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The Impact of Borderline Quantiferon-TB Gold Plus Results for Latent Tuberculosis Screening under Routine Conditions in a Low-Endemicity Setting
Karolinska Univ Hosp Solna, Sweden; Karolinska Inst, Sweden.
Publ Hlth Agcy Sweden, Sweden.
Karolinska Univ Hosp, Sweden; Karolinska Inst, Sweden.
Linköping University, Department of Biomedical and Clinical Sciences, Division of Inflammation and Infection. Linköping University, Faculty of Medicine and Health Sciences. Region Östergötland, Center for Diagnostics, Department of Clinical Microbiology.ORCID iD: 0000-0002-9315-8901
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2021 (English)In: Journal of Clinical Microbiology, ISSN 0095-1137, E-ISSN 1098-660X, Vol. 59, no 12, article id e01370-21Article in journal (Refereed) Published
Abstract [en]

Quantiferon-TB Gold Plus (QFT-Plus) is an interferon gamma release assay used to diagnose latent tuberculosis (LTB). A borderline range (0.20 to 0.99 IU/ml) around the cutoff (0.35 IU/ml) has been suggested for the earlier QFT version. Our aims were to evaluate the borderline range for QFT-Plus and the contribution of the new TB2 antigen tube. QFT-Plus results were collected from clinical laboratories in Sweden and linked to incident active TB within 3 to 24 months using the national TB registry. Among QFT-Plus results from 58,539 patients, 83% were negative (<0.20 IU/ml), 2.4% were borderline negative (0.20 to 0.34 IU/ml), 3.4% were borderline positive (0.35 to 0.99 IU/ml), 9.6% were positive (>= 1.0 IU/ml), and 1.6% were indeterminate. Follow-up tests after initial borderline results were negative (<0.20 IU/ml) in 38.3%, without any cases of incident active TB within 2 years. Applying the 0.35-IU/ml cutoff, 1.5% of TB1 and TB2 results were discrepant, of which 52% were within the borderline range. A TB2 result of >= 0.35 IU/ml with a TB1 result of <0.20 IU/ml was found in 0.4% (231/58,539) of all included baseline QFT-Plus test results, including 1.8% (1/55) of incident TB cases. A borderline range for QFT-Plus is clinically useful as more than one-third of those with borderline results are convincingly negative upon retesting, without developing incident active TB. The TB2 tube contribution to LTB diagnosis appears limited.

Place, publisher, year, edition, pages
AMER SOC MICROBIOLOGY , 2021. Vol. 59, no 12, article id e01370-21
Keywords [en]
latent tuberculosis; interferon gamma release assay; active tuberculosis; borderline-range results; Quantiferon Plus
National Category
Infectious Medicine
Identifiers
URN: urn:nbn:se:liu:diva-181776DOI: 10.1128/JCM.01370-21ISI: 000720776400013PubMedID: 34550805Scopus ID: 2-s2.0-85122048485OAI: oai:DiVA.org:liu-181776DiVA, id: diva2:1619881
Available from: 2021-12-14 Created: 2021-12-14 Last updated: 2022-05-19

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Schön, Thomas

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Jonsson Henningsson, AnnaBaqir, HaithamKholod, VitaSchön, Thomas
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Division of Inflammation and InfectionFaculty of Medicine and Health SciencesDepartment of Clinical MicrobiologyDivision of Clinical Chemistry and PharmacologyDepartment of Infectious Diseases
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