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 |
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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 |
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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 |
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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 |
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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' |
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Comparative | |||
Notes | Funding: No funding statement reported Publication status: Published Source: Arch Path Lab Med Author COI: No COI statement reported |
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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? | 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 |