Ann Lab Med.  2020 Jan;40(1):33-39. 10.3343/alm.2020.40.1.33.

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

• Kim JJ
• Park Y
• Choi D
• Kim HS

• KMID: 2457491
• DOI: http://doi.org/10.3343/alm.2020.40.1.33

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.

Keyword

Performance; Interferon-γ releasing assay; Latent tuberculosis infection; Chemiluminescent immunoanalyzer; QuantiFERON-TB Gold In-Tube

MeSH Terms

Biological Science Disciplines
Delivery of Health Care
Diagnosis
Humans
Interferon-gamma*
Latent Tuberculosis
Limit of Detection
ROC Curve
Seoul
Tertiary Healthcare
Interferon-gamma

Figure

• 

  Fig. 1 Comparison of the calculated IFN-γ value of the TB antigen tube minus the negative control between QFT-GIT and the CLIA-IGRA. The correlation between the two assays was determined for three subgroups: samples with a calculated IFN-γ value of (A)<5 IU/mL, (B)<2 IU/mL, and (C)<1 IU/mL.Abbreviations: IFN-γ, interferon gamma; TB, tuberculosis; QFT-GIT, QuantiFERON-TB Gold In-Tube; CLIA-IGRA, chemiluminescent immunoanalyzer-based IFN-γ releasing assay; R, Pearson's correlation coefficient.

• 

  Fig. 2 ROC curve of the CLIA-IGRA to diagnose latent tuberculosis infection. Infection was assessed based on the results of the QFT-GIT assay.Abbreviations: AUC, area under the curve; CI, confidence interval; CLIA, chemiluminescent immunoanalyzer-based interferon-gamma releasing assay; QFT-GIT, QuantiFERON-TB Gold In-Tube.

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