Table 1.
Demographics of the study subjects in the discovery and verification stages.
| Characteristics | CON | Target Screening Stage | Clinical Validation Stage | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| SIRS | Sepsis | Severe sepsis | Death | P value | CON | sepsis | septic shock | P value | ||
| N = 20 | N = 20 | N = 20 | N = 20 | N = 20 | N = 10 | N = 12 | N = 19 | |||
| Age (years) | 61.5 ± 14.2 | 57.7 ± 16.8 | 63.8 ± 17.7 | 69.6 ± 14.2 | 59.0 ± 17.4 | 0.158 | 64.7 ± 16.1 | 58.1 ± 12.2 | 68.9 ± 12.5 | 0.104 |
| Gender (n, %) | 0.456 | 0.201 | ||||||||
| Male | 11 (55) | 12 (60) | 11 (55) | 15 (75) | 15 (75) | 6 (60) | 11 (91.7) | 15 (8.9) | ||
| Female | 9 (45) | 8 (40) | 9 (45) | 5 (25) | 5 (25) | 4 (40) | 1 (8.3) | 4 (21.1) | ||
| WBC counts (×109/L) | 7.9 ± 2.9 | 16.4 ± 4.2 | 10.9 ± 3.9 | 13.4 ± 7.9 | 13.3 ± 7.6 | <0.001 | 6.6 ± 1.2 | 11.9 ± 7.9 | 15.7 ± 7.5 | 0.005 |
| APACHE II score | — | 8 ± 3 | 13.2 ± 6.5 | 19.5 ± 6.5 | 23.4 ± 5.4 | <0.001 | 10 ± 4 | 17.9 ± 6.7 | 25.4 ± 6.1 | <0.001 |
| SOFA score | — | — | 3.9 ± 2.5 | 8.6 ± 4.1 | 12.2 ± 3.4 | <0.001 | — | 9.5 ± 3.5 | 13.0 ± 3.7 | 0.015 |
| Pathogens detected (n, %) | ||||||||||
| Gram-positive bacteria | — | — | 6 (30) | 7 (35) | 8 (40) | 0.803 | — | 7 (58.3) | 10 (52.6) | 0.756 |
| Gram-negative bacteria | — | — | 16 (80) | 13 (65) | 16 (80) | 0.449 | — | 10 (83.3) | 16 (86.2) | 0.948 |
| Fungi | — | — | 5 (25) | 8 (40) | 8 (40) | 0.517 | — | 5 (41.7) | 7 (36.8) | 0.788 |
| Etiological factors (n, %) | ||||||||||
| Pulmonary infection | — | — | 14 (70) | 14 (70) | 16 (80) | 0.711 | — | 11 (91.7) | 15 (78.9) | 0.348 |
| Abdominal infection | — | — | 4 (20) | 5 (25) | 2 (10) | 0.459 | — | 4 (33.3) | 6 (31.6) | 0.919 |
| Bacteremia | — | — | 5 (25) | 3 (15) | 5 (25) | 0.675 | — | 2 (16.7) | 2 (10.5) | 0.619 |
| Urinary infection | — | — | 4 (20) | 6 (30) | 4 (20) | 0.689 | — | 4 (33.3) | 6 (31.6) | 0.919 |
| Trauma/soft tissue infection | — | — | 4 (20) | 7 (35) | 7 (35) | 0.49 | — | 4 (33.3) | 11 (57.9) | 0.183 |
| Others | — | — | 0 (0) | 2 (10) | 1 (5) | 0.349 | — | 0 (0) | 2 (10.5) | 0.245 |
*A patient might have more than one pathogenic bacterial infection. Therefore, the sum of the frequencies (pathogens detected and etiological factors) was higher than effective, and the sum of the percentages could be greater than 100%.