Table 4.
Sensitivities and specificities of the multiplex and singleplex real-time PCR assays for detection of meningitis pathogens from clinical specimens
| Specimen group (reference standard) | Assay (type)a | No. positive/no. tested | Sensitivity (95% CI) | No. negative/no. tested | Specificity (95% CI) |
|---|---|---|---|---|---|
| Lackland (fucK PCR) | H. influenzae hpd (M) | 206/244 | 84.4 (79.3–88.7) | 217/243 | 89.3 (84.7–92.9) |
| H. influenzae hpd (S) | 206/244 | 84.4 (79.3–88.7) | 218/243 | 89.7 (85.2–93.2) | |
| Brazil (CIEb) | N. meningitidis ctrA (M) | 72/75 | 96.0 (88.8–99.2) | 8/24 | 33.3 (15.6–55.3) |
| N. meningitidis ctrA (S) | 72/75 | 96.0 (88.8–99.2) | 9/24 | 37.5 (18.8–59.4) | |
| Serogroup C synE (M) | 71/75 | 94.7 (86.9–98.5) | 17/24 | 70.8 (48.9–87.4) | |
| Serogroup C synE (S) | 72/75 | 96.0 (88.8–99.2) | 17/24 | 70.8 (48.9–87.4) | |
| South Africa (compositec) | N. meningitidis ctrA (M) | 56/76 | 73.7 (62.3–83.1) | 43/44 | 97.7 (88.0–99.9) |
| N. meningitidis ctrA (S) | 58/76 | 76.3 (65.2–85.3) | 37/44 | 84.1 (69.9–93.4) | |
| H. influenzae hpd (M) | 16/21 | 76.2 (52.8–91.8) | 98/99 | 99.0 (94.5–100.0) | |
| H. influenzae hpd (S) | 18/21 | 85.7 (63.7–97.0) | 91/99 | 91.9 (84.7–96.4) | |
| S. pneumoniae lytA (M) | 16/17 | 94.1 (71.3–99.8) | 102/103 | 99.0 (94.7–100.0) | |
| S. pneumoniae lytA (S) | 16/17 | 94.1 (71.3–99.8) | 96/103 | 93.2 (86.5–97.2) |
a
M, multiplex; S, singleplex.
b
One specimen was not tested by CIE and was therefore excluded from this analysis.
c
Combined laboratory tests (culture and/or latex agglutination) were used as the composite reference standard, where a positive result was defined as culture or latex agglutination positive (negative otherwise). One specimen was not tested by culture or latex agglutination and was therefore excluded from this analysis.