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. 2021 Mar 24;2021(3):CD013705. doi: 10.1002/14651858.CD013705.pub2

Jin 2020.

Study characteristics
Patient Sampling Laboratory‐based study presenting data on a total of 8043 specimens for different RT‐PCR tests (n=7251) and ID NOW (n=792). States that a significant proportion of specimens tested by ID NOW were pre‐admission screening specimens for surgical patients but does not report percentage.
Eligible data refer to
[1] single group study to estimate sensitivity and specificity in paired dry swabs and NP or OP swabs in UTM (n=52)
[Additional cases only set: [2] 124 RT‐PCR positive NP/OP samples in UTM samples included 117 'retested with ID NOW' and 7 samples diluted in UTM from 4 positive specimens (the diluted samples cannot be distinguished from the set of 117 and data have been excluded from review)
Recruitment: Unclear
Prospective or retrospective: Retrospective
Patient characteristics and setting Setting: Unclear; may be predominantly screening of surgical patients
Location: Molecular & Genomic Pathology Laboratory, Thomas Jefferson University Hospital, Philadelphia
Country: USA
Dates: April 23 to 26, 2020
Symptoms and severity: Not stated
Demographics: Not stated
Exposure history: Not stated
Index tests Test name: ID NOW (product code not reported)
Manufacturer: Abbott Laboratories
Target gene(s): RdRp
Antigen target: n/a
Test method: Isothermal PCR
Samples used: 'dry swabs' as per manufacturer EUA protocol
Transport media: None
Sample storage: No storage reported (appears to be immediate testing)
Test operator: Not stated; laboratory staff presumed
Definition of test positivity: As per manufacturer
Blinding reported: Not stated 'tested in parallel'
Timing of samples: Not stated
Target condition and reference standard(s) Reference standard: RT‐PCR; cobas SARS‐CoV‐2 Test (Roche Molecular Systems, Inc., Pleasanton, CA) using a cobas 6800 analyzer (Roche Molecular Systems, Inc). Either target present considered positive
Definition of non‐COVID cases: As above; single PCR negative required
Genetic target(s): ORF1/a, E gene
Samples used: Not specifically described for subset of paired samples, but for full cohort NP and OP swabs in VTM used (400 uL)
Timing of reference standard: Not stated
Blinded to index test: Not stated; tested in parallel
Incorporated index test: No
Flow and timing Time interval between index and reference tests: Simultaneous (paired swabs)
All patients received same reference standard: Yes
Missing data: None reported
Uninterpretable results: None reported, no participant flow diagram reported
Indeterminate results (index test): None reported
Indeterminate results (reference standard): None reported
Unit of analysis: Not stated; described as 'paired patient specimens'
Comparative  
Notes Funding: No funding statement reported
Publication status: Published
Source: Arch Path Lab Med
Author COI: No COI 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)
DOMAIN 2: Index Test (Rapid molecular 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? 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? Unclear    
Did all participants receive a reference standard? Yes    
Were results presented per patient? Unclear    
Could the patient flow have introduced bias?   Unclear risk