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. 2020 Aug 31;81(5):681–697. doi: 10.1016/j.jinf.2020.08.043

Table 6.

Studies assessing agreement between NAAT platforms.

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).

a

Loeffelholz et al. and Moore et al. also appear in Table 5.

b

Zhen, Smith et al. appears twice in Table 6 for ease of comparison of studies of the same platform.

c

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.