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Diagnosis of Tuberculosis Infection and Th1 Immune Response in Pregnant Women in India
This study was terminated April 16, 2018.
Tuberculosis (TB) disease is a major cause of mortality among Indian women of reproductive age; approximately 20-50% of women in India are latently infected with Mycobacterium tuberculosis (MTB). Due to immune changes of pregnancy, women are particularly at risk of reactivation and progression to active TB disease during the peripartum period. HIV-TB co-infection during pregnancy contributes to increased morbidity and mortality of both the mother and the neonate. However, Indian women are not routinely tested for latent tuberculosis infection (LTBI) during pregnancy out of concern that the tuberculin skin test (TST) returns too many false positives, and over-treatment of latent TB infection might spur the emergence of drug-resistant strains. In 2007, the US Food and Drug Administration approved the use of an interferon gamma releasing assay (IGRA), named QuantiFERON® TB Gold Test in tube (QGIT), for the detection of LTBI. Studies have demonstrated a higher specificity of the QuantiFERON tests compared to TST, especially in populations vaccinated with BCG vaccine. However, there are no published data on QGIT performance characteristics in pregnant women. This observational cohort study will compare TST to QGIT for the diagnosis of LTBI among 450 HIV-negative and 200 HIV-postive pregnant women.