TABLE 2

Population-specific determination of sensitivity and specificity of the SHC test performance compared to TR assays only or with a laboratory test panel consensus that includes both TR and NTR assays

PopulationaAssay resultsSensitivity (95% CI)Specificity (95% CI)
Treponemal onlybTest panel consensuscTreponemal onlyTest panel consensuscTreponemal onlyTest panel consensusc
SHCTR+TR−TR+/NTR+TR−/NTR−
Age (yrs)
    11–20+181414140.896 (0.845, 0.934)0.972 (0.931, 0.992)0.927 (0.824, 0.980)0.922 (0.811, 0.978)
2151447
    21–30+134310330.843 (0.777, 0.896)0.963 (0.907, 0.990)0.880 (0.688, 0.975)0.875 (0.676, 0.973)
2522421
    ≤31+19134166330.917 (0.877, 0.947)0.946 (0.910, 0.971)0.933 (0.908, 0.953)0.934 (0.909, 0.954)
184749468
Sex
    Female+18210119100.831 (0.775, 0.878)0.937 (0.880, 0.972)0.926 (0.868, 0.964)0.924 (0.865, 0.963)
371258122
    Male+301126900.907 (0.870, 0.936)0.968 (0.939, 0.985)0.900 (0.555, 0.997)1.000 (0.478, 1.000)
31995
Pregnancy status
    Nonpregnant+4604200.780 (0.653, 0.877)0.875 (0.749, 0.953)1.000 (0.478, 1.000)1.000 (0.292, 1.000)
13563
    Pregnant+961039100.814 (0.731, 0.879)0.951 (0.835, 0.994)0.923 (0.863, 0.962)0.922 (0.862, 0.962)
221202119
HIV positive+184340.667 (0.460, 0.835)0.600 (0.147, 0.947)0.923 (0.815, 0.973)0.922 (0.811, 0.978)
948247
  • a A total of 1,406 sample results were stratified based on age, sex, pregnancy, and HIV status. Populations may overlap across categories. For a given category, not all information was available for the remaining categories.

  • b TR assays include TP-PA, EIA, and CIA platforms.

  • c Test panel consensus refers to results that were either reactive by both treponemal and nontreponemal (RPR) tests or nonreactive by both treponemal and nontreponemal tests; discordant treponemal and nontreponemal results were excluded from analysis.