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A borderline range for Quantiferon Gold In-Tube results
Public Health Agency Sweden, Sweden; Karolinska Institute, Sweden.
Danderyd Hospital, Sweden; Karolinska University Hospital Lab, Sweden.
Karolinska Institute, Sweden; Karolinska University Hospital Solna, Sweden.
Lund University, Sweden.
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2017 (English)In: PLoS ONE, ISSN 1932-6203, E-ISSN 1932-6203, Vol. 12, no 11, article id e0187313Article in journal (Refereed) Published
Abstract [en]

Objective Interferon gamma release assays like Quantiferon Gold In-Tube (QFT) are used to identify individuals infected with Mycobacterium tuberculosis. A dichotomous cut-off (0.35 IU/ml) defines a positive QFT without considering test variability. Our objective was to evaluate the introduction of a borderline range under routine conditions. Methods Results of routine QFT samples from Sweden (2009-2014) were collected. A borderline range (0.20-0.99 IU/ml) was introduced in 2010 recommending a follow-up sample. The association between borderline results and incident active TB within 3 to 24 months was investigated through linkage with the national TB-register. Results Using the recommended QFT cut-off, 75.1 % tests were negative, 21.4% positive and 3.5% indeterminate. In total, 9% (3656/40773) were within the borderline range. In follow-up samples, individuals with initial results between 0.20-0.34 IU/ml and 0.35-0.99 IU/ml displayed negative results below the borderline range (amp;lt;0.20 IU/ml) in 66.1% (230/348) and 42.5% (285/671) respectively, and none developed incident TB. Among 6712 individuals with a positive initial test amp;gt;0.99 IU/ml, 65 (0.97%) developed incident TB within 3-24 months. Conclusions We recommend retesting of subjects with QFT results in the range 0.20-0.99 IU/ml to enhance reliability and validity of the test. Half of the subjects in the borderline range will be negative at a levelamp;lt;0.20 IU/ml when retested and have a very low risk of developing incident active TB.

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PUBLIC LIBRARY SCIENCE , 2017. Vol. 12, no 11, article id e0187313
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URN: urn:nbn:se:liu:diva-143074DOI: 10.1371/journal.pone.0187313ISI: 000414340200071PubMedID: 29095918OAI: oai:DiVA.org:liu-143074DiVA, id: diva2:1159448
Note

Funding Agencies|Swedish Research council [201602043]; Swedish Heart and Lung Foundation (Oscar II Jubilee foundation) [20150236, 20150237]

Available from: 2017-11-22 Created: 2017-11-22 Last updated: 2017-12-14

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