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. 2020 Jun 25;6(6):CD013652.
doi: 10.1002/14651858.CD013652.

Antibody tests for identification of current and past infection with SARS-CoV-2

Jonathan J Deeks  1   2 , Jacqueline Dinnes  1   2 , Yemisi Takwoingi  1   2 , Clare Davenport  1   2 , René Spijker  3   4 , Sian Taylor-Phillips  1   5 , Ada Adriano  1 , Sophie Beese  1 , Janine Dretzke  1 , Lavinia Ferrante di Ruffano  1 , Isobel M Harris  1 , Malcolm J Price  1   2 , Sabine Dittrich  6 , Devy Emperador  6 , Lotty Hooft  4 , Mariska Mg Leeflang  7   8 , Ann Van den Bruel  9 ; Cochrane COVID-19 Diagnostic Test Accuracy Group  1
Affiliations

Antibody tests for identification of current and past infection with SARS-CoV-2

Jonathan J Deeks et al. Cochrane Database Syst Rev. .

Update in

  • Antibody tests for identification of current and past infection with SARS-CoV-2.
    Fox T, Geppert J, Dinnes J, Scandrett K, Bigio J, Sulis G, Hettiarachchi D, Mathangasinghe Y, Weeratunga P, Wickramasinghe D, Bergman H, Buckley BS, Probyn K, Sguassero Y, Davenport C, Cunningham J, Dittrich S, Emperador D, Hooft L, Leeflang MM, McInnes MD, Spijker R, Struyf T, Van den Bruel A, Verbakel JY, Takwoingi Y, Taylor-Phillips S, Deeks JJ; Cochrane COVID-19 Diagnostic Test Accuracy Group. Fox T, et al. Cochrane Database Syst Rev. 2022 Nov 17;11(11):CD013652. doi: 10.1002/14651858.CD013652.pub2. Cochrane Database Syst Rev. 2022. PMID: 36394900 Free PMC article.

Abstract

Background: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus and resulting COVID-19 pandemic present important diagnostic challenges. Several diagnostic strategies are available to identify current infection, rule out infection, identify people in need of care escalation, or to test for past infection and immune response. Serology tests to detect the presence of antibodies to SARS-CoV-2 aim to identify previous SARS-CoV-2 infection, and may help to confirm the presence of current infection.

Objectives: To assess the diagnostic accuracy of antibody tests to determine if a person presenting in the community or in primary or secondary care has SARS-CoV-2 infection, or has previously had SARS-CoV-2 infection, and the accuracy of antibody tests for use in seroprevalence surveys.

Search methods: We undertook electronic searches in the Cochrane COVID-19 Study Register and the COVID-19 Living Evidence Database from the University of Bern, which is updated daily with published articles from PubMed and Embase and with preprints from medRxiv and bioRxiv. In addition, we checked repositories of COVID-19 publications. We did not apply any language restrictions. We conducted searches for this review iteration up to 27 April 2020.

Selection criteria: We included test accuracy studies of any design that evaluated antibody tests (including enzyme-linked immunosorbent assays, chemiluminescence immunoassays, and lateral flow assays) in people suspected of current or previous SARS-CoV-2 infection, or where tests were used to screen for infection. We also included studies of people either known to have, or not to have SARS-CoV-2 infection. We included all reference standards to define the presence or absence of SARS-CoV-2 (including reverse transcription polymerase chain reaction tests (RT-PCR) and clinical diagnostic criteria).

Data collection and analysis: We assessed possible bias and applicability of the studies using the QUADAS-2 tool. We extracted 2x2 contingency table data and present sensitivity and specificity for each antibody (or combination of antibodies) using paired forest plots. We pooled data using random-effects logistic regression where appropriate, stratifying by time since post-symptom onset. We tabulated available data by test manufacturer. We have presented uncertainty in estimates of sensitivity and specificity using 95% confidence intervals (CIs).

Main results: We included 57 publications reporting on a total of 54 study cohorts with 15,976 samples, of which 8526 were from cases of SARS-CoV-2 infection. Studies were conducted in Asia (n = 38), Europe (n = 15), and the USA and China (n = 1). We identified data from 25 commercial tests and numerous in-house assays, a small fraction of the 279 antibody assays listed by the Foundation for Innovative Diagnostics. More than half (n = 28) of the studies included were only available as preprints. We had concerns about risk of bias and applicability. Common issues were use of multi-group designs (n = 29), inclusion of only COVID-19 cases (n = 19), lack of blinding of the index test (n = 49) and reference standard (n = 29), differential verification (n = 22), and the lack of clarity about participant numbers, characteristics and study exclusions (n = 47). Most studies (n = 44) only included people hospitalised due to suspected or confirmed COVID-19 infection. There were no studies exclusively in asymptomatic participants. Two-thirds of the studies (n = 33) defined COVID-19 cases based on RT-PCR results alone, ignoring the potential for false-negative RT-PCR results. We observed evidence of selective publication of study findings through omission of the identity of tests (n = 5). We observed substantial heterogeneity in sensitivities of IgA, IgM and IgG antibodies, or combinations thereof, for results aggregated across different time periods post-symptom onset (range 0% to 100% for all target antibodies). We thus based the main results of the review on the 38 studies that stratified results by time since symptom onset. The numbers of individuals contributing data within each study each week are small and are usually not based on tracking the same groups of patients over time. Pooled results for IgG, IgM, IgA, total antibodies and IgG/IgM all showed low sensitivity during the first week since onset of symptoms (all less than 30.1%), rising in the second week and reaching their highest values in the third week. The combination of IgG/IgM had a sensitivity of 30.1% (95% CI 21.4 to 40.7) for 1 to 7 days, 72.2% (95% CI 63.5 to 79.5) for 8 to 14 days, 91.4% (95% CI 87.0 to 94.4) for 15 to 21 days. Estimates of accuracy beyond three weeks are based on smaller sample sizes and fewer studies. For 21 to 35 days, pooled sensitivities for IgG/IgM were 96.0% (95% CI 90.6 to 98.3). There are insufficient studies to estimate sensitivity of tests beyond 35 days post-symptom onset. Summary specificities (provided in 35 studies) exceeded 98% for all target antibodies with confidence intervals no more than 2 percentage points wide. False-positive results were more common where COVID-19 had been suspected and ruled out, but numbers were small and the difference was within the range expected by chance. Assuming a prevalence of 50%, a value considered possible in healthcare workers who have suffered respiratory symptoms, we would anticipate that 43 (28 to 65) would be missed and 7 (3 to 14) would be falsely positive in 1000 people undergoing IgG/IgM testing at days 15 to 21 post-symptom onset. At a prevalence of 20%, a likely value in surveys in high-risk settings, 17 (11 to 26) would be missed per 1000 people tested and 10 (5 to 22) would be falsely positive. At a lower prevalence of 5%, a likely value in national surveys, 4 (3 to 7) would be missed per 1000 tested, and 12 (6 to 27) would be falsely positive. Analyses showed small differences in sensitivity between assay type, but methodological concerns and sparse data prevent comparisons between test brands.

Authors' conclusions: The sensitivity of antibody tests is too low in the first week since symptom onset to have a primary role for the diagnosis of COVID-19, but they may still have a role complementing other testing in individuals presenting later, when RT-PCR tests are negative, or are not done. Antibody tests are likely to have a useful role for detecting previous SARS-CoV-2 infection if used 15 or more days after the onset of symptoms. However, the duration of antibody rises is currently unknown, and we found very little data beyond 35 days post-symptom onset. We are therefore uncertain about the utility of these tests for seroprevalence surveys for public health management purposes. Concerns about high risk of bias and applicability make it likely that the accuracy of tests when used in clinical care will be lower than reported in the included studies. Sensitivity has mainly been evaluated in hospitalised patients, so it is unclear whether the tests are able to detect lower antibody levels likely seen with milder and asymptomatic COVID-19 disease. The design, execution and reporting of studies of the accuracy of COVID-19 tests requires considerable improvement. Studies must report data on sensitivity disaggregated by time since onset of symptoms. COVID-19-positive cases who are RT-PCR-negative should be included as well as those confirmed RT-PCR, in accordance with the World Health Organization (WHO) and China National Health Commission of the People's Republic of China (CDC) case definitions. We were only able to obtain data from a small proportion of available tests, and action is needed to ensure that all results of test evaluations are available in the public domain to prevent selective reporting. This is a fast-moving field and we plan ongoing updates of this living systematic review.

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Conflict of interest statement

Jonathan J Deeks: none known

Jacqueline Dinnes: none known

Yemisi Takwoingi: none known

Clare Davenport: none known

René Spijker: the Dutch Cochrane Centre (DCC) has received grants for performing commissioned systematic reviews. In no situation, the commissioner had any influence on the results of the work.

Sian Taylor‐Phillips: none known

Ada Adriano: none known

Sophie Beese: none known

Janine Dretzke: none known

Lavinia Ferrante di Ruffano: none known

Isobel Harris: none known

Malcolm Price: none known

Sabine Dittrich: is employed by FIND with funding from DFID and Australian Aid. FIND is a global non‐for profit product development partnership and WHO Diagnostic Collaboration Centre. It is FIND’s role to accelerate access to high quality diagnostic tools for low resource settings and this is achieved by supporting both R&D and access activities for a wide range of diseases, including COVID‐19. .FIND has several clinical research projects to evaluate multiple new diagnostic tests against published Target Product Profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know‐how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review.

Devy Emperador: is employed by FIND with funding from DFID and KFW. FIND is a global non‐for profit product development partnership and WHO Diagnostic Collaboration Centre. It is FIND’s role to accelerate access to high quality diagnostic tools for low resource settings and this is achieved by supporting both R&D and access activities for a wide range of diseases, including COVID‐19. .FIND has several clinical research projects to evaluate multiple new diagnostic tests against published Target Product Profiles that have been defined through consensus processes. These studies are for diagnostic products developed by private sector companies who provide access to know‐how, equipment/reagents, and contribute through unrestricted donations as per FIND policy and external SAC review.

Lotty Hooft: none known

Mariska MG Leeflang: none known

Ann Van den Bruel: none known

Figures

1
1
Study flow diagram
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Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies
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3
Meta‐analytical estimates of sensitivity (with 95% CI) by antibody class and time since onset of symptoms
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4
Forest plot of studies evaluating tests for detection of IgG according to week post‐symptom onset and type of test
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5
Forest plot of studies evaluating tests for detection of IgM according to week post‐symptom onset and type of test
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6
Forest plot of studies evaluating tests for detection of IgG/IgM according to week post‐symptom onset and type of test
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7
Sensitivity of IgG in PCR+ve and PCR‐ve COVID‐19 cases by week since onset of symptoms.
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Sensitivity of IgM in PCR+ve and PCR‐ve COVID‐19 cases by week since onset of symptoms.
9
9
Sensitivity of IgG/IgM in PCR+ve and PCR‐ve COVID‐19 cases by week since onset of symptoms.
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Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study
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Forest plot of studies evaluating tests for detection of IgG at all time post‐symptom onset
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Forest plot of studies evaluating tests for detection of IgM at all time post‐symptom onset
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Forest plot of studies evaluating tests for detection of IgG/IgM at all time post‐symptom onset.
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Forest plot of tests: 19 IgA (all time points), 25 Total antibodies (Ab) (all time points), 38 IgA/IgM (all time points).
1
1. Test
IgG (all time points)
2
2. Test
IgG (1 to 7 days)
3
3. Test
IgG (8 to 14 days)
4
4. Test
IgG (15 to 21 days)
5
5. Test
IgG (22 to 35 days)
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6. Test
IgG (over 35 days)
7
7. Test
IgM (all time points)
8
8. Test
IgM (8 to 14 days)
9
9. Test
IgM (1 to 7 days)
10
10. Test
IgM (15 to 21 days)
11
11. Test
IgM (22 to 35 days)
12
12. Test
IgM (over 35 days)
13
13. Test
IgG/IgM (all time points)
14
14. Test
IgG/IgM (1 to 7 days)
15
15. Test
IgG/IgM (8 to 14 days)
16
16. Test
IgG/IgM (15 to 21 days)
17
17. Test
IgG/IgM (22 to 35 days)
18
18. Test
IgG/IgM (over 35 days)
19
19. Test
IgA (all time points)
20
20. Test
IgA (1 to 7 days)
21
21. Test
IgA (8 to 14 days)
22
22. Test
IgA (15 to 21 days)
23
23. Test
IgA (22 to 35 days)
24
24. Test
IgA (over 35 days)
25
25. Test
Total antibodies (Ab) (all time points)
27
27. Test
Total antibodies (Ab) (1 to 7 days)
29
29. Test
Total antibodies (Ab) (8 to 14 days)
30
30. Test
Total antibodies (Ab) (15 to 21 days)
31
31. Test
Total antibodies (Ab) (21 to 35 days)
32
32. Test
Total antibodies (Ab) (over 35 days)
33
33. Test
IgA/IgG (all time points)
34
34. Test
IgA/IgG (1 to 7 days)
35
35. Test
IgA/IgG (8 to 14 days)
36
36. Test
IgA/IgG (15 to 21 days)
37
37. Test
IgA/IgG (22 to 35 days)
38
38. Test
IgA/IgM (all time points)
39
39. Test
IgG in PCR+ve (all time points)
40
40. Test
IgG in PCR +ve (1 to 7 days)
41
41. Test
IgG in PCR+ve (8 to 14 days)
42
42. Test
IgG in PCR+ve (15 to 21 days)
43
43. Test
IgG in PCR‐ve (all time points)
44
44. Test
IgG in PCR‐ve (1 to 7 days)
45
45. Test
IgG in PCR‐ve (8 to 14 days)
46
46. Test
IgG in PCR‐ve (15 to 21 days)
47
47. Test
IgM in PCR+ve (all time points)
48
48. Test
IgM in PCR+ve (1 to 7 days)
49
49. Test
IgM in PCR+ve (8 to 14 days)
50
50. Test
IgM in PCR+ve (15 to 21 days)
51
51. Test
IgM in PCR‐ve (all time points)
52
52. Test
IgM in PCR‐ve (1 to 7 days)
53
53. Test
IgM in PCR‐ve (8 to 14 days)
54
54. Test
IgM in PCR‐ve (15 to 21 days)
55
55. Test
IgG/IgM in PCR+ve (all time points)
56
56. Test
IgG/IgM in PCR+ve (1 to 7 days)
57
57. Test
IgG/IgM in PCR+ve (8 to 14 days)
58
58. Test
IgG/IgM in PCR+ve (15 to 21 days)
59
59. Test
IgG/IgM in PCR‐ve (all time points)
60
60. Test
IgG/IgM in PCR‐ve (1 to 7 days)
61
61. Test
IgG/IgM in PCR‐ve (8 to 14 days)
62
62. Test
IgG/IgM in PCR‐ve (15 to 21 days)
63
63. Test
IgG (moderate)
64
64. Test
IgG (severe)
65
65. Test
IgG (critical)
66
66. Test
IgM (moderate)
67
67. Test
IgM (severe)
68
68. Test
IgM (critical)
69
69. Test
RT‐PCR (all time points ‐ throat)
70
70. Test
RT‐PCR (1 to 7 days throat)
71
71. Test
RT‐PCR (8 to 14 days ‐ throat)
72
72. Test
RT‐PCR (15 to 21 days ‐ throat)
73
73. Test
RT‐PCR (all time points ‐ sputum)
74
74. Test
RT‐PCR (1 to 7 days ‐ sputum)
75
75. Test
RT‐PCR (8 to 14 days ‐ sputum)
76
76. Test
RT‐PCR (15 to 21 days ‐ sputum)
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References

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Wang 2020a [A] {published data only}
    1. Wang Q, Du Q, Guo B, Guo Y, Fang L, X Guo. Performance of urea-mediated dissociation in reducing false-positive of 2019-nCoV IgM test. Chinese Journal of Laboratory Medicine 2020. [DOI: 10.3760/cma.j.cn114452-20200219-00091] - DOI
    1. Wang Q, Du Q, Guo B, Mu D, Lu X, Ma Q, et al. A method to prevent SARS-CoV-2 IgM false positives in gold immunochromatography and enzyme-linked immunosorbent assays. Journal of Clinjcal Microbiology 2020. [DOI: 10.1128/JCM.00375-20] - DOI - PMC - PubMed
Xiang 2020a [A] {published data only}
    1. Xiang J, Yan M, Li H, Liu T, Lin C, Huang S, et al. Evaluation of enzyme-linked immunoassay and colloidal gold- immunochromatographic assay kit for detection of novel coronavirus (SARS-Cov-2) causing an outbreak of pneumonia (COVID-19). medRxiv [Preprint] 2020. [DOI: ]
Xiang 2020b {published data only}
    1. Xiang F, Wang X, He X, Peng Z, Yang B, Zhang J, et al. Antibody detection and dynamic characteristics in patients with COVID-19. Clinical Infectious Diseases 2020;ciaa461. [DOI: ] - PMC - PubMed
Xiao 2020a {published data only}
    1. Xiao DA, Gao DC, Zhang DS. Profile of specific antibodies to SARS-CoV-2: the first report. Journal of Infection 2020. [DOI: ] - PMC - PubMed
Xie 2020a {published data only}
    1. Xie J, Ding C, Li J, Wang Y, Guo H, Lu Z, et al. Characteristics of patients with coronavirus disease (COVID-19) confirmed using an IgM-IgG antibody test. Journal of Medical Virology 2020. [DOI: ] - PMC - PubMed
Xu 2020a {published data only}
    1. Xu Y. Dynamic profile of severe or critical COVID-19 cases. medRxiv [Preprint] 2020. [DOI: ]
Yongchen 2020 {published data only}
    1. Yongchen Z, Shen H, Wang X, Shi X, Li Y, Yan J, et al. Different longitudinal patterns of nucleic acid and serology testing results based on disease severity of COVID-19 patients. Emerging Microbes and Infections 2020;9(1):833-6. - PMC - PubMed
Zeng 2020a {published data only}
    1. Zeng Z, Chen L, Pan Y, Deng Q, Ye G, Li Y, et al. Re: Profile of specific antibodies to SARS-CoV-2: the first report. Journal of Infection 2020. [DOI: ] - PMC - PubMed
Zhang 2020a {published data only}
    1. Zhang B, Zhou X, Zhu C, Feng F, Qiu Y, Feng J, et al. Immune phenotyping based on neutrophil-to-lymphocyte ratio and IgG predicts disease severity and outcome for patients with COVID-19. medRxiv [Preprint] 2020. [DOI: ] - PMC - PubMed
Zhang 2020b {published data only}
    1. Zhang J, Liu J, Li N, Liu Y, Ye R, Qin X, et al. Serological detection of 2019-nCoV respond to the epidemic: a useful complement to nucleic acid testing. medRxiv [Preprint] 2020. [DOI: ] - PMC - PubMed
Zhang 2020c {published data only}
    1. Zhang W, Du RH, Li B, Zheng XS, Yang X L, Hu B, et al. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerging Microbes and Infections 2020;9(1):386-9. - PMC - PubMed
Zhang 2020d {published data only}
    1. Zhang P, Gao Q, Wang T, Ke Y, Mo F, Jia R, et al. Evaluation of recombinant nucleocapsid and spike proteins for serological diagnosis of novel coronavirus disease 2019 (COVID-19). medRxiv [Preprint] 2020. [DOI: ]
Zhao 2020a {published data only}
    1. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clinical Infectious Diseases 2020;ciaa344. [DOI: ] - PMC - PubMed
    1. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. medRxiv [Preprint] 2020. [DOI: ] - PMC - PubMed
Zhao 2020b {published data only}
    1. Zhao R, Li M, Song H, Chen J, Ren W, Feng Y, et al. Serological diagnostic kit of SARS-CoV-2 antibodies using CHO-expressed full-length SARS-CoV-2 S1 proteins. medRxiv [Preprint] 2020. [DOI: ]
Zhong 2020 [A] {published data only}
    1. Zhong L, Chuan J, Gong BO, Shuai P, Zhou Y, Zhang Y, et al. Detection of serum IgM and IgG for COVID-19 diagnosis. Science China. Life Sciences 2020;63(5):777-80. [DOI: 10.1007/s11427-020-1688-9] - DOI - PMC - PubMed

References to studies excluded from this review

Ai 2020 {published data only}
    1. Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, et al. Correlation of Chest CT and RT-PCR testing in coronavirus disease 2019 (COVID-19) in China: a report of 1014 cases. Radiology 2020. [DOI: 10.1148/radiol.2020200642 10.1148/radiol.2020200642] - PMC - PubMed
Aitken 2020 {published data only}
    1. Aitken J, Ambrose K, Barrell S, Beale R, Bineva-Todd G, Biswas D, et al. Scalable and resilient SARS-CoV2 testing in an academic centre. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.19.20071373] - DOI
Amanat 2020 {published data only}
    1. Amanat F, Nguyen T, Chromikova V, Strohmeier S, Stadlbauer D, Javier A, et al. A serological assay to detect SARS-CoV-2 seroconversion in humans. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.17.20037713] - DOI - PMC - PubMed
Annamalai 2020 {published data only}
    1. Annamalai P, Kanta M, Ramu P, Ravi B, Veerapandian K, Srinivasan R. A simple colorimetric molecular detection of novel coronavirus (COVID-19), an essential diagnostic tool for pandemic screening. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.10.20060293] - DOI
Argenziano 2020 {published data only}
    1. Argenziano MG, Bruce SL, Slater CL, Tiao JR, Baldwin MR, Barr RG. Characterization and clinical course of 1000 patients with COVID-19 in New York: retrospective case series. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.20.20072116] - DOI - PMC - PubMed
Arons 2020 {published data only}
    1. Arons MM, Hatfield KM, Reddy SC, Kimball A, James A, Jacobs JR. Presymptomatic SARS-CoV-2 infections and transmission in a skilled nursing facility. New England Journal of Medicine 2020. [DOI: 10.1056/NEJMoa2008457] - DOI - PMC - PubMed
Arumugam 2020 {published data only}
    1. Arumugam A, Wong SS. The potential use of unprocessed sample for RT-qPCR detection of COVID-19 without an RNA extraction step. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.06.028811] - DOI
Baggett 2020 {published data only}
    1. Baggett TP, Keyes H, Sporn N, Gaeta JM. COVID-19 outbreak at a large homeless shelter in Boston: implications for universal testing. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.12.20059618] - DOI - PubMed
Bai 2020 {published data only}
    1. Bai SL, Wang JY, Zhou YQ, Yu DS, Gao XM, Li LL, et al. Analysis of the first cluster of cases in a family of novel coronavirus pneumonia in Gansu Province. Zhonghua Yu Fang Yi Xue Za Zhi 2020;54(0):E005. [DOI: 10.3760/cma.j.issn.0253-9624.2020.0005 10.3760/cma.j.issn.0253-9624.2020.0005.] - PubMed
Bajema 2020 {published data only}
    1. Bajema KL, Oster AM, McGovern OL, Lindstrom S, Stenger MR, Anderson TC, et al. Persons evaluated for 2019 novel coronavirus - United States, January 2020. MMWR. Morbidity and Mortality Weekly Report 2020;69(6):166-70. [DOI: 10.15585/mmwr.mm6906e1 10.15585/mmwr.mm6906e1] - PMC - PubMed
Barra 2020 {published data only}
    1. Barra GB, Santa Rita TH, Mesquita PG, Jacomo RH, Nery LF. Analytical sensibility and specificity of two RT-qPCR protocols for SARS-CoV-2 detection performed in an automated workflow. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.07.20032326] - DOI - PMC - PubMed
Batista 2020 {published data only}
    1. Batista, AF, Miraglia JL, Donato TH, Chiavegatto Filho AD. COVID-19 diagnosis prediction in emergency care patients: a machine learning approach. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.04.20052092] - DOI
Beltran Corbellini 2020 {published data only}
    1. Beltran-Corbellini NA, Chico-Garcia JL, Martinez-Poles J, Rodriguez-Jorge F, Natera-Villalba E, Gomez-Corral J, et al. Acute-onset smell and taste disorders in the context of COVID-19: a pilot multicenter PCR-based case-control study. European Journal of Neurology 2020 Apr 22 [Epub ahead of print]. [DOI: 10.1111/ene.14273] - DOI - PMC - PubMed
Beltran Pavez 2020 {published data only}
    1. Beltran-Pavez C, Marquez CL, Munoz G, Valiente-Echeverria F, Gaggero A, Soto-Rifo R, et al. SARS-CoV-2 detection from nasopharyngeal swab samples without RNA extraction. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.28.013508] - DOI
Ben Ami 2020 {published data only}
    1. Ben-Ami R, Klochendler A, Seidel M, Sido T, Gurel-Gurevich O, Yassour M, et al. Pooled RNA extraction and PCR assay for efficient SARS-CoV-2 detection. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.17.20069062] - DOI - PMC - PubMed
Bhadra 2020 {published data only}
    1. Bhadra S, Maranhao AC, Ellington AD. A one-enzyme RT-qPCR assay for SARS-CoV-2, and procedures for reagent production. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.29.013342] - DOI
Bordi 2020 {published data only}
    1. Bordi L, Nicastri E, Scorzolini L, Di Caro A, Capobianchi MR, Castilletti C, et al, on behalf of Inmi COVID-Study Group Collaborating Centers. Differential diagnosis of illness in patients under investigation for the novel coronavirus (SARS-CoV-2), Italy, February 2020. Eurosurveillance 2020;25(8):pii=2000170. [DOI: 10.2807/1560-7917.Es.2020.25.8.2000170 10.2807/1560-7917.ES.2020.25.8.2000170] - PMC - PubMed
Burhan 2020 {published data only}
    1. Burhan E, Prasenohadi P, Rogayah R, Isbaniyah F, Reisa T, Dharmawan I. Clinical progression of COVID-19 patient with extended incubation period, delayed RT-PCR time-to-positivity, and potential role of chest CT-scan. Acta Medica Indonesiana 2020;52(1):80-3. - PubMed
Cai 2020 {published data only}
    1. Cai J, Xu J, Lin D, Yang Z, Xu L, Qu Z, et al. A case series of children with 2019 novel coronavirus infection: clinical and epidemiological features. Clinical Infectious Diseases 2020. [DOI: 10.1093/cid/ciaa198 10.1093/cid/ciaa198] - PMC - PubMed
Callahan 2020 {published data only}
    1. Callahan CJ, Lee R, Zulauf K, Tamburello L, Smith KP, Previtera J, et al. Rapid open development and clinical validation of multiple new 3D-printed nasopharyngeal swabs in response to the COVID-19 pandemic. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.14.20065094] - DOI - PMC - PubMed
Chan 2020 {published data only}
    1. Chan JF, Yuan S, Kok KH, To KK, Chu H, Yang J, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. Lancet 2020;395(10223):514-23. [DOI: 10.1016/s0140-6736(20)30154-9 10.1016/S0140-6736(20)30154-9. Epub 2020 Jan 24.] - PMC - PubMed
Chandler Brown 2020 {published data only}
    1. Chandler-Brown D, Bueno AM, Atay O, Tsao DS. A highly scalable and rapidly deployable RNA extraction-free COVID-19 assay by quantitative Sanger sequencing. BioRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.07.029199] - DOI
Chen 2020b {published data only}
    1. Chen X, Ling J, Mo P, Zhang Y, Jiang Q, Ma Z, et al. Restoration of leukomonocyte counts is associated with viral clearance in COVID-19 hospitalized patients. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.03.20030437] - DOI
Chen 2020c {published data only}
    1. Chen C, Li J, Di L, Jing Q, Du P, Song C, et al. MINERVA: A facile strategy for SARS-CoV-2 whole genome deep sequencing of clinical samples. BioRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.25.060947] - DOI - PMC - PubMed
Cheng 2020a {published data only}
    1. Cheng Z, Lu Y, Cao Q, Qin L, Pan Z, Yan F, et al. Clinical features and chest CT manifestations of coronavirus disease 2019 (COVID-19) in a single-center study in Shanghai, China. American Journal of Roentgenology 2020:1-6. [DOI: 10.2214/ajr.20.22959 10.2214/AJR.20.22959] - PubMed
Chu 2020 {published data only}
    1. Chu DK, Pan Y, Cheng SM, Hui KP, Krishnan P, Liu Y, et al. Molecular diagnosis of a novel coronavirus (2019-nCoV) causing an outbreak of pneumonia. Clinical Chemistry 2020. [DOI: 10.1093/clinchem/hvaa029 10.1093/clinchem/hvaa029.] - PMC - PubMed
Colson 2020 {published data only}
    1. Colson P, Lagier JC, Baudoin JP, Bou Khalil J, La Scola B, Raoult D. Ultrarapid diagnosis, microscope imaging, genome sequencing, and culture isolation of SARS-CoV-2. European Journal of Clinical Microbiology & Infectious Diseases 2020. [DOI: 10.1007/s10096-020-03869-w] - DOI - PMC - PubMed
Comar 2020 {published data only}
    1. Comar M, Brumat M, Concas MP, Argentini G, Bianco A, Bicego L, et al. COVID-19 experience: first Italian survey on healthcare staff members from a mother-child research hospital using combined molecular and rapid immunoassays test. MedRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.19.20071563] - DOI
Corman 2020 {published data only}
    1. Corman VM, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu DK, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Eurosurveillance 2020;25(3). [DOI: 10.2807/1560-7917.Es.2020.25.3.2000045 10.2807/1560-7917.ES.2020.25.3.2000045.] - PMC - PubMed
Cui 2020 {published data only}
    1. Cui P, Chen Z, Wang T, Dai J, Zhang J, Ding T, et al. Clinical features and sexual transmission potential of SARS-CoV-2 infected female patients: a descriptive study in Wuhan, China. medRxiv [preprint] 2020. [DOI: 10.1101/2020.02.26.20028225] - DOI
Curti 2020 {published data only}
    1. Curti L, Pereyra-Bonnet F, Gimenez C. An ultrasensitive, rapid, and portable coronavirus SARS-CoV-2 sequence detection method based on CRISPR-Cas12. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.02.29.971127] - DOI
Dahlke 2020 {published data only}
    1. Dahlke C, Heidepriem J, Kobbe R, Santer R, Koch T, Fathi A. Distinct early IgA profile may determine severity of COVID-19 symptoms: an immunological case series. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.14.20059733] - DOI
Ding 2020 {published data only}
    1. Ding X, Yin K, Li Z, Liu C. All-in- one dual CRISPR-Cas12a (AIOD-CRISPR) assay: a case for rapid, ultrasensitive and visual detection of novel coronavirus SARS-CoV-2 and HIV virus. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.19.998724] - DOI - PMC - PubMed
Fang 2020z {published data only}
    1. Fang D, Ma J, Guan J, Wang M, Song Y, Tian D, et al. Manifestations of digestive system in hospitalized patients with novel coronavirus pneumonia in Wuhan, China: a single-center, descriptive study. Chinese Journal of Digestion 2020. [DOI: 10.3760/cma.j.issn. 0254-1432.2020.03.000]
Farfan 2020 {published data only}
    1. Farfan MJ, Torres JP, Oryan M, Olivares M, Gallardo P, Salas C. Optimizing RT-PCR detection of SARS-CoV-2 for developing countries using pool testing. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.15.20067199] - DOI - PubMed
Feng 2020 {published data only}
    1. Feng K, Yun YX, Wang XF, Yang GD, Zheng YJ, Lin CM, et al. Analysis of CT features of 15 children with 2019 novel coronavirus infection. Zhonghua Er Ke Za Zhi 2020;58(0):E007. [DOI: 10.3760/cma.j.issn.0578-1310.2020.0007 10.3760/cma.j.issn.0578-1310.2020.0007.] - PubMed
Fontanet 2020 {published data only}
    1. Fontanet A, Tondeur L, Madec Y, Grant R, Besombes C, Jolly N, et al. Cluster of COVID-19 in northern France: a retrospective closed cohort study. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.18.20071134] - DOI
Fu 2020a {published data only}
    1. Fu H, Xu H, Zhang N, Xu H, Li Z, Chen H, et al. Association between clinical, laboratory and CT characteristics and RT-PCR results in the follow-up of COVID-19 patients. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.19.20038315] - DOI
Fu 2020b {published data only}
    1. Fu YQ, Sun YL, Lu SW, Yang Y, Wang Y, Xu F. Impact of blood analysis and immune function on the prognosis of patients with COVID-19. medRxiv [preprint] 2020. [DOI: 10.1101/2020.04.16.20067587] - DOI - PMC - PubMed
Fumeaux 2020 {published data only}
    1. Fumeaux T. COVID-19: Que sait-on des patients admis en soins intensifs? Revue Medicale Suisse 2020;16(690):756. - PubMed
Gao 2020 {published data only}
    1. Gao Y, Li T, Han M, Li X, Wu D, Xu Y, et al. Diagnostic utility of clinical laboratory data determinations for patients with the severe COVID-19. Journal of Medical Virology 2020. [DOI: 10.1002/jmv.25770 10.1002/jmv.25770] - PMC - PubMed
Giamarellos Bourboulis 2020 {published data only}
    1. Giamarellos-Bourboulis EJ, Netea MG, Rovina N, Akinosoglou K, Antoniadou A, Antonakos N, et al. Complex immune dysregulation in COVID-19 patients with severe respiratory failure. Cell Host & Microbe 2020. [DOI: ] - PMC - PubMed
Gietema 2020 {published data only}
    1. Gietema HA, Zelis N, Nobel JM, Lambriks LJ, Van Alphen LB, Oude Lashof AM, et al. CT in relation to RT-PCR in diagnosing COVID-19 in the Netherlands: a prospective study. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.22.20070441] - DOI - PMC - PubMed
Gonzalez Gonzalez 2020a {published data only}
    1. Gonzalez-Gonzalez E, Lara-Mayorga IM, Garcia-Rubio A, Garciamendez-Mijares CE, Guerra-Alvarez GE, Garcia-Martinez G, et al. Scaling diagnostics in times of COVID-19: rapid prototyping of 3D-printed water circulators for loop-mediated isothermal amplification (LAMP) and detection of SARS-CoV-2 virus. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.09.20058651] - DOI
Gonzalez Gonzalez 2020b {published data only}
    1. Gonzalez-Gonzalez E, Trujillo-de Santiago G, Lara-Mayorga IM, Martinez-Chapa SO, Alvarez MM. Portable and accurate diagnostics for COVID-19: combined use of the miniPCR thermocycler and a well-plate reader for SARS-Co2 virus detection. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.03.20052860] - DOI - PMC - PubMed
Guan 2020 {published data only}
    1. Guan WD, Chen LP, Ye F, Ye D, Wu SG, Zhou HX, et al. High-throughput sequencing for confirmation of suspected 2019-nCoV infection identified by fluorescence quantitative polymerase chain reaction. Chinese Medical Journal 2020. [DOI: 10.1097/cm9.0000000000000792 10.1097/CM9.0000000000000792.] - PMC - PubMed
Guo 2020b {published data only}
    1. Guo L, Sun X, Wang X, Liang C, Jiang H, Gao Q, et al. SARS-CoV-2 detection with CRISPR diagnostics. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.10.023358] - DOI - PMC - PubMed
Guo 2020c {published data only}
    1. Guo X, Guo Z, Duan C, Chen Z, Wang G, Lu Y, et al. Long- term persistence of IgG antibodies in SARS-CoV infected healthcare workers. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.02.12.20021386] - DOI
Han 2020 {published data only}
    1. Han R, Huang L, Jiang H, Dong J, Peng H, Zhang D. Early clinical and CT manifestations of coronavirus disease 2019 (COVID-19) pneumonia. American Journal of Roentgenology 2020:1-6. [DOI: 10.2214/ajr.20.22961 10.2214/AJR.20.22961.] - PubMed
Hao 2020 {published data only}
    1. Hao W, Li M. Clinical diagnostic value of CT imaging in COVID-19 with multiple negative RT-PCR testing. Travel Medicine and Infectious Disease 2020:101627. [DOI: 10.1016/j.tmaid.2020.101627] - DOI - PMC - PubMed
Hass 2020 {published data only}
    1. Hass K, Bao M, He Q, Park M, Qin P, Du K. Integrated micropillar polydimethylsiloxane accurate CRISPR detection (IMPACT) system for rapid viral DNA sensing. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.17.994137] - DOI - PMC - PubMed
Hirotsu 2020 {published data only}
    1. Hirotsu Y, Mochizuki H, Omata M. Double- quencher probes improved the detection sensitivity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by One-Step RT-PCR. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.17.20037903] - DOI - PMC - PubMed
Hogan 2020 {published data only}
    1. Hogan CA, Sahoo MK, Pinsky BA. Sample pooling as a strategy to detect community transmission of SARS-CoV-2. JAMA 2020. [DOI: 10.1001/jama.2020.5445] - DOI - PMC - PubMed
Holland 2020 {published data only}
    1. Holland M, Negron D, Mitchell S, Dellinger N, Ivancich M, Barrus T, et al. BioLaboro: a bioinformatics system for detecting molecular assay signature erosion and designing new assays in response to emerging and reemerging pathogens. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.08.031963] - DOI
Hu 2020b {published data only}
    1. Hu F, Chen F, Wang Y, Xu T, Tang X, Li F. Failed detection of the full-length genome of SARS-CoV-2 by ultra-deep sequencing from the recovered and discharged patients retested viral PCR positive. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.27.20043299] - DOI
Hu 2020c {published data only}
    1. Hu, X, An, T, Situ, B, Hu, Y, Ou, Z, Li, Q, et al. Heat inactivation of serum interferes with the immunoanalysis of antibodies to SARS-CoV-2. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.12.20034231] - DOI - PMC - PubMed
Hu 2020d {published data only}
    1. Hu Z, Song C, Xu C, Jin G, Chen Y, Xu X, et al. Clinical characteristics of 24 asymptomatic infections with COVID-19 screened among close contacts in Nanjing, China. Science China. Life Sciences 2020 Mar 4 [Epub ahead of print]. [DOI: 10.1007/s11427-020-1661-4] - DOI - PMC - PubMed
Huang 2020a {published data only}
    1. Huang WH, Teng LC, Yeh TK, Chen YJ, Lo WJ, Wu MJ, et al. 2019 novel coronavirus disease (COVID-19) in Taiwan: reports of two cases from Wuhan, China. Journal of Microbiology, Immunology and Infection 2020;53(3):481-4. [DOI: 10.1016/j.jmii.2020.02.009 10.1016/j.jmii.2020.02.009.] - PMC - PubMed
Jenkins 2020 {published data only}
    1. Jenkins C, Orsburn B. In silico approach to accelerate the development of mass spectrometry-based proteomics methods for detection of viral proteins: application to COVID-19. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.08.980383] - DOI
Jiang 2020a {published data only}
    1. Jiang DM. Recurrent PCR positivity after hospital discharge of people with coronavirus disease 2019 (COVID-19). Journal of Infection 2020. [DOI: ] - PMC - PubMed
Jiang 2020b {published data only}
    1. Jiang HW, Li Y, Zhang HN, Wang W, Men D, Yang X, et al. Global profiling of SARS-CoV-2 specific IgG/ IgM responses of convalescents using a proteome microarray. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.20.20039495] - DOI - PMC - PubMed
Jung 2020 {published data only}
    1. Jung YJ, Park GS, Moon JH, Ku K, Beak SH, Kim S, et al. Comparative analysis of primer-probe sets for the laboratory confirmation of SARS-CoV-2. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.02.25.964775] - DOI - PubMed
Khan 2020 {published data only}
    1. Khan S, Nakajima R, Jain A, Assis RR, Jasinskas A, Obiero JM, et al. Analysis of serologic cross-reactivity between common human coronaviruses and SARS-CoV-2 using coronavirus antigen microarray. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.24.006544] - DOI
Kim 2019 {published data only}
    1. Kim JH, Kang M, Park E, Chung DR, Kim J, Hwang ES. A simple and multiplex loop-mediated isothermal amplification (LAMP) assay for rapid detection of SARS-CoV. BioChip Journal 2019;13(4):341-51. [DOI: 10.1007/s13206-019-3404-3] - DOI - PMC - PubMed
Kong 2020 {published data only}
    1. Kong WH, Li Y, Peng MW, Kong DG, Yang XB, Wang L, Liu MQ. SARS-CoV-2 detection in patients with influenza-like illness. Nature Microbiology 2020;5:675-8. [DOI: 10.1038/s41564-020-0713-1] - DOI - PubMed
Konrad 2020 {published data only}
    1. Konrad R, Eberle U, Dangel A, Treis B, Berger A, Bengs K, et al. Rapid establishment of laboratory diagnostics for the novel coronavirus SARS-CoV-2 in Bavaria, Germany, February 2020. Eurosurveillance 2020;25(9). [DOI: 10.2807/1560-7917.Es.2020.25.9.2000173 10.2807/1560-7917.ES.2020.25.9.2000173.] - PMC - PubMed
Kurstjens 2020 {published data only}
    1. Kurstjens S, Van der Horst A, Herpers R, Geerits MW, Kluiters-de Hingh YC, Göttgens EL, et al. Rapid identification of SARS-CoV-2-infected patients at the emergency department using routine testing. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.20.20067512] - DOI - PubMed
Lamb 2020 {published data only}
    1. Lamb LE, Bartolone SN, Ward E, Chancellor MB. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.02.19.20025155] - DOI
Lan 2020 {published data only}
    1. Lan L, Xu D, Ye G, Xia C, Wang S, Li Y, et al. Positive RT-PCR test results in patients recovered from COVID-19. JAMA 2020. [DOI: 10.1001/jama.2020.2783 10.1001/jama.2020.2783.] - PMC - PubMed
Lechien 2020 {published data only}
    1. Lechien J, Cabaraux P, Chiesa-Estomba C, Khalife M, Plzak J, Hans S, et al. Objective olfactory testing in patients presenting with sudden onset olfactory dysfunction as the first manifestation of confirmed COVID-19 infection. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.15.20066472] - DOI
Lei 2020 {published data only}
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Li 2020c {published data only}
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Li 2020d {published data only}
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Li 2020e {published data only}
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Li 2020f {published data only}
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Liang 2020b {published data only}
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Ling 2020 {published data only}
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Lu 2020 {published data only}
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McRae 2020 {published data only}
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Meng 2020 {published data only}
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Mercurio 2020 {published data only}
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Nelson 2020 {published data only}
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Nie 2020 {published data only}
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Xu 2020b {published data only}
    1. Xu SP, Kuang D, Hu Y, Liu C, Duan YQ, Wang GP. Detection of 2019-nCoV in the pathological paraffin embedded tissue. Zhonghua Bing Li Xue Za Zhi 2020;49(0):E004. [DOI: 10.3760/cma.j.cn112151.20200219.00001 10.3760/cma.j.cn112151.20200219.00001.] - PubMed
Xu 2020c {published data only}
    1. Xu Y, Xiao M, Liu X, Xu S, Du T, Xu J, et al. Significance of serology testing to assist timely diagnosis of SARS-CoV-2 infections: implication from a family cluster. Emerging Microbes and Infection 2020:01/Dec. [DOI: 10.1080/22221751.2020.1752610] - DOI - PMC - PubMed
Xu 2020d {published data only}
    1. Xu K, Chen Y, Yuan J, Yi P, Ding C, Wu W, et al. Factors associated with prolonged viral RNA shedding in patients with COVID-19. Clinical Infectious Diseases 2020. [DOI: ] - PMC - PubMed
Yan 2020 {published data only}
    1. Yan S, Song X, Lin F, Zhu H, Wang X, Li M, et al. Clinical characteristics of coronavirus disease 2019 in Hainan, China. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.19.20038539] - DOI
Yang 2020a {published data only}
    1. Yang Y, Yang M, Shen C, Wang F, Yuan J, Li J, et al. Evaluating the accuracy of different respiratory specimens in the laboratory diagnosis and monitoring the viral shedding of 2019-nCoV infections. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.02.11.20021493] - DOI
Yang 2020b {published data only}
    1. Yang P, Shao FL, Wang GJ. Clinical observation on increasing the positive rate of novel coronavirus nucleic acid tests by sputum excretion induced by nebulizer therapy. Zhonghua Jie He He Hu Xi Za Zhi 2020;43(4):335-6. [DOI: 10.3760/cma.j.cn112147-20200212-00076] - DOI - PubMed
Yelin 2020 {published data only}
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Yuan 2020 {published data only}
    1. Yuan J, Zou R, Zeng L, Kou S, Lan J, Li X, et al. The correlation between viral clearance and biochemical outcomes of 94 COVID-19 infected discharged patients. Inflammation Research 2020. [DOI: 10.1007/s00011-020-01342-0] - DOI - PMC - PubMed
Yun 2020 {published data only}
    1. Yun H, Sun Z, Wu J, Tang A, Hu M, Xiang Z. Laboratory data analysis of novel coronavirus (COVID-19) screening in 2510 patients. Clinica Chimica Acta 2020. [DOI: ] - PMC - PubMed
Zeng 2020b {published data only}
    1. Zeng F, Dai C, Cai P, Wang J, Xu L, Li J, et al. A comparison study of SARS-CoV-2 IgG antibody between male and female COVID-19 patients: a possible reason underlying different outcome between gender. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.26.20040709] - DOI - PMC - PubMed
Zhang 2020e {published data only}
    1. Zhang X, Wu X, Wang D, Lu M, Hou X, Wang H, et al. Proteome-wide analysis of differentially-expressed SARS-CoV-2 antibodies in early COVID-19 infection. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.14.20064535] - DOI
Zhang 2020f {published data only}
    1. Zhang G, Zhang J, Wang B, Zhu X, Wang Q, Qiu S. Analysis of clinical characteristics and laboratory findings of 95 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a retrospective analysis. Respiratory Research 2020;21(1):74. [DOI: 10.1186/s12931-020-01338-8] - DOI - PMC - PubMed
Zhang 2020g {published data only}
    1. Zhang L, Pang R, Xue X, Bao J, Ye S, Dai Y, et al. Anti-SARS-CoV-2 virus antibody levels in convalescent plasma of six donors who have recovered from COVID-19. Aging (Albany NY) 2020;12. [DOI: 10.18632/aging.103102] - DOI - PMC - PubMed
Zhang 2020h {published data only}
    1. Zhang N, Gong Y, Meng F, Bi Y, Yang P, Wang F. Virus shedding patterns in nasopharyngeal and fecal specimens of COVID-19 patients. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.28.20043059] - DOI - PMC - PubMed
Zhao 2020c {published data only}
    1. Zhao D, Yao F, Wang L, Zheng L, Gao Y, Ye J, et al. A comparative study on the clinical features of COVID-19 pneumonia to other pneumonias. Clinical Infectious Diseases 2020. [DOI: 10.1093/cid/ciaa247 10.1093/cid/ciaa247] - PMC - PubMed
Zhao 2020d {published data only}
    1. Zhao Z, Cui H, Song W, Ru X, Zhou W, Yu X. A simple magnetic nanoparticles-based viral RNA extraction method for efficient detection of SARS-CoV-2. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.02.22.961268] - DOI
Zhifeng 2020 {published data only}
    1. Zhifeng J, Feng A, Li T. Consistency analysis of COVID-19 nucleic acid tests and the changes of lung CT. Journal of Clinical Virology 2020;127:104359. [DOI: 10.1016/j.jcv.2020.104359] - DOI - PMC - PubMed
Zhou 2020 {published data only}
    1. Zhou J, Bai Z, Liu X, Guo Y, Jiang N, Li X, et al. Flocked swab might be one main reason causing the high false-negative rate in COVID-19 screening----the advantages of a novel silicone swab. bioRxiv [Preprint] 2020. [DOI: 10.1101/2020.03.29.014415] - DOI
Zhuang 2020 {published data only}
    1. Zhuang GH, Shen MW, Zeng LX, Mi BB, Chen FY, Liu WJ, et al. Potential false-positive rate among the 'asymptomatic infected individuals' in close contacts of COVID-19 patients. Zhonghua Liu Xing Bing Xue Za Zhi 2020;41(4):485-8. [DOI: 10.3760/cma.j.cn112338-20200221-00144 10.3760/cma.j.cn112338-20200221-00144.] - PubMed

References to studies awaiting assessment

Li 2020b {published data only}
    1. Li H, Li Y, Zhang Z, Lu Z, Wang Y, Lin G, et al. Establishment and clinical performance evaluation of 2019 novel coronavirus antibody colloidal gold detection method. Chinese Journal of Infectious Diseases 2020.
Thompson 2020 {published data only}
    1. Thompson C, Grayson N, Paton R, Lourenco J, Penman B, Lee LN, et al. Neutralising antibodies to SARS coronavirus 2 in Scottish blood donors - a pilot study of the value of serology to determine population exposure. medRxiv [Preprint] 2020. [DOI: 10.1101/2020.04.13.20060467] - DOI - PMC - PubMed
Xiong 2020 {published data only}
    1. Xiong Z, Fu L, Zhou H, Liu JK, Wang AM, Huang, Y, et al. Construction and evaluation of a novel diagnosis process for 2019-corona virus disease. Zhonghua Yi Xue Za Zhi 2020;100(0):E019. [DOI: 10.3760/cma.j.cn112137-20200228-00499 10.3760/cma.j.cn112137-20200228-00499.] - PubMed

References to ongoing studies

ChiCTR2000029625 {published data only}
    1. ChiCTR2000029625. Construction of early warning and prediction system for patients with severe / critical novel coronavirus pneumonia (COVID-19). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000029625 (first received 27 April 2020).
ChiCTR2000029695 {published data only}
    1. ChiCTR2000029695. Early detection of novel coronavirus pneumonia (COVID-19) based on a novel high-throughput mass spectrometry analysis with exhaled breath. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000029695 (first received 27 April 2020).
ChiCTR2000029810 {published data only}
    1. ChiCTR2000029810. Clinical study of a novel high sensitivity nucleic acid assay for novel coronavirus pneumonia (COVID-19) based on CRISPR-cas protein. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000029810 (first received 27 April 2020).
ChiCTR2000029870 {published data only}
    1. ChiCTR2000029870. Evaluation of rapid diagnostic kit (IgM/IgG) for novel coronavirus pneumonia (COVID-19). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000029870 (first received 27 April 2020).
ChiCTR2000029883 {published data only}
    1. ChiCTR2000029883. A comparative study on the sensitivity of nasopharyngeal and oropharyngeal swabbing for the detection of SARS-CoV-2 by real-time PCR. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000029883 (first received 27 April 2020).
ChiCTR2000029982 {published data only}
    1. ChiCTR2000029982. Study for using multiomics in the diagnosis and treatment of novel coronavirus pneumonia (COVID-19). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000029982 (first received 27 April 2020).
ChiCTR2000030005 {published data only}
    1. ChiCTR2000030005. Nucleic acid analysis of novel coronavirus pneumonia (COVID-19) in morning sputum samples and pharyngeal swabs-a prospectively diagnostic test. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030005 (first received 27 April 2020).
ChiCTR2000030085 {published data only}
    1. ChiCTR2000030085. Cancelled by the investigator Study for the false positive rate of IgM / IgG antibody test kit for novel coronavirus pneumonia (COVID-19) in different inpatients. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030085 (first received 27 April 2020).
ChiCTR2000030185 {published data only}
    1. ChiCTR2000030185. The value of critical care ultrasound in rapid screening, diagnosis, evaluation of effectiveness and intensive prevention of novel coronavirus pneumonia (COVID-19). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030185 (first received 27 April 2020).
ChiCTR2000030253 {published data only}
    1. ChiCTR2000030253. Exploration and research for a new method for detection of novel coronavirus (COVID-19) nucleic acid. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030253 (first received 27 April 2020).
ChiCTR2000030334 {published data only}
    1. ChiCTR2000030334. MicroRNA as a marker for early diagnosis of novel coronavirus infection (COVID-19). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030334 (first received 27 April 2020).
ChiCTR2000030542 {published data only}
    1. ChiCTR2000030542. A clinical study about the diagnosis and prognosis evaluation of novel coronavirus pneumonia (COVID-19) based on viral genome, host genomic sequencing, relative cytokines and other laboratory indexes. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030542 (first received 27 April 2020).
ChiCTR2000030543 {published data only}
    1. ChiCTR2000030543. Detection of coronavirus in simultaneously collecting tears and throat swab samples collected from the patients with novel coronavirus pneumonia (COVID-19). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030543 (first received 27 April 2020).
ChiCTR2000030558 {published data only}
    1. ChiCTR2000030558. Cancelled by the investigator Epidemiological research of novel coronavirus pneumonia (COVID-19) suspected cases based on virus nucleic acid test combined with low-dose chest CT screening in primary hospital. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030558 (first received 27 April 2020).
ChiCTR2000030706 {published data only}
    1. ChiCTR2000030706. Cancelled by the investigator Application of cas13a-mediated RNA detection in the assay of novel coronavirus nucleic acid (COVID-19). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030706 (first received 27 April 2020).
ChiCTR2000030721 {published and unpublished data}
    1. ChiCTR2000030721. A comparative study for the sensitivity of induced sputum and throat swabs for the detection of SARS-CoV-2 by real-time PCR in patients with novel coronavirus pneumonia (COVID-19). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030721 (first received 27 April 2020).
ChiCTR2000030754 {published data only}
    1. ChiCTR2000030754. Medical records based study for the accuracy of SARS-CoV-2 IgM antibody screening for diagnosis of novel coronavirus pneumonia (COVID-19). apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030754 (first received 27 April 2020).
ChiCTR2000030833 {published data only}
    1. ChiCTR2000030833. Clinical validation and application of high-throughput novel coronavirus (2019-nCoV) screening detection kit. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030833 (first received 27 April 2020).
ChiCTR2000030834 {published data only}
    1. ChiCTR2000030834. Epidemiological characteristics and antibody levels of novel coronavirus pneumonia (COVID-19) of pediatric medical staff working in quarantine area. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030834 (first received 27 April 2020).
ChiCTR2000030838 {published data only}
    1. ChiCTR2000030838. Development of warning system with clinical differential diagnosis and prediction for severe type of novel coronavirus pneumonia (COVID-19) patients based on artificial intelligence and CT images. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030838 (first received 27 April 2020).
ChiCTR2000030856 {published data only}
    1. ChiCTR2000030856. An artificial intelligence assistant system for suspected novel coronavirus pneumonia (COVID-19) based on chest CT. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030856 (first received 27 April 2020).
ChiCTR2000030859 {published data only}
    1. ChiCTR2000030859. A medical based analysis for influencing factors of death of novel coronavirus pneumonia (COVID-19) patients in Wuhan Third Hospital. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030859 (first received 27 April 2020).
ChiCTR2000030860 {published data only}
    1. ChiCTR2000030860. A medical records based study for investigation of dynamic profile of RT-PCR test for SARS-CoV-2 nucleic acid of novel coronavirus pneumonia (COVID-19) patients. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030860 (first received 27 April 2020).
ChiCTR2000030862 {published data only}
    1. ChiCTR2000030862. Correlation analysis of blood eosinophil cell levels and clinical type category of novel coronavirus pneumonia (COVID-19): a medical records based retrospective study. apps.who.int/trialsearch/Trial2.aspx?TrialID=ChiCTR2000030862 (first received 27 April 2020).
NCT04245631 {published data only}
    1. NCT04245631. Development of a simple, fast and portable recombinase aided amplification assay for 2019-nCoV. clinicaltrials.gov/ct2/show/NCT04245631 (first received 27 April 2020).
NCT04259892 {published data only}
    1. NCT04259892. Viral excretion in contact subjects at high/moderate risk of coronavirus 2019-nCoV infection. ClinicalTrials.gov/show/NCT04259892 (first received 27 April 2020).
NCT04279795 {published data only}
    1. NCT04279795. Detection of 2019 novel coronavirus in multiple organ system and its relationship with clinical manifestations. ClinicalTrials.gov/show/NCT04279795 (first received 27 April 2020).
NCT04304690 {published data only}
    1. NCT04304690. SARS-CoV2 seroconversion among front line medical and paramedical staff in emergency, intensive care units and infectious disease departments during the 2020 epidemic. clinicaltrials.gov/ct2/show/NCT04304690 (first received 27 April 2020).
NCT04311398 {published data only}
    1. NCT04311398. Development and verification of a new coronavirus multiplex nucleic acid detection system. ClinicalTrials.gov/show/NCT04311398 (first received 27 April 2020).
NCT04316728 {published data only}
    1. NCT04316728. Clinical performance of the VivaDiag ™ COVID-19 lgM IgG rapid test in early detecting the infection of COVID-19. ClinicalTrials.gov/show/NCT04316728 (first received 27 April 2020).
NCT04321369 {published data only}
    1. NCT04321369. Impact of swab site and sample collector on testing sensitivity for SARS-CoV-2 virus in symptomatic individuals. clinicaltrials.gov/ct2/show/NCT04321369 (first received 27 April 2020).
NCT04322279 {published data only}
    1. NCT04322279. Factors associated with a positive SARS-CoV-2 serology in contact subjects at high/moderate risk of coronavirus SARS-CoV-2 infection (CoV-CONTACT-SERO). clinicaltrials.gov/ct2/show/NCT04322279 (first received 27 April 2020).
NCT04322513 {published data only}
    1. NCT04322513. Biomarkers for identification of SARS-COV-2 infection. clinicaltrials.gov/ct2/show/NCT04322513 (first received 27 April 2020).
Sullivan 2020 {published data only}
    1. Sullivan PS, Sailey C, Guest JL, Guarner J, Siegler AJ, Valentine-Graves, et al. Detection of SARS-CoV-2 RNA and antibodies in diverse samples: protocol to validate the sufficiency of provider-observed home-collected blood, saliva and oropharyngeal samples. JMIR Public Health and Surveillance 2020. [DOI: 10.2196/19054] - DOI - PMC - PubMed

Additional references

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Cheng 2020b
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McInnes 2018
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References to other published versions of this review

Deeks 2020
    1. Deeks JJ, Dinnes J, Takwoingi Y, Davenport C, Leeflang MM, Spijker R, et al. Diagnosis of SARS-CoV-2 infection and COVID-19: accuracy of signs and symptoms; molecular, antigen, and antibody tests; and routine laboratory markers. Cochrane Database of Systematic Reviews 2020, Issue 4. [DOI: 10.1002/14651858.CD013596] - DOI

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