Pan 2020a.

Study characteristics
Patient Sampling	Purpose: Single group of cases to estimate sensitivity in acute disease Design: SARS‐CoV‐2‐positive cases (n = 105, 134 samples) of which 67 cases (86 samples) confirmed by RT‐PCR, and 37 patients (39 samples) clinically diagnosed (RT‐PCR‐negative, radiography‐positive) Recruitment method: NR Exclusion criteria: NR
Patient characteristics and setting	Setting: Inpatients Location: Zhongnan hospital (Wuhan University) Country: China Dates: Testing 6 February‐23 February 2020, symptom onset 7 January‐18 February 2020 (for subgroup of 108) Participant characteristics: 48 male, 57 female, median age 58 years (range 20‐96) Symptoms and severity: NR Exposure status: NR
Index tests	Test name: Zhuhai Livzon Commercial Ab test Manufacturer: Zhuhai Livzon Diagnositic Inc Test method: LFA (conducted in laboratory setting). Colloidal gold‐based immunochromatographic strip assay Antibody target: IgM, IgG Antigen used: NR (as per manufacturer) Definition of positive: Presence of T line indicating positive Samples used: Serum or plasma samples used (included comparison with whole blood for subgroup; not extracted) Timing: No information on timing or who read the test results.
Target condition and reference standard(s)	Reference standard: 1. RT‐PCR following WHO guidelines for qRT‐PCR, using throat swabs (Chinese CDC recommended kit used, BioGerm, Shanghai, China) 2. clinically diagnosed as SARS‐CoV‐2 infection according to the 5th edition of guideline on diagnosis and treatment of the novel coronavirus pneumonia. Specifically, the clinical diagnosis means the suspected cases were negative to the real‐time RT‐PCR test but presented with viral pneumonia by radiography. Timing: Samples taken during inpatient stay but no details about timing or personnel for test interpretation
Flow and timing	Same reference standard: All participants received a reference standard, but there was differential verification with some patients confirmed by RT‐PCR and others RT‐PCR‐negative but confirmed by radiography. Subset who were RT‐PCR‐positive were reported separately. Timing of index tests and reference standard unclear Data reported only for those with symptom onset information; 26 samples excluded. No reporting of test failures or indeterminate results Unit of analysis: Per‐sample analysis; multiple samples (2 or 3) per participant disaggregated over time
Comparative
Notes	Funding: from the National Key Research and Development Program of China (2018YFE0204500) Author COI: Declared no conflict of interest Published in the Journal of Infection
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	Unclear
Was a case‐control design avoided?	No
Did the study avoid inappropriate exclusions?	Unclear
Did the study avoid inappropriate inclusions?	Unclear
Could the selection of patients have introduced bias?		High risk
Are there concerns that the included patients and setting do not match the review question?			High
DOMAIN 2: Index Test (All tests)
DOMAIN 2: Index Test (Antibody tests)
Were the index test results interpreted without knowledge of the results of the reference standard?	Unclear
If a threshold was used, was it pre‐specified?	Yes
Could the conduct or interpretation of the index test have introduced bias?		Unclear risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	Unclear
The reference standard does not incorporate the index test	Yes
Could the reference standard, its conduct, or its interpretation have introduced bias?		Unclear risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Unclear
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Unclear
Did all participants receive a reference standard?	Yes
Were results presented per patient?	Yes
Could the patient flow have introduced bias?		Unclear risk