|  | RDT (n = 1381) | Microscopy (n = 1381) | 18S PCR (n = 788) |
|---|
Positive | Negative | Positive | Negative | Positive | Negative |
|---|
var
ATS
qPCR
| Positive | 13 | 128 | 15 | 126 | 56 | 56 |
Negative | 8 | 1232 | 25 | 1215 | 10 | 666 |
Specificity (95% CI) | 99.4% (98.7–99.7) | 98.0% (97.0–98.7) | 98.5% (97.3–99.3) |
Sensitivity (95% CI) | 9.2% (5.0–15.3) | 10.6% (6.1–16.9) | 50.0% (40.4–59.6) |
Risk ratioa (95% CI),
p value | 1 | 1.2 (0.66–2.0) 0.80 | 5.6 (3.1–10.1) < 0.0001 |
- Using varATS qPCR as the ‘gold standard’ comparator, assay results are shown for RDT and microscopy in the analysis cohort (n = 1381) and for 18S PCR in the subgroup analysis (n = 788). Assay sensitivity was calculated as the number of assay positives detected divided by the number of true total positives (i.e. varATS positive). Assay specificity was calculated as the number of assay negatives detected divided by the number of true total negatives (i.e. varATS negative)
- aRisk Ratios (with confidence intervals) and p-values comparing sensitivity estimates obtained from McNemar’s test (comparator = RDT)
