Table 2.
Sensitivity, specificity, and positive and negative predictive values of different systems compared with HPLC before and after harmonization
| System | Before harmonization | After harmonization | ||||||
|---|---|---|---|---|---|---|---|---|
| ECL‐Roche | CLIA‐Diasorin | EIA‐DIAsource | RIA‐DIAsource | ECL‐Roche | CLIA‐Diasorin | EIA‐DIAsource | RIA‐DIAsource | |
| Sensitivity | 86.4 CI: 80.2‐90.9 | 99.3 CI: 95.9‐99.9 | 78.1 CI: 71.1‐83.7 | 82.7 CI: 74.9‐88.5 | 90.3 CI: 84.8‐94.1 | 93.5 CI: 88.1‐96.6 | 91.4 CI:86.0‐94.9 | 87.2 CI: 80.0‐92.1 |
| Specificity | 87.9 CI: 78.9‐93.5 | 47.3 CI: 36.9‐57.8 | 87.9 CI: 78.9‐93.5 | 81.7 CI: 72.0‐88.6 | 83.1 CI: 73.4‐89.9 | 78.4 CI: 68.5‐86.0 | 69.2 CI: 58.5‐78.2 | 72.5 CI: 62.0‐81.1 |
| PPV | 93.2 CI: 88.0‐96.4 | 75.8 CI: 69.2‐81.4 | 92.6 CI: 86.9‐96.0 | 86.6 CI: 79.1‐91.7 | 91.4 CI: 86.0‐94.9 | 87.8 CI: 81.6‐92.2 | 85.1 CI: 79.0‐89.7 | 82.2 CI: 74.7‐87.9 |
| NPV | 76.9 CI: 67.4‐84.3 | 97.7 CI: 86.7‐99.8 | 67.2 CI: 57.9‐75.3 | 76.7 CI: 67.0‐84.4 | 81.3 CI: 71.4‐88.4 | 87.9 CI: 78.5‐93.7 | 80.7 CI: 69.9‐88.4 | 79.5 CI: 68.9‐87.2 |
NPV, negative predictive value; PPV, positive predictive value.
Vitamin D status was defined based on serum 25(OH)D concentrations (nmol/L): desirable >50, undesirable <50.