Dried Blood Spot Test to Assess TB in Pregnancy

Summary

Despite being a key contributor to maternal mortality in high-burden regions, TB in pregnancy is a hugely neglected area of global public health. During pregnancy, the symptoms of TB are often overlooked and undiagnosed because they are vague, non-specific, and can be very similar to common complaints during pregnancy. Women with TB in pregnancy are at an increased risk of anemia and perinatal death.

The DROP-TB project aims to expand the tuberculosis (TB) detection testing in pregnancy by creating a system where blood samples are collected from women at their local healthcare clinics instead of/or at national-level TB diagnostic centres where visits can require substantial travel and cost. Blood samples collected in specific RNA stabilizing tubes and on specific storing paper filters are collected from pregnant women with presumptive TB and transported to a central TB testing facility and analyzed by real-time polymerase chain reaction (qPCR).

The DROP-TB method measures the mRNA expressions known to be markers of TB infection and disease. Based on veinous blood sampling, those signatures have showed high sensitivity (93%) and specificity (97%), can differentiate between active and latent infection, and performs well in the presence of other infections such as HIV. The DROP-TB program was specifically designed to increase the coverage of TB testing in pregnancy to improve health outcomes for women and their unborn children.

The evidence generated from this program will demonstrate the feasibility of this program in providing TB diagnosis to women in rural and remote regions of LMIC with the example of Madagascar. Evidence will be presented to policy makers as a case to support the national scale up of the program in LMICs.

Conditions

• Tuberculosis

Interventions

DIAGNOSTIC_TEST

3G DBS

Collection of capillary blood samples for the 3G q-PCR test

DIAGNOSTIC_TEST

Sputum Test

Collection of sputum for test culture, microscopy, GeneXpert

DIAGNOSTIC_TEST

3G Veinous Blood

Collection liquid veinous blood for the 3G q-PCR test

Sponsors & Collaborators

• National Tuberculosis Program, Madagascar

  collaborator UNKNOWN

• Analakely Hospital University Care and Public Health, Madagascar

  collaborator UNKNOWN

• Virginia-Maryland College Veterinary Medecine, Blacksburg

  collaborator UNKNOWN

• Johns Hopkins Bloomberg School of Public Health

  collaborator OTHER

• Institut Pasteur de Madagascar

  lead OTHER

Principal Investigators

• Niaina RAKOTOSAMIMANANA, PhD · Institut Pasteur Madagascar

Eligibility

Min Age

15 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-10-27

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• Madagascar

Study Locations