Performance Evaluation of a New Automated Chemiluminescent Immunoanalyzer-Based Interferon-Gamma Releasing Assay AdvanSure I3 in Comparison With the QuantiFERON-TB Gold In-Tube Assay
Annals of Laboratory Medicine
;
: 33-39, 2020.
Article
in English
| WPRIM
| ID: wpr-762457
ABSTRACT
BACKGROUND:
The interferon-gamma (IFN-γ) releasing assay (IGRA) is widely used for latent tuberculosis infection (LTBI) diagnosis. We evaluated the analytical performance of a new automated chemiluminescent immunoanalyzer-based IGRA (CLIA-IGRA), AdvanSure I3 (LG Life Sciences, Seoul, Korea) and compared it with that of the QuantiFERON-TB Gold In-Tube (QFT-GIT) assay.METHODS:
Repeatability and reproducibility were evaluated at four levels. Detection capability, including limit of blank (LoB), limit of detection (LoD), and limit of quantification (LoQ), was evaluated using IFN-γ standard material (National Institute for Biological Standards and Control code 87/586). Agreement between the results of two assays was evaluated using 341 blood samples from healthcare workers and patients at a tertiary care hospital. To determine the cut-off value of CLIA-IGRA for diagnosing LTBI, the ROC curve was analyzed.RESULTS:
Repeatability and reproducibility were 4.86–7.00% and 6.36–7.88% CV, respectively. LoB, LoD, and LoQ were 0.022, 0.077, and 0.249 IU/mL, respectively. IFN-γ values between CLIA-IGRA and QFT-GIT showed a strong correlation within the analytical measurable range of both assays, especially when the value was low. Qualitative comparison of the two assays yielded a 99.1% overall agreement (kappa coefficient=0.98). A cut-off value of 0.35 IU/mL was appropriate for diagnosing LTBI.CONCLUSIONS:
CLIA-IGRA is a reliable assay for LTBI diagnosis, with performance similar to that of QFT-GIT.
Full text:
Available
Index:
WPRIM (Western Pacific)
Main subject:
Tertiary Healthcare
/
ROC Curve
/
Biological Science Disciplines
/
Interferon-gamma
/
Delivery of Health Care
/
Diagnosis
/
Latent Tuberculosis
/
Limit of Detection
/
Seoul
Type of study:
Diagnostic study
/
Practice guideline
/
Prognostic study
/
Qualitative research
Limits:
Humans
Country/Region as subject:
Asia
Language:
English
Journal:
Annals of Laboratory Medicine
Year:
2020
Type:
Article
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