DIAGNOSIS of PULMONARY TUBERCULOSIS Through HUMAN BREATH (TBENOSE)

It is a 12 -month dynamic, open, descriptive and analytical type case-control study in adults. The present study intends to recruit , all the Pulmonary TB suspects and case notified by TB Loop-mediated isothermal Amplification(LAMP), sputum culture or GeneXpert Mycobacterium Tuberculosis/Rifampicin (MTB/RIF) Assay, Pulmonary TB+HIV patients, healthy control patients, HIV patients without TB. Each patient will undergo at least two tests: the Breath Test Measurement and the TB LAMP. The TB LAMP will be used like the reference test for positive TB cases.

The enrolment phase of the participants will take 12 months. After this period, additional 6 months will be dedicated to the data analysis and dissemination of results.

Each patient meeting the inclusion criteria will be asked to join the study. Detailed information will be provided him/her. In case of acceptance the participants will undergo further sampling: breath test measurement. All data will be collected ensuring anonymity and privacy. Standard protocols used in the center will not be changed by the research, but each patient will be asked to provide 1 additional sample (exhaled breath in the bag sampler). Each study participant will be properly informed, and a consent form will be signed.

Preparation to participate: It will be required to patients to avoid drinking, eating, smoking, or brushing their teeth 2 hours before the breath test.

Sampling collection: In order to collect breath samples, two bags will be used, one for collecting airways breath (about 0.5 liter volume) and one for alveolar exhaled air (3 liters). It is asked to the patient after putting a clip nose, to inspire with the mouth and to deeply breath inside the bags through an antibacterial filter connected to the sampling apparatus.

At the end, the second bag (volume of 3 liters) contains the alveolar portion of breath that will be analyzed by the TV eNose. During the measurement, the TV eNose will be connected to the computer, to read and store the Volatile Organic Compounds (VOCs) pattern from breath given by the sensor array.

Other data are collected: clinical symptoms, TB LAMP results, and results of others test if available: chest X-ray, smear microscopic, sputum culture and GeneXpert MTB/RIF Assay examinations.

All personal data and results of the patients will be collected in a specific sheet elaborated by the partners (University di Roma Tor Vergata). It will be an Excel database and it will be store in the study site. All data collected will be anonymous.

Inclusion criteria

• Accept to participate in the study through a signed informed consent approved by the Ethical Committee (CEI of Douala - Cameroon)
• Suspected of having TB on clinical base (4SS + or other clinical suggestions) with HIV+/- status
• Healthy control patient
• Able to produce exhaled air samples
• Able to produce sputum samples for TB LAMP test

Exclusion criteria

• Unable to breath normally for 2 minutes due to respiratory illness
• By discretion of the research team.