The GBD TB Rapid Screen™ is expected to be a rapid, qualitative in vitro diagnostic test for the detection of live tuberculosis bacteria in sputum. The test is intended to aid in the rapid diagnosis of tuberculosis in smear negative, culture positive infections where antigen or antibody based diagnostics do not have adequate performance. The test is intended for professional and laboratory use only.

Tuberculosis (TB) is a contagious bacterial disease spread primarily by coughing. It is prevalent in developing countries, and up to a third of the world's population is infected. TB is one of the greatest threats to health worldwide, with nearly 9 million new cases and 2 million deaths a year due to the disease. The spread of TB has been exacerbated by (i) the large numbers of people from all over the world who travel; (ii) the worldwide rise of multi-drug resistance TB strains; and (iii) the global spread of HIV, with markedly increases susceptibility to TB.

EXPECTED PRODUCT CHARACTERISTICS (actual product specifications to be determined):

• Detects live M. TB complex bacilli in sputum utilizing a patent pending biophotonic assay platform.
• Sensitivity – Expected sensitivity similar to culture in both smear +, culture + and smear -, culture + clinical samples.
• Specificity – Expected specificity similar to culture in both smear +, culture + and smear -, culture + clinical samples.
• Sputum samples are to be collected and prepared in a BSL2 laboratory environment.
• Fluorescent reading can be taken in less than 30 minutes with a simple and low cost fluorescent reader available from GBD.
• Handle all samples as capable of transmitting infectious diseases.
• Stable for up to 24 months from the date of manufacture when stored between 2 to 30C.

The GBD TB Rapid Screen™ is not available for sale in the United States of America.