Table 2.
Diagnostic method | No. true positive | No. false positive | No. false negative | No. true negative | Invalid results⁎, % | Sensitivity† |
Specificity |
Predictive value, % |
Youden index, % | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|
% | 95% CI | % | 95% CI | Positive | Negative | |||||||
GeneOhm Cdiff assay | 25 | 0 | 1 | 55 | 4.0 | 96.2 | 88.0–96.2 | 100 | 96.1 to 100 | 100 | 98.2 | 96.2 |
Xpert C. difficile test | 25 | 2 | 1 | 53 | 1.1 | 96.2 | 86.0–99.2 | 96.4 | 91.6 to 97.8 | 92.6 | 98.1 | 92.5 |
ProGastro Cd assay | 23 | 0 | 3 | 55 | 0 | 88.5 | 79.3–88.5 | 100 | 95.6 to 100 | 100 | 94.8 | 88.5 |
Quik Chek Complete‡ | 16 | 0 | 10 | 55 | NA | 61.5 | 51.4–61.5 | 100 | 95.2 to 100 | 100 | 84.6 | 61.5 |
GDH/EIA§ | 11 | 0 | 15 | 55 | NA | 42.3 | 32.4–42.3 | 100 | 95.3 to 100 | 100 | 78.6 | 57.7 |
Eighty-one specimens were analyzed using all methods.
CDI, Clostridium difficile infection; CI, confidence interval; NA, not applicable.
Xpert demonstrated an additional 5.5% “error rate.” At repeat testing, 100% of invalid specimens and errors for both GeneOhm and Xpert were resolved and provided definitive results, which are included in the total.
P < 0.03 for all molecular methods versus nonmolecular methods; Quik Chek Complete versus GDH/EIA was not significant.
GDH component was 96.2% sensitive and 81.8% specific.
GDH component was 96.2% sensitive and 76.4% specific.