/IgM Antibody Test 1 (26/40) 65.0a (48.3, 79.4)* 1 (33/40) 82.5a (67.2, 92.7)* 1 (39/40) 97.5a (86.8, 99.9)*
Anhui Deep Blue SARS‐CoV‐2 IgG/IgM Ab test kit 1 (9/10) 90.0a (55.5, 99.7)* 1 (10/10) 100a (69.2, 100)** 2 (38/38) 100a (90.7, 100)**
Artron
CGIA
Artron COVID‐19 IgG/IgM         1 (8/8) 100a (63.1, 100)**
Augurix Diagnostics One Step Test for Novel Coronavirus (2019‐nCoV) IgG/IgM Antibody 1 (41/44) 93.2a(81.3, 98.6)* 1 (6/33) 18.2a (7.0, 35.5)*    
Augurix Diagnostics Augurix SARS‐CoV‐2 IgG/IgM RDT 1 (12/12) 100a (73.5, 100)** 1 (1/12) 8.3a (0.2, 38.5)*    
Augurix Diagnostics SimtomaX Corona Check IgG/IgM 1 (124/220) 56.4a (49.5, 63.0)* 1 (160/224) 71.4a (65.0, 77.2)*    
Autobio Diagnostics
CGIA
Anti‐SARS‐CoV‐2 Rapid Test IgG/IgM 1 (13/13) 100a (75.3, 100)** 1 (9/13) 69.2a (38.6, 90.9)* 2 (21/21) 100a (83.9, 100)**
Avioq Bio‐Tech
CGIA
Novel Coronavirus (2019‐nCov) Antibody IgG/IgM Assay Kit         1 (31/33) 93.9a (79.8, 99.3)*
AYTU Biosciences COVID‐19 IgG/IgM Rapid Test Cassette 1 (31/40) 77.5a (61.5, 89.2)* 1 (18/40) 45.0a (29.3, 61.5)* 1 (33/40) 82.5a (67.2, 92.7)*
Beijing Diagreat Biotechnology
FIA
2019‐nCoV IgG/IgM Antibody Determination Kit 1 (468/525) 89.1a (86.2, 91.7)* 1 (269/525) 51.2a (46.9, 55.6)*    
Beijing Wantai Wantai Ab rapid assay         1 (87/98) 88.8a (80.8, 94.3)*
Biohit Healthcare
CGIA
SARS‐CoV‐2 IgG/IgM ANTIBODY TEST KIT         1 (27/28) 96.4a (81.7, 99.9)*
Biolidics 2019 nCoV IgG/IgM detection kit 2 (15/17) 88.2 (63.2, 97.0) 2 (8/17) 47.0 (25.5, 69.7) 2 (16/17) 94.1 (68.0, 99.2)
BioMedomics COVID‐19 IgG/IgM Rapid Test 2 (15/18) 83.3 (59.1, 94.5) 3 (27/30) 90.0 (73.2, 96.7) 2 (15/18) 83.3(59.1, 94.5)
bioMerieux
FIA
Vidas SARS‐CoV‐2 IgG/IgM 2 (101/107) 94.4 (88.1, 97.5) 1 (203/224) 90.6a (86.0, 94.1)*    
Biopanda COVID‐19 Rapid Ab test 1 (102/163) 62.6 (54.7, 70.0)        
Bioperfectus Technologies PerfectPOC Novel Corona Virus (SARS CoV‐2) IgG/IgM Rapid Test Kit 1 (9/10) 90.0a (55.5, 99.7)* 1 (1/6) 16.7a(0.4, 64.1)* 1 (10/10) 100a (69.2, 100)*
Biosynex COVID‐19 BSS IgG/IgM 2 (147/195) 84.5 (58.2, 95.5) 2 (24/39) 61.5 (45.6, 75.3) 3 (119/125) 95.2 (89.7, 97.8)
BTNX Rapid Response™ COVID‐19 Test Cassette (BTNX Inc.) Kit1 IgG/IgM 2 (44/47) 93.6 (82.0, 97.9) 2 (38/42) 90.5(77.2, 97.4) 2 (45/47) 95.7 (84.5, 98.9)
Cellex qSARS‐CoV‐ 2 IgG/IgM Cassette Rapid Test 2 (19/23) 82.6 (61.8, 93.3) 2 (26/42) 56.9 (27.5, 82.1) 2 (19/23) 82.6 (61.8, 93.3)
Clungene Biotech Clungene SARS‐CoV‐2 IgG/IgM Rapid Test Cassettes 1 (55/63) 87.3a (76.5, 94.4)* 1 (160/212) 75.5a (69.1, 81.1)* 1 (56/63) 88.9a (78.4, 95.4)*
CTK Biotech
CGIA
OnSite COVID‐19 IgG/IgM Rapid Test 2 (181/242) 74.8 (68.8, 79.9) 1 (60/220) 27.3a (21.5, 33.7)* 1 (8/8) 100a (63.1, 100)**
Decombio Biotechnology Novel Coronavirus (SARS‐CoV‐2) IgG/IgM Combo Rapid Test‐Cassette 1 (10/11) 90.9a (58.7, 99.8)* 1 (10/11) 90.9a (58.7, 99.8)* 1 (10/11) 90.9a (58.7, 99.8)*
DeepBlue Medical
CGIA
COVID‐19 (SARS CoV‐2) IgG/IgM Antibody Test Kit (Colloidal Gold) 1 (9/11) 81.8a (48.2, 97.7)* 1 (8/11) 72.7a (39.0, 94.0)* 1 (10/11) 90.9a (58.7, 99.8)*
DNA Link AccuFind COVID19 IgG/IgM 1 (38/40) 95.0a (83.1, 99.4)* 1 (33/40) 82.5a (67.2, 92.7)* 1 (39/40) 97.5a (86.8, 99.9)*
Dynamiker Biotechnology 2019‐nCOV IgG/IgM Rapid Test 1 (72/75) 96.0a (88.8, 99.2)* 1 (72/74) 97.3a (90.6, 99.7)* 3 (87/93) 97.1 (58.3, 99.9)
Fortress Diagnostics COVID‐19 Total Ab 1 (258/307) 84.0 (79.5, 88.0)        
GenBody
CGIA
GenBody COVID‐19 IgG/IgM         1 (25/28) 89.3a (71.8, 97.7)*
Genrui Biotech Novel Coronavirus IgG/IgM test kit 1 (10/10) 100a (69.2, 100)** 1 (10/10) 100a (69.2, 100)** 1 (10/10) 100a (69.2, 100)**
Getein Biotech
CGIA
One Step Test for Novel Coronavirus IgG/IgM 1 (9/10) 90.0a (55.5, 99.7)* 1 (0/10) 0a (0, 30.8)** 2 (25/28) 89.3 (71.5, 96.5)
Guangzhou Wondfo Wondfo SARS‐CoV‐2 Antibody Test         6 (211/265) 85.1 (69.0, 93.6)
Hangzhou Alltest
CGIA
Unlabelled packaging IgG/IgM 1 (25/30) 83.3a (65.3, 94.4)* 1 (17/30) 56.7a (37.4, 74.5)* 1 (25/30) 83.3a (65.3, 94.4)*
Hangzhou Alltest
CGIA
2019‐nCoV IgG/IgM Rapid Test Cassette 4 (97/109) 89.0 (81.6, 93.6) 4 (36/137) 11.6 (0.6, 72.8) 4 (123/135) 91.4 (83.7, 95.6)
Hangzhou Biotest (distributed by Premier Biotech) The RightsignTM COVID‐19 IgG/IgM Rapid Test Casette / Lumiratek (also distributed as COVID‐19 IgG/IgM Rapid Test Casette and CoronaChek IgG/IgM) 3 (175/185) 93.6 (84.5, 97.5) 3 (55/82) 67.1 (56.2, 76.4) 2 (48/51) 94.1 (83.3, 98.1)
Hightop Biotech
CGIA
Hightop SARS‐CoV‐2 IgG/IgM Antibody Rapid Test 1 (28/30) 93.3a (77.9, 99.2)* 1 (141/160) 88.1a (82.1, 92.7)* 1 (28/30) 93.3a (77.9, 99.2)*
Innovita Biological Technology CGIA 2019‐nCoV Ab test IgG/IgM 6 (117/152) 77.2 (64.4, 86.4) 6 (172/335) 60.8 (46.0, 73.8) 5 (106/134) 79.1 (71.4, 85.2)
InTec
CGIA
Rapid SARS‐CoV‐2 Antibody (IgG/IgM) Test 1 (5/7) 71.4a (29.0, 96.3)* 1 (6/7) 85.7a (42.1, 99.6)* 1 (6/7) 85.7a (42.1, 99.6)*
Intelligent Endoscopy Smart screen IgG/IgM 1 (10/40) 25.0a (12.7, 41.2)* 1 (24/40) 60.0a (43.3, 75.1)* 1 (26/40) 65.0a (48.3, 79.4)*
Inzec BIOZEK COVID‐19 IgG/IgM 1 (106/115) 92.2a (85.7, 96.4)* 1 (26/115) 22.6a (15.3, 31.3)*    
Jiangsu Medomics
CGIA
Rapid IgM‐IgG combined antibody test kit for SARS‐CoV‐2 1 (13/18) 72.2a (46.5, 90.3)* 1 (13/16) 81.3a (54.4, 96.0)* 2 (41/46) 89.8 (68.3, 97.3)
LabOn Time LaboOn Time rapid test cassette IgG/IgM         1 (31/33) 93.9a (79.8, 99.3)*
Leccurate
CGIA
SARS‐CoV‐2 antibody test IgG/IgM 1 (29/35) 82.9a (66.4, 93.4)* 1 (13/20) 65.0a (40.0, 84.6)* 1 (12/16) 75.0a (47.6, 92.7)*
Liming Bio StrongStep SARS‐CoV‐2 IgG/IgM 1 (29/35) 82.9a (66.4, 93.4)* 1 (12/18) 66.7a (41.0, 86.7)* 1 (29/35) 82.9a (66.4, 93.4)*
MEDsan MEDsan COVID‐19 IgG/IgM Rapid Test 2 (227/254) 89.4 (84.9, 92.6) 2 (207/254) 81.5 (76.2, 85.8) 1 (92/99) 92.9a (86.0, 97.1)*
MEXACARE QuickTestCorona COVID‐19 IgG/IgM 1 (190/224) 84.8a (79.4, 89.3)* 1 (26/115) 22.6a (15.3, 31.3)*    
Mologic IgG COVID‐19 1 (35/50) 70.0a (55.4, 82.1)*        
Multi‐G 2019‐nCoV IgG/IgM Rapid Test Cassette single lane 1 (32/33) 97.0a (84.2, 99.9)* 1 (15/33) 45.5a (28.1, 63.6)* 1 (24/25) 96.0a (79.6, 99.9)*
Multi‐G 2019‐nCoV IgG/IgM Rapid Test Cassette dual lane 1 (32/33) 97.0a (84.2, 99.9)* 1 (28/33) 84.8a (68.1, 94.9)* 1 (24/25) 96.0a (79.6, 99.9)*
Nal Von Minden NADAL COVID‐19 IgG/IgM Test 1 (26/31) 83.9a (66.3, 94.5)* 1 (30/32) 93.8a (79.2, 99.2)*    
Nirmidas Biotech COVID‐19 (SARS‐CoV‐2) IgG/IgM Antibody Detection Kit 1 (33/40) 82.5a (67.2, 92.7)* 1 (33/40) 82.5a (67.2, 92.7)* 1 (37/40) 92.5a (79.6, 98.4)*
NTBIO® Diagnostics NTBIO One Step Rapid Test ‐ COVID‐19 IgG/IgM Antibody Test 1 (188/219) 85.8a (80.5, 90.2)* 1 (167/200) 83.5a (77.6, 88.4)*    
Qingdao HIGHTOP SARS‐CoV‐2 IgG/IgM Ab Rapid Test 1 (216/229) 94.3a (90.5, 96.9)* 1 (30/46) 65.2a (49.8, 78.6)*    
Render COVID‐19 IgG/IgM Test 1 (15/20) 75.0a (50.9, 91.3)* 1 (34/65) 52.3a (39.5, 64.9)* 1 (16/20) 80.0a (56.3, 94.3)*
Safecare Biotech SafeCare Bio‐Tech COVID‐19 IgG/IgM Rapid Test Device 1 (37/40) 92.5a (79.6, 98.4)* 1 (31/40) 77.5a (61.5, 89.2)* 1 (38/40) 95.0a (83.1, 99.4)*
Screen Italia Screen Test Covid‐19 2019‐nCOV IgG/IgM 1 (79/109) 72.5a (63.1, 80.6)* 1 (89/109) 81.7a (73.1, 88.4)* 1 (108/109) 99.1a (95.0, 100.0)*
SD Biosensor COVID‐19 IgG/IgM Duo 4 (50/69) 74.2 (52.1, 88.3) 3 (17/23) 63.5 (5.4, 98.1) 1 (6/7) 85.7a (42.1, 99.6)*
Sensing Self Covid‐19 Rapid IgG/IgM combined Antibody assay 1 (35/40) 87.5a (73.2, 95.8)* 1 (6/40) 15.0a (5.7, 29.8)* 1 (35/40) 87.5a (73.2, 95.8)*
Servibio/VEDALAB COVID‐19 Sign IgG/IgM         1 (33/42) 78.6a (63.2, 89.7)*
SIDAK Life Care Sidak Covid 19 Antibody IgG/IgM Rapid Test Kit 1 (9/14) 64.3a (35.1, 87.2)* 1 (17/33) 51.5a (33.5, 69.2)* 1 (9/14) 64.3a (35.1, 87.2)*
Spring Healthcare Services
CGIA
COVID‐19 Spring IgG/IgM Rapid Test Cassette         1 (28/28) 100a (87.7, 100)**
Sure Biotech SARS‐CoV‐2 IgG/IgM Antibody Rapid Test 2 (226/235) 96.2 (92.8, 98.0) 2 (212/235) 90.2 (85.7, 93.4) 1 (10/11) 90.9a (58.7, 99.8)*
SureScreen Diagnostics COVID‐19 Coronavirus Rapid Test Cassette IgG/IgM 1 (31/33) 93.9a (79.8, 99.3)* 1 (16/19) 84.2a (60.4, 96.6)* 3 (248/257) 96.5 (93.4, 98.2)
TAmiRNA SARS‐CoV‐2 Antibody Lateral Flow Test IgG/IgM         1 (203/222) 91.4a (87.0, 94.8)*
TBG Biotechnology TBG SARS‐CoV‐2 IgG/IgM Rapid Test Kit 1 (38/40) 95.0a (83.1, 99.4)* 1 (35/40) 87.5a (73.2, 95.8)** 1 (38/40) 95.0a (83.1, 99.4)*
TONYAR Biotech ASK COVID‐19 IgG/IgM Rapid Test         2 (83/85) 97.6 (91.1, 99.4)
Trillium IgG/IgM rapid assay 1 (20/28) 71.4a (51.3, 86.8)* 1 (19/28) 67.9a (47.6, 84.1)*    
UCP Biosciences Coronavirus IgG/IgM Antibody (COVID‐19) Test Cassette 1 (9/11) 81.8a (48.2, 97.7)* 1 (21/47) 44.7a (30.2, 59.9)* 1 (10/11) 90.9a (58.7, 99.8)*
Unknown manufacturer Ready Result IgG/IgM 1 (35/38) 92.1a (78.6, 98.3)* 1 (33/38) 86.8a (71.9, 95.6)* 1 (38/39) 97.4a (86.5, 99.9)*
Vazyme Biotech 2019‐nCoV IgG/IgM Detection Kit 1 (4/4) 100a (39.8, 100)** 1 (9/11) 81.8a (48.2, 97.7)*    
VivaChek Biotech
CGIA
VivaDiag COVID‐19 IgG/IgM Rapid Test 3 (67/105) 72.8 (49.0, 88.1) 2 (35/39) 89.7 (75.7, 96.1) 2 (43/75) 68.7 (32.9, 90.8)
W.H.P.M. COVISURE COVID‐19 IgG/IgM Rapid Test 1 (26/38) 68.4a (51.3, 82.5)* 1 (25/38) 65.8a (48.6, 80.4)* 1 (26/38) 68.4a (51.3, 82.5)*
Wells Bio CareUS COVID‐19 IgG/IgM 1 (35/37) 94.6a (81.8, 99.3)* 1 (33/38) 86.8a (71.9, 95.6)*    
Xiamen Biotime SARS‐Cov‐2 IgG/IgM Rapid Qualitative Test 1 (183/200) 91.5a (86.7, 95.0)* 1 (167/200) 83.5a (77.6, 88.4)*    
ZenTech
CGIA
QuickZen COVID‐19 IgG/IgM         1 (30/33) 90.9a (75.7, 98.1)*
Zeus Scientific ZEUS SARS‐CoV‐2 IgG/IgM rapid test 1 (22/40) 55.0a (38.5, 70.7)* 1 (14/40) 35.0a (20.6, 51.7)* 1 (23/40) 57.5a (40.9, 73.0)*
Zhejiang Orient‐Gene
CGIA
COVID‐19 IgG rapid test cassette 7 (322/355) 90.7 (87.2, 93.3) 6 (170/310) 63.7 (25.7, 89.9) 5 (184/194) 94.8 (90.7, 97.2)
ELISA
Beijing Wantai Wantai ELISA IgG/IgM assay     3 (63/91) 58.4 (32.1, 80.6)    
Bio‐Rad Laboratories Novel coronavirus COVID‐19 IgG/IgM EIA 1 (10/10) 100a (69.2, 100)** 1 (5/10) 50.0a (18.7, 81.3)* 1 10/10) 100a (69.2, 100)**
Creative Diagnostics SARS‐CoV‐2 IgG/IgM ELISA Kit 1 (38/41) 92.7a (80.1, 98.5)* 1 (38/41) 92.7a (80.1, 98.5)*    
EDI/Eagle Biosciences COVID‐19 IgG/IgM Quantitative ELISA 1 (539/1134) 47.5a (44.6, 50.5)* 1 (100/123) 81.3a (73.3, 87.8)*    
Epitope Diagnostics EDITM Novel Coronavirus COVID‐19 IgG/IgM ELISA kit 13 (780/934) 87.7 (78.1, 93.4) 7 (340/662) 61.3 (33.2, 83.4) 2 (42/50) 84.0 (71.1, 91.8)
Euroimmun anti‐SARS‐COV‐2 IgG 41
(2200/2442)
90.8 (88.6, 92.7)        
Euroimmun anti‐SARS‐COV‐2 IgG (N‐based) 2 (85/100) 84.8 (37.3, 99.8)        
Gold Standard Diagnostics (GSD) Gold Standard SARS‐CoV‐2 IgG ELISA 1 (85/123) 69.1a (60.1, 77.1)*        
Hotgen Beijing Hotgen SARS‐CoV‐2 IgG/IgM ELISA 1 (39/45) 86.7 (73.2, 94.9) 1 (40/45) 88.9a (75.9, 96.3)* 1 (41/45) 91.1a (78.8, 97.5)*
ImmunoDiagnostics SARS‐CoV‐2 NP IgG/IgM ELISA Kit 2 (151/186) 87.9 (64.8, 96.6) 1 (43/46) 93.5a (82.1, 98.6)*    
Mediagnost Mediagnost Anti‐SARS‐CoV‐2 ELISA IgG/IgM 2 (84/94) 89.4(81.3, 94.2) 1 (14/16) 87.5a (61.7, 98.4)*    
Mikrogen Mikrogen IgG anti‐N 1 (24/24) 100a (85.8, 100)**        
Novatek Novatec Novalisa SARS‐CoV‐2 IgG ELISA 1 (38/48) 79.2a (65.0, 89.5)*        
Vircell COVID‐19 ELISA IgG 2 (56/60) 93.3 (83.5, 97.5)        
Virotech Virotec(h SARS‐CoV‐2 ELISA IgG 2 (45/64) 70.3a (58.1, 80.2)*        
Zhuhai Livzon Zhuhai Livzon SARS‐CoV‐2 IgG/IgM ELISA 2 (91/104) 85.6 (77.4, 91.1) 2 (78/104) 81.1 (66.8, 90.1) 1 (43/45) 95.6a (84.9, 99.5)*
Zydus diagnostics Covid Kavach IgG ELISA 2 (320/421) 76.0 (71.7, 79.8)        
CLIA
Abbott Diagnostics Abbott Alinity anti‐SARS‐CoV‐2 nucleocapsid IgG 2 (149/163) 91.3 (83.8, 95.5)        
Abbott Diagnostics Abbott Architect anti‐SARS‐CoV‐2 nucleocapsid IgG/IgM 33 (1824/1977) 92.5 (90.3, 94.3) 2 (32/38) 85.1a (64.5, 94.7)*    
Autobio Diagnostics SARS‐CoV‐2 CLIA Microparticles IgM/IgG 1 (271/273) 99.3a (97.4, 99.9)* 1 (53/62) 85.5a (74.2, 93.1)*    
Beckman Coulter Access SARS‐CoV‐2 IgG 2 (78/94) 92.4 (38.8, 99.6)        
Beijing Wantai Wantai CLIA IgG/IgM assay 1 (47/47) 100a (92.5, 100)* 1 (4/8) 50.0a (15.7, 84.3)*    
Bioscience Co Bioscience Co (Chongqing) SARS‐CoV‐2 IgG/IgM 1 (13/13) 100a (75.3, 100)** 1 (12/13) 92.3 (64.0, 99.8) 1 (13/13) 100a (75.3, 100)**
DiaSorin LIAISON SARS‐CoV‐2 S1/S1 IgG CLIA 21 (1523/1735) 88.1 (84.1, 91.2)        
Diazyme Diazyme DZ‐LITE 2019‐nCoV IgG/IgM (CLIA) Assay Kit 2 (41/43) 95.3 (83.2, 98.8) 2 (20/21) 95.2 (72.9, 99.3) 1 (18/18) 100a (81.5, 100)**
Ortho Clinical Diagnostics Vitros (VITROS) Anti‐SARS‐Cov‐2 Total assay IgG 3 (201/221) 92.3 (80.8, 97.1)        
Shenzhen YHLO Biotech YHLO iFlash IgG/IgM assay 5 (260/268) 97.0 (94.1, 98.5) 5 (109/184) 68.7 (44.6, 85.7) 1 (8/8) 100a (63.1, 100)**
SNIBE Shenzhen MAGLUMI 2019‐nCoV IgG/IgM kits 7 (325/369) 89.9 (83.3, 94.1) 5 (174/299) 63.6 (37.4, 83.7) 1 (30/32) 93.8a (79.2, 99.2)*
Xiamen InnoDx Biotech Novel coronavirus (2019‐nCoV) antibody test kit IgM     1 (31/61) 50.8a (37.7, 63.9)*    
Other/unclear
ET Healthcare Pylon 3D automated immunoassay system IgG/IgM 2 (37/37) 100a (90.5, 100)** 2 (35/58) 71.2 (28.3, 93.9) 1 (21/21) 100a (83.9, 100)**
Genalyte Maverick SARS‐CoV‐2 Multi‐Antigen Serology Panel IgG (S‐based) 1 (24/26) 92.3 (74.9, 99.1)        
Genalyte Maverick SARS‐CoV‐2 Multi‐Antigen Serology Panel IgG (N‐based) 1 (23/26) 88.5 (69.8, 97.6)        
Quotient MosaiQ COVID‐19 antibody microarray IgG/IgM         1 (30/30) 100a (88.4, 100)**
a Estimates and confidence intervals by summing the counts of true positive and false negative across 2 x 2 tables
*95% exact binomial confidence interval
**97.5% one‐sided exact binomial confidence interval
Ab: antibodyCI: confidence intervalCLIA: chemiluminescence immunoassayELISA: enzyme‐linked immunosorbent assayFN: false negativeTP: true positive