Skip to main content
. 2022 Nov 17;2022(11):CD013652. doi: 10.1002/14651858.CD013652.pub2
Test brand Test name Week 1 Week 2 Week 3
Lateral flow assays Test groups (true positives/COVID cases)
Sensitivity (95% CI)
AAZ‐LMB Covid‐Duo test rapid Covid‐19 IgG/IgM 1 (5/14) 1 (59/86) 1 (26/26)
CGIA   35.7a
(12.8, 64.9)*		 68.6a
(57.7, 78.2)*		 100a
(86.8, 100)**
AAZ‐LMB Covid‐Presto test rapid Covid‐19 IgG/IgM 2 (17/38) 2 (84/125) 1 (24/24)
CGIA   42.8
(4.2, 9.3)		 85.3
(34.7, 98.4)		 100a
(85.8, 100)**
AccuBiotech Accu‐Tell COVID‐19 IgG/IgM Cassette 2(30/47) 1 (11/14) 2 (51/59)
CGIA   42.4
(6.1, 89.2)		 78.6a
(49.2, 95.3)*		 86.4
(75.2, 93.1)
ACON Laboratories SARS‐COV‐2 IgG/IgM Rapid Test     1 (56/58)
LFA       96.6a
(88.1, 99.6)*
Acro Biotech 2019‐nCoV IgG/IgM Rapid Test 1 (0/9) 1 (13/14) 1 (12/15)
LFA   0a
(0, 33.6)**		 92.9a
(66.1, 99.8)*		 80.0a
(51.9, 95.7)*
Anhui Deep Blue SARS‐CoV‐2 IgG/IgM Ab test kit 1 (30/38)   2 (46/54)
LFA   78.9a
(62.7, 90.4)*		   85.2
(73.1, 92.4)
Artron Artron COVID‐19 IgG/IgM 1 (25/90) 2 (17/32) 2 (35/39)
CGIA   27.8a
(18.9, 38.2)*		 53.1
(36.1, 69.4)		 89.9
(73.3, 96.6)
Assure Tech FaStep (COVID‐19 IgG/IgM) rapid test cassettes   1 (10/16) 1 (15/16)
LFA     62.5a
(35.4, 84.8)*		 93.8a
(69.8, 99.8)*
Autobio Diagnostics Anti‐SARS‐CoV‐2 Rapid Test IgG/IgM 1 (52/100) 2 (80/92) 2 (22/23)
CGIA   52.0a
(41.8, 62.1)*		 87.0
(78.4, 92.4)		 95.7a
(74.8, 99.4)*
Avioq Bio‐Tech Novel Coronavirus (2019‐nCov) Antibody IgG/IgM Assay Kit 1 (8/29) 1 (46/62)  
CGIA   27.6a
(12.7, 47.2)*		 74.2a
(61.5, 84.5)*		  
Biohit Healthcare SARS‐CoV‐2 IgG/IgM ANTIBODY TEST KIT 1 (22/38)   1 (34/44)
CGIA   57.9a
(40.8, 73.7)*		   77.3a
(62.2, 88.5)*
Biolidics 2019 nCoV IgG/IgM detection kit 1 (0/7) 1 (24/26) 1 (8/10)
LFA   0a
(0, 41.0)**		 92.3a
(74.9, 99.1)*		 80.0a
(44.4, 97.5)*
BioMedomics COVID‐19 IgG/IgM Rapid Test 2 (32/70) 2 (48/57) 1 (17/19)
LFA   45.7
(34.5, 57.4)		 84.2
(72.4, 91.6)		 89.5a
(66.9, 98.7)*
Bioperfectus Technologies PerfectPOC Novel Corona Virus (SARS CoV‐2) IgG/IgM Rapid Test Kit 1 (38/63) 1 (30/37) 1 (17/21)
LFA   60.3a
(47.2, 72.4)*		 81.1a
(64.8, 92.0)*		 81.0a
(58.1, 94.6)*
Biosynex COVID‐19 BSS IgG/IgM 2 (22/48) 2 (40/46) 3 (164/171)
LFA   50.0
(21.7, 78.3)		 86.9
(71.5, 94.6)		 95.9
(61.7, 98.0)
BTNX Rapid ResponseTM COVID‐19 Test Cassette (BTNX Inc.) Kit1 IgG/IgM 1 (33/154) 1 (64/103) 2 (64/68)
LFA   21.4a
(15.2, 28.8)*		 62.1a
(52.0, 71.5)*		 93.4
(77.4, 98.3)
Cellex Cellex qSARS‐CoV‐ 2 IgG/IgM Cassette Rapid Test 2 (12/28) 2 (54/67) 3 (51/58)
LFA   41.8
(15.8, 73.4)		 80.6
(69.4, 88.4)		 87.9
(76.8, 94.1)
Chongqing iSIA BIO‐Technology 2019‐nCoV IgG/IgM Diagnostic Test Kit 1 (0/9) 1 (7/14) 1 (14/15)
LFA   0a
(0, 33.6)**		 50.0a
(23.0, 77.0)*		 93.3a
(68.1, 99.8)*
Clungene Biotech Clungene SARS‐CoV‐2 IgG/IgM Rapid Test Cassettes 1 (13/37) 1 (50/78) 1 (37/38)
LFA   35.1a
(20.2, 52.5)*		 64.1a
(52.4, 74.7)*		 97.4a
(86.2, 99.9)*
CTK Biotech OnSite COVID‐19 IgG/IgM Rapid Test   1 (5/7) 1 (14/15)
CGIA     71.4a
(29.0, 96.3)*		 93.3a
(68.1, 99.8)*
DecombioBiotechnology Novel Coronavirus (SARS‐CoV‐2) IgG/IgM Combo Rapid Test‐Cassette 1 (32/62) 1 (29/34) 1 (14/16)
LFA   51.6a
(38.6, 64.5)*		 85.3a
(68.9, 95.0)*		 87.5a
(61.7, 98.4)*
DeepBlue Medical COVID‐19 (SARS CoV‐2) IgG/IgM Antibody Test Kit (Colloidal Gold) 1 (40/64) 1 (28/37) 1 (17/21)
CGIA   62.5a
(49.5, 74.3)*		 75.7a
(58.8, 88.2)*		 81.0a
(58.1, 94.6)*
Dynamiker Biotechnology Dynamiker Biotechnology ‐ 2019‐nCOV IgG/IgM Rapid Test 3 (54/144) 3 (100/158) 4 (118/136)
LFA   37.6
(29.6, 46.3)		 63.3
(55.5, 70.4)		 90.7
(77.2, 96.6)
Epigentek Group SeroFlash SARS‐CoV‐2 IgG/IgM 1 (4/18) 1 (11/14)  
LFA   22.2a
(6.4, 47.6)*		 78.6a
(49.2, 95.3)		  
GenBody GenBody COVID‐19 IgG/IgM 1 (13/38)   1 (31/44)
CGIA   34.2a
(19.6, 51.4)*		   70.5a
(54.8, 83.2)*
Genrui Biotech Novel Coronavirus IgG/IgM test kit     1 (8/10)
LFA       80.0a
(44.4, 97.5)*
Getein Biotech One Step Test for Novel Coronavirus Total Ab 1 (8/13) 1 (8/13) 2 (27/32)
CGIA   61.5a
(31.6, 86.1)*		 61.5a
(31.6, 86.1)*		 84.4
(67.5, 93.3)
Guangzhou Wondfo Wondfo SARS‐CoV‐2 Antibody Test 6 (106/280) 6 (181/245) 5 (103/117)
LFA   29.8
(14.4, 51.7)		 73.9
(68.0, 79.0)		 88.0
(80.8, 92.8)
Hangzhou Hangzhou unlabelled packaging IgG/IgM 1 (13/51) 1 (15/21) 1 (6/8)
CGIA   25.5a
(14.3, 39.6)*		 71.4a
(47.8, 88.7)*		 75.0a
(34.9, 96.8)*
Hangzhou Alltest 2019‐nCoV IgG/IgM Rapid Test Cassette 4 (43/134) 4 (45/73) 5 (85/88)
CGIA   30.6
(19.1, 45.1)		 63.1
(45.8, 77.5)		 96.6
(90.0, 98.9)
Hangzhou Biotest (also distributed by Premier Biotech) RightSign IgM/IgG (distributed as COVID‐19 IgG/IgM Rapid Test Cassette) 1 (35/63) 1 (29/33) 1 (17/21)
LFA   55.6a
(42.5, 68.1)*		 87.9a
(71.8, 96.6)*		 81.0a
(58.1, 94.6)*
Hightop Biotech Hightop SARS‐CoV‐2 IgG/IgM Antibody Rapid Test 1 (8/51) 1 (15/21) 1 (7/8)
CGIA   15.7a
(7.0, 28.6)*		 71.4a
(47.8, 88.7)*		 87.5a
(47.3, 99.7)*
Innovita Biological Technology 2019‐nCoV Ab test IgG/IgM 5 (75/169) 4 (72/106) 5 (89/113)
CGIA   44.4
(37.1, 51.9)		 67.9
(58.5, 76.1)		 78.8
(70.3, 85.3)
InTec Rapid SARS‐CoV‐2 Antibody (IgG/IgM) Test 1 (9/14) 1 (44/47) 1 (13/16)
CGIA   64.3a
(35.1, 87.2)*		 93.6a
(82.5, 98.7)*		 81.3a
(54.4, 96.0)*
Jiangsu Medomics Rapid IgM‐IgG Combined Antibody Test Kit for SARS‐ CoV‐2 IgG/IgM 2 (28/50) 1 (7/12) 2 (50/64)
CGIA   56.0
(42.1, 69.0)		 58.3a
(27.7, 84.8)*		 78.1
(66.4, 86.6)
LabOn Time LaboOn Time rapid test cassette IgG/IgM 1 (11/29) 1 (47/62)  
LFA   37.9a
(20.7, 57.7)*		 75.8a
(63.3, 85.8)*		  
Leccurate SARS‐CoV‐2 antibody test IgG/IgM 1 (11/14) 1 (13/20) 1 (15/20)
CGIA   78.6a
(49.2, 95.3)*		 65.0a
(40.8, 84.6)*		 75.0a
(50.9, 91.3)*
Liming Bio StrongStep1 SARS‐CoV‐2 IgG/IgM 2 (28/61) 2 (74/111) 2 (65/72)
LFA   47.4
(29.1, 66.4)		 66.7
(57.4, 74.8)		 91.8
(72.7, 97.9)
Maccura Biotechnology Maccura LFIA SARS‐CoV‐2 IgG/IgM 1 (9/21)    
CGIA   42.9a
(21.8, 66.0)*		    
Multi‐G Multi‐G MGA 2019‐nCoV IgG/IgM Rapid test cassette 1 (16/37) 1 (56/78) 1 (37/38)
LFA   43.2a
(27.1, 60.5)*		 71.8a
(60.5, 81.4)*		 97.4a
(86.2, 99.9)*
NG Biotech NG‐Test IgG/IgM COVID‐19 3 (97/273) 4 (172/219) 1 (29/34)
CGIA   36.5
(28.6, 45.1)		 78.6
(67.3, 86.8)		 85.3a
(68.9, 95.0)*
Not stated KHB Diagnostic Kit for SARS‐ CoV‐2 IgG/IgM Antibody     1
(2/6)
CGIA       33.3a
(4.3, 77.7)*
Prima Lab Prima COVID‐19 IgG/IgM Rapid test 1 (21/37) 1 (62/78) 1 (38/38)
LFA   56.8a
(39.5, 72.9)*		 79.5a
(68.8, 87.8)*		 100a
(90.7, 100)**
Prometheus Bio Prometheus Bio ‐ 2019‐nCoV IgG/IgM 1 (24/35) 1 (10/11) 1 (2/2)
LFA   68.6a
(50.7, 83.1)*		 90.9a
(58.7, 99.8)*		 100a
(15.8, 100)**
Render COVID‐19 IgG/IgM Test 1 (8/24) 1 (18/28) 1 (17/24)
LFA   33.3a
(15.6, 55.3)*		 64.3a
(44.1, 81.4)*		 70.8a
(48.9, 87.4)*
SD Biosensor COVID‐19 IgG/IgM Duo 2 (3/18) 1 (24/37)  
LFA   16.7
(5.5, 40.9)		 64.9a
(47.5, 79.8)*		  
Servibio/VEDALAB COVID‐19 Sign IgG/IgM 1 (12/30) 1 (12/17) 1 (24/27)
LFA   40.0a
(22.7, 59.4)*		 70.6a
(44.0, 89.7)*		 88.9a
(70.8, 97.6)*
Shanghai Outdo Biotech SARS‐CoV‐2 IgG/IgM GICA kit 1 (22/40) 1 (24/57) 1 (23/47)
CGIA   55.0a
(38.5, 70.7)*		 42.1a
(29.1, 55.9)*		 48.9a
(34.1, 63.9)*
SIDAK Life Care Sidak Covid 19 Antibody IgG/IgM Rapid Test Kit 1 (2/23) 1 (20/27) 1 (30/36)
LFA   8.7a
(1.1, 28.0)*		 74.1a
(53.7, 88.9)*		 83.3a
(67.2, 93.6)*
Spring Healthcare Services COVID‐19 Spring IgG/IgM Rapid Test Cassette 1 (29/38)   1 (36/44)
CGIA   76.3a
(59.8, 88.6)*		   81.8a
(67.3, 91.8)*
Sure Biotech SARS‐CoV‐2 IgG/IgM Antibody Rapid Test 1 (24/63) 1 (25/35) 1 (15/16)
LFA   38.1a
(26.1, 51.2)*		 71.4a
(53.7, 85.4)*		 93.8a
(69.8, 99.8)*
SureScreen Diagnostics COVID‐19 Coronavirus Rapid Test Cassette IgG/IgM 2 (41/60) 1 (10/14) 3 (129/150)
LFA   68.3
(55.6, 78.8)		 71.4a
(41.9, 91.6)*		 85.0
(74.3, 91.8)
Syzbio Biotech Syzbio SARS‐CoV‐2 IgG/IgM Antibody Assay Kit 1 (14/22) 1 (9/13) 1 (6/10)
LFA   63.6a
(40.7, 82.8)*		 69.2a
(38.6, 90.9)*		 60.0a
(26.2, 87.8)*
T&D Diagnostics Sienna 2019‐nCoV IgG/IgM Rapid Test 1 (15/41) 1 (39/48) 1 (9/9)
LFA   36.6a
(22.1, 53.1)*		 81.3a
(67.4, 91.1)*		 100a
(66.4, 100)**
TAmiRNA SARS‐CoV‐2 Antibody Lateral Flow Test IgG/IgM     1 (49/58)
LFA       84.5a
(72.6, 92.7)*
TONYAR Biotech ASK COVID‐19 IgG/IgM Rapid Test 2 (46/107) 1 (54/73) 2 (70/100)
LFA   43.0
(34.0, 52.5)		 74.0a
(62.4, 83.5)*		 69.0a
(44.2, 86.1)*
UCP Biosciences Coronavirus IgG/IgM Antibody (COVID‐19)
Test Cassette		 1 (28/64) 1 (27/37) 1 (15/18)
LFA   43.8a
(31.4, 56.7)*		 73.0a
(55.9, 86.2)*		 83.3a
(58.6, 96.4)*
UNscience Biotechnology COVID‐19 IgG/IgM Rapid Test Kit 1 (2/9) 1 (10/14) 1 (13/15)
LFA   22.2a
(2.8, 60.0)*		 71.4a
(41.9, 91.6)*		 86.7a
(59.5, 98.3)*
VivaChek Biotech VivaDiag COVID‐19 IgG/IgM Rapid Test 3 (66/196) 2 (76/116) 2 (52/56)
CGIA   34.8
(23.8, 47.8)		 65.5
(56.4, 73.6)		 93.0
(76.8, 98.1)
Beijing Wantai Wantai Ab rapid assay 1 (6/30) 1 (20/25) 1 (22/22)
LFA   20.0a
(7.7, 38.6)*		 80.0a
(59.3, 93.2)*		 100a
(84.6, 100)**
ZenTech QuickZen COVID‐19 IgG/IgM 1 (10/29) 1 (48/62)  
CGIA   34.5a
(17.9, 54.3)*		 77.4a
(65.0, 87.1)*		  
Zhejiang Orient‐Gene Biotech COVID‐19 IgG/IgM rapid test cassette 5 (79/154) 5 (158/195) 4 (123/130)
CGIA   53.1
(38.0, 67.6)		 85.0
(69.6, 93.3)		 94.6
(89.1, 97.4)
Zhuhai Livzon Zhuhai Livzon SARS‐CoV‐2 IgG/IgM 2 (8/45) 2 (41/48) 1 (14/15)
LFA   17.8
(9.1, 31.7)		 84.9
(67.7, 93.8)		 93.3a
(68.1, 99.8)*
ELISA
Beijing Wantai Wantai ELISA IgG/IgM assay 1 (12/24) 1 (64/80) 1 (33/37)
    50.0a
(29.1, 70.9)* 80.0a
(69.6, 88.1)*		 89.2a
(74.6, 97.0)*
Bio‐Rad Laboratories Novel coronavirus COVID‐19 IgG/IgM assay     1 (10/11)
        90.9a
(58.7, 99.8)*
Dia.Pro Diagnostic Bioprobes DiaPro COVID‐19 IgG/IgM Confirmation 1 (9/16) 1 (18/20)  
    56.3a
(29.9, 80.2)*		 90.0a
(68.3, 98.8)*		  
Epitope Diagnostics EDITM Novel Coronavirus COVID‐19 IgG/IgM ELISA kit 3 (22/96) 3 (72/120) 4 (77/79)
    18.5
(5.2, 48.5)		 60.0
(51.0, 68.4)		 97.5
(90.4, 99.4)
Hotgen Beijing Hotgen SARS‐CoV‐2 IgG/IgM ELISA 1 (10/22) 1 (72/92) 1 (53/55)
    45.5 (24.4, 67.8) 78.3 (68.4, 86.2) 96.4 (87.5, 99.6)
Zhuhai Livzon Zhuhai Livzon SARS‐CoV‐2 IgG/IgM ELISA 2 (14/39) 2 (150/202) 1 (52/55)
    35.9
(22.5, 51.9)		 74.3
(67.8, 79.8)		 94.5a
(84.9, 98.9)*
CLIA
Bioscience Bioscience Co (Chongqing) SARS‐CoVCoV‐2 IgG/IgM 1 (34/67) 1 (124/149) 1 (131/134)
    50.7a
(38.2, 63.2)*		 83.2a
(76.2, 88.8)*		 97.8a
(93.6, 99.5)*
Shenzhen YHLO YHLO iFlash IgG/IgM assay 1 (5/7) 1 (8/14)  
    71.4a
(29.0, 96.3)*		 57.1a
(28.9, 82.3)*		  
SNIBE Shenzhen MAGLUMI 2019‐nCoV IgG/IgM kits 2 (39/99) 2 (92/123) 1 (42/44)
    33.0
(15.1, 57.7)		 74.8
(66.4, 81.7)		 95.5a
(84.5, 99.4)*
Other/unclear
ET Healthcare Pylon 3D automated immunoassay system IgG/IgM 1 (9/41) 1 (29/33) 1 (14/27)
    22.0a
(10.6, 37.6)*		 87.9a
(71.8, 96.6)*		 51.9a
(31.9, 71.3)*
Quotient MosaiQ COVID‐19 antibody microarray IgG/IgM     1 (32/33)
        97.0a
(84.2, 99.9)*
aEstimates 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
CGIA: colloidal gold immunoassay
CI: confidence interval
CLIA: chemiluminescence immunoassay
ELISA: enzyme linked immusorbent assay
LFA: lateral flow assay