TABLE 5

Clinical performance of Cobas versus PIS by symptomatic status for N. gonorrhoeaea

Sex, sample typeSymptom statusTotal% sensitivity (no. of samples positive/total no. tested)95% CI for sensitivity% specificity (no. of samples positive/total no. tested)95% CI for specificityPrevalence (%)PPV (%)NPV (%)
Women
    UrineSymptomatic1,53596.7 (59/61)88.8–99.199.8 (1,471/1,474)99.4–99.94.095.299.9
    Asymptomatic2,51993.2 (68/73)84.9–97.0100.0 (2,446/2,446)99.8–100.02.9100.099.8
    Overall4,05494.8 (127/134)89.6–97.499.9 (3,917/3,920)99.8–100.03.397.799.8
    CC vaginal swabSymptomatic711100.0 (11/11)74.1–100.099.7 (698/700)99.0–99.91.584.6100.0
    Asymptomatic1,225100.0 (17/17)81.6–100.099.8 (1,205/1,208)99.3–99.91.485.0100.0
    Overall1,936100 (28/28)87.9–100.099.7 (1,903/1,908)99.4–99.91.484.8100.0
    SC vaginal swabSymptomatic720100.0 (14/14)78.5–100.099.7 (704/706)99.0–99.91.987.5100.0
    Asymptomatic1,187100.0 (14/14)78.5–100.099.7 (1,169/1,173)99.1–99.91.277.8100.0
    Overall1,907100.0 (28/28)87.9–100.099.7 (1,873/1,879)99.3–99.91.582.4100.0
    PreservCytSymptomatic1,48697.9 (44/48)89.1–99.699.9 (1,437/1,438)99.6–100.03.297.999.9
    Asymptomatic2,43695.1 (39/41)83.9–98.7100.0 (2,394/2,395)99.8–100.01.797.599.9
    Overall3,92296.6 (86/89)90.6–98.899.9 (3,831/3,833)99.8–100.02.397.799.9
    Endocervical swabSymptomatic1,484100.0 (45/45)92.1–100.099.9 (1,438/1,439)99.6–100.03.097.8100.0
    Asymptomatic2,46494.5 (52/55)85.1–98.1100.0 (2,408/2,409)99.8–100.02.298.199.9
    Overall3,94897.0 (97/100)91.5–99.099.9 (3,846/3,848)99.8–100.02.598.099.9
Men, urineSymptomatic305100.0 (82/82)95.5–100.098.7 (220/223)96.1–99.526.996.5100.0
Asymptomatic887100.0 (5/5)56.6–100.099.7 (879/882)99.0–99.90.662.5100.0
Overall1,193100.0 (87/87)95.8–100.099.5 (1,099/1,105)98.8–99.87.393.5100.0
Overall16,95997.2 (453/466)95.3–98.499.9 (16,469/16,493)99.8–99.92.795.099.9
  • a CC, clinician collected; Cobas, Cobas CT/NG test for use on the Cobas 6800/8800 systems; NPV, negative predictive value; PIS, patient infected status; PPV, positive predictive value; PreservCyt, cervical sample collected in PreservCyt cytology medium; SC, self-collected.