Table 1.
Broth Enrichment Followed by | ||||
---|---|---|---|---|
Test Characteristic | Chromogenic Agar Culture (n = 188) | Direct PCR (n = 222) | Chromogenic Agar Culture (n = 63) | PCR (n = 64) |
Diagnostic sensitivity, % (95% CI) | 1000 CFU/mL: 95.5 (77.2–99.9) |
100 CFU/mL: 100.0 (90.7–100.0) |
ND | ND |
100 CFU/mL: 96.7 (82.8–99.9) |
10 CFU/mL: 82.1 (66.5–92.5) |
|||
Diagnostic specificity, % (95% CI) | 1000 CFU/mL: 100 (66.4–100) |
100 CFU/mL: 100 (83.2–100.0) |
ND | ND |
100 CFU/mL: 94.7 (74.0–99.9) |
10 CFU/mL: 100 (80.5–100.0) |
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Analytical sensitivity, CFU/mL (95% CI)a | 256.34 (81.02–811.02) | 27.11 (11.34–64.76) | 16.32 (2.36–112.82) | 2.75 (.63–12.06) |
Analytical specificity, % | NA | 100 | NA | NA |
95% time to pigment production, d (95% CI)b | 4.26 (4.02–4.51) | NA | 2.92 (—)c | NA |
Approximate turnaround time, d | 5 | 1 | 5 | 3 |
Standardized definitions from Clinical and Laboratory Standards Institute documents MM17 [11] and EP12 [12] were used for test characteristics.
Abbreviations: CFU, colony-forming units; NA, not applicable; ND, not determined; PCR, polymerase chain reaction.
a95% lower limit of detection.
bWe defined a colony as characteristic of C auris when the colony color was pink with a surrounding diffusible blue halo.
cProbit regression did not converge; therefore, 95% CI is not reliably estimable.