Wu 2020 [A].

Study characteristics
Patient Sampling	Purpose: Diagnosis of acute and convalescent‐phase infection Design: Two‐group study to estimate sensitivity and specificity, however it appeared that all participants met Taiwanese reporting criteria for COVID‐19: [1] PCR‐confirmed symptomatic and hospitalised Covid‐19 patients (n = 16) [2] Inpatients with respiratory tract infection or fever but 2 negative PCR results for SARS‐CoV‐2 (n = 58) (All patients meeting criteria for testing were simultaneously evaluated for SARS‐CoV‐2 and influenza A/B; if both PCR results were negative, an additional SARS‐CoV‐2 test was performed using a second sample from the suspected COVID patient) Recruitment: All admitted cases between January 23 and April 25 2020 Prospective or retrospective: Retrospective Sample size: 74 (16) Further detail: No more details available
Patient characteristics and setting	Setting: Hospital inpatient Location: National Taiwan University Hospital Country: Taiwan Dates: January 23rd to April 25, 2020 Symptoms and severity: 12/16 (75%) with lower respiratory tract symptoms 10/16 (63%) with upper airway symptoms 8/16 (50%) with body temperature > 38 C 5/16 (31%) with headache or myalgia 3/16 (19%) with gastrointestinal symptoms 3/16 (19%) required intensive care, 1/16 (6%) of which received extracorporeal membrane oxygenation support Demographics: Age: mean 45.6 years, SD 15.5; sex: 9/16 (56%) male) Exposure history: Unclear Non‐Covid group 1: Control group Source: January 23rd to April 25, 2020 Characteristics: Patients hospitalised with respiratory tract infection or fever but with two negative RT‐PCR results for SARS‐CoV‐2
Index tests	Test name: [A] ALLTEST 2019‐nCoV IgG/IgM Rapid Test [B] Dynamiker 2019‐nCoV IgG/IgM Rapid Test [C] ASK COVID‐19 IgG/IgM Rapid Test [D] Wondfo SARS‐CoV‐2 Antibody Test Manufacturer: [A] Hangzhou ALLTEST Biotech Co., Ltd., China [B] Dynamiker Biotechnology (Tianjin) Co., Ltd., China [C] TONYAR Biotech Inc., Taiwan [D] Guangzhou Wondfo Biotech Co., Ltd., China Antibody: [A] IgG/IgM [B] IgG/IgM [C] IgG/IgM [D] Total antibody (Separate results were plotted for IgG and for IgM alone, however insufficient data were available to construct 2 x 2 tables) Antigen target: [A] Nucleocapsid [B] Nucleocapsid [C] Spike [D] Not described Evaluation setting: Designed POC, unclear use Test method: [A]‐[D] Lateral flow assays (no further details) Timing of samples: [1] Day 1‐14 post‐symptom onset: 46/99 (46%) Day 15‐21 post‐symptom onset: 23/99 (23%) > Day 21 post‐symptom onset: 30/99 (30%) [2] Day 1‐14 post‐symptom onset: 37/58 (64%) Day 15‐21 post‐symptom onset: 11/58 (19%) > Day 21 post‐symptom onset: 10/58 (17%) Samples used: Serum Test operator: Unclear Definition of test positivity: Considered as positive according to the manufacturers’ instructions Blinding reported: Unclear Threshold predefined: Yes
Target condition and reference standard(s)	Reference standard: rRT‐PCR targeting envelope, nucleocapsid and RNA‐dependent RNA polymerase genes Samples used: Throat or lower respiratory specimens (OP, NP, sputum, gargling) Timing of reference standard: Unclear Blinded to index test: Unclear Incorporated index test: No Definition of non‐COVID cases: rRT‐PCR targeting envelope, nucleocapsid and RNA‐dependent RNA polymerase genes (at least two negative results) Samples used: Throat or lower respiratory specimens Timing of reference standard: Unclear Blinded to index test: Unclear Incorporated index test: No
Flow and timing	Time interval between index and reference tests: Unclear All patients received same reference standard: Yes Missing data: None reported Uninterpretable results: None reported Indeterminate results: None reported Unit of analysis: Samples; 99 samples from 16 patients, disaggregated by time period, but certainly multiple examples of multiple samples from the same patient within each time period. If multiple samples per day then only one sample used for rapid antibody testing
Comparative
Notes	Funding: No funding statement reported Publication status: Published Source: Journal of Infection Author COI: The authors declared no conflict of interest.
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?			High
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?	No
Could the patient flow have introduced bias?		High risk