Evaluation of concordance of new QuantiFERON-TB Gold Plus platforms for Mycobacterium tuberculosis infection diagnosis in a prospective cohort of household contacts

dc.catalogadorjlo
dc.contributor.authorRuiz-Tagle Seguel, Cinthya Grace
dc.contributor.authorGarcía Cañete, Patricia Del Carmen
dc.contributor.authorHernández, Mariluz
dc.contributor.authorBalcells Marty, María Elvira
dc.date.accessioned2024-07-18T19:52:28Z
dc.date.available2024-07-18T19:52:28Z
dc.date.issued2024
dc.description.abstractInterferon-gamma (IFN-γ) release assays play a pivotal role in tuberculosis infection (TBI) diagnosis, with QuantiFERON-TB Gold Plus—an enzyme-linked immunosorbent assay (ELISA)—among the most widely utilized. Newer QuantiFERON-TB platforms with shorter turnaround times were recently released. We aimed to evaluate these platforms’ agreement in the diagnosis of TBI. Blood samples from a prospective cohort of tuberculosis household contacts were collected at baseline and after 12 weeks of follow-up, and tested with LIAISON, an automated chemiluminescence immunoassay (CLIA) system, QIAreach, a lateral flow (QFT-LF) semi-automated immunoassay, and the ELISA QuantiFERON-TB Gold Plus platform. Test concordances were analyzed. ELISA vs CLIA overall agreement was 83.3% for all tested samples (120/144) [Cohen’s kappa coefficient (κ): 0.66 (95% CI: 0.54–0.77)]. Samples positive with CLIA provided consistently higher IFN-γ levels than with ELISA (P < 0.001). Twenty-four (16.7%) discordant pairs were obtained, all CLIA-positive/ELISA-negative: 15 (62.5%) had CLIA IFN-γ levels within borderline values (0.35–0.99 IU/mL) and 9 (37.5%) >0.99 IU/mL. QFT-LF showed only 76.4% (68/89) overall agreement with ELISA [κ: 0.53 (95% CI: 0.37–0.68)] with 21 (23.6%) discordant results obtained, all QFT-LF-positive/ELISA-negative. Overall concordance between ELISA and CLIA platforms was substantial, and only moderate between ELISA and QFT-LF. The CLIA platform yielded higher IFN-γ levels than ELISA, leading to an almost 17% higher positivity rate. The techniques do not seem interchangeable, and validation against other gold standards, such as microbiologically-confirmed tuberculosis disease, is required to determine whether these cases represent true new infections or whether CLIA necessitates a higher cutoff.
dc.fechaingreso.objetodigital2024-07-18
dc.format.extent11 páginas
dc.fuente.origenORCID
dc.identifier.doi10.1128/spectrum.00469-24
dc.identifier.urihttps://doi.org/10.1128/spectrum.00469-24
dc.identifier.urihttps://repositorio.uc.cl/handle/11534/87129
dc.information.autorucEscuela de Medicina; Ruiz-Tagle Seguel, Cinthya Grace; 0000-0002-4712-3302; 1098594
dc.information.autorucEscuela de Medicina; García Cañete, Patricia Del Carmen; 0000-0002-3817-4896; 73909
dc.information.autorucEscuela de Medicina; Balcells Marty, María Elvira; 0000-0002-7223-9665; 7462
dc.language.isoen
dc.nota.accesocontenido completo
dc.revistaMicrobiology Spectrum
dc.rightsacceso abierto
dc.subjectMycobacterium tuberculosis
dc.subjectTuberculosis
dc.subjectQuantiFERON
dc.subject.ddc610
dc.subject.deweyMedicina y saludes_ES
dc.subject.ods03 Good health and well-being
dc.subject.odspa03 Salud y bienestar
dc.titleEvaluation of concordance of new QuantiFERON-TB Gold Plus platforms for Mycobacterium tuberculosis infection diagnosis in a prospective cohort of household contacts
dc.typeartículo
sipa.codpersvinculados1098594
sipa.codpersvinculados73909
sipa.codpersvinculados7462
sipa.trazabilidadORCID;2024-07-15
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