Diagnostic accuracy study of STANDARD TB-Feron FIA and STANDARD TB-Feron ELISA tests for tuberculosis infection diagnosis in Eastern European setting

IF 1.9 Q3 INFECTIOUS DISEASES

Journal of Clinical Tuberculosis and Other Mycobacterial Diseases Pub Date : 2025-03-14 DOI:10.1016/j.jctube.2025.100518

Valeriu Crudu , Dumitru Chesov , Alexandru Codreanu , Nadejda Turcanu , Nelly Ciobanu , Liuba Nepoliuc , Doina Rusu

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引用次数: 0

Abstract

Introduction

Tuberculosis infection (TBI) is diagnosed based on a positive immune response to M. tuberculosis antigens. This study aimed to evaluate both the qualitative and quantitative performance of two novel IGRA-based tests, the STANDARD E TB-Feron ELISA (TB-Feron-ELISA) and the STANDARD F TB-Feron FIA (IFN-γ) (TB-Feron-FIA), and compare their results to those of QuantiFERON-TB Gold Plus (QuantiFERON).

Methods

At Chiril Draganiuc Phthisiopneumology Institute in the Republic of Moldova, we prospectively enrolled three cohorts of adults: healthy individuals with no known close contact with TB, patients with active tuberculosis (TB), and individuals with a history of TB. The active TB and past TB cohorts were used to assess the tests’ sensitivity, while the healthy group was used to evaluate specificity. Both qualitative and quantitative results from the TB-Feron ELISA and TB-Feron FIA were compared with those of QuantiFERON.

Results

The TB-Feron-FIA demonstrated a sensitivity of 80.58 % (95 %CI: 71.90–87.06) in the active TB cohort and 82.93 % (95 %CI: 68.74–91.47) in the past TB cohort, with a specificity of 85.19 % (95 % CI: 73.40–92.30). The TB-Feron-ELISA showed a sensitivity of 80.58 % (95 %CI: 71.90–87.06) in the active TB cohort and 78.57 % (95 %CI: 64.06–88.29) in the past TB cohort, with a specificity of 85.19 % (95 %CI: 73.40–92.30). The agreement coefficient (κ) with QuantiFERON was 0.766 (95 %CI: 0.689–0.843) for TB-Feron-FIA and 0.809 (95 %CI: 0.739–0.880) for TB-Feron-ELISA.

Conclusions

Both the TB-Feron-ELISA and TB-Feron-FIA demonstrated good diagnostic accuracy for identifying individuals with TBI, comparable to the performance of QuantiFERON.

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标准结核-铁离子FIA和标准结核-铁离子ELISA试验诊断东欧地区结核感染的准确性研究

结核感染（TBI）的诊断是基于对结核分枝杆菌抗原的阳性免疫反应。本研究旨在评估两种基于igra的新型检测方法——STANDARD E TB-Feron ELISA （TB-Feron-ELISA）和STANDARD F TB-Feron FIA (IFN-γ) （TB-Feron-FIA）的定性和定量性能，并将其结果与QuantiFERON- tb Gold Plus （QuantiFERON）的结果进行比较。方法在摩尔多瓦共和国的Chiril Draganiuc肺病学研究所，我们前瞻性地招募了3组成年人：未与结核病有过密切接触的健康个体、活动性结核病患者和有结核病史的个体。活动性结核病和既往结核病队列用于评估试验的敏感性，而健康组用于评估特异性。将TB-Feron ELISA和TB-Feron FIA的定性和定量结果与QuantiFERON进行比较。结果TB- feron - fia在活动性结核队列中的敏感性为80.58% (95% CI: 71.90 ~ 87.06)，在既往结核队列中的敏感性为82.93% (95% CI: 68.74 ~ 91.47)，特异性为85.19% （95% CI: 73.40 ~ 92.30）。TB- feron - elisa在活动性结核队列中灵敏度为80.58% (95% CI: 71.90 ~ 87.06)，在既往结核队列中灵敏度为78.57% (95% CI: 64.06 ~ 88.29)，特异性为85.19% （95% CI: 73.40 ~ 92.30）。TB-Feron-FIA与QuantiFERON的一致系数（κ）为0.766 (95% CI: 0.689 ~ 0.843)， TB-Feron-ELISA与QuantiFERON的一致系数（κ）为0.809 （95% CI: 0.739 ~ 0.880）。结论TB-Feron-ELISA和TB-Feron-FIA对TBI患者的诊断准确性与QuantiFERON相当。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Tuberculosis and Other Mycobacterial Diseases Medicine-Pulmonary and Respiratory Medicine

CiteScore

4.00

自引率

5.00%

发文量

审稿时长

30 weeks

期刊介绍： Journal of Clinical Tuberculosis and Mycobacterial Diseases aims to provide a forum for clinically relevant articles on all aspects of tuberculosis and other mycobacterial infections, including (but not limited to) epidemiology, clinical investigation, transmission, diagnosis, treatment, drug-resistance and public policy, and encourages the submission of clinical studies, thematic reviews and case reports. Journal of Clinical Tuberculosis and Mycobacterial Diseases is an Open Access publication.