TABLE 4.
Unyvero LRT BAL panel performance compared to that of SoC testing for bacterial species as isolated in routine culture
| Species | Study arma | No. positive by Unyvero and SoC/ no. positive by SoC |
PPA (%) (95% CI) |
No. negative by Unyvero and SoC/ no. negative by SoC |
NPA (%) (95% CI) |
|---|---|---|---|---|---|
| Acinetobacter species | Prospective | 10/11 | 90.9 (62.3–98.4) | 993/1,004 | 98.9 (98.0–99.4) |
| Archived | 18/18 | 100.0 (82.4–100.0) | 371/374 | 99.2 (97.7–99.7) | |
| Total | 28/29 | 96.6 (82.8–99.4) | |||
| C. freundii | Prospective | 1/1 | 100.0 (20.7–100.0) | 1,011/1,014 | 99.7 (99.1–99.9) |
| Archived | 5/5 | 100.0 (56.6–100.0) | 382/387 | 98.7 (97.0–99.4) | |
| Total | 6/6 | 100.0 (61.0–100.0) | |||
| E. cloacae complex | Prospective | 13/17 | 76.5 (52.7–90.4) | 991/998 | 99.3 (98.6–99.7) |
| Archived | 15/19 | 78.9 (56.7–91.5) | 373/373 | 100.0 (99.0–100.0) | |
| Total | 28/36 | 77.8 (61.9–88.3) | |||
| E. coli | Prospective | 17/18 | 94.4 (74.2–99.0) | 968/998 | 97.0 (95.7–97.9) |
| Archived | 46/49 | 93.9 (83.5–97.9) | 326/343 | 95.0 (92.2–96.9) | |
| Total | 63/67 | 94.0 (85.6–97.7) | |||
| H. influenzae | Prospective | 8/9 | 88.9 (56.5–98.0) | 958/1,006 | 95.2 (93.7–96.4) |
| Archived | 50/50 | 100.0 (92.9–100.0) | 321/342 | 93.9 (90.8–95.9) | |
| Total | 58/59 | 98.3 (91.0–99.7) | |||
| K. oxytoca | Prospective | 6/7 | 85.7 (48.7–97.4) | 1,001/1,009 | 99.2 (98.4–99.6) |
| Archived | 16/17 | 94.1 (73.0–99.0) | 369/375 | 98.4 (96.6–99.3) | |
| Total | 22/24 | 91.7 (74.2–97.7) | |||
| K. pneumoniae | Prospective | 20/24 | 83.3 (64.1–93.3) | 982/992 | 99.0 (98.2–99.5) |
| Archived | 29/31 | 93.5 (79.3–98.2) | 351/361 | 97.2 (95.0–98.5) | |
| Total | 49/55 | 89.1 (78.2–94.9) | |||
| K. variicola | Prospective | 0/2 | 0.0 (0.0–65.8) | 1,012/1,014 | 99.8 (99.3–99.9) |
| Archived | 2/2 | 100.0 (34.2–100.0) | 386/390 | 99.0 (97.4–99.6) | |
| Total | 2/4 | 50.0 (15.0–85.0) | |||
| M. catarrhalis | Prospective | 2/2 | 100.0 (34.2–100.0) | 997/1,010 | 98.7 (97.8–99.2) |
| Archived | 21/21 | 100.0 (84.5–100.0) | 362/371 | 97.6 (95.5–98.7) | |
| Total | 23/23 | 100.0 (85.7–100.0) | |||
| M. morganii | Prospective | 0/0 | NA | 1,009/1,012 | 99.7 (99.1–99.9) |
| Archived | 1/1 | 100.0 (20.7–100.0) | 391/391 | 100.0 (99.0–100.0) | |
| Total | 1/1 | 100.0 (20.7–100.0) | |||
| Proteus species | Prospective | 4/4 | 100.0 (51.0–100.0) | 1,006/1,012 | 99.4 (98.7–99.7) |
| Archived | 15/15 | 100.0 (79.6–100.0) | 370/377 | 98.1 (96.2–99.1) | |
| Total | 19/19 | 100.0 (83.2–100.0) | |||
| P. aeruginosa | Prospective | 69/72 | 95.8 (88.5–98.6) | 900/943 | 95.4 (93.9–96.6) |
| Archived | 54/56 | 96.4 (87.9–99.0) | 334/336 | 99.4 (97.9–99.8) | |
| Total | 123/128 | 96.1 (91.2–98.3) | |||
| S. marcescens | Prospective | 12/12 | 100.0 (75.8–100.0) | 998/1,003 | 99.5 (98.8–99.8) |
| Archived | 23/25 | 92.0 (75.0–97.8) | 364/367 | 99.2 (97.6–99.7) | |
| Total | 35/37 | 94.6 (82.3–98.5) | |||
| S. aureus | Prospective | 63/71 | 88.7 (79.3–94.2) | 904/945 | 95.7 (94.2–96.8) |
| Archived | 56/58 | 96.6 (88.3–99.1) | 313/334 | 93.7 (90.6–95.9) | |
| Total | 119/129 | 92.2 (86.3–95.7) | |||
| S. maltophilia | Prospective | 19/21 | 90.5 (71.1–97.4) | 972/994 | 97.8 (96.7–98.5) |
| Archived | 37/40 | 92.5 (80.1–97.4) | 342/352 | 97.2 (94.9–98.4) | |
| Total | 56/61 | 91.8 (82.2–96.4) | |||
| S. pneumoniae | Prospective | 3/3 | 100.0 (43.9–100.0) | 1,003/1,013 | 99.0 (98.2–99.5) |
| Archived | 34/35 | 97.1 (85.5–99.5) | 352/357 | 98.6 (96.8–99.4) | |
| Total | 37/38 | 97.4 (86.5–99.5) | |||
| Total | Prospective | 247/274 | 90.1 (86.0–93.1) | 15,705/15,967 | 98.4 (98.2–98.5) |
| Archived | 422/442 | 95.5 (93.1–97.1) | 5,707/5,830 | 97.9 (97.5–98.2) | |
| Total | 669/716 | 93.4 (91.4–95.0) | 21,412/21,797 | 98.3 (98.1–98.4) | |
a
Prospective study arm, n = 1,016; archived study arm, n = 392.