Evaluating the Accuracy of New Tests for TB Infection Diagnosis

Launched by FREUNDESKREIS FÜR INTERNATIONALE TUBERKULOSEHILFE E.V · Jan 15, 2024

Keywords

ClinConnect Summary

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...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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
• * 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.
• Exclusion Criteria:
• * 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).