Lambert‐Niclot 2020.

Study characteristics
Patient Sampling	Single‐group study to estimate sensitivity and specificity: ‐ samples submitted for RT‐PCR testing (n = 138) Recruitment: not stated Prospective or retrospective: unclear; testing conducted prospectively Number of samples (samples with confirmed SARS‐CoV‐2): 138 (94)
Patient characteristics and setting	Setting: not stated Location: samples collected from virology laboratories of 3 university hospital groups from Assistance‐Publique‐Hôpitaux de Paris (APHP), (Saint‐Antoine‐Tenon‐Trousseau, Saint‐Louis‐Lariboisière and Kremlin Bicêtre‐Paul Brousse) Country: France Dates: 1‐15 April 2020 Symptoms and severity: not stated Demographics: not stated Exposure history: not stated
Index tests	Test name: COVID‐19 Ag Respi‐Strip CORIS (no product code) Manufacturer: BioConcept, Gembloux, Belgium Antigen target: SARS‐CoV‐2 NP Antibody: monoclonal antibodies Test method: CGIA Samples used: NP swabs in VTM (collection process not described) Transport media: either of: COPAN UTM 3 mL, Virocult 1 mL, Eswab Amies 1 mL, 4MRT 3 mL, 0.9% NaCl buffer and cobas ROCHE Sample storage: no cooling or freezing step used Test operator: not stated; presume laboratory staff Definition of test positivity: not stated; as per manufacturer Blinding reported: not stated Timing of samples: not stated; presume on presentation
Target condition and reference standard(s)	Reference standard: RT‐PCR (different kits used including RealStar Altona®, Anatolia®, cobas 6800 Roche®, Allplex™ 2019‐nCoV Assay Seegene®) Definition of non‐COVID cases: single negative PCR Genetic target(s): E gene Samples used: NP swabs (same as for index) Timing of reference standard: within a few hours after collection; time post onset of symptoms not reported Blinded to index test: unclear Incorporated index test: no
Flow and timing	Time interval between index and reference tests: same sample, both tests conducted within a few hours All participants received same reference standard: yes (different kits) Missing data: none reported Uninterpretable results: 4 samples collected in cobas VTM gave invalid results and all samples in cobas medium were excluded Indeterminate results (index test): control lines reported as "barely visible" for 9 positive and 8 negative tests Indeterminate results (reference standard): none reported Unit of analysis: not reported, but samples tested on day of collection so considered to be 1 per participant
Comparative
Notes	Funding: no funding sources reported Publication status: accepted manuscript Source: Journal of Clinical Microbioloby Author COI: no conflict of interest statement reported
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?	Yes
Did the study avoid inappropriate exclusions?	Unclear
Did the study avoid inappropriate inclusions?	Unclear
Could the selection of patients have introduced bias?		Unclear risk
Are there concerns that the included patients and setting do not match the review question?			Unclear
DOMAIN 2: Index Test (Antigen 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 2: Index Test (Rapid molecular tests)
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	No
Were the reference standard results interpreted without knowledge of the results of the index tests?	Unclear
Reference standard does not incorporate result of index test?	Yes
Could the reference standard, its conduct, or its interpretation have introduced bias?		High 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?	Yes
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