Table 1 HandiLab-C performance versus nucleic acid amplification tests
Roche AmplicorAbbott m2000Total
++
HandiLab-C
    +71871825
    −3117532174206
Total3819339192231
  • 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).