This Small Business Innovation Research (SBIR) Phase I Project proposes the development of a device to detect M. tuberculosis instantaneously in patients and in open environments using a single laser source. The device will be portable and have the ability to provide essential information about the presence of bioaerosols within seconds, thus saving lives, time and money. The proposed system will use spatial light scattering methods to determine particle sizing, and 2-photon Laser Induced Fluorescence (2-PLIF) methods to identify the infectious organism. The novelty of the detection machine lies in the use of non-invasive techniques to measure these two important parameters simultaneously using a single laser source resulting in a far more simplified and accurate device from current technologies. The market added value over existing technology is instantaneous speciation.
The broader/commercial impact of this research is the deployment to the markets of a device for instantaneous detection of infectious and airborne transmitted diseases, such as tuberculosis. The identified markets include hospitals, medical offices, and open public environments. Expected sales for these niche markets are expected to generate revenues in excess of $20M/year. The short term outlook includes basic research and development to detect particle sizing and 2-PLIF using a single laser source, build and test a prototype unit with patients, and pursue approval by the National and International Agencies. The project is a partnership between Caribbean Biotechnologies, Inc., a small, minority owned company from Puerto Rico, and the capital arm of the Puerto Rico Development Bank.
reports the results obtained from Phase I and from improvements made in Phase IB. An experienced team of engineers and scientists joined efforts to develop this unique sensor proposed in Phase I guided by the managerial leadership of Caribbean Biotechnologies, located in Mayaguez, Puerto Rico; a company dedicated to research and development. In Phase I, we proposed to explore the instantaneous detection of multiple airborne particles in open environments, which we consider a limitation to our technology, using a single light source. Technical challenges in open environments included increasing accuracy in the particle sizing detection and integration time due to possible low fluorescence response, and detection of multiple bioaerosols. To address these challenges, we propose to explore combining our current TPE detection with a Spatial Light Scattering and Fluorescence Detection System, in substitution of the TOF. This simplified the technology, making it more accurate when searching for a wide range of bioaerosols, and reduced the projected manufacturing costs. The concept of instantaneous detection of environmental bioaerosols in open environments was tested to ultimately design a reliable and cost-competitive compact and portable instrument to characterize bioaerosols (bacteria, fungi, and viruses) in indoor and outdoor conditions. The design of the proposed equipment addresses several issues including technical suitability, reliability, accuracy, cost competitiveness, and manufacturability. As a result, the proposed device in Phase I uses a combined signal of spatial light scattering methods to determine particle sizing, and 2-photon Laser Induced Fluorescence (2-PLIF) to identify the airborne organisms. The device has been adapted to diagnose patients that may be infected with airborne transmitted diseases such as TB. The novelty of the detection machine lies in the use of non-invasive techniques to measure size and 2-PLIF simultaneously using a single laser source resulting in a far more simplified and accurate device from current technologies. In SBIR Phase IB Supplement, we proposed the design and execution of field studies with patients to detect M. tuberculosis (TB). To achieve such goal the existing device will use 2-PLIF methods with improvements in the optical setup to increase the fluorescence signal reception in a confined vacuum space. Additionally, a unique prototype mouth piece with a flow system for patients has been developed and is undergoing further testing for validation purposes. As a result, the optical system, component which captures the fluorescent light, used a concave mirror which was replaced by an elliptical reflector. Therefore, allowing the optical system to collect a much higher fraction of total emitted light than before. Elliptical reflectors are widely used to couple the radiation of a light source into an optical system. A pre-clinical pilot study has been designed to be executed in an area of high TB incidence, such as, Bolivia. The proposed study will be supported by National Program of TB Control in Bolivia and the USAID. CBT’s Instantaneous biodetection system will be tested at the Atencion Integral Senkata 79 Health Center in Alto, La Paz, Bolivia. An acceptable sample size of 200 patients will be used to conduct the study. The patient selection will be based on an inclusion and exclusion criteria and the patients that have the disease. The test will begin when a patient reports to the clinic with TB symptoms. A medical specialist will examine the patient and will conduct a Sputum Smear test, to determine if the patient is positive or not to TB. Immediately after, the patient is asked whether he/she agrees to participate in a preclinical pilot study in which a new device will be used to detect TB. Once the patient agrees, he/she will be interviewed and will receive several documents, for instance, a Patient Information Sheet, explaining what exactly will the study include; the Patient Questionnaire, to record the patients contact information, demographics, clinical history learning this information will help verify if the participant is already a TB patient and how long he/ she has been infected. Also, as part of the documents a Letter of Consent will be handed by which each patient should agree on and sign in order to participate in the study. Each patient will receive a disposable breathing kit and will proceed to initiate testing with CBT’s Instantaneous biodetection system. Afterwards the patient will undergo chest radiography to confirm disease. This pilot study will be of great value prior to a potential Phase II SBIR effort. The request will be matched by our minority shareholder, The Puerto Rico Development Bank.
