Latent TuberculosisTB infectionNCT06221735
Evaluating the Accuracy of New Tests for TB Infection Diagnosis
A study testing Cy-TB test and STANDARD F TB-Feron FIA test in people with Latent Tuberculosis and TB Infection, run by Freundeskreis Für Internationale Tuberkulosehilfe e.V at 1 site in Vietnam.
Trial summary
Introduction: The large reservoir of tuberculosis infections is a key driver of sustained tuberculosis (TB) incidence. Accurate diagnostic tests are crucial to correctly identify and treat people with TB infection, which is vital to eliminate TB globally. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Latent Tuberculosis, TB Infection, Tuberculosis
- What is being tested?
- Cy-TB test and STANDARD F TB-Feron FIA test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 1 siteVietnam
- Study dates
- 11 Jun 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants:
- Agree to remain in contact and provide updated information as necessary, and have no current plans to relocate outside the designated area for the duration of the study
- Capable of providing signed informed consent and informed assent (as appropriate)
- Group 1:
- + Microbiologically-confirmed pulmonary TB (either drug-susceptible TB or drug-resistant TB) via Xpert MTB/RIF or Xpert MTB/RIF Ultra (Cepheid, Sunnyvale, California) and abnormal chest X-ray (CXR) result
- To reduce the false positive rate of molecular diagnostic assays for M. tuberculosis
Show all 11Show fewer
- Group 2:
- + Household contacts without symptoms of active TB disease of people with microbiologically-confirmed, pulmonary TB who initiated treatment with residents in Ha Noi, Vietnam.
- Group 3:
- Known past negative IGRA test results among those at low risk for TB infection
- No known and/or reported history of contact or exposure to either TB disease or M. tuberculosis bacteria.
Who cannot join
- All participants:
- + Declines to provide informed consent to participate in the study
- Groups 2 \&3:
- Presumed TB disease with symptoms (cough, fever, night sweats, unintentional weight loss) and/or an abnormal CXR result suggestive of TB disease
- Microbiologically - or clinically-confirmed TB disease in all forms or report having taken treatment for TB disease.
- History of TB infection (self-record or documented).
Trial locations and contacts
1 site in 1 country.
About this study
Introduction: The large reservoir of tuberculosis infections is a key driver of sustained tuberculosis (TB) incidence. Accurate diagnostic tests are crucial to correctly identify and treat people with TB infection, which is vital to eliminate TB globally. The Cy-TB skin test and STANDARD F TB-Feron FIA (TB-Feron) fluorescent immunoassay are two newly developed TB infection tests, which could offer quality and cost advantages over other commercially available TB infection tests, especially the standard TST test. Both tests have a higher sensitivity and specificity than the currently most used tuberculin skin test. The proposed study aims to evaluate the performance of these two tests for the diagnosis of TB infection, compared with the QuantiFERON-TB Gold Plus (QFT-Plus) assay.
Methods and analysis: This diagnostic accuracy study will employ a cross-sectional, observational design that aims to assess the accuracy of the Cy-TB and TB-Feron tests for diagnosing TB infection, using the QFT-Plus assay as the reference standard. The sensitivity and specificity will be reported. Three different cohorts of study participants will be recruited: Adults with microbiologically-confirmed pulmonary TB (n=100); Household contacts* of people with TB (n=200) and negative controls** (n=50). All participants will be examined with Cy-TB, TB-Feron, and QFT-Plus.
Read more
*Household contacts: of a person with TB are defined as members who live under the same roof as the person with pulmonary tuberculosis (PTB) or who meet the following conditions:
- Sleeping under the same roof or sharing a kitchen space as PTB-affected persons at least one night/week for three months before the person was diagnosed with PTB
- Staying under the same roof with PTB-affected persons for at least one hour/day and continuously five days/week for three months before the person was diagnosed with PTB
- Negative controls are defined as people with a negative QFT-Plus result in the past year and likely to have no or very low rates of TB exposure history.
Read the detailed description
Latent TB infection, hereafter referred to as TB infection, continues to be a significant driver of the global TB burden. A recent re-estimation using mathematical modeling demonstrated that to end TB by 2050, at least one-quarter of the global population living with TB infection would require TB preventive therapy (TPT).
The Tuberculin Skin Test (TST) and Interferon-Gamma Release Assays (IGRA) are the two preferred diagnostic methods for detecting TB infection. TST utilizes Tuberculin PPD RT 23 intradermally, which is low-cost and can easily be performed in the field. TST is currently the most frequently used TB infection test in Vietnam. However, TST has a low sensitivity and specificity, particularly in people who have had the BCG vaccine or are immunocompromised. IGRAs are more costly and more technically complex, requiring blood to be processed within a limited time-frame in a laboratory. Neither method is ideal for the detection of TB infection during community TB screening and contact investigations. Therefore, there is a need for a simple, affordable, and accurate diagnostic test for TB infection, to scale up TPT in Vietnam and globally.
Cy-TB (Serum Institute of India Pvt. Ltd, Pune, India) is a Mycobacterium Tuberculosis (MTB) antigen-based skin test, representing a new class of skin tests that were recommended by the World Health Organization in 2022. Cy-TB's MTB-specific antigens (ESAT6 and CFP10) are injected intradermally and provide results after 48-72 hours, similar to TST. The literature indicates that Cy-TB has a similar sensitivity and specificity to QuantiFERON TB Gold Plus.
Simplified versions of IGRAs are emerging, including TB-Feron (SD BIOSENSOR, INC, Gyeonggi-do, Republic of Korea). TB-Feron testing requires less manual handling than other IGRAs and testing takes only 15 minutes to complete after the specimen has been incubated for 16-24 hours. A recent clinical trial comparing the sensitivity and specificity of the TB-Feron against QIAreach QuantiFERON-TB (QIAGEN, Venlo, The Netherlands) showed that the TB-Feron has high accuracy in TB infection diagnosis (the sensitivity was 88.89% and specificity was 92.5%). There are currently no published evaluations comparing the performance of Cy-TB and TB-Feron to QFT-Plus in the literature.
Therefore, this study aims to evaluate the sensitivity and specificity of the Cy-TB and TB-Feron testing for the diagnosis of TB infection.
Aims
- Main objective To evaluate the accuracy of the Cy-TB and TB-Feron tests versus the QFT-Plus assay as TB infection diagnostic methods in Vietnam, a high TB burden setting.
- Specific objectives Objective 1: To verify the sensitivity of the Cy-TB and TB-Feron tests for TB infection diagnosis among adults with microbiologically confirmed pulmonary TB using QFT-Plus as the reference standard.
Objective 2: To evaluate the specificity and sensitivity of the Cy-TB test and TB-Feron tests compared to the QFT-Plus assay for the diagnosis of TB infections.
- Conditions
- Latent Tuberculosis, TB Infection, Tuberculosis
- Being tested
- Cy-TB test, STANDARD F TB-Feron FIA test
- Keywords
- Tuberculosis, TB Infection, LTBI, TBI
- Medical subject headings
- Latent Tuberculosis, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cy-TB testDiagnostic test
Also called C-TB
The study will include people with confirmed TB infection and negative controls to compare the specificity and sensitivity of the Cy-TB and TB-Feron tests versus the QFT-Plus assay
STANDARD F TB-Feron FIA testDiagnostic test
Also called TB-Feron
The study will include people with confirmed TB infection and negative controls to compare the specificity and sensitivity of the Cy-TB and TB-Feron tests versus the QFT-Plus assay
| Study group | Role | What they receive |
|---|---|---|
| Cy-TB test | Experimental | The study will include people with confirmed TB infection and negative controls to compare the specificity and sensitivity of the Cy-TB and TB-Feron tests versus the QFT-Plus assay Receives: Diagnostic Test: Cy-TB test; Diagnostic Test: STANDARD F TB-Feron FIA test |
| STANDARD F TB-Feron FIA test | Experimental | The study will include people with confirmed TB infection and negative controls to compare the specificity and sensitivity of the Cy-TB and TB-Feron tests versus the QFT-Plus assay Receives: Diagnostic Test: Cy-TB test; Diagnostic Test: STANDARD F TB-Feron FIA test |
| QuantiFERON-TB Gold Plus assay | Active comparator | The QuantiFERON-TB Gold Plus assay will be used as the study's reference standard Receives: Diagnostic Test: Cy-TB test; Diagnostic Test: STANDARD F TB-Feron FIA test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Point estimates of sensitivity with 95% confidence interval for the Cy-TB and TB-Feron tests, using the QFT-Plus assay as the reference standard
Measured: From study entry at the time of blood collection and Cy-TB injection until 72 hours post-injection, reported at the end of the trial.
Secondary outcomes (1)
Specificity
Point estimates of specificity with 95% confidence intervals of the Cy-TB and TB-Feron tests, using the QFT-Plus assay as the reference standard
Measured: From study entry at the time of blood collection and Cy-TB injection until 72 hours post-injection, reported at the end of the trial.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start11 Jun 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Latent TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be injected with Cy-TB and the results will be read after 48-72 hours. 10 mL of blood will be obtained from each participant and transferred to three TB-Feron tubes and four QFT-Plus tubes whereby the tubes will be incubated at 37℃ for 16 to 24 hours. The TB-Feron tubes will be analyzed with the fully automated STANDARD F2400 device, while QFT-Plus tubes will be analyzed using an ELISE microplate reader
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Freundeskreis Für Internationale Tuberkulosehilfe e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06221735
- Sponsor's protocol ID
- TBI Testing
- Acronym
- TB infection
- Status last verified
- Mar 2025
- First submitted
- 15 Jan 2024
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nguyen HT, Vo LNQ, Codlin A, Forse R, Wingfield T, Sidney K, MacLean EL, Creswell J, Kirubi B, Davies Forsman L. Study protocol: diagnostic accuracy study comparing Cy-Tb and STANDARD F TB-Feron FIA tests for tuberculosis infection diagnosis in Vietnam. BMJ Open. 2024 Aug 9;14(8):e085614. doi: 10.1136/bmjopen-2024-085614.
PubMed 39122402
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Accuracy of New Tests for TB Infection Diagnosis
- ClinicalTrials.gov ID
- NCT06221735
- Acronym / sponsor ID
- TB infection / TBI Testing
- Conditions
- Latent Tuberculosis, TB Infection, Tuberculosis
- Keywords
- Tuberculosis, TB Infection, LTBI, TBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Freundeskreis Für Internationale Tuberkulosehilfe e.VUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: The large reservoir of tuberculosis infections is a key driver of sustained tuberculosis (TB) incidence. Accurate diagnostic tests are crucial to correctly identify and treat people with TB infection, which is vital to eliminate TB globally. The Cy-TB skin test and STANDARD F TB-Feron FIA (TB-Feron) fluorescent immunoassay are two newly developed TB infection tests, which could offer quality and cost advantages over other commercially available TB infection tests, especially the standard TST test. Both tests have a higher sensitivity and specificity than the currently most used tuberculin skin test. The proposed study aims to evaluate the performance of these two tests for the diagnosis of TB infection, compared with the QuantiFERON-TB Gold Plus (QFT-Plus) assay.
Methods and analysis: This diagnostic accuracy study will employ a cross-sectional, observational design that aims to assess the accuracy of the Cy-TB and TB-Feron tests for diagnosing TB infection, using the QFT-Plus assay as the reference standard. The sensitivity and specificity will be reported. Three different cohorts of study participants will be recruited: Adults with microbiologically-confirmed pulmonary TB (n=100); Household contacts* of people with TB (n=200) and negative controls** (n=50). All participants will be examined with Cy-TB, TB-Feron, and QFT-Plus.
*Household contacts: of a person with TB are defined as members who live under the same roof as the person with pulmonary tuberculosis (PTB) or who meet the following conditions:
- Sleeping under the same roof or sharing a kitchen space as PTB-affected persons at least one night/week for three months before the person was diagnosed with PTB
- Staying under the same roof with PTB-affected persons for at least one hour/day and continuously five days/week for three months before the person was diagnosed with PTB
- Negative controls are defined as people with a negative QFT-Plus result in the past year and likely to have no or very low rates of TB exposure history.
Detailed description
Latent TB infection, hereafter referred to as TB infection, continues to be a significant driver of the global TB burden. A recent re-estimation using mathematical modeling demonstrated that to end TB by 2050, at least one-quarter of the global population living with TB infection would require TB preventive therapy (TPT).
The Tuberculin Skin Test (TST) and Interferon-Gamma Release Assays (IGRA) are the two preferred diagnostic methods for detecting TB infection. TST utilizes Tuberculin PPD RT 23 intradermally, which is low-cost and can easily be performed in the field. TST is currently the most frequently used TB infection test in Vietnam. However, TST has a low sensitivity and specificity, particularly in people who have had the BCG vaccine or are immunocompromised. IGRAs are more costly and more technically complex, requiring blood to be processed within a limited time-frame in a laboratory. Neither method is ideal for the detection of TB infection during community TB screening and contact investigations. Therefore, there is a need for a simple, affordable, and accurate diagnostic test for TB infection, to scale up TPT in Vietnam and globally.
Cy-TB (Serum Institute of India Pvt. Ltd, Pune, India) is a Mycobacterium Tuberculosis (MTB) antigen-based skin test, representing a new class of skin tests that were recommended by the World Health Organization in 2022. Cy-TB's MTB-specific antigens (ESAT6 and CFP10) are injected intradermally and provide results after 48-72 hours, similar to TST. The literature indicates that Cy-TB has a similar sensitivity and specificity to QuantiFERON TB Gold Plus.
Simplified versions of IGRAs are emerging, including TB-Feron (SD BIOSENSOR, INC, Gyeonggi-do, Republic of Korea). TB-Feron testing requires less manual handling than other IGRAs and testing takes only 15 minutes to complete after the specimen has been incubated for 16-24 hours. A recent clinical trial comparing the sensitivity and specificity of the TB-Feron against QIAreach QuantiFERON-TB (QIAGEN, Venlo, The Netherlands) showed that the TB-Feron has high accuracy in TB infection diagnosis (the sensitivity was 88.89% and specificity was 92.5%). There are currently no published evaluations comparing the performance of Cy-TB and TB-Feron to QFT-Plus in the literature.
Therefore, this study aims to evaluate the sensitivity and specificity of the Cy-TB and TB-Feron testing for the diagnosis of TB infection.
Aims
- Main objective To evaluate the accuracy of the Cy-TB and TB-Feron tests versus the QFT-Plus assay as TB infection diagnostic methods in Vietnam, a high TB burden setting.
- Specific objectives Objective 1: To verify the sensitivity of the Cy-TB and TB-Feron tests for TB infection diagnosis among adults with microbiologically confirmed pulmonary TB using QFT-Plus as the reference standard.
Objective 2: To evaluate the specificity and sensitivity of the Cy-TB test and TB-Feron tests compared to the QFT-Plus assay for the diagnosis of TB infections.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants will be injected with Cy-TB and the results will be read after 48-72 hours. 10 mL of blood will be obtained from each participant and transferred to three TB-Feron tubes and four QFT-Plus tubes whereby the tubes will be incubated at 37℃ for 16 to 24 hours. The TB-Feron tubes will be analyzed with the fully automated STANDARD F2400 device, while QFT-Plus tubes will be analyzed using an ELISE microplate reader
| Arm | Type | Receives |
|---|---|---|
| Cy-TB test | Experimental | Diagnostic Test: Cy-TB test, Diagnostic Test: STANDARD F TB-Feron FIA testThe study will include people with confirmed TB infection and negative controls to compare the specificity and sensitivity of the Cy-TB and TB-Feron tests versus the QFT-Plus assay |
| STANDARD F TB-Feron FIA test | Experimental | Diagnostic Test: Cy-TB test, Diagnostic Test: STANDARD F TB-Feron FIA testThe study will include people with confirmed TB infection and negative controls to compare the specificity and sensitivity of the Cy-TB and TB-Feron tests versus the QFT-Plus assay |
| QuantiFERON-TB Gold Plus assay | Active comparator | Diagnostic Test: Cy-TB test, Diagnostic Test: STANDARD F TB-Feron FIA testThe QuantiFERON-TB Gold Plus assay will be used as the study's reference standard |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All participants:
- Group 1:
- + Microbiologically-confirmed pulmonary TB (either drug-susceptible TB or drug-resistant TB) via Xpert MTB/RIF or Xpert MTB/RIF Ultra (Cepheid, Sunnyvale, California) and abnormal chest X-ray (CXR) result
- To reduce the false positive rate of molecular diagnostic assays for M. tuberculosis
- Group 2:
Key exclusion criteria (6 listed)
- All participants:
- + Declines to provide informed consent to participate in the study
- Groups 2 \&3:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cy-TB testAlso: C-TBThe study will include people with confirmed TB infection and negative controls to compare the specificity and sensitivity of the Cy-TB and TB-Feron tests versus the QFT-Plus assay | Diagnostic test | Cy-TB test, QuantiFERON-TB Gold Plus assay, STANDARD F TB-Feron FIA test |
| STANDARD F TB-Feron FIA testAlso: TB-FeronThe study will include people with confirmed TB infection and negative controls to compare the specificity and sensitivity of the Cy-TB and TB-Feron tests versus the QFT-Plus assay | Diagnostic test | Cy-TB test, QuantiFERON-TB Gold Plus assay, STANDARD F TB-Feron FIA test |
Primary outcome
Sensitivity
Time frame: From study entry at the time of blood collection and Cy-TB injection until 72 hours post-injection, reported at the end of the trial.
Point estimates of sensitivity with 95% confidence interval for the Cy-TB and TB-Feron tests, using the QFT-Plus assay as the reference standard
1 secondary outcome
Specificity
Time frame: From study entry at the time of blood collection and Cy-TB injection until 72 hours post-injection, reported at the end of the trial.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Derived from this study: PubMed 39122402Nguyen HT, Vo LNQ, Codlin A, Forse R, Wingfield T, Sidney K, MacLean EL, Creswell J, Kirubi B, Davies Forsman L. Study protocol: diagnostic accuracy study comparing Cy-Tb and STANDARD F TB-Feron FIA tests for tuberculosis infection diagnosis in Vietnam. BMJ Open. 2024 Aug 9;14(8):e085614. doi: 10.1136/bmjopen-2024-085614.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cy-TB test and STANDARD F TB-Feron FIA test in people with Latent Tuberculosis and TB Infection, run by Freundeskreis Für Internationale Tuberkulosehilfe e.V at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: From study entry at the time of blood collection and Cy-TB injection until 72 hours post-injection, reported at the end of the trial.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06221735, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.