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. 2022 Nov 17;2022(11):CD013652. doi: 10.1002/14651858.CD013652.pub2
Test name Test name Week 1 Week 2 Week 3
Test brand Test brand Test groups (true positives/COVID cases) Sensitivity (95% CI)  
Lateral flow assays
AAZ‐LMB Covid‐Presto test rapid Covid‐19 IgM 1 (12/18) 1 (29/33)  
LFA   66.7a
(41.0, 86.7)*		 87.9a
(71.8, 96.6)*		  
AccuBiotech Accu‐Tell COVID‐19 IgM Cassette IgM 1 (1/9) 1 (11/14) 1 (14/15)
CGIA   11.1a
(0.3, 48.2)*		 78.6a
(49.2, 95.3)*		 93.3a
(68.1, 99.8)*
ACON Laboratories SARS‐COV‐2 IgM Rapid Test     1 (54/58)
LFA       93.1a
(83.3, 98.1)*
Acro Biotech 2019‐nCoV IgM Rapid Test 1 (0/9) 1 (6/14) 1 (11/15)
LFA   0a
(0, 33.6)**		 42.9a
(17.7, 71.1)*		 73.3a
(44.9, 92.2)*
Anhui Deep Blue SARS‐CoV‐2 IgM Ab test kit     1 (7/10)
LFA       70.0a
(34.8, 93.3)*
Artron Artron COVID‐19 IgM 1 (25/90) 1 (12/25) 1 (23/24)
LFA   27.8a
(18.9, 38.2)*		 48.0a
(27.8, 68.7)*		 95.8a
(78.9, 99.9)*
Augurix Diagnostics One Step Test for Novel Coronavirus (2019‐nCoV) IgM Antibody 1 (2/18) 1 (1/33)  
LFA   11.1a
(1.4, 35.7)*		 3.0a
(0.1, 15.8)*		  
Augurix SimtomaX Corona Check IgM     1 (13/59)
LFA       22.0a
(12.3, 34.7)*
Autobio Diagnostics Anti‐SARS‐CoV‐2 Rapid Test IgM 1 (46/100) 1 (69/85) 2 (64/78)
CGIA   46.0a
(36.0, 56.3)*		 81.2a
(71.3, 88.8)*		 82.1
(71.9, 89.1)
Beijing Beier Bioengineerin Beijing Beier Bioengineering – 2019 nCov IgM 1 (5/10) 1 (5/13) 1 (9/14)
CGIA   50.0a
(18.7, 81.3)*		 38.5a
(13.9, 68.4)*		 64.3a
(35.2, 87.2)*
Beijing Diagreat Biotechnology 2019‐nCoV IgM Antibody Determination Kit     1 (30/38)
FIA       78.9a
(62.7, 90.4)*
Biolidics 2019 nCoV IgM detection kit 1 (0/7) 1 (11/34) 1 (2/10)
LFA   0a
(0, 41.0)*		 32.4a
(17.4, 50.5)*		 20.0a
(2.5, 55.6)*
BioMedomics COVID‐19 IgM Rapid Test 3 (60/142) 3 (86/115) 2 (37/42)
LFA   42.2
(34.4, 50.5)		 74.8
(60.2, 85.4)		 88.1
(74.4, 95.0)
bibioMerieux Vidas SARS‐CoV‐2 IgM 2 (21/57) 2 (49/60) 1 (26/26)
LFA   36.8
(25.4, 50.0)		 81.7
(69.8, 89.5)		 100a
(86.8, 100)**
Bioperfectus Technologies PerfectPOC Novel Corona Virus (SARS CoV‐2) IgM Rapid Test Kit 1 (37/63) 1 (28/34) 1 (16/19)
LFA   58.7a
(45.6, 71.0)*		 82.4a
(65.5, 93.2)*		 84.2a
(60.4, 96.6)*
Biosynex COVID‐19 BSS IgM 1 (11/18)   1 (37/45)
LFA   61.1a
(35.7, 82.7)*		   82.2a
(67.9, 92.0)*
BTNX Rapid ResponseTM COVID‐19 Test Cassette (BTNX Inc.) Kit1 IgM 1 (23/24) 1 (44/103) 2 (35/68)
LFA   95.8a
(78.9, 99.9)*		 42.7a
(33.0, 52.8)*		 51.5
(39.7, 63.1)
Cellex Cellex qSARS‐CoV‐ 2 IgM Cassette Rapid Test 2 (12/28) 2 (37/67) 3 (40/58)
LFA   41.8
(15.8, 73.4)		 58.9
(37.8, 77.2)		 69.8
(37.3, 90.0)
Chongqing iSIA BIO‐Technology 2019‐nCoV 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 IgM Rapid Test Cassettes 1 (6/37) 1 (33/78) 1 (21/38)
LFA   16.2a
(6.2, 32.0)*		 42.3a
(31.2, 54.0)*		 55.3a
(38.3, 71.4)*
CTK Biotech OnSite COVID‐19 IgM Rapid Test     1 (47/57)
CGIA       82.5a
(70.1, 91.3)*
DecombioBiotechnology Novel Coronavirus (SARS‐CoV‐2) IgM Combo Rapid Test‐Cassette 1 (32/62) 1 (29/33) 1 (14/18)
LFA   51.6a
(38.6, 64.5)*		 87.9a
(71.8, 96.6)*		 77.8a
(52.4, 93.6)*
DeepBlue Medical
Technology		 COVID‐19 (SARS CoV‐2) IgM Antibody Test Kit (Colloidal Gold) 1 (40/64) 1 (28/34) 1 (16/19)
CGIA   62.5a
(49.5, 74.3)*		 82.4a
(65.5, 93.2)*		 84.2a
(60.4, 96.6)*
DNA Link AccuFind COVID‐19 IgM 1 (35/48)   1 (9/9)
LFA   72.9a
(58.2, 84.7)*		   100a
(66.4, 100)**
Dynamiker Biotechnology Dynamiker Biotechnology ‐ 2019‐nCOV IgM Rapid Test 2 (31/65) 2 (105/153) 1 (37/38)
LFA   47.7
(35.9, 59.7)		 68.6
(60.9, 75.5)		 97.4a
(86.2, 99.9)*
Genrui Biotech Novel Coronavirus IgM test kit     1 (8/10)
LFA       80.0a
(44.4, 97.5)*
Guangdong Hecin Biotech 2019‐nCoV IgM Antibody Test Kit 1 (1/9) 1 (11/14) 1 (13/15)
LFA   11.1a
(0.3, 48.2)*		 78.6a
(49.2, 95.3)*		 86.7a
(59.5, 98.3)*
Hangzhou Hangzhou unlabelled packaging IgM 1 (7/51) 1 (5/21) 1 (4/8)
CGIA   13.7a
(5.7, 26.2)*		 23.8a
(8.2, 47.2)*		 50.0a
(15.7, 84.3)*
Hangzhou Alltest 2019‐nCoV IgM Rapid Test Cassette 5 (19/129) 7 (31/153) 7 (44/114)
CGIA   14.7
(9.6, 21.9)		 19.8
(11.8, 31.5)		 37.0
(25.4, 50.2)
Hangzhou Biotest RightSign IgM/IgG (also distributed as CoronaChek IgG and Premier Biotech Covid‐19 IgG) 2 (50/126) 2 (169/218) 3 (72/78)
    38.6
(19.2, 62.5)		 77.5
(71.5, 82.6)		 92.3
(82.3, 96.9)
Hightop Biotech Hightop SARS‐CoV‐2 IgM Antibody Rapid Test 1 (5/51) 1 (10/21) 1 (6/8)
CGIA   9.8a
(3.3, 21.4)*		 47.6a
(25.7, 70.2)*		 75.0a
(34.9, 96.8)*
Innovita Biological Technology 2019‐nCoV Ab test IgM 7 (55/184) 6 (84/143) 6 (70/118)
CGIA   29.9
(23.5, 37.2)		 58.0
(38.5, 75.3)		 60.0
(41.0, 76.5)
InTec Rapid SARS‐CoV‐2 Antibody (IgM) Test 1 (5/14) 1 (43/47) 1 (11/16)
CGIA   35.7a
(12.8, 64.9)*		 91.5a
(79.6, 97.6)*		 68.8a
(41.3, 89.0)*
Inzec BIOZEK COVID‐19 IgG/IgM     1 (5/29)
LFA       17.2a
(5.8, 35.8)*
Jiangsu Medomics Rapid IgM‐IgG Combined Antibody Test Kit for SARS‐ CoV‐2 IgM 1 (6/12) 1 (5/12) 1 (15/20)
CGIA   50.0a
(21.1, 78.9)*		 41.7a
(15.2, 72.3)*		 75.0a
(50.9, 91.3)*
Lansion Biotechnology (COVID‐19) IgM Test Kit 1 (3/5) 1 (8/11)  
FIA   60.0a
(14.7, 94.7)*		 72.7a
(39.0, 94.0)*		  
Leccurate SARS‐CoV‐2 antibody test IgM 1 (9/14) 1 (13/20) 1 (15/20)
CGIA   64.3a
(35.1, 87.2)*		 65.0a
(40.8, 84.6)*		 75.0a
(50.9, 91.3)*
Liming Bio StrongStep1 SARS‐CoV‐2 IgM 2 (17/61) 2 (47/111) 2 (45/72)
LFA   27.5
(6.9, 66.0)		 46.9
(26.9, 68.1)		 63.6
(43.4, 80.0)
Maccura Biotechnology Maccura LFIA SARS‐CoV‐2 IgM 2 (16/49) 1 (13/18) 1 (14/14)
CGIA   32.7
(21.1, 46.8)		 72.2a
(46.5, 90.3)*		 100a
(76.8, 100)**
MEDsan MEDsan COVID‐19 IgM Rapid Test     1 (49/64)
LFA       76.6 (64.3, 86.2)
Multi‐G Multi‐G MGA 2019‐nCoV IgM Rapid test cassette 1 (10/37) 1 (35/78) 1 (22/38)
LFA   27.0a
(13.8, 44.1)*		 44.9a
(33.6, 56.6)*		 57.9a
(40.8, 73.7)*
Nal Von Minden NADAL COVID‐19 IgM Test 1 (7/17) 1 (30/35)  
LFA   41.2a
(18.4, 67.1)*		 85.7a
(69.7, 95.2)*		  
NG Biotech NG‐Test IgM COVID‐19 3 (97/273) 4 (172/219)  
CGIA   36.5 (28.6, 45.1) 78.6 (67.3, 86.8)  
Nirmidas Biotech Nirmidas COVID‐19 (SARS‐CoV‐2) IgM Antibody Detection Kit 1 (46/73) 1 (52/52) 1 (19/19)
LFA   63.0a
(50.9, 74.0)*		 100a
(93.2, 100)**		 100a
(82.4, 100)*
Not stated KHB Diagnostic Kit for SARS‐ CoV‐2 IgM Antibody     1 (1/6)
CGIA       16.7a
(0.4, 64.1)*
NTBIO® Diagnostics NTBIO One Step Rapid Test ‐ COVID‐19 IgM Antibody Test     1 (29/59)
        49.2a
(35.9, 62.5)*
Prima Lab Prima COVID‐19 IgM Rapid test 1 (16/37) 1 (44/78) 1 (26/38)
LFA   43.2a
(27.1, 60.5)*		 56.4a
(44.7, 67.6)*		 68.4a
(51.3, 82.5)*
Prometheus Bio Prometheus Bio ‐ 2019‐nCoV IgM 1 (20/35) 1 (10/11) 1 (2/2)
LFA   57.1a
(39.4, 73.7)*		 90.9a
(58.7, 99.8)*		 100a
(15.8, 100)**
Qingdao HIGHTOP Biotech SARS‐CoV‐2 IgM Ab Rapid Test     1 (55/64)
        85.9a
(75.0, 93.4)*
Render COVID‐19 IgM Test 1 (6/16) 1 (13/28) 1 (15/24)
LFA   37.5a
(15.2, 64.6)*		 46.4a
(27.5, 66.1)*		 62.5a
(40.6, 81.2)*
SD Biosensor COVID‐19 IgM Duo 4 (16/62) 4 (84/130) 2 (32/38)
LFA   21.1
(6.1, 52.2)		 64.6
(56.0, 72.3)		 84.2
(69.0, 92.7)
Sensing Self Covid‐19 Rapid IgM combined Antibody assay 1 (4/28) 1 (89/136) 1 (21/21)
LFA   14.3a
(4.0, 32.7)*		 65.4a
(56.8, 73.4)*		 100a
(83.9, 100)**
SIDAK Life Care Sidak Covid 19 Antibody IgM Rapid Test Kit 1 (2/23) 1 (11/27) 1 (8/36)
LFA   8.7a
(1.1, 28.0)*		 40.7a
(22.4, 61.2)*		 22.2a
(10.1, 39.2)*
Sure Biotech SARS‐CoV‐2 IgM Antibody Rapid Test 1 (18/63) 1 (22/34) 2 (68/80)
LFA   28.6a
(17.9, 41.3)*		 64.7a
(46.5, 80.3)*		 85.0
(75.4, 91.3)
SureScreen Diagnostics COVID‐19 Coronavirus Rapid Test Cassette IgM 1 (14/22) 1 (10/14) 1 (7/9)
LFA   63.6a
(40.7, 82.8)*		 71.4a
(41.9, 91.6)*		 77.8a
(40.0, 97.2)*
Syzbio Biotech Syzbio SARS‐CoV‐2 IgM Antibody Assay Kit 1 (14/22) 1 (9/14) 1 (6/9)
LFA   63.6a
(40.7, 82.8)*		 64.3a
(35.1, 87.2)*		 66.7a
(29.9, 92.5)*
T&D Diagnostics Sienna 2019‐nCoV IgM Rapid Test 1 (13/41) 1 (33/48) 1 (8/9)
LFA   31.7a
(18.1, 48.1)*		 68.8a
(53.7, 81.3)*		 88.9a
(51.8, 99.7)*
TBG Biotechnology TBG SARS‐CoV‐2 IgM Rapid Test Kit 1 (2/6) 1 (31/46) 1 (19/19)
LFA   33.3a
(4.3, 77.7)*		 67.4a
(52.0, 80.5)*		 100a
(82.4, 100)**
UCP Biosciences Coronavirus IgM Antibody (COVID‐19)
Test Cassette		 1 (28/64) 1 (26/34) 1 (15/19)
LFA   43.8a
(31.4, 56.7)*		 76.5a
(58.8, 89.3)*		 78.9a
(54.4, 93.9)*
UNscience Biotechnology COVID‐19 IgM Rapid Test Kit 1 (2/9) 1 (5/14) 1 (12/15)
LFA   22.2a
(2.8, 60.0)*		 35.7a
(12.8, 64.9)*		 80.0a
(51.9, 95.7)*
VivaChek Biotech VivaDiag COVID‐19 IgM Rapid Test 2 (42/97) 2 (76/108) 2 (52/57)
LFA   43.3
(33.8, 53.3)		 74.8
(54.6, 88.0)		 91.7
(68.9, 98.2)
Wells Bio careUS COVID‐19 IgM 1 (0/3) 1 (4/6) 1 (6/6)
LFA   0a
(0, 70.8)**		 66.7a
(22.3, 95.7)*		 100a
(54.1, 100)**
Xiamen Biotime Biotechnology SARS‐Cov‐2 IgM Rapid Qualitative Test     1 (46/52)
LFA       88.5a (76.6, 95.6)*
Zhejiang Orient‐Gene Biotech COVID‐19 IgM rapid test cassette 4 (63/115) 5 (150/186) 5 (125/139)
CGIA   54.7
(43.4, 65.5)		 81.6
(72.0, 88.5)		 90.4
(82.1, 95.1)
Zhuhai Livzon Zhuhai Livzon SARS‐CoV‐2 IgM 2 (6/45) 2 (31/48) 1 (12/15)
LFA   13.3
(6.1, 26.7)		 64.6
(50.2, 76.7)		 80.0a
(51.9, 95.7)*
ELISA
Ash Laboratories Ash Laboratories SARS‐CoV2 IgM ELISA Immunoassay 1 (1/10) 1 (7/9) 1 (7/9)
    10.0a
(0.3, 44.5)*		 77.8a
(40.0, 97.2)*		 77.8a
(40.0, 97.2)*
Beijing Beier Bioengineerin Beijing Beier Bioengineering – 2019 nCov IgM 1 (4/10) 1 (1/13) 1 (6/14)
    40.0a
(12.2, 73.8)*		 7.7a
(0.2, 36.0)*		 42.9a
(17.7, 71.1)*
Beijing Wantai Wantai ELISA IgM assay 4 (58/187) 4 (247/315) 2 (52/59)
    31.0
(24.8, 38.0)		 80.4
(71.6, 87.0)		 94.5
(43.0, 99.7)
Bio‐Rad Laboratories Novel coronavirus COVID‐19 IgM assay     1 (7/11)
        63.6a
(30.8, 89.1)*
Creative Diagnostics SARS‐CoV‐2 IgM ELISA Kit 1 (12/19) 1 (37/38)  
    63.2a
(38.4, 83.7)*		 97.4a
(86.2, 99.9)*		  
Epitope Diagnostics EDITM Novel Coronavirus COVID‐19 IgM ELISA kit 5 (43/217) 7 (205/381) 7 (127/163)
    10.7
(3.1, 30.9)		 58.3
(43.9, 71.4)		 88.8
(69.6, 96.5)
Hotgen Beijing Hotgen SARS‐CoV‐2 IgM ELISA 2 (30/62) 1 (64/92) 1 (53/55)
    48.4
(36.3, 60.7)		 69.6a
(59.1, 78.7)*		 96.4a
(87.5, 99.6)*
ImmunoDiagnostics SARS‐CoV‐2 NP IgM ELISA Kit 1 (10/19) 1 (34/38)  
    52.6a
(28.9, 75.6)*		 89.5a
(75.2, 97.1)*		  
Theradiag ELISA COVID‐19 THERA02 IgM assay 1 (11/22) 1 (7/14) 1 (6/9)
    50.0a
(28.2, 71.8)*		 50.0a
(23.0, 77.0)*		 66.7a
(29.9, 92.5)*
Vazyme Biotech 2019‐nCoV IgM Detection Kit 1 (2/18) 1 (4/22) 1 (4/18)
    11.1a
(1.4, 34.7)*		 18.2a
(5.2, 40.3)*		 22.2a
(6.4, 47.6)*
Zhuhai Livzon Zhuhai Livzon SARS‐CoV‐2 IgM ELISA 4 (29/93) 3 (188/288) 2 (95/112)
    31.2
(22.6, 41.3)		 65.3
(59.6, 70.6)		 84.8
(76.9, 90.4)
CLIA
Autobio Diagnostics SARS‐CoV‐2 CLIA Microparticles IgM/IgG 1 (34/66)   1 (58/70)
    51.5a
(38.9, 64.0)*		   82.9a
(72.0, 90.8)*
Beijing Beier Bioengineerin Beijing Beier Bioengineering – 2019 nCov IgM 1 (4/10) 1 (4/13) 1 (6/14)
    40.0a
(12.2, 73.8)*		 30.8a
(9.1, 61.4)*		 42.9a
(17.7, 71.1)*
Bioscience Bioscience Co (Chongqing) SARS‐CoVCoV‐2 IgM 2 (28/88) 2 (175/269) 2 (167/217)
    31.8
(23.0, 42.2)		 65.1
(59.2, 70.5)		 76.2
(60.4, 87.0)
Beijing Wantai Wantai CLIA IgM assay 1 (8/31) 1 (12/29) 1 (26/38)
    25.8a
(11.9, 44.6)*		 41.4a
(23.5, 61.1)*		 68.4a
(51.3, 82.5)*
Hangzhou Biotest The RightSignTM COVID‐19 IgM Rapid Test Cassette / Lumiratek     1 (33/36)
        91.7a
(77.5, 98.2)*
MEXACARE QuickTestCorona COVID‐19 IgM     1 (49/61)
        80.3a
(68.2, 89.4)*
Shenzhen YHLO YHLO iFlash IgM assay 6 (76/135) 5 (144/188) 4 (55/73)
    48.1
(20.7, 76.7)		 77.0
(48.7, 92.2)		 75.3
(64.2, 83.9)
SNIBE Shenzhen MAGLUMI 2019‐nCoV IgM kits 7 (52/197) 7 (205/327) 4 (123/147)
    23.8
(14.1, 37.3)		 60.9
(51.7, 69.4)		 83.4
(74.3, 89.7)
Xiamen InnoDx Biotech Novel coronavirus (2019‐nCoV) antibody test kit IgM 1 (9/26) 1 (45/70) 1 (62/72)
    34.6a
(17.2, 55.7)*		 64.3a
(51.9, 75.4)*		 86.1a
(75.9, 93.1)*
Other/unclear
ET Healthcare Pylon 3D automated immunoassay system IgM 1 (6/41) 1 (23/42) 1 (13/15)
    14.6a
(5.6, 29.2)*		 54.8a
(38.7, 70.2)*		 86.7a
(59.5, 98.3)*
Genalyte Maverick SARS‐CoV‐2 Multi‐Antigen Serology Panel IgM (S‐based) 1 (7/48)    
    14.6 (6.1, 27.8)    
Genalyte Maverick SARS‐CoV‐2 Multi‐Antigen Serology Panel IgM (N‐based) 1 (7/48)    
    14.6 (6.1, 27.8)    
Vibrant America Vibrant COVID‐19 Ab IgM 1 (322/330) 1 (330/330)  
    97.6a
(95.3, 98.9)*		 100a
(98.9, 100)**		  
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
Ab: antibodyCI: confidence intervals
CGIA: colloidal gold immunoassayCLIA: chemiluminescence immunoassay
DNA: deoxyribonucleic acidELISA: enzyme‐linked immunosorbent assay
FIA: fluorescence immunoassay
LFA: lateral flow assayMIA: magnetic immunoassay
RT‐PCR: reverse transcription polymerase chain reaction