Dataset Information

High Proportion of Indeterminate QuantiFERON-TB Gold In-Tube Results in an Inpatient Population Is Related to Host Factors and Preanalytical Steps.

ABSTRACT: QuantiFERON-TB Gold In-Tube test (QFT-GIT) can be used as an alternative to tuberculin skin testing (TST) for the targeted testing of latent tuberculosis. Due to many shortcomings with TST, QFT-GIT usage is increasing. QFT-GIT implementation in the inpatient setting remains unclear.We retrospectively identified patients admitted to a tertiary care academic center who received either a TST or a QFT-GIT in the 18 months prior to and after QFT-GIT implementation in March 2012. Risk factors associated with indeterminate results were evaluated.The proportion of inpatients receiving a test for tuberculosis infection doubled following QFT-GIT implementation (1.4% vs 2.9%). After QFT-GIT became available, 75% of tested people received a QFT-GIT and 25% received a TST. We found indeterminate test results in 19.8%. Independent predictors of indeterminate results were female sex (adjusted odds ratio [AOR], 1.64), lymphopenia (AOR, 2.21), hypoalbuminemia (AOR, 6.81) and sample collection by nonphlebotomists (AOR, 3.0, vs phlebotomists). Of patients who had indeterminate results, 42% had a subsequent indeterminate result on repeat testing. All indeterminate results were due to a low mitogen response.QFT-GIT testing in the inpatient setting is associated with a high proportion of indeterminate results that is associated with host factors and preanalytical errors. Careful selection of patients to be tested and training on sample processing for QFT-GIT testing should be considered to decrease indeterminate results.

SUBMITTER: Fabre V

PROVIDER: S-EPMC4281799 | biostudies-other | 2014 Sep

REPOSITORIES: biostudies-other

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High Proportion of Indeterminate QuantiFERON-TB Gold In-Tube Results in an Inpatient Population Is Related to Host Factors and Preanalytical Steps.

Fabre Valeria V Shoham Shmuel S Page Kathleen R KR Shah Maunank M

Open forum infectious diseases 20140919 2

<h4>Background</h4>QuantiFERON-TB Gold In-Tube test (QFT-GIT) can be used as an alternative to tuberculin skin testing (TST) for the targeted testing of latent tuberculosis. Due to many shortcomings with TST, QFT-GIT usage is increasing. QFT-GIT implementation in the inpatient setting remains unclear.<h4>Methods</h4>We retrospectively identified patients admitted to a tertiary care academic center who received either a TST or a QFT-GIT in the 18 months prior to and after QFT-GIT implementation i ...[more]

PMID: 25734154

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Project description:BackgroundThe QuantiFERON®-TB Gold In-Tube test (QFT-GIT) is a viable alternative to the tuberculin skin test (TST) for detecting Mycobacterium tuberculosis infection. However, within-subject variability may limit test utility. To assess variability, we compared results from the same subjects when QFT-GIT enzyme-linked immunosorbent assays (ELISAs) were performed in different laboratories.MethodsSubjects were recruited at two sites and blood was tested in three labs. Two labs used the same type of automated ELISA workstation, 8-point calibration curves, and electronic data transfer. The third lab used a different automated ELISA workstation, 4-point calibration curves, and manual data entry. Variability was assessed by interpretation agreement and comparison of interferon-? (IFN-?) measurements. Data for subjects with discordant interpretations or discrepancies in TB Response >0.05 IU/mL were verified or corrected, and variability was reassessed using a reconciled dataset.ResultsNinety-seven subjects had results from three labs. Eleven (11.3%) had discordant interpretations and 72 (74.2%) had discrepancies >0.05 IU/mL using unreconciled results. After correction of manual data entry errors for 9 subjects, and exclusion of 6 subjects due to methodological errors, 7 (7.7%) subjects were discordant. Of these, 6 (85.7%) had all TB Responses within 0.25 IU/mL of the manufacturer's recommended cutoff. Non-uniform error of measurement was observed, with greater variation in higher IFN-? measurements. Within-subject standard deviation for TB Response was as high as 0.16 IU/mL, and limits of agreement ranged from -0.46 to 0.43 IU/mL for subjects with mean TB Response within 0.25 IU/mL of the cutoff.ConclusionGreater interlaboratory variability was associated with manual data entry and higher IFN-? measurements. Manual data entry should be avoided. Because variability in measuring TB Response may affect interpretation, especially near the cutoff, consideration should be given to developing a range of values near the cutoff to be interpreted as "borderline," rather than negative or positive.

Dataset Information

High Proportion of Indeterminate QuantiFERON-TB Gold In-Tube Results in an Inpatient Population Is Related to Host Factors and Preanalytical Steps.

Publications

High Proportion of Indeterminate QuantiFERON-TB Gold In-Tube Results in an Inpatient Population Is Related to Host Factors and Preanalytical Steps.

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