Table 4.

Performance of Allplex™H pylori and ClariR Assay and DPO-PCR for detection of A2142G mutation compared with gene sequencing

Tests performances	Allplex™	DPO-PCR
Total positive results of the reference method (n)	2	2
Total positive results of the used test (n)	2	4
Total negative results of the used test (n)	140	138
False positive (n)	0	3
False negative (n)	0	1
Sensitivity %, (95% CI)	100 (15.8–100)	50.0 (1.3–98.7)
Specificity %, (95% CI)	100 (97.4–100)	97.9 (93.9–99.6)
Positive predictive value %, (95%CI)	100	25.0 (5.3–66.4)
Negative predictive value %, (95% CI)	100	99.3 (97.2–99.8)
Test Accuracy %, (95% CI)	100 (97.4–100)	97.2 (92.9–99.2)
Kappa (κ) (95% CI)†	1.00 (1.00–1.00)	0.62 (0.00-0.98)

† 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

Abbreviations: Allplex™, Allplex™H pylori and ClariR Assay; DPO-PCR, dual priming oligonucleotide-based multiplex polymerase chain reaction; CI, confidence interval