Comparative evaluation of CLIA and EIA for Quantiferon‐TB Gold Plus

Abstract

The purpose of this study was to compare the Quantiferon‐TB Gold Plus test analysed with chemiluminescence immunoassay (CLIA) to immunoassay (EIA). One hundred and twenty‐five clinical specimens submitted to Karolinska University Hospital for Quantiferon‐TB Gold Plus analysis were used to analyse agreement of the CLIA and EIA assays. The imprecision on CLIA was determined by analysis of pooled clinical samples of antigen tubes (TB1 and TB2), a reference material from National Institute for Biological Standards and Control (NIBSC 82/587) and two controls of the test. Recovery on CLIA was determined by analysis of the TB1 and TB2 samples and NIBSC 82/587. Concordant results were obtained for 110 (88.0%) of 125 samples with cut‐off including a borderline range. With no borderline range, 121 of 125 samples (96.8%) showed concordant results. Repeatability had a coefficient of variation (CV) of 14.9%. Reproducibility for pooled clinical samples TB1 and TB2 had a CV of 10.5% and 11.0%, respectively, and for the NIBSC 82/587 7.45%, and kit controls 31.0% respective 12.2%. Overall recovery had a mean of 94.1% (SD 12%). We concluded that Quantiferon‐TB Gold Plus analysed with the CLIA assay shows good concordance with EIA and acceptable imprecision.

QuantiFERON-TB Gold Plus with Chemiluminescence Immunoassay: Do We Need a Higher Cutoff?

“…According to this recommendation, agreement between the two assays was moderate (70.4%), lower than the agreement observed when the manufacturer's cutoff was used. Similarly, Brantestig et al found a lower agreement (88%) when using the Swedish National recommendations that define a broad borderline range (0.20 to 0.99 IFN-␥ IU/ml) than when applying the manufacturer's cutoff (96.8%) (12). However, in our study, among the ELISA borderline samples (n ϭ 79), the increased CLIA values remained in the borderline range (0.29 versus 0.59 IU/ml for TB1 and 0.32 versus 0.60 IU/ml for TB2), suggesting that this range may not need to be revised for CLIA.…”

“…A new fully automated CLIA detection system to measure IFN-␥ in human plasma has recently been developed on the Liaison XL analyzer (DiaSorin, Italy). CLIA repeatability and reproducibility on this platform were studied by Brantestig et al, who found that the imprecision of the method is within an acceptable range and analysis of linearity showed acceptable recovery (12). Furthermore, a recent study by De Maertelaere et al conducted on 92 samples showed that CLIA gave significantly higher values for TB1 and TB2 than ELISA (11).…”

“…Recently, new chemiluminescence immunoassays (CLIA) have been developed to detect IFN-␥ in human plasma samples. However, to date, only a few studies have been published comparing QFT-Plus and the previous version QFT-TB Gold In-Tube by ELISA to CLIA (11)(12)(13). Among these, the study with the most relevant sample size (341 samples) reports a high degree of agreement (99.1%) between the two methods, using the AdvanSure I3 platform for CLIA (13).…”

The paradigm shift in the approach to management of latent tuberculosis infection in high tuberculosis burden countries

“…A recent study reported that the LIOFeron TB/LTBI assay may have higher sensitivity than the QuantiFERON-TB Gold Plus test [28]. Chemiluminescence immunoassays (CLIA) have also been studied in comparison to the QuantiFERON-TB Gold test [29].…”

Advancing new diagnostic tests for latent tuberculosis infection due to multidrug-resistant strains of Mycobacterium tuberculosis — End of the road?

“…A recent study (Della Bella et al, 2020) reported that the LIOFeron TB/LTBI assay may have higher sensitivity than the QuantiFERON-TB Gold Plus test and that further evaluation is required in controlled studies in different geographical areas. Chemiluminescence immunoassays (CLIA) have also been studied in comparison to the QuantiFERON-TB Gold test (Brantestig et al, 2020).…”