Roche Amplicor | Abbott m2000 | Total | |||
+ | − | + | − | ||
HandiLab-C | |||||
+ | 7 | 18 | 7 | 18 | 25 |
− | 31 | 175 | 32 | 174 | 206 |
Total | 38 | 193 | 39 | 192 | 231 |
The sensitivity and specificity of HandiLab-C compared with Abbott m2000 were 17.9% (7/39; 95% CI 5.9 to 30.0) and 90.6% (174/192; 95% CI 86.5 to 94.8), respectively. If compared with the Roche assay, the sensitivity and specificity of HandiLab-C were thus 18.4% (7/38; 95% CI 6.1 to 30.8) and 90.7% (175/193; 95% CI 79.5 to 89.4), respectively. The kappa agreement between the HandiLab-C home test and the Abbott assay was poor (Kappa: 0.100; 95% CI −0.121 to 0.321).