Table 1.
Performance of the CareStart RDT compared to the Trinity Biotech spectrophotometric method
| Trinity (+) | Trinity (–) | Total | Performance measures | Percent | |
|---|---|---|---|---|---|
| Severe G6PD deficiency | |||||
| Sensitivity | 90.0 | ||||
| RDT (+) | 9 | 56 | 65 | Specificity | 87.4 |
| RDT (–) | 1 | 390 | 391 | Accuracy | 87.5 |
| Total | 10 | 446 | 456 | Positive predictive value | 13.8 |
| Prevalence of deficiency (%) | 2.19 | Negative predictive value | 99.7 | ||
| Moderate and severe G6PD deficiency | |||||
| Sensitivity | 84.8 | ||||
| RDT (+) | 39 | 26 | 65 | Specificity | 93.7 |
| RDT (–) | 7 | 384 | 391 | Accuracy | 92.8 |
| Total | 46 | 410 | 456 | Positive predictive value | 60.0 |
| Prevalence of deficiency (%) | 10.09 | Negative predictive value | 98.2 | ||
Test performance measures are based on the ability to detect severe (less than 10% residual G6PD activity) and moderate to severe (less than 30% residual G6PD activity) deficiency in study participants compared with the spectrophotometric method.