TABLE 4

Sensitivities of the assays tested, including individual site data

Result by testing siteElecsys syphilis assay lot AArchitect syphilis TP assayLIAISON Treponema screenSerodia-TPPAImmulite 2000 syphilis screen
Laboratory Enders, Germany
    Total no. of samples tested30130154
    No. of false-negative samples0 (1)a00
    Sensitivity (% [2-sided 95% CI])100.00 (98.78–100.00)a100.00 (98.78–100.00)100.00 (93.40–100.00)
Labor Schottdorf, Germany
    Total no. of samples tested83838383
    No. of false-negative samples0101
    Sensitivity (% [2-sided 95% CI])100.00 (95.65–100.00)98.80 (93.47–99.97)100.00 (95.65–100.00)98.80 (93.47–99.97)
Hub Laboratory of the Greater Romagna
Area, Italy
    Total no. of samples tested218218218
    No. of false-negative samples0 (3)a00
    Sensitivity (% [2-sided 95% CI])100.00 (98.32–100.00)a100.00 (98.32–100.00)100.00 (98.32–100.00)
National Blood Center, Thailand
    Total no. of samples tested124124
    No. of indeterminate samples2b2b
    No. of false-negative samples00
    Sensitivity (% [2-sided 95% CI])100.00 (97.02–100.00)100.00 (97.02–100.00)
West China Hospital, China
    Total no. of samples tested202
    No. of false-negative samples0
    Sensitivity (% [2-sided 95% CI])100.00 (98.19–100.00)
Overall sensitivity (% [2-sided 95% CI])100.00 (99.60–100.00), 99.57 (98.90–99.88)a99.51 (97.31–99.99)100.00 (99.50–100.00)100.00 (93.40–100.00)99.67 (98.16–99.99)
  • a One sample at Laboratory Enders and three samples at the Hub Laboratory were initially nonreactive with the Elecsys syphilis assay, due to a probable handling error, but they were positive on repetition and with the confirmatory assays. The laboratory-specific result has been calculated assuming this sample tested positive; however, an additional overall calculation (99.57% [98.90 to 99.88%]) is included that treats these samples as false negatives.

  • b Two samples gave negative results with the Elecsys syphilis assay but could not be resolved with the confirmatory assays and hence were excluded from the calculation.