Point-of-care Triage Test for Active Tuberculosis
Point-of-care Triage Test for Active Tuberculosis
Background:

 Tuberculosis (TB) is a bacterial lung infection leaving 3.6 million people undiagnosed each
 year. Thirty percent of infected people do not receive treatment due to failure to receive
 diagnostic testing or being lost to follow-up between testing and availability of results.

 Objective:

 To refine and field-validate a point-of-care (POC) finger stick blood test for use worldwide
 to triage for active TB.

 Eligibility:

 Persons aged 15 - 70 years with symptoms suggestive of TB disease

 Study design:

 Participants will be screened with:

 Medical history Physical exam HIV test, diabetes screening Blood (finger stick and venous),
 sputum and urine collection Chest X-ray TB positive participants will receive treatment from
 the National TB Program at Community Health Centres and clinics.
This study aims to make widely available an inexpensive, easy to use point-of-care finger
 stick test to triage patients presenting with signs and symptoms consistent with active TB.
 From previous experience in EDCTP-funded studies, approximately 30% of such patients test
 positive for TB, with the vast majority having respiratory illnesses other than active TB,
 including acute upper or lower respiratory tract infections or exacerbations of chronic
 obstructive pulmonary disease. The proposed finger stick test is designed, with the aim of
 use, as a TB rule out test such that resources required for further testing can be used with
 more efficiency.

 The majority (60%) of suspected TB cases are seen at public health facilities, however many
 facilities in high TB prevalence areas still do not have access to efficient TB diagnostic
 services due to logistical and financial constraints that plague these settings. Currently
 available diagnostics include radiological and microbiological testing, though each has
 drawbacks for use in primary care facilities.

 The TriageTB consortium will be evaluating combinations of biomarkers in samples from African
 and Non-African individuals suspected of having TB in order to identify the optimal biomarker
 signature for global identification of patients with high likelihood of TB. A device has been
 developed, which measures a combination of biomarkers in finger stick capillary blood and has
 been validated in the laboratory setting. Previous EDCTP-funded projects identified a
 promising 6-marker biosignature which has been shown to have potential for being reduced to a
 3- or 4- marker signature. The 3-marker signature has the added benefit of potential for
 treatment monitoring applications. A triage test as proposed here would significantly speed
 up and streamline diagnostic approaches in resource-limited settings.
Inclusion Criteria:

 -  Symptoms suggestive of TB disease: cough for more than two weeks plus at least one of
 the following: fever, malaise, weight loss, night sweats, haemoptysis, chest pain or
 loss of appetite.

 -  Willingness to give consent to take part in the study.

 -  Willingness to undergo HIV testing or be willing to have their HIV infection status
 disclosed to the study field workers.

 -  Aged 18 to 70 years.

 Participants who had previous TB, extra-pulmonary TB in addition to pulmonary TB, drug
 resistance detected on GeneXpert® or culture or other concomitant diseases, will not be
 excluded from enrolment. Both HIV positive and HIV negative individuals will be enrolled.
 Potential re-treatment cases with positive GeneXpert® tests will be carefully evaluated, as
 it is known that GeneXpert® can give false positive results in these patients.

 Exclusion Criteria:

 -  Permanent residence in study area for less than 3 months or with no permanent address.

 -  Pregnancy or breastfeeding.

 -  HB<9g/l.

 -  Chronic systemic steroid use.

 -  On TB treatment currently or in the last ninety days.

 -  Known quinolone or aminoglycoside antibiotic use reported in the past 60 days.