Table 3.
Diagnostic performance of the ‘Fluidigm’ high-throughput BioMark HD nano-fluidic real-time qPCR Fluidigm.
| Serogroup/type | Sensitivity (%) | Specificity (%) | Correctly classified (%) | ROC AUC* | Cohen’s Kappa | Concordant samples | Discordant Fluidigm | Discordant Quellung | p-value† |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 66.7 | 99.4 | 99.4 | 0.83 | Fair (0.40) | 4 | 10 | 2 | 0.039 |
| 3 | 88.5 | 98.4 | 98.3 | 0.93 | Moderate (0.57) | 23 | 30 | 3 | < 0.001 |
| 4 | 100 | 99.0 | 99.0 | 1.00 | Moderate (0.48) | 9 | 19 | 0 | < 0.001 |
| 5 | 100 | 97.5 | 97.5 | 0.99 | Fair (0.24) | 8 | 49 | 0 | < 0.001 |
| 6A | 92.9 | 98.8 | 98.4 | 0.96 | Excellent (0.88) | 131 | 22 | 10 | 0.050 |
| 6B | 91.7 | 95.9 | 95.7 | 0.94 | Good (0.72) | 122 | 74 | 11 | < 0.001 |
| 6C | 100 | 99.9 | 100 | 1.00 | Excellent (0.91) | 5 | 1 | 0 | 1.00 |
| 7A/F | 100 | 99.9 | 99.9 | 1.00 | Moderate (0.50) | 1 | 2 | 0 | 0.500 |
| 7B/C/40 | 70.0 | 99.5 | 99.2 | 0.85 | Good (0.65) | 14 | 9 | 6 | 0.607 |
| 8 | 100 | 99.6 | 99.7 | 1.00 | Good (0.67) | 6 | 6 | 0 | 0.031 |
| 9A/V | 93.1 | 99.3 | 99.2 | 0.96 | Good (0.78) | 27 | 13 | 2 | 0.007 |
| 9L/N | 90.0 | 99.7 | 99.7 | 0.95 | Good (0.75) | 9 | 5 | 1 | 0.219 |
| 10A | 87.5 | 99.5 | 99.5 | 0.94 | Good (0.73) | 14 | 8 | 2 | 0.109 |
| 11A/D | 85.4 | 99.0 | 98.7 | 0.92 | Good (0.73) | 35 | 19 | 6 | 0.015 |
| 11B/C | 100 | 99.9 | 99.9 | 1.00 | Moderate (0.50) | 1 | 2 | 0 | 0.500 |
| 12A/F/44 | 100 | 99.3 | 99.3 | 1.00 | Moderate (0.60) | 10 | 13 | 0 | < 0.001 |
| 13 | 96.8 | 99.1 | 99.1 | 0.98 | Good (0.78) | 30 | 16 | 1 | < 0.001 |
| 14 | 86.6 | 97.6 | 97.3 | 0.92 | Good (0.67) | 58 | 45 | 9 | < 0.001 |
| 15A/F | 94.1 | 99.3 | 99.3 | 0.97 | Good (0.71) | 16 | 12 | 1 | 0.003 |
| 15B/C | 88.9 | 99.0 | 98.6 | 0.94 | Excellent (0.84) | 80 | 18 | 10 | 0.185 |
| 16F | 96.2 | 98.9 | 98.9 | 0.98 | Excellent (0.82) | 51 | 20 | 2 | < 0.001 |
| 17F | 96.6 | 99.1 | 99.1 | 0.98 | Good (0.76) | 28 | 16 | 1 | < 0.001 |
| 18C | 94.4 | 99.9 | 99.9 | 0.97 | Excellent (0.92) | 17 | 2 | 1 | 1.00 |
| 19A | 94.4 | 97.2 | 97.2 | 0.96 | Good (0.74) | 85 | 51 | 5 | < 0.001 |
| 19B | 88.9 | 97.7 | 97.7 | 0.93 | Fair (0.26) | 8 | 44 | 1 | < 0.001 |
| 19F | 96.5 | 95.7 | 95.8 | 0.96 | Good (0.80) | 195 | 75 | 7 | < 0.001 |
| 20 | 85.2 | 99.4 | 99.2 | 0.92 | Good (0.75) | 23 | 11 | 4 | 0.119 |
| 21 | 100 | 99.7 | 99.8 | 1.00 | Excellent (0.81) | 11 | 5 | 0 | 0.063 |
| 22F | 85.7 | 100 | 100 | 0.93 | Excellent (0.92) | 6 | 0 | 1 | 1.00 |
| 23A | 58.8 | 97.8 | 97.5 | 0.78 | Fair (0.28) | 10 | 42 | 7 | < 0.001 |
| 23B | 81.3 | 99.3 | 98.9 | 0.90 | Good (0.77) | 39 | 13 | 9 | 0.524 |
| 23F | 84.2 | 96.6 | 95.8 | 0.90 | Good (0.71) | 112 | 62 | 21 | < 0.001 |
| 25A/F | 100 | 99.8 | 99.9 | 1.00 | Fair (0.40) | 1 | 3 | 0 | 0.250 |
| 29 | 50.0 | 99.5 | 99.5 | 0.75 | Poor (0.18) | 1 | 8 | 1 | 0.039 |
| 31 | 100 | 99.4 | 99.5 | 1.00 | Good (0.64) | 9 | 10 | 0 | 0.002 |
| 33A/F | 100 | 99.4 | 99.4 | 1.00 | Moderate (0.42) | 4 | 11 | 0 | 0.001 |
| 33B | 50.0 | 99.7 | 99.7 | 0.75 | Fair (0.22) | 1 | 6 | 1 | 0.125 |
| 34 | 97.7 | 99.5 | 99.5 | 0.99 | Excellent (0.89) | 43 | 9 | 1 | 0.022 |
| 35A/C/42 | 73.3 | 98.9 | 98.7 | 0.86 | Moderate (0.46) | 11 | 21 | 4 | < 0.001 |
| 35B | 100 | 99.2 | 99.3 | 1.00 | Good (0.65) | 13 | 14 | 0 | < 0.001 |
| 35F | 83.3 | 99.3 | 99.3 | 0.91 | Moderate (0.41) | 5 | 13 | 1 | 0.002 |
| 38 | 91.7 | 99.1 | 99.1 | 0.95 | Moderate (0.55) | 11 | 17 | 1 | < 0.001 |
There were no samples for which serotypes 2; 10B; 10C/F; 17A; 18A; 18B; 18F; 22A; 24A/B/F; 28A/F; 33D; 36; 37; 41; 43; 45; 47A/F and 48 were detected with the referent standard Quellung method for comparison of diagnostic performance.
*ROC AUC: Receiver operator curve, area under curve, †McNemar’s Test.