Table 3. Test results, sensitivity, specificity, and confidence intervals.
Test Result | Seropositive (reference test) |
Seronegative (reference test) |
---|---|---|
Seropositive (whole blood–POC Test) |
101+ | 0 |
Seronegative (whole blood–POC Test) |
0++ | 143 |
Test parameter | Diagnostic performance | 95% Confidence Interval |
Sensitivity | 100% | 96.41%–100%++ |
Specificity | 100% | 97.45%–100%++ |
+Confirmatory tests allow a provider to distinguish acute from chronic infection. Acute infection during gestation requires anti-Toxoplasma medicines to prevent or reduce vertical transmission. Chronic infection requires no further testing during gestation. The first test should be performed by 12 weeks gestation to facilitate distinction of acute and chronic infection [1].
++A very faint grey Toxoplasma (T) band was noted transiently for one person tested prospectively. This band was not visible when photographed at 20 and 30 minutes. In accordance with the manufacturer’s instructions, this result was designated “equivocal or indeterminate.” This patient was determined, through confirmatory testing, to have been negative for T. gondii antibodies, and subsequent testing with the POC test failed to show any Toxoplasma band. Any such equivocal result requires back-up testing, as does any first positive result for a pregnant woman.
Abbreviation: POC, point of care.