Table 3.
Studies that calculate test performance characteristics of rRT-PCR or automated rRT-PCR platforms compared to composite reference standards.
| Authors | Country | Study Type | No. Patients | Demographics† | Specimen | Index Test | Composite Reference Standard Definition | Study Findings (95% CI) | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total | Cases* | Age (y)‡ | % M | Type | Primers | Platform | rSN | rSP | rPPV | rNPV | rAcc | rPPA | rNPA | Cohen's κ | |||||
| Cradic et al. 18 | USA | Cohort||¶ | 184 | 33 | nr | nr | NPS in VTM (184) | Automated Multiplex rRT-PCR | ORF1ab, S | Diasorin Simplexa | Result obtained from at least 2 of the 3 assays is consensus result. | 100% (90–100) | 100% (98–100) | ||||||
| Automated Isothermal NAAT | RdRp | Abbott ID NOW |
91% (79–97) | 100% (98–100) | |||||||||||||||
| Automated Multiplex rRT-PCR | ORF1, E | Roche cobas 6800 | 100% (90–100) | 100% (98–100) | |||||||||||||||
| Suo et al. 19,a | China | Cohort⁎⁎ | 58 | 52 | nr | nr | Throat swab (58) | Initial rRT-PCR (China CDC protocol) | ORF1ab, N | N/A | Positive result of repeated rRT-PCR, or serology is considered a positive result. | 40% (27–55) | 100% (54–100) | 100% (N/A) | 16% (13–19) | 47% (33–60) | |||
| Zhen & Mangi et al. 20 | USA | Case Control†† | 104 | 51 | nr | nr | NPS (104) | rRT-PCR (US CDC protocol) | N1, N2 | N/A | Result obtained by 3 out of 4 assays tested is consensus result | 100% (93–100) | 98% (89–99) | 0.98 (0.94–1) | |||||
| Automated multiplex rRT-PCR | ORF1ab, S | Diasorin Simplexa |
100% (93–100) | 100% (93–100) | 1.0 (0.99–1) | ||||||||||||||
| Automated rRT-PCR w/sensor | N | GenMark ePlex | 96% (87–99) | 100% (93–100) | 0.96 (0.91–1) | ||||||||||||||
| Automated multiplex rRT-PCR | ORF1ab (2 targets) |
Hologic Panther | 100% (93–100) | 96% (87–99) | 0.96 (0.91–1) | ||||||||||||||
Cases according to composite reference standard.
Of cohort or cases.
Format: median (range), median(IQR), or mean±SD. Patient Population.
Hospitalized patients.
Emergency Room patients.
Outpatients, some of whom were later hospitalized.
not reported.
Suo et al. data is also present in Table 4. Abbreviations- E: envelope, IQR: Interquartile range, κ: kappa coefficient, M: male, N/A: not applicable, N: nucleocapsid, NPS: nasopharyngeal swab, nr: not reported, ORF1ab: open reading frame 1ab, rRT-PCR: real-time Reverse Transcription Polymerase Chain Reaction, rAcc: reported accuracy, RdRp: RNA-dependent RNA polymerase, rNPA: reported negative percent agreement, rNPV: reported negative predictive value, rPPA: reported positive percent agreement, rPPV: reported positive predicted value, rSN: reported sensitivity, rSP: reported specificity, S: spike, VTM: viral transport media, y:years.