Table 3.

Performance of Allplex™H pylori and ClariR Assay and DPO-PCR for detection of A2143G mutation compared with gene sequencing

Tests performances	Allplex™	DPO-PCR
Total positive results of the reference method (n)	42	42
Total positive results of the used test (n)	45	47
Total negative results of the used test (n)	97	95
False positive (n)	4	18
False negative (n)	1	7
Sensitivity %, (95% CI)	97.6 (87.4–99.9)	88.3 (68.6–93.0)
Specificity %, (95% CI)	96.0 (90.1–98.9)	82.0 (73.1–89.0)
Positive predictive value %, (95%CI)	91.1 (79.7–96.4)	66.0 (55.6–75.1)
Negative predictive value %, (95% CI)	99.0 (93.3–99.9)	92.1 (85.6–95.9)
Test Accuracy %, (95% CI)	96.5 (92.0-98.9)	82.4 (75.1–88.3)
Kappa (κ) (95% CI)†	0.92 (0.85–0.99)	0.61 (0.47–0.75)

† 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