Background

Globally, Indonesia the country with the third highest burden of tuberculosis (TB), with pulmonary TB comprising 89% of cases. Establishing TB diagnosis requires laboratory testing, and is critical for prompt initiation of effective treatment to cure the patient and reduce transmission.

However, mostly used diagnostic tests include microscopic examination of sputum smears, GeneXpert PCR testing and, the reference test, bacterial cultures. Their effectiveness is limited because of sboptimal diagnostic accuracy, requirements for laboratory infrastructure and the need for high-quality sputum samples, which are difficult to acquire, especially from specific populations such as children.

Therefore, to attain the goal of TB elimination worldwide, there is a huge need to develop more practical diagnostic modalities that are accessible, point-of-care (POC) and suitable to field conditions in resource-limited settings such as in Indonesia. Leiden University Medical Center (LUMC), The Netherlands, has developed a blood-based, field-friendly quantitative Multi Biomarker Test, based on a lateral flow assay (LFA) of a host biomarker signature (of PGL-I IgM, IP-10, CRP, ApoA1, and S100A12).

Aims

The main objective is to explore the biomarker signatures that can discriminate between pulmonary TB cases, healthy controls, and non-TB control groups. We will compare the assay with the current reference standard diagnosis by a combination of smear microscopy, GeneXpert and bacterial culture. The results of the study will contribute to developing better diagnostic tools for rapid, large-scale diagnostic screening of TB in Indonesia and globally.