Ragnesola 2020.

Study characteristics
Patient Sampling	Purpose: Diagnosis of current convalescent‐phase infection Design: Two‐group study to estimate sensitivity and specificity [1] Confirmed COVID patients, convalescent plasma donor samples (n = 63) [2] Pre‐pandemic samples (n = 10) Group [2] has < 25 samples and was excluded from our review. Recruitment: [1] Convalescent donor plasma was collected by the New York Blood Center (NYBC). Recruitment not stated. [2] Not stated Prospective or retrospective: [1] Prospective [2] Retrospective Sample size: 73 (63) of which 63 (63) were eligible for our review Further detail: Inclusion: [1] All donors had self‐reported documented COVID‐19 disease by positive SARS‐CoV‐2 RT‐PCR test (manufacturer and documentation not provided from referring institution of CP donors), had complete resolution of symptoms at least 14 days prior to donation, and otherwise met all criteria for donating blood consistent with FDA’s policy on the Collection of COVID‐19 Convalescent Plasma. [2] Frozen plasma was used that was collected prior to the beginning of the epidemic. Exclusions not reported
Patient characteristics and setting	Setting: Convalescent plasma donors Location: New York Blood Center Lindsley F. Kimball Research Institute, 310 E 67th Street, New York, NY 10065, USA Country: New York, USA Dates: Not stated Symptoms and severity: Convalescent, at least 14 days since symptom resolution Demographics: Not stated Exposure history: Not stated
Index tests	Test name: Clungene® SARS‐CoV‐2 IgG/IgM Rapid Test Cassettes Manufacturer: Hangzhou Clongene Biotech Co., Ltd., Hangzhou, China Antibody: IgM / IgG Antigen target: receptor‐binding domain (RBD) of the spike and nucleocapsid protein Evaluation setting: POCT performed in lab Test method: Lateral flow test (no details) Timing of samples: Symptom‐free for at least 14 days so at least 14 days post‐PCR+ Samples used: Plasma Test operator: four independently trained operators Definition of test positivity: Positive and negative IgG/IgM band determinations were made by visual inspection with accordance to manufacturer instructions. Blinding reported: Not stated Threshold predefined: yes (visual‐based)
Target condition and reference standard(s)	Reference standard: Self‐reported documented COVID‐19 disease by positive SARS‐CoV‐2 RT‐PCR test (manufacturer and documentation not provided from referring institution of CP donors), threshold not stated Samples used: Not stated Timing of reference standard: Not stated Blinded to index test: yes, prior to index test Incorporated index test: no
Flow and timing	Time interval between index and reference tests: Not stated All patients received same reference standard: Yes (unclear as self‐reported) Missing data: yes, group [2] excluded from review Uninterpretable results: All samples yielded an interpretable result with no invalid result. Indeterminate results: No intermediate range Unit of analysis: [1] Not quite clear, possibly yes
Comparative
Notes	Funding: The LFD used in the testing were provided by CL/BioSolutions services LLC. Publication status: Published paper Source: BMC Research Notes Author COI: CL worked with the LFD manufacturer on the Emergency Use Authorization submission to the US FDA.
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?			Unclear
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Unclear
Were the reference standard results interpreted without knowledge of the results of the index tests?	Yes
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?	No
Did all participants receive a reference standard?	Yes
Were results presented per patient?	Yes
Could the patient flow have introduced bias?		High risk