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 |
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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 |
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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 |
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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 |
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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 |
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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. |
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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 |