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. 2020 Aug 26;2020(8):CD013705. doi: 10.1002/14651858.CD013705

Zhen 2020 [B].

Study characteristics
Patient Sampling See Zhen 2020 [A] for full study details and QUADAS entries
Patient characteristics and setting See Zhen 2020 [A] for full study details and QUADAS entries
Index tests Zhen 2020 [B] is the entry for test [B] from the list below, see Zhen 2020 [A] for full study details and QUADAS entries
Test name:
[A] Xpert® Xpress SARS‐CoV‐2
[B] ID NOWCOVID‐19
(no product codes reported)
Manufacturer: [A] Cepheid, [B] Abbott
Antigen target: [A] N2, E; [B] RdRp
Antibody: N/A
Test method: rapid PCR
Samples used: NP swabs
Transport media: UTM (various manufacturers)
Sample storage: on collection, stored at 2‐8 ⁰C for up to 72 h; after routine testing, stored at −80 ⁰C
88 samples tested using ePlex on collection, then frozen prior to testing with ID NOW, Xpert Xpress and Hologic RT‐PCR; 20 samples tested prospectively after collection on all systems
Test operator: not stated; presume laboratory staff
Definition of test positivity: not stated; states “testing was performed according to the manufacturer’s instructions” but no presumptive positives reported
Blinding reported: not stated
Timing of samples: not stated
Study also evaluates [C] GenMar kePlex® SARS‐CoV‐2 Test (not eligible for this review)
Target condition and reference standard(s) See Zhen 2020 [A] for full study details and QUADAS entries
Flow and timing See Zhen 2020 [A] for full study details and QUADAS entries
Comparative  
Notes Funding: none stated; study authors thank Cepheid for providing the reagents used
Publication status: accepted manuscript
Source: Journal of Clinical Microbioloby
Author COI: Gregory Berry has previously given education seminars for Abbott, Cepheid, and Hologic, Inc. and has received Honorariums

BAL: bronchoalveolar lavage; CDC: Center for Disease Control; CGIA: colloidal gold immunoassay; COI: conflict of interest; Ct: cycle threshold; ED: Emergency Department; EUA: emergency use authorisation; FIA: fluorescence immunochromatographic; FN: false negative; FP: false positive; GLY: Glucose‐Lactalbumin‐Yeast; HCW: healthcare worker; ICU: intensive care unit; IFU: instructions for use; IQR: interquartile range; LDT: laboratory‐developed test; N/A: not applicable; NAAT: nucleic acids amplification test; NIH: National Institutes of Health; NOP: naso‐oropharyngeal; NP: nasopharyngeal; OP: oropharyngeal; PCR: polymerase chain reaction; PHE: Public Health England; qRT‐PCR: quantitative reverse transcription polymerase chain reaction; RNA: ribonucleic acid; RT‐PCR: reverse transcription polymerase chain reaction; SD: standard deviation; TA: tracheal aspirate; TN: true negative; TP: true positive; UTM: universal transport medium; UV: ultraviolet; UW: University of Washington; VTM: viral transport medium;