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T-SPOT.TB® Performance in Routine Pediatric Practice in a Low TB Burden Setting.

T-SPOT.TB® Performance in Routine Pediatric Practice in a Low TB Burden Setting.
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Mandalakas AM, Highsmith HY, Harris NM, Pawlicka A, Kirchner HL,


Mandalakas AM, Highsmith HY, Harris NM, Pawlicka A, Kirchner HL, (click to view)

Mandalakas AM, Highsmith HY, Harris NM, Pawlicka A, Kirchner HL,

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The Pediatric infectious disease journal 2017 11 14() doi 10.1097/INF.0000000000001792

Abstract
BACKGROUND
The T-SPOT.TB, an interferon-γ release assay (IGRA), is an indirect test of Mycobacterium tuberculosis infection. Due to sparse and conflicting evidence, IGRA use is limited in young and HIV-infected children. We determined the prevalence of invalid, borderline, positive, and negative results and associations with key demographic variables during routine pediatric use in a TB low-burden setting.

METHODS
For pediatric samples received at Oxford Diagnostic Laboratories from 2010-2015, the associations between initial test outcome and demographics were estimated by bivariate analysis and logistic regression.

RESULTS
44,289 samples (median age 12.5 years; IQR 7.7-15.5), including 5,057 samples (11.6 %) from children under five years old, were received from 46 U.S. states, Washington, DC and Puerto Rico. 592 samples (1.3%) could not be tested. T-SPOT.TB positivity was strongly correlated (r=0.60; p<0.0001) with state TB incidence. Compared to negative results, positive results were more likely in samples from older children (p<0.0001), public health clinics (p<0.0001), and rural locations (p=0.005). Although infrequent (0.6%), invalid results were more common in samples collected at HIV clinics (OR=2.5, 95% CI 1.3-4.9) and from younger children (p=0.03). These invalid results were more likely due to a robust nil (negative) control response rather than a weak mitogen (positive) control response. CONCLUSIONS
The T-SPOT.TB test correlated strongly with well-recognized risk factors for tuberculosis infection and provided evaluable results in 98% of children. To optimize the impact f testing on clinical decision making and patient outcomes, local epidemiology and individual patient risk should be considered when incorporating IGRAs into pediatric guidelines.

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