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 |