Table 6.
Authors | Country | Study Type | No. Patients | Demographics† | Specimen | Platform #1 | Platform #2 | Study Findings (95% CI) | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Total | Cases* | Age (y)‡ | % M | Type | Primers | Platform | Type | Primers | Platform | rPPA | rNPA | rOA | rPPV | rNPV | Cohen's κ | ||||
Harrington et al. 48 | USA | Cohort¶ | 524 | 188 | nr | nr | Paired NPS in VTM (RealTime) & foam nasal swab (ID NOW) (524 pairs) | Automated Multiplex RT-PCR | RdRp, N | Abbott RealTime | Automated Isothermal NAAT | RdRp | Abbott ID NOW |
75% (67.7–80.6) |
99% (97.6–99.8) |
||||
Moore et al34,a | USA | Cohort||,¶,⁎⁎ | 200 | 125 | 50 ± 17 | 46% | NPS in VTM (200) | Automated Multiplex RT-PCR | RdRp, N | Abbott RealTime | Automated Isothermal NAAT | RdRp | Abbott ID NOW |
75.2% (66.7–82.5) |
100% (95.4–100) |
||||
Basu et al. 49 | USA | Cohort¶ | 101 | 32 | (28 - 90) | nr | NPS dry (101) | Automated Multiplex RT-PCR | N2, E | Cepheid Xpert Xpress |
Automated Isothermal NAAT | RdRp | Abbott ID NOW |
54.8% (37.8–70.8) |
98.6% (92.3–99.7) |
85.1% (76.9–90.8) |
94.4% (74.3–99) |
83.1% (73–89.7) |
|
Cases only¶ | 15 | 15 | nr | nr | NPS in VTM (15) | 66.7% | |||||||||||||
Hogan et al. JCV, 5–1 50 | USA | Case Control†† | 100‡‡ | 53‡‡ | nr | nr | NPSc (100) | Automated Multiplex RT-PCR | ORF1ab (2) | Hologic Panther | Automated Isothermal NAAT | RdRp | Abbott ID NOW |
80.4% (66.9–90.2) | 95.9% (86.0–99.5) | ||||
Zhen, Smith et al51,b | USA | Cohort†† | 108 | 58 | nr | nr | NPS in VTM (108) | Automated Multiplex RT-PCR | ORF1ab (2) | Hologic Panther | Automated Isothermal NAAT | RdRp | Abbott ID NOW |
87.7% (76–95) |
100% (93–100) |
0.87 (0.78–0.96) |
|||
Smithgall et al. 52 | USA | Case Control||¶ | 113 | 90 | 65 (0–101) |
60.2% | NPS in VTM or UTM (113) | Automated Multiplex RT-PCR | ORF1, E | Roche cobas 6800 | Automated Isothermal NAAT | RdRp | Abbott ID NOW |
73.9% (63.2–82.3) |
100% (83.4–100) |
||||
Automated Multiplex RT-PCR | ORF1, E | Roche cobas 6800 | Automated Multiplex RT-PCR | N2, E | Cepheid Xpert Xpress | 98.9% (92.9–100) |
92% (72.4–98.6) |
||||||||||||
Moran et al. 53 | USA | Cohort||,⁎⁎ | 103‡‡ | 42‡‡ | nr | nr | NPS (95), nasal swab (8) | Automated Multiplex RT-PCR | ORF1, E | Roche cobas 6800 | Automated Multiplex RT-PCR | N2, E | Cepheid Xpert Xpress | 99% | |||||
Craney et al. 54 | USA | Cohort†† | 389 | 147 | nr | nr | NPS (389) | Automated Multiplex RT-PCR | ORF1ab (2) | Hologic Panther | Automated Multiplex RT-PCR | ORF1, E | Roche cobas 6800 | 96.4% | 0.922 | ||||
Zhen, Smith et al51,b | USA | Cohort†† | 108 | 58 | nr | nr | NPS in VTM (108) | Automated Multiplex RT-PCR | ORF1ab (2) | Hologic Panther | Automated Multiplex RT-PCR | N2, E | Cepheid Xpert Xpress | 98.3% (91–100) |
100% (93–100) |
0.98 (0.95–1.0) |
|||
Automated Multiplex RT-PCR | ORF1ab (2) | Hologic Panther | Automated RT-PCR w/sensor | N | GenMark ePlex |
91.4% (81–97) |
100% (93–100) |
0.91 (0.83–0.99) |
|||||||||||
Loeffelholz et al39,a | USA, UK, FR, IT | Cohort†† (enriched for positive cases) | 18‡‡ | 8‡‡ | nr | nr | NPS, OPS, NPS+OPS, Trach Asp (nr) | Automated Multiplex RT-PCR | RdRp, N | Abbott RealTime | Automated Multiplex RT-PCR | N2, E | Cepheid Xpert Xpress | 100% (67.6–100) |
100% (77.2–100) |
||||
Norz et al. 55 | Germany | Case Control†† | 165‡‡ | 36‡‡ | nr | nr | NPS, OPS (nr) | Automated Multiplex RT-PCR | ORF1, E | Roche cobas 6800 | Automated RT-PCR |
E | NeuMoDx 96 | 100% | 99.2% |
Case estimated as a positive result of any evaluated platform.
Of cohort or cases.
Format: median (range), median(IQR), or mean±SD. Patient Population.
Hospitalized patients.
Emergency Room/Immediate Care Center patients.
Outpatient.
not reported.
Number of samples (when number of patients not reported).
Loeffelholz et al. and Moore et al. also appear in Table 5.
Zhen, Smith et al. appears twice in Table 6 for ease of comparison of studies of the same platform.
Dry or VTM status not reported. Rhoads et al. appears twice in Table 5 for ease of comparison of studies of the same platform Abbreviations- CI: confidence interval, E: envelope, IQR: Interquartile range, κ: kappa statistic, M: male, N: nucleocapsid, NAAT: nucleic acid amplification test, No.: number, NPS: nasopharyngeal swab, nr: not reported, OPS: oropharyngeal swab, ORF1ab: open reading frame 1ab, RdRp: RNA-dependent RNA polymerase, rNPA: reported negative percent agreement, rNPV: reported negative predictive value, rOA: reported overall agreement, rPPA: reported positive percent agreement, rPPV: reported positive predictive value, rRT-PCR: real-time Reverse Transcription Polymerase Chain Reaction, S: spike, Trach Asp: Tracheal Aspirate, UTM: universal transport medium, VTM: viral transport medium, y: years.