Multicenter Analytical Performance Evaluation of the BD Phoenix NMIC-461 Panel for Carbapenemase Classification and Antimicrobial Susceptibility Testing of Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp.
Abstract
1. Introduction
2. Results
2.1. Isolates Information
2.2. Performance Evaluation of BD NMIC-461 Detection and Classification of Carbapenemase-Producing Organisms
2.2.1. Performance Evaluation of CPO Detection
2.2.2. Performance Evaluation of CPO Classification
2.3. Performance of BD NMIC-461 AST Results
3. Discussion
4. Materials and Methods
4.1. Isolates
4.2. BD Phoenix
4.3. Broth Microdilution (BMD)
4.4. Modified Carbapenem Inactivation Method (mCIM)
4.5. Screening of Carbapenemase Genes
4.6. Data Analysis
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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| Organism | NMIC-461 Result | mCIM Result | ||||||
|---|---|---|---|---|---|---|---|---|
| Positive, n (%) | Negative, n (%) | Total, n (%) | Sensitivity, % (95% CI) | Specificity, % (95% CI) | PPV, % (95% CI) | NPV, % (95% CI) | ||
| Total | Positive | 133 (98.5) | 27 (7.4) | 160 (32.1) | 98.5 (94.8–99.6) | 92.6 (89.4–94.8) | 83.1 (77.5–87.7) | 99.4 (97.9–99.8) |
| Negative | 2 (1.5) | 336 (92.6) | 338 (67.9) | |||||
| Total | 135 (100) | 363 (100) | 498 (100) | |||||
| Enterobacterales | Positive | 127 (99.2) | 7 (2.3) | 134 (30.9) | 99.2 (95.7–99.9) | 97.7 (95.3–98.9) | 94.8 (89.9–97.4) | 99.7 (98.2–99.9) |
| Negative | 1 (0.8) | 298 (97.7) | 299 (69.1) | |||||
| Total | 128 (100) | 305 (100) | 433 (100) | |||||
| Pseudomonas aeruginosa | Positive | 6 (85.7) | 20 (34.5) | 26 (40) | 85.7 (48.7–97.4) | 65.5 (52.7–76.4) | 23.1 (13.7–31.6) | 97.4 (91.2–99.5) |
| Negative | 1 (14.3) | 38 (65.5) | 39 (60) | |||||
| Total | 7 (100) | 58 (100) | 65 (100) | |||||
| Organism | PCR Results | NMIC_461 Results | Sensitivity, % (95% CI) | Specificity, % (95% CI) | PPV, % (95% CI) | NPV, % (95% CI) | Kappa (95% CI) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Positive | Negative, n | Total, n | ||||||||||||
| A, n | B, n | D, n | Positive Unclassified, n | Total, n | ||||||||||
| All CPOs | Positive | A | 6 | 0 | 0 | 58 | 64 | 0 | 64 | 9.4 (4.4–18.8) d 100 (94.0–100) * | 97.3 (95.6–98.4) d | 27.3 (12.9–48.1) d 80 (69.7–87.6) * | 90.9 (88.3–92.9) d 100 (99.3–100) * | 0.09 (0.01–0.18) d 0.875 (0.815–0.936) * |
| B | 1 | 61 | 1 | 5 | 68 | 0 | 68 | 89.7 (79.9–95.3) e 97.1 (89.7–99.2) * | 97.6 (96.0–98.6) e | 81.3 (71.3–88.5) e 82.5 (72.8–89.3) * | 98.8 (97.5–99.5) e 99.7 (98.6–99.9) * | 0.888 (0.832–0.945) e 0.807 (0.739–0.876) * | ||
| D | 0 | 4 | 89 | 21 | 114 | 3 | 117 | 76.1 (67.2–83.2) f 94.0 (87.9–97.3) * | 99.1 (97.8–99.7) f 99.1 (97.8–99.7) * | 94.7 (88.4–97.7) f 95.7 (90.2–98.2) * | 95.0 (92.8–96.6) f 98.7 (97.3–99.4) * | 0.807 (0.739–0.876) f 0.942 (0.904–0.979) * | ||
| Negative | 15 | 10 | 4 | 2 | 31 | 376 | 407 | - | ||||||
| Total | 22 | 75 | 94 | 86 | 277 | 379 | 656 a | 98.8 (96.6–99.6) g | 92.4 (89.5–94.6) g | 88.8 (84.5–92.1) g | 99.2 (97.8–99.8) g | 0.909 (0.874–0.944) g | ||
| Acinetobacter baumannii | Positive | A | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | 100 (100–100) d | - | 100 (100–100) d | – |
| B | 0 | 1 | 0 | 0 | 1 | 0 | 1 | 100 (20.7–100) e | 96.9 (92.3–98.9) e | 20.0 (3.6–62.5) e | 100 (97.2–100) e | 0.305 (0.014–0.595) e | ||
| D | 0 | 4 | 89 | 21 | 114 | 3 | 117 | 76.1 (67.2–83.2) f 94.0 (87.9–97.3) * | 97.0 (84.2–99.6) f 97.0 (84.2–99.6) * | 98.9 (94.1–99.8) f 99.1 (95.1–99.9) * | 53.5 (41.3–65.0) f 82.1 (67.3–91.1) * | 0.523 (0.406–0.641) f 0.848 (0.749–0.947) * | ||
| Negative | 0 | 0 | 1 | 0 | 1 | 11 | 12 | - | ||||||
| Total | 0 | 5 | 90 | 21 | 116 | 14 | 130 b | 97.5 (92.8–99.2) g | 91.7 (61.5–98.4) g | 99.1 (95.3–99.9) g | 78.6 (52.4–92.4) g | 0.834 (0.671–0.997) g | ||
| Enterobacterales | Positive | A | 5 | 0 | 0 | 58 | 63 | 0 | 63 | 7.9 (1.3–14.6) d 100 (94.2–100) * | 99.5 (98.2–99.9) d | 71.4 (35.9–91.8) d 96.9 (89.3–99.2) * | 87.2 (83.7–90.0) d 100 (99.0–100) * | 0.125 (0.041–0.209) d 0.978 (0.949–1.000) * |
| B | 0 | 56 | 1 | 4 | 61 | 0 | 61 | 91.8 (81.9–96.6) e 98.4 (91.1–99.8) * | 98.2 (96.4–99.2) e | 88.9 (79.0–94.4) e 89.6 (79.9–95.0) * | 98.7 (97.1–99.5) e 99.7 (98.6–99.9) * | 0.894 (0.836–0.953) e 0.936 (0.886–0.987) * | ||
| D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | 99.8 (98.9–99.99) f | 0 (0.0–79.4) f | 100 (99.2–100) f | – | ||
| Negative | 2 | 7 | 0 | 1 | 10 | 325 | 335 | - | ||||||
| Total | 7 | 63 | 1 | 63 | 134 | 325 | 459 | 100 (97.0–100) g | 97.0 (94.6–98.5) g | 92.5 (86.9–96.0) g | 100 (98.9–100) g | 0.95 (0.919–0.981) g | ||
| Pseudomonas aeruginosa | Positive | A | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 100 (20.7–100.0) d | 78.8 (67.0–87.3) d | 6.7 (1.2–32.0) d | 100 (93.1–100) d | 0.105 (0.008–0.201) d |
| B | 1 | 4 | 0 | 1 | 6 | 0 | 6 | 66.7 (31.0–89.1) e 83.3 (43.7–97.0) * | 95.1 (86.6–98.3) e | 57.1 (25.1–84.2) e 62.5 (30.6–86.3) * | 96.7 (88.7–99.1) e 98.3 (90.9–99.8) * | 0.605 (0.340–0.871) e 0.727 (0.490–0.964) * | ||
| D | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | 95.5 (87.5–98.6) f | 0 (0.0–56.2) f | 100 (94.2–100) f | – | ||
| Negative | 13 | 3 | 3 | 1 | 20 | 40 | 60 | - | ||||||
| Total | 15 | 7 | 3 | 2 | 27 | 40 | 67 c | 100 (64.6–100.0) g | 66.7 (53.7–77.6) g | 25.9 (13.5–44.4) g | 100 (91.2–100) g | 0.29 (0.147–0.432) g | ||
| Antimicrobial Agent | Organism | BMD SIR Result | NMIC_461 Agreement Result Compared to BMD | ||||||
|---|---|---|---|---|---|---|---|---|---|
| S, n (%) | I, n (%) | R, n (%) | EA, % (95% CI) | CA, % (95% CI) | MIE, % (95% CI) | ME, % (95% CI) | VME, % (95% CI) | ||
| Amoxicillin-Clavulanate | Total | 230 (53.7%) | 40 (9.3%) | 158 (36.9%) | 98.8% (97.3%, 99.5%) | 93.5% (90.7%, 95.4%) | 6.5% (4.6%, 9.3%) | 0.0% (0.0%, 1.6%) | 0.0% (0.0%, 2.4%) |
| Enterobacterales | 230 (53.7%) | 40 (9.3%) | 158 (36.9%) | 98.8% (97.3%, 99.5%) | 93.5% (90.7%, 95.4%) | 6.5% (4.6%, 9.3%) | 0.0% (0.0%, 1.6%) | 0.0% (0.0%, 2.4%) | |
| Acinetobacter | not tested | not tested | not tested | ||||||
| Pseudomonas aeruginosa | not tested | not tested | not tested | ||||||
| Other negative organisms | not tested | not tested | not tested | ||||||
| Ceftaroline | Total | 176 (41.9%) | 5 (1.2%) | 239 (56.9%) | 99.8% (98.7%, 100.0%) | 98.1% (96.3%, 99.0%) | 1.7% (0.8%, 3.4%) | 0.6% (0.1%, 3.1%) | 0.0% (0.0%, 1.6%) |
| Enterobacterales | 176 (41.9%) | 5 (1.2%) | 239 (56.9%) | 99.8% (98.7%, 100.0%) | 98.1% (96.3%, 99.0%) | 1.7% (0.8%, 3.4%) | 0.6% (0.1%, 3.1%) | 0.0% (0.0%, 1.6%) | |
| Acinetobacter | not tested | not tested | not tested | ||||||
| Pseudomonas aeruginosa | not tested | not tested | not tested | ||||||
| Other negative organisms | not tested | not tested | not tested | ||||||
| Ceftazidime-Avibactam | Total | 395 (85.5%) | 0 (0%) | 67 (14.5%) | 97.2% (95.2%, 98.4%) | 100.0% (99.2%, 100.0%) | 0.0% (0.0%, 0.8%) | 0.0% (0.0%, 1.0%) | 0.0% (0.0%, 5.4%) |
| Enterobacterales | 366 (85.5%) | 0 (0%) | 62 (14.5%) | 97.0% (94.9%, 98.2%) | 100.0% (99.1%, 100.0%) | 0.0% (0.0%, 0.9%) | 0.0% (0.0%, 1.0%) | 0.0% (0.0%, 5.8%) | |
| Acinetobacter | not tested | not tested | not tested | ||||||
| Pseudomonas aeruginosa | 29 (85.3%) | 0 (0%) | 5 (14.7%) | 100.0% (89.8%, 100.0%) | 100.0% (89.8%, 100.0%) | 0.0% (0.0%, 10.2%) | 0.0% (0.0%, 11.7%) | 0.0% (0.0%, 43.4%) | |
| Other negative organisms | not tested | not tested | not tested | ||||||
| Ceftazidime 1 | Total | 251 (44.7%) | 23 (4.1%) | 287 (51.2%) | 98.4% (97.0%, 99.2%) | 94.7% (92.5%, 96.2%) | 4.6% (3.2%, 6.7%) | 0.4% (0.1%, 2.2%) | 1.0% (0.4%, 3.0%) |
| Enterobacterales | 198 (50.8%) | 19 (4.9%) | 173 (44.4%) | 98.7% (97.0%, 99.4%) | 95.1% (92.5%, 96.9%) | 4.4% (2.7%, 6.9%) | 0.0% (0.0%, 1.9%) | 1.2% (0.3%, 4.1%) | |
| Acinetobacter | 21 (18.6%) | 1 (0.9%) | 91 (80.5%) | 98.2% (93.8%, 99.5%) | 96.5% (91.2%, 98.6%) | 2.7% (0.9%, 7.5%) | 4.8% (0.8%, 22.7%) | 0.0% (0.0%, 4.0%) | |
| Pseudomonas aeruginosa | 18 (78.3%) | 1 (4.3%) | 4 (17.4%) | 100.0% (85.7%, 100.0%) | 95.7% (79.0%, 99.2%) | 4.3% (0.8%, 21.0%) | 0.0% (0.0%, 17.6%) | 0.0% (0.0%, 49.0%) | |
| Other negative organisms | 14 (40%) | 2 (5.7%) | 19 (54.3%) | 94.3% (81.4%, 98.4%) | 82.9% (67.3%, 91.9%) | 14.3% (6.3%, 29.4%) | 0.0% (0.0%, 21.5%) | 5.3% (0.9%, 24.6%) | |
| Ceftriaxone 1 | Total | 189 (43.9%) | 1 (0.2%) | 241 (55.9%) | 99.5% (98.3%, 99.9%) | 99.5% (98.3%, 99.9%) | 0.2% (0.0%, 1.3%) | 0.0% (0.0%, 2.0%) | 0.4% (0.1%, 2.3%) |
| Enterobacterales | 186 (43.5%) | 1 (0.2%) | 241 (56.3%) | 99.5% (98.3%, 99.9%) | 99.5% (98.3%, 99.9%) | 0.2% (0.0%, 1.3%) | 0.0% (0.0%, 2.0%) | 0.4% (0.1%, 2.3%) | |
| Acinetobacter | 3 (100%) | 0 (0%) | 0 (0%) | 100.0% (43.8%, 100.0%) | 100.0% (43.8%, 100.0%) | 0.0% (0.0%, 56.2%) | 0.0% (0.0%, 56.2%) | ||
| Pseudomonas aeruginosa | not tested | not tested | not tested | ||||||
| Other negative organisms | not tested | not tested | not tested | ||||||
| Ciprofloxacin | Total | 184 (32.2%) | 38 (6.6%) | 350 (61.2%) | 97.0% (95.3%, 98.1%) | 90.7% (88.1%, 92.8%) | 9.3% (7.2%, 11.9%) | 0.0% (0.0%, 2.0%) | 0.0% (0.0%, 1.1%) |
| Enterobacterales | 137 (32.2%) | 36 (8.5%) | 252 (59.3%) | 97.9% (96.0%, 98.9%) | 88.5% (85.1%, 91.2%) | 11.5% (8.8%, 14.9%) | 0.0% (0.0%, 2.7%) | 0.0% (0.0%, 1.5%) | |
| Acinetobacter | 22 (19.5%) | 1 (0.9%) | 90 (79.6%) | 94.7% (88.9%, 97.5%) | 99.1% (95.2%, 99.8%) | 0.9% (0.2%, 4.8%) | 0.0% (0.0%, 14.9%) | 0.0% (0.0%, 4.1%) | |
| Pseudomonas aeruginosa | 25 (73.5%) | 1 (2.9%) | 8 (23.5%) | 94.1% (80.9%, 98.4%) | 91.2% (77.0%, 97.0%) | 8.8% (3.0%, 23.0%) | 0.0% (0.0%, 13.3%) | 0.0% (0.0%, 32.4%) | |
| Other negative organisms | not tested | not tested | not tested | ||||||
| Colistin 2 | Total | 0 (0%) | 469 (90.2%) | 51 (9.8%) | 96.0% (93.9%, 97.3%) | 95.8% (93.7%, 97.2%) | 4.2% (2.8%, 6.3%) | 0.0% (0.0%, 7.0%) | |
| Enterobacterales | 0 (0%) | 339 (88.1%) | 46 (11.9%) | 95.6% (93.0%, 97.2%) | 95.6% (93.0%, 97.2%) | 4.4% (2.8%, 7.0%) | 0.0% (0.0%, 7.7%) | ||
| Acinetobacter | 0 (0%) | 106 (95.5%) | 5 (4.5%) | 96.4% (91.1%, 98.6%) | 95.5% (89.9%, 98.1%) | 4.5% (1.9%, 10.1%) | 0.0% (0.0%, 43.4%) | ||
| Pseudomonas aeruginosa | 0 (0%) | 24 (100%) | 0 (0%) | 100.0% (86.2%, 100.0%) | 100.0% (86.2%, 100.0%) | 0.0% (0.0%, 13.8%) | |||
| Other negative organisms | not tested | not tested | not tested | ||||||
| Imipenem | Total | 313 (60.3%) | 5 (1%) | 201 (38.7%) | 95.8% (93.7%, 97.2%) | 97.7% (96.0%, 98.7%) | 1.7% (0.9%, 3.3%) | 0.6% (0.2%, 2.3%) | 0.5% (0.1%, 2.8%) |
| Enterobacterales | 275 (72%) | 3 (0.8%) | 104 (27.2%) | 95.8% (93.3%, 97.4%) | 97.9% (95.9%, 98.9%) | 1.8% (0.9%, 3.7%) | 0.0% (0.0%, 1.4%) | 1.0% (0.2%, 5.2%) | |
| Acinetobacter | 21 (18.6%) | 0 (0%) | 92 (81.4%) | 97.3% (92.5%, 99.1%) | 100.0% (96.7%, 100.0%) | 0.0% (0.0%, 3.3%) | 0.0% (0.0%, 15.5%) | 0.0% (0.0%, 4.0%) | |
| Pseudomonas aeruginosa | 17 (70.8%) | 2 (8.3%) | 5 (20.8%) | 87.5% (69.0%, 95.7%) | 83.3% (64.1%, 93.3%) | 8.3% (2.3%, 25.8%) | 11.8% (3.3%, 34.3%) | 0.0% (0.0%, 43.4%) | |
| Other negative organisms | not tested | not tested | not tested | ||||||
| Levofloxacin | Total | 214 (36.3%) | 31 (5.3%) | 344 (58.4%) | 98.1% (96.7%, 99.0%) | 89.8% (87.1%, 92.0%) | 10.2% (8.0%, 12.9%) | 0.0% (0.0%, 1.8%) | 0.0% (0.0%, 1.1%) |
| Enterobacterales | 148 (36.5%) | 13 (3.2%) | 245 (60.3%) | 98.3% (96.5%, 99.2%) | 90.6% (87.4%, 93.1%) | 9.4% (6.9%, 12.6%) | 0.0% (0.0%, 2.5%) | 0.0% (0.0%, 1.5%) | |
| Acinetobacter | 22 (19.3%) | 7 (6.1%) | 85 (74.6%) | 98.2% (93.8%, 99.5%) | 91.2% (84.6%, 95.2%) | 8.8% (4.8%, 15.4%) | 0.0% (0.0%, 14.9%) | 0.0% (0.0%, 4.3%) | |
| Pseudomonas aeruginosa | 20 (58.8%) | 4 (11.8%) | 10 (29.4%) | 94.1% (80.9%, 98.4%) | 85.3% (69.9%, 93.6%) | 14.7% (6.4%, 30.1%) | 0.0% (0.0%, 16.1%) | 0.0% (0.0%, 27.8%) | |
| Other negative organisms | 24 (68.6%) | 7 (20%) | 4 (11.4%) | 100.0% (90.1%, 100.0%) | 80.0% (64.1%, 90.0%) | 20.0% (10.0%, 35.9%) | 0.0% (0.0%, 13.8%) | 0.0% (0.0%, 49.0%) | |
| Meropenem | Total | 356 (61.3%) | 3 (0.5%) | 222 (38.2%) | 97.8% (96.2%, 98.7%) | 98.8% (97.5%, 99.4%) | 1.2% (0.6%, 2.5%) | 0.0% (0.0%, 1.1%) | 0.0% (0.0%, 1.7%) |
| Enterobacterales | 310 (72.3%) | 2 (0.5%) | 117 (27.3%) | 98.6% (97.0%, 99.4%) | 99.3% (98.0%, 99.8%) | 0.7% (0.2%, 2.0%) | 0.0% (0.0%, 1.2%) | 0.0% (0.0%, 3.2%) | |
| Acinetobacter | 22 (19.1%) | 0 (0%) | 93 (80.9%) | 94.8% (89.1%, 97.6%) | 98.3% (93.9%, 99.5%) | 1.7% (0.5%, 6.1%) | 0.0% (0.0%, 14.9%) | 0.0% (0.0%, 4.0%) | |
| Pseudomonas aeruginosa | 21 (61.8%) | 1 (2.9%) | 12 (35.3%) | 97.1% (85.1%, 99.5%) | 94.1% (80.9%, 98.4%) | 5.9% (1.6%, 19.1%) | 0.0% (0.0%, 15.5%) | 0.0% (0.0%, 24.2%) | |
| Other negative organisms | 3 (100%) | 0 (0%) | 0 (0%) | 100.0% (43.8%, 100.0%) | 100.0% (43.8%, 100.0%) | 0.0% (0.0%, 56.2%) | 0.0% (0.0%, 56.2%) | ||
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Zhang, J.; Sun, L.; Zhang, G.; Kang, W.; Wang, T.; Li, J.; Gao, H.; Yang, Q.; Sun, K.; Wang, Q.; et al. Multicenter Analytical Performance Evaluation of the BD Phoenix NMIC-461 Panel for Carbapenemase Classification and Antimicrobial Susceptibility Testing of Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp. Antibiotics 2026, 15, 286. https://doi.org/10.3390/antibiotics15030286
Zhang J, Sun L, Zhang G, Kang W, Wang T, Li J, Gao H, Yang Q, Sun K, Wang Q, et al. Multicenter Analytical Performance Evaluation of the BD Phoenix NMIC-461 Panel for Carbapenemase Classification and Antimicrobial Susceptibility Testing of Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp. Antibiotics. 2026; 15(3):286. https://doi.org/10.3390/antibiotics15030286
Chicago/Turabian StyleZhang, Jingjia, Liying Sun, Ge Zhang, Wei Kang, Tong Wang, Jin Li, Haotian Gao, Qiwen Yang, Kuixia Sun, Qian Wang, and et al. 2026. "Multicenter Analytical Performance Evaluation of the BD Phoenix NMIC-461 Panel for Carbapenemase Classification and Antimicrobial Susceptibility Testing of Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp." Antibiotics 15, no. 3: 286. https://doi.org/10.3390/antibiotics15030286
APA StyleZhang, J., Sun, L., Zhang, G., Kang, W., Wang, T., Li, J., Gao, H., Yang, Q., Sun, K., Wang, Q., & Sun, H. (2026). Multicenter Analytical Performance Evaluation of the BD Phoenix NMIC-461 Panel for Carbapenemase Classification and Antimicrobial Susceptibility Testing of Enterobacterales, Pseudomonas aeruginosa, and Acinetobacter spp. Antibiotics, 15(3), 286. https://doi.org/10.3390/antibiotics15030286

