TABLE 1.
Ct-DT assay result (no. [%] of samples) | No. of samples with observed HC2 assay results of:
|
No. of samples with extrapolated HC2 assay results of:
|
||
---|---|---|---|---|
Negative (n = 402) | Positive (n = 827) | Negative (n = 4,998 [85.8%]) | Positive (n = 827 [14.2%]) | |
Observed data (1,229) | ||||
Negative (423) | 396 | 27 | ||
Positive (806) | 6 | 800 | ||
Extrapolated data (5,825) | ||||
Negative (4,950 [85.0]) | 4,923 | 27 | ||
Positive (875 [15.0]) | 75 | 800 |
The agreement between observed assay results was 97% (unweighted kappa = 0.94 [CI, 0.92 to 0.96]). The agreement between extrapolated assay results was 98% (unweighted kappa = 0.92 [CI, 0.89 to 0.97]). McNemar's P = 0.03.