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) |
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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;