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

Thwe 2020.

Study characteristics
Patient Sampling Single group study to estimate sensitivity and specificity:
symptomatic patients with paired samples tested with both ID NOW (dry NP swabs) and a real‐time RT‐PCR assay (NP swabs in VTM) (n=182)
[samples with RT‐PCR using Xpert Xpress (n=21) were excluded from this review]
Recruitment: Not stated
Prospective or retrospective: Retrospective
Patient characteristics and setting Setting: Mixed (inpatient and ED); lab‐based study
Location: University of Texas Medical Branch, Galveston
Country: USA
Dates: April to May 2020 ('4 weeks data')
Symptoms and severity: Not stated
Demographics: Not stated
Exposure history: Not stated
Index tests Test name: ID NOW (no product code)
Manufacturer: Abbott
Antibody: Not stated
Antigen target: n/a
Test method: Isothermal PCR
Samples used: dry NP swabs
Transport media: None
Sample storage: in plain untreated sterile urine collection tubes
Test operator: Not stated
Definition of test positivity: As per manufacturer
Blinding reported: Yes; conducted first
Timing of samples: Not stated
Target condition and reference standard(s) Reference standard: One of 4 RT‐PCR assays;
1. Abbott RealTime SARS‐CoV‐2 (Abbott Park, IL, USA) (n=22)
2. Panther Fusion® SARS‐COV‐2 (San Diego, CA, USA) (n=129)
3. Cepheid Xpert® Xpress SARS‐CoV‐2 (Sunnyvale, CA, USA)) (n=21; excluded from this review)
4. a laboratory developed
test (LDT) (n=10)
Definition of non‐COVID cases: As for cases (single negative)
Genetic target(s): Not stated
Samples used: NP in VTM (paired)
Timing of reference standard: Not stated
Blinded to index test: Not stated
Incorporated index test: No
Flow and timing Time interval between index and reference tests: Paired
All patients received same reference standard: Yes
Missing data: None reported (review team excluded 21 samples tested with RT‐PCR)
Uninterpretable results: None reported
Indeterminate results (index test): None reported
Indeterminate results (reference standard): None reported; no discrepant analysis
Unit of analysis: Patient
Comparative  
Notes Funding: This project did not receive any funding support from any agencies in the public, commercial, or not for‐profit sectors
Publication status: Published
Source: Diagnostic Microbiol Infect Dis
Author COI: All authors have 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? 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? Yes    
If a threshold was used, was it pre‐specified? Yes    
Could the conduct or interpretation of the index test have introduced bias?   Low 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? Yes    
Could the patient flow have introduced bias?   Unclear risk