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Original Article
DOI: 10.1016/j.arbr.2021.06.002
Available online 11 July 2021
Diagnosis of tuberculous infection in immunosuppressed patients and/or candidates for biologics using a combination of 2 IGRA tests: T-SPOT.TB/QuantiFERON TB Gold In-Tube vs. T-SPOT.TB/QuantiFERON TB Gold Plus
Diagnóstico de la infección tuberculosa en pacientes inmunodeprimidos y/o candidatos a terapias biológicas mediante el uso combinado de dos pruebas IGRA: T-SPOT.TB/QuantiFERON TB Gold In-Tube vs. T-SPOT.TB/QuantiFERON TB Gold Plus
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Ana Fernández-Blázqueza,b,
Corresponding author
anafdezblazquez@hotmail.com

Corresponding author.
, Pablo Argüelles Menéndeza, Christian Sabater-Cabreraa,b, José-María García-Garcíac, Víctor Asensi Álvarezd, Juan José Palacios Gutiérreza,b, on behalf of the Red de Laboratorios de Microbiología del SESPA 1
a Unidad de Referencia Regional de Micobacterias, Servicio de Microbiología, Hospital Universitario Central de Asturias, Spain
b Instituto de Investigación Sanitaria del Principado de Asturias (ISPA), Spain
c Servicio de Neumología, Hospital Universitario San Agustín, Asturias, Spain
d Unidad de Enfermedades Infecciosas, Servicio de Medicina Interna, Hospital Universitario Central de Asturias, Facultad de Medicina, Universidad de Oviedo, Spain
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Figures (1)
Tables (4)
Table 1. Demographic characteristics of patients and origin of immunosuppression and/or indication of biological therapy.
Table 2. Overall IGRA results for each period (QFT-GIT vs. T-SPOT.TB and QTF-Plus vs. T-SPOT.TB, respectively).
Table 3. Comparison of matched and mismatched results between IGRA during the two study periods (QTF-GIT/T-SPOT.TB vs. QTF-PLUS/T-SPOT.TB).
Table 4. Average IFN-γ values detected in QTF-Plus TB1 and TB2 tubes in QTF-positive samples in at least one of the two tubes. Broken down according to the result obtained with T-SPOT.TB.
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Abstract
Introduction

The diagnosis of latent tuberculous infection (LTI) by IGRA continues to generate debate. Experience in the simultaneous use of 2 IGRA tests is scant. The aim of this study was to compare the results of 2 versions of QuantiFERON-TB Gold (In-Tube/Plus) with those of T-SPOT.TB, and to analyse the effectiveness of a dual strategy (T-SPOT.TB + QTF) for the diagnosis of LTI in an immunosuppressed population.

Methods

We conducted a prospective study (May 2015–June 2017) that included 2999 immunosuppressed patients and/or candidates for biologics, in whom 2 simultaneous IGRA tests were performed: Group 1 (1535 patients): T-SPOT.TB + QuantiFERON-TB Gold-In-Tube (QTF-GIT); Group 2 (1464 patients): T-SPOT.TB + QuantiFERON-TB Gold Plus (QTF-Plus.

Results

The concordance between QTF-GIT and T-SPOT.TB was 83.19% (κ = 0.532). The percentage of positive, negative, and indeterminate results were, respectively: 14.33% vs. 17.06%; 82.41% vs. 74.46%; and 3.25% vs. 8.46%. The concordance between QTF-Plus and T-SPOT.TB was 87.56% (κ = 0.609). The percentage of positive, negative, and indeterminate results were, respectively: 15.02% vs. 15.36%; 82.92% vs. 79.37%; and 2.04% vs. 5.25%. Discrepancies between T-SPOT.TB and QTF-Plus were 12.43%, suggesting that 103 patients were positive and another 79 were negative due exclusively to 1 of the 2 IGRAs.

Conclusions

Greater concordance was found between QTF-Plus and T-SPOT.TB than between QTF-GIT and T-SPOT.TB. However, we believe that the proportion of discrepancies between T-SPOT.TB and QTF-Plus is sufficiently important from a clinical point of view to justify the simultaneous use of 2 IGRA in this specific patient group.

Keywords:
Latent tuberculous infection
IGRAs
QuantiFERON
T-SPOT.TB
Biological immunomodulators
Resumen
Introducción

El diagnóstico de la infección tuberculosa latente (ITL) mediante IGRA sigue generando debate. La experiencia empleando dos pruebas IGRA de manera simultánea es escasa. El objetivo de este estudio es comparar los resultados de dos versiones de QuantiFERON-TB Gold (In-Tube/Plus) con los de T-SPOT.TB y analizar la eficacia de esta estrategia dual (T-SPOT.TB + QTF) para el diagnóstico de la ITL en población con alguna condición inmunosupresora.

Métodos

Estudio prospectivo (mayo 2015–junio 2017) que incluye 2.999 pacientes inmunodeprimidos y/o candidatos a terapias biológicas, a los que se les realizó de manera simultánea dos IGRA: grupo-1 (1.535 pacientes): T-SPOT.TB + QuantiFERON-TB Gold-In-Tube (QTF-GIT); grupo-2 (1.464 pacientes): T-SPOT.TB + QuantiFERON-TB Gold Plus (QTF-Plus).

Resultados

La concordancia entre QTF-GIT y T-SPOT.TB fue del 83,19% (κ = 0,532). Las proporciones de resultados positivos, negativos e indeterminados fueron, respectivamente: 14,33 vs. 17,06%; 82,41 vs. 74,46%; y 3,25 vs. 8,46%. La concordancia entre QTF-Plus y T-SPOT.TB fue del 87,56% (κ = 0,609). Las proporciones de resultados positivos, negativos e indeterminados fueron, respectivamente: 15,02 vs. 15,36%; 82,92 vs. 79,37%; y 2,04 vs. 5,25%. Las discordancias entre T-SPOT.TB y QTF-Plus fueron del 12,43%, que implicaban que había 103 pacientes positivos y otros 79 pacientes negativos a expensas exclusivamente de uno de los dos IGRA.

Conclusiones

Se evidenció una mayor concordancia entre QTF-Plus y T-SPOT.TB que entre QTF-GIT y T-SPOT.TB. Sin embargo, creemos que la proporción de resultados discordantes entre T-SPOT.TB y QTF-Plus es lo suficientemente relevante clínicamente como para justificar el empleo simultáneo de dos IGRA en este grupo específico de pacientes.

Palabras clave:
Infección tuberculosa latente
IGRA
QuantiFERON
T-SPOT.TB
Inmunomoduladores biológicos

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