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Diagnosing Pulmonary Tuberculosis with the Xpert MTB/RIF Test
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Repeatability of QuantiFERON-TB gold plus testing utilizing microparticle chemiluminescence.

Caleb Cornaby1, Christopher K Giardina2, John L Schmitz3

  • 1Immunology, Histocompatibility and Immunogenetics Laboratories/McLendon Clinical Laboratories UNC Hospitals, Chapel Hill, NC, USA.

Journal of Immunological Methods
|August 28, 2022
PubMed
Summary

Repeat testing of latent tuberculosis infection (LTBI) samples on the DiaSorin Liaison XL platform showed significant variability. Specific thresholds can identify samples most likely to repeat positive, guiding retesting strategies for improved accuracy.

Keywords:
IGRALTBITBTuberculosis

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Area of Science:

  • Clinical diagnostics
  • Infectious disease research
  • Immunological assays

Background:

  • Accurate detection of latent Mycobacterium tuberculosis (LTBI) is crucial for preventing active disease and transmission, especially in vulnerable populations.
  • A new QuantiFERON-TB Gold Plus assay kit for the DiaSorin Liaison XL system is available, but initial testing suggested issues with sample repeatability.
  • This study comprehensively evaluated the repeatability of the QuantiFERON-TB Gold Plus assay when performed on the DiaSorin Liaison XL platform.

Purpose of the Study:

  • To assess the repeatability of the QuantiFERON-TB Gold Plus assay on the DiaSorin Liaison XL system.
  • To identify factors influencing sample variability and determine optimal retesting strategies.
  • To establish thresholds for predicting repeat positive results and guiding clinical decisions.

Main Methods:

  • Repeat testing was performed on 481 Interferon-Gamma Release Assay (IGRA) positive samples.
  • Concordance between initial and repeat results for TB1 and TB2 tubes was analyzed.
  • Statistical analysis was used to identify thresholds associated with consistent positive repeat results.

Main Results:

  • Substantial variability was observed, with 73.73% and 72.82% concordance for TB1 and TB2 tubes, respectively.
  • Samples with higher TB1 and TB2 values (minus nil) were significantly more likely to be repeat positive (p < 0.001).
  • Specific thresholds (TB1 ≥ 4.54 IU/mL, TB2 ≥ 4.78 IU/mL) consistently predicted repeat positive results, and thresholds of 1.55 IU/mL (TB1) and 1.45 IU/mL (TB2) yielded a positive predictive value ≥95%.

Conclusions:

  • The high rate of sample variability on the DiaSorin Liaison XL platform suggests a need for retesting select IGRA positive samples.
  • Identified thresholds can help determine which samples are most likely to repeat positive and warrant retesting.
  • These findings support the development of refined protocols for IGRA testing to improve diagnostic accuracy.