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

Table 4.

Studies reporting test performance characteristics of other nucleic acid amplification test methods compared to rRT-PCR.

Authors	Country	Study Type	No. Patients		Demographics^†		Specimen (No.)	Index Test			Ref Stnd: rRT-PCR	Study Findings (95% CI or p-value)
			Total	Cases^*	Age (y)^‡	% Male		Type	Primers	Platform	Ref Stnd: rRT-PCR	Study Findings (95% CI or p-value)
			Total	Cases^*	Age (y)^‡	% Male		Type	Primers	Platform	Primers	rSN	rSP	rPPV	rNPV	rAcc	rOA	Cohen's κ
Baek et al. ²¹	Korea	Case Control^\|\|	154	14	nr	nr	Nasal swab (154)	RT-LAMP	N	nr	ORF1ab, S	100%	98.7%					0.826
Kitagawa et al. ²²	Japan	Cohort^\|\|	76	30	nr	nr	NPS (76)	RT-LAMP	nr	LA-200 turbidimeter	N	100%	95.6%				97.4%
Lau et al. ²³	Malaysia	Case Control^††	89^‡‡	47^‡‡	nr	nr	NPS (89)	RT-LAMP	N	LA-320 turbidimeter	RdRp,E	100%	100%
Lu et al. ²⁴	China	Case Control^\|\|	56	36	nr	nr	Throat swab (56)	RT-LAMP	N	nr	ORF1ab, N					92.9%
Yan et al. ²⁵	China	Cohort^††	130	58	nr	nr	Throat swab, BAL (nr)	RT-LAMP	ORF1ab, S	nr	ORF1ab, N	100% (92.3–100)	100% (93.7–100)
Wang, Cai, & He et al. ²⁶	China	Cohort^††	947	338	44 ± 17.1	60%	OPS (834), sputum (82), NPS (16), nasal swab (8), BAL (4), stool (2), blood (1)	RT-RAA	ORF1ab	RAA-F1620 fluorescent detector	ORF1ab &N, or ORF1ab	97.6% (95.2–98.9)	97.8% (96.2–98.8)	96.2% (93.4–97.8)	98.6% (97.3–99.3)			0.952 p<0.05
Xue et al. ²⁷	China	Cohort^††	120^‡‡	22^‡‡	nr	nr	NPS, sputum (nr)	RT-RAA	ORF1ab	RAA-1620 fluorescent detector	ORF1ab, S	100%	100%					1.0 p < 0.001
Perchetti et al. ²⁸	USA	Case Control^††	356	186	nr	nr	NPS (356)	Triplex rRT-PCR	N1, N2	n/a	N1, N2	98.4%	100%				99.2%
Waggoner et al. ²⁹	USA	Cohort^\|\|	27	11	nr	nr	NPS, OPS (nr)	Triplex rRT-PCR	N2, E	n/a	N2, E						100%
Li et al. ³⁰	China	Cohort^††	303^‡‡	126^‡‡	nr	nr	throat swab (267), sputum (22), nose swab (8), BAL (3), blood (3)	AIGS	ORF1ab, N, S	LifeReady 1000	ORF1ab, N	97.62% (93.2–99.5)	100%
Suo et al. ¹⁹^,^a	China	Cohort^⁎⁎	58	52	nr	nr	Throat swab (58)	ddPCR	ORF1ab, N	QX200 System	ORF1ab, N	94% (83–99)	100% (48–100)	100% (NA)	63% (36–83)	95% (84–99)
Bulterys et al. ³¹	USA	Cohort^††	80	30	nr	nr	NPS (80)	Isothermal amplification	ORF1ab, N	Atila iAMP kit	E	82.8% (65.0–92.9)						0.86 (0.74–0.98)
Wang , Cai, & Zhang et al. ³²	China	Cohort^††	181^‡‡	25^‡‡	nr	nr	Throat swab (181)	OSN-qRT-PCR	ORF1ab, N	Life Tech. 480	ORF1ab, N							0.737

^⁎

Cases according to reference standard.

^†

Of cohort or cases.

^‡

Format: median (range), median(IQR), or mean±SD. Patient Population.

^||

Hospitalized patients

¶Emergency Room/Immediate Care Center patients.

^⁎⁎

Outpatients, who were later hospitalized.

^††

not reported.

^‡‡

Number of samples (when number of patients not reported).

Suo et al. data is also present in Table 2. Abbreviations- AIGS: Automatic integrated gene detection system, BAL: Bronchoalveolar lavage, CI: confidence interval, ddPCR: digital droplet polymerase chain reaction, E: envelope, iAMP: isothermal amplification, IQR: Interquartile range, κ: kappa statistic, n/a: not applicable, N: nucleocapsid, No.: number, NPS: nasopharyngeal swab, nr: not reported, OPS: oropharyngeal swab, ORF1ab: open reading frame 1ab, OSN-qRT-PCR: one-step single-tube nested quantitative real-time polymerase chain reaction, rAcc: reported accuracy, RdRp: RNA-dependent RNA polymerase, Ref Stnd: reference standard, 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, rSN: reported sensitivity, rSP: reported specificity, RT-LAMP: reverse transcription loop-mediated isothermal amplification, RT-RAA: reverse-transcription recombinase-aided amplification, S: spike, y: years.