Diagnostic Accuracy of the STANDARD F TB-Feron FIA Assay for Tuberculosis Infection in Vietnam: A Cross-Sectional Study

TBI Testing Team; Han Thi Nguyen; Luan Nguyen Quang Vo; Andrew James Codlin; Rachel Jeanette Forse; Tom Wingfield; Kristi Sidney Annerstedt; Emily Lai Ho Maclean; Jacob Creswell; Beatrice Kirubi; Hoa Binh Nguyen; Luong Van Dinh; Doan Thi Thuy Duong; Lina Davies Forsman

doi:10.1093/cid/ciaf561

Diagnostic Accuracy of the STANDARD F TB-Feron FIA Assay for Tuberculosis Infection in Vietnam: A Cross-Sectional Study

TBI Testing Team
, Han Thi Nguyen
, Luan Nguyen Quang Vo
, Andrew James Codlin
, Rachel Jeanette Forse
, Tom Wingfield
, Kristi Sidney Annerstedt
, Emily Lai Ho Maclean
, Jacob Creswell
, Beatrice Kirubi
, Hoa Binh Nguyen
, Luong Van Dinh
, Doan Thi Thuy Duong
, Lina Davies Forsman

Clinical Sciences

Karolinska Institutet
Friends for International TB Relief
Friends for International TB Relief
World Health Organization
University of Sydney
Stop TB Partnership
Kenya Medical Research Institute
Viet Nam National Lung Hospital
National Lung Hospital
Hanoi University of Public Health
Karolinskal University Hospital

Research output: Contribution to journal › Article › peer-review

1 Citation (Scopus)

Abstract

Background
Tuberculosis (TB) infection is a driver of the global TB epidemic. Accurate, affordable, and simpler diagnostics are crucial for identifying people for preventive therapy. We evaluated the diagnostic performance of the STANDARD F TB-Feron FIA (TB-Feron), a near-point-of-care (POC) assay for detecting TB infection.

Methods
From June to December 2024, we conducted a cross-sectional study at the Vietnam National Lung Hospital, enrolling 352 participants, including 345 eligible participants: 95 with microbiologically confirmed pulmonary TB (Group 1), 200 household contacts of people with pulmonary TB (Group 2), and 50 with a recent history of a negative QFT-Plus result and no known TB exposure (Group 3). Participants were tested with TB-Feron and the reference standard, QuantiFERON TB Gold Plus (QFT-Plus). Results were compared for sensitivity and specificity (primary endpoints), with inter-test agreement (Cohen's κ) and reproducibility (Bland–Altman analysis) as secondary outcomes.

Results
Among 345 eligible participants, TB-Feron sensitivity was 88.4% (95% confidence interval [CI] 80.2–94.1) in Group 1, and specificity was 70.0% (55.4–82.1) in Group 3. In Group 2, positive and negative agreements with QFT-Plus were 89.2% (79.8–95.2%) and 75.4% (66.9–82.6), respectively, with inter-test agreement of 80.5% (Cohen's κ=0.6069, P < .0001). Intra-test reproducibility showed no significant differences in IFN-γ levels (mean difference = 2.08 IU/mL, 95% CI −1.28 to 5.44, P = .206).

Conclusions
With high sensitivity, the TB-Feron assay is a potential near-POC alternative to the QFT-Plus assay for diagnosing TB infection, but requires consideration of its suboptimal specificity.

Original language	English
Article number	ciaf561
Pages (from-to)	e996-e1004
Number of pages	10
Journal	Clinical Infectious Diseases
Volume	82
Issue number	5
Early online date	26 Nov 2025
DOIs	https://doi.org/10.1093/cid/ciaf561
Publication status	Published - 26 Nov 2025

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

fluorescent immunoassay
interferon-gamma release assays
point of care
QuantiFERON-TB Gold Plus
TB

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ciaf561Final published version, 1.27 MBLicence: CC BY

Cite this

TBI Testing Team, Nguyen, H. T., Vo, L. N. Q., Codlin, A. J., Forse, R. J., Wingfield, T., Annerstedt, K. S., Maclean, E. L. H., Creswell, J., Kirubi, B., Nguyen, H. B., Van Dinh, L., Duong, D. T. T., & Davies Forsman, L. (2025). Diagnostic Accuracy of the STANDARD F TB-Feron FIA Assay for Tuberculosis Infection in Vietnam: A Cross-Sectional Study. Clinical Infectious Diseases, 82(5), e996-e1004. Article ciaf561. https://doi.org/10.1093/cid/ciaf561

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title = "Diagnostic Accuracy of the STANDARD F TB-Feron FIA Assay for Tuberculosis Infection in Vietnam: A Cross-Sectional Study",

abstract = "Background Tuberculosis (TB) infection is a driver of the global TB epidemic. Accurate, affordable, and simpler diagnostics are crucial for identifying people for preventive therapy. We evaluated the diagnostic performance of the STANDARD F TB-Feron FIA (TB-Feron), a near-point-of-care (POC) assay for detecting TB infection. Methods From June to December 2024, we conducted a cross-sectional study at the Vietnam National Lung Hospital, enrolling 352 participants, including 345 eligible participants: 95 with microbiologically confirmed pulmonary TB (Group 1), 200 household contacts of people with pulmonary TB (Group 2), and 50 with a recent history of a negative QFT-Plus result and no known TB exposure (Group 3). Participants were tested with TB-Feron and the reference standard, QuantiFERON TB Gold Plus (QFT-Plus). Results were compared for sensitivity and specificity (primary endpoints), with inter-test agreement (Cohen's κ) and reproducibility (Bland–Altman analysis) as secondary outcomes. Results Among 345 eligible participants, TB-Feron sensitivity was 88.4\% (95\% confidence interval [CI] 80.2–94.1) in Group 1, and specificity was 70.0\% (55.4–82.1) in Group 3. In Group 2, positive and negative agreements with QFT-Plus were 89.2\% (79.8–95.2\%) and 75.4\% (66.9–82.6), respectively, with inter-test agreement of 80.5\% (Cohen's κ=0.6069, P < .0001). Intra-test reproducibility showed no significant differences in IFN-γ levels (mean difference = 2.08 IU/mL, 95\% CI −1.28 to 5.44, P = .206). Conclusions With high sensitivity, the TB-Feron assay is a potential near-POC alternative to the QFT-Plus assay for diagnosing TB infection, but requires consideration of its suboptimal specificity.",

keywords = "fluorescent immunoassay, interferon-gamma release assays, point of care, QuantiFERON-TB Gold Plus, TB",

author = "\{TBI Testing Team\} and Nguyen, \{Han Thi\} and Vo, \{Luan Nguyen Quang\} and Codlin, \{Andrew James\} and Forse, \{Rachel Jeanette\} and Tom Wingfield and Annerstedt, \{Kristi Sidney\} and Maclean, \{Emily Lai Ho\} and Jacob Creswell and Beatrice Kirubi and Nguyen, \{Hoa Binh\} and \{Van Dinh\}, Luong and Duong, \{Doan Thi Thuy\} and \{Davies Forsman\}, Lina",

year = "2025",

month = nov,

day = "26",

doi = "10.1093/cid/ciaf561",

language = "English",

volume = "82",

pages = "e996--e1004",

journal = "Clinical Infectious Diseases",

issn = "1058-4838",

publisher = "Oxford University Press",

number = "5",

}

TBI Testing Team, Nguyen, HT, Vo, LNQ, Codlin, AJ, Forse, RJ, Wingfield, T, Annerstedt, KS, Maclean, ELH, Creswell, J, Kirubi, B, Nguyen, HB, Van Dinh, L, Duong, DTT & Davies Forsman, L 2025, 'Diagnostic Accuracy of the STANDARD F TB-Feron FIA Assay for Tuberculosis Infection in Vietnam: A Cross-Sectional Study', Clinical Infectious Diseases, vol. 82, no. 5, ciaf561, pp. e996-e1004. https://doi.org/10.1093/cid/ciaf561

TY - JOUR

T1 - Diagnostic Accuracy of the STANDARD F TB-Feron FIA Assay for Tuberculosis Infection in Vietnam: A Cross-Sectional Study

AU - TBI Testing Team

AU - Nguyen, Han Thi

AU - Vo, Luan Nguyen Quang

AU - Codlin, Andrew James

AU - Forse, Rachel Jeanette

AU - Wingfield, Tom

AU - Annerstedt, Kristi Sidney

AU - Maclean, Emily Lai Ho

AU - Creswell, Jacob

AU - Kirubi, Beatrice

AU - Nguyen, Hoa Binh

AU - Van Dinh, Luong

AU - Duong, Doan Thi Thuy

AU - Davies Forsman, Lina

PY - 2025/11/26

Y1 - 2025/11/26

N2 - Background Tuberculosis (TB) infection is a driver of the global TB epidemic. Accurate, affordable, and simpler diagnostics are crucial for identifying people for preventive therapy. We evaluated the diagnostic performance of the STANDARD F TB-Feron FIA (TB-Feron), a near-point-of-care (POC) assay for detecting TB infection. Methods From June to December 2024, we conducted a cross-sectional study at the Vietnam National Lung Hospital, enrolling 352 participants, including 345 eligible participants: 95 with microbiologically confirmed pulmonary TB (Group 1), 200 household contacts of people with pulmonary TB (Group 2), and 50 with a recent history of a negative QFT-Plus result and no known TB exposure (Group 3). Participants were tested with TB-Feron and the reference standard, QuantiFERON TB Gold Plus (QFT-Plus). Results were compared for sensitivity and specificity (primary endpoints), with inter-test agreement (Cohen's κ) and reproducibility (Bland–Altman analysis) as secondary outcomes. Results Among 345 eligible participants, TB-Feron sensitivity was 88.4% (95% confidence interval [CI] 80.2–94.1) in Group 1, and specificity was 70.0% (55.4–82.1) in Group 3. In Group 2, positive and negative agreements with QFT-Plus were 89.2% (79.8–95.2%) and 75.4% (66.9–82.6), respectively, with inter-test agreement of 80.5% (Cohen's κ=0.6069, P < .0001). Intra-test reproducibility showed no significant differences in IFN-γ levels (mean difference = 2.08 IU/mL, 95% CI −1.28 to 5.44, P = .206). Conclusions With high sensitivity, the TB-Feron assay is a potential near-POC alternative to the QFT-Plus assay for diagnosing TB infection, but requires consideration of its suboptimal specificity.

AB - Background Tuberculosis (TB) infection is a driver of the global TB epidemic. Accurate, affordable, and simpler diagnostics are crucial for identifying people for preventive therapy. We evaluated the diagnostic performance of the STANDARD F TB-Feron FIA (TB-Feron), a near-point-of-care (POC) assay for detecting TB infection. Methods From June to December 2024, we conducted a cross-sectional study at the Vietnam National Lung Hospital, enrolling 352 participants, including 345 eligible participants: 95 with microbiologically confirmed pulmonary TB (Group 1), 200 household contacts of people with pulmonary TB (Group 2), and 50 with a recent history of a negative QFT-Plus result and no known TB exposure (Group 3). Participants were tested with TB-Feron and the reference standard, QuantiFERON TB Gold Plus (QFT-Plus). Results were compared for sensitivity and specificity (primary endpoints), with inter-test agreement (Cohen's κ) and reproducibility (Bland–Altman analysis) as secondary outcomes. Results Among 345 eligible participants, TB-Feron sensitivity was 88.4% (95% confidence interval [CI] 80.2–94.1) in Group 1, and specificity was 70.0% (55.4–82.1) in Group 3. In Group 2, positive and negative agreements with QFT-Plus were 89.2% (79.8–95.2%) and 75.4% (66.9–82.6), respectively, with inter-test agreement of 80.5% (Cohen's κ=0.6069, P < .0001). Intra-test reproducibility showed no significant differences in IFN-γ levels (mean difference = 2.08 IU/mL, 95% CI −1.28 to 5.44, P = .206). Conclusions With high sensitivity, the TB-Feron assay is a potential near-POC alternative to the QFT-Plus assay for diagnosing TB infection, but requires consideration of its suboptimal specificity.

KW - fluorescent immunoassay

KW - interferon-gamma release assays

KW - point of care

KW - QuantiFERON-TB Gold Plus

KW - TB

U2 - 10.1093/cid/ciaf561

DO - 10.1093/cid/ciaf561

M3 - Article

SN - 1058-4838

VL - 82

SP - e996-e1004

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

IS - 5

M1 - ciaf561

ER -

Diagnostic Accuracy of the STANDARD F TB-Feron FIA Assay for Tuberculosis Infection in Vietnam: A Cross-Sectional Study

Abstract

UN SDGs

Keywords

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