TABLE 1.
Sample population | No. of samples | No. of samples with indicated CLIA result
|
Comparison with EIA
|
Comparison with testing algorithm
|
||||
---|---|---|---|---|---|---|---|---|
Positive | Negative | Equivocal | No. of results in agreement with CLIA/no. of samples tested | % Agreement with CLIA (95% CI)a | No. of results in agreement with CLIA/no. of samples tested | % Agreement with CLIA (95% CI) | ||
Patients with primary or secondary syphilis | 51 | 48 | 3 | 0 | 48/51 | 94.1 (83.8-98.8) | 51/51 | 100 (93.0-100) |
Patients providing samples for routine testing | 999 | 41 | 957 | 1 | 931/999 | 93.2 (91.4-94.7) | 986/999 | 98.7 (97.8-99.3) |
HIV-positive patients | 200 | 75 | 123 | 2 | 169/200 | 84.5 (78.7-89.2) | 188/200 | 94.0 (90.7-97.3) |
Pregnant patients | 200 | 4 | 196 | 0 | 196/200 | 98.0 (95.0-99.5) | 200/200 | 100 (98.2-100) |
Apparently healthy adults | 992 | 63 | 929 | 0 | 935/992 | 94.3 (92.6-95.6) | 975/992 | 98.3 (97.3-99.0) |
CI, confidence interval.