Table 2.

Performance of the Allplex™H pylori and ClariR Assay and DPO-PCR in H. pylori detection compared with gene sequencing

	No. (%) of results by reference standard					Analytical performance (%)‡
	TP	TN	FP	FN		Sensitivity	Specificity	PPV	NPV	Accuracy	Kappa (κ)†
Allplex™	124 (98.3)	17 (12.0)	0 (0)	1 (0.7)		99.2 (95.6–100.0)	100 (80.5–100)	100	94.4 (70.7–99.2)	99.3 (96.1–100)	0.97 (0.91-1)
DPO-PCR	120 (84.5)	17 (12.0)	0 (0)	5 (3.5)		96.0 (90.9–98.7)	100 (80.5–100)	100	77.3 (59.0-88.9)	96.5 (92.0-98.9)	0.85 (0.72–0.98)

† Cohen’s kappa coefficient, Kappa values representing levels of agreement are categorized as follows: >0.90, almost perfect; 0.80 to 0.90, strong, 0.60 to 0.79, moderate; 0.40 to 0.59, week; 0.21 to 0.39, minimal; (0 to 0.20), none

‡ Values in parentheses are 95% confidence intervals

Abbreviations: Allplex™, Allplex™H pylori and ClariR Assay; DPO-PCR, dual priming oligonucleotide-based multiplex polymerase chain reaction; TP, true positive; TN, true negative; FP, false positive; FN, false negative; PPV, positive predictive value; NPV, negative predictive value