AI Article Synopsis
- The study aimed to assess the performance of the TB-IGRA® assay on the VIDAS3 platform in a low-risk population in a low-incidence area for tuberculosis.
- Results showed that 88% of TB test results matched between TB-IGRA® and QuantiFERON®-TB Gold-Plus, but there were inconsistencies, with 12.1% showing positive results only from TB-IGRA®; these discrepancies were often unexplained.
- The TB-IGRA® assay was found to be susceptible to contamination and demonstrated a reproducibility rate of only 80%, indicating potential reliability issues.
Article Abstract
Objectives: To evaluate the analytical performance of the TB-IGRA® assay on the VIDAS3 platform (bioMérieux) when testing a predominantly low risk population in a low incidence area.
Results: Eighty-eight percent of the results were concordant between QuantiFERON®-TB Gold-Plus (QFT®-Plus, QIAGEN) and TB-IGRA®. All 12 of 99 (12.1%) discordant results were determined positive only with the TB-IGRA® assay. In 11 of 12 of these discordant cases, no explanation could be found in the medical record. Five of these discrepant results were probably caused by the use of contaminated stimulation reagents. The remaining 6 discrepant samples were also part of the reproducibility experiment and only 2 results were reproducible positive. Overall, in the reproducibility experiment 5 of 25 (20.0 %) results were not repeatable.
Conclusions: the TB-IGRA® assay seems prone to contamination. Besides, we documented a reproducibility of only 80.0% with the TB-IGRA® assay.
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| http://dx.doi.org/10.1016/j.diagmicrobio.2022.115885 | DOI Listing |
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