Mycobacterium tuberculosis, MTB or TB is a gram-positive bacteria that most commonly attacks the lungs. It is suspected that one third of the world's population tests positive for M. Tuberculosis, either in active or latent form. In 2007, there were an estimated 13.7 million chronic active cases, 9.3 million new cases, and 1.8 million deaths from TB, mostly in developing countries. However, tuberculosis infections are not evenly spread among the world’s populations. About 80% of the population in many Asian and African countries test positive in tuberculin tests, while only 5–10% of the US population test positive. (source: World Health Organization)
As a droplet infection, tuberculosis can spread in a very small concentrations though coughing, sneezing, or transmission of saliva through the air. Most infections in humans result in little to no symptoms, known as latent infection. About 10% of latent infections eventually progresses to active disease. If left untreated, active disease has a mortality rate of 50%.
TB cells have a very hard outer shell. This makes them very resilient and slow growing. As such, the common protocol for treatment is a six month treatment of three very powerful antibiotics. Like most bacterial infections, if this treatment is discontinued before the six months are complete, the bacteria that survive the initial treatment can develop a resistance to this first-line of antibiotics.
Over the past decade this and other mismanagement of TB has resulted in highly resistance strains. Multidrug-resistant TB (MDR-TB) and Extensively drug-resistant tuberculosis (XDR-TB) are a going problem around the world. It is estimated there are around 40,000 cases per year of XDR-TB. Between June of 2008 and 2010 alone the number of countries that confirmed cases of XDR-TB rose from 49-58. (source: World Health Organization)
Many contend that the rise of MDR-TB and XDR-TB strains, like other drug resistant bacteria, can be attributed to the mismanagement of TB in detection and treatment. This mismanagement can take the form of inaccurate lab work, a lack of lab work and/or the misdiagnosis of cousin microorganisms which resemble TB. Mismanagement of TB can also mean the administration of TB antibiotics over the counter or the discontinuation of antibiotics before the bacteria can be eradicated from the system.
In addition to antibiotic resistance, the traditional testing and diagnosis of TB has proven slow and/or prohibitively expensive. Traditional culture methods can take from 15-21 days, because TB grows very slowly, (dividing about once ever 16 to 20 hours compared to other bacteria which often divide multiple times in hour). This is another attribute linked to TB’s hard outer shell, which makes it difficult for nutrients to penetrate.
As a result of this slow growth and because the antibiotics used can be harmful to the liver and kidneys, patients suspected of a TB infection and tested with conventional methods are forced to wait 15 to 21 days before they can be diagnosed and given treatments. During that time their illness may worsen and they may transmit the illness to people in close proximity to them.
While PCR (DNA analysis) is another option for TB detection, it is often cost-prohibitive and beyond the expertise of lab technicians in developing regions, where TB is most prevalent. To set up a PCR lab alone can cost at least $10,000 in equipment, not to mention the costs of supplies and salaries.
In addition, extracting DNA from a TB microorganism is a difficult task and is often only 50% effective in obtaining a useful sample. Even if DNA extraction is successful, the amplification of the DNA for analysis is an additional complicated and tedious task. Furthermore, reagents used for DNA amplification can be easily rendered useless if they are not properly transported or stored, a common occurrence in developing regions. Finally, because DNA analysis does not detect viable (living) cells, it cannot tell physicians if the TB detected in the sample is living or dead. Since only living cells can harm patients, this is the answer physicians look for and why culturing still remains the “gold standard” for detection. It is reasons like these that so-called “two day” rapid tests have not taken hold in microbiology community as realistic answers to the problem of waiting 15-21 days for TB results.
The NanoLogix BNP Test it is a truly rapid test for TB. Based on sound parameters, it detects Mycobacterium tuberculosis in as little as 4 days. This is 3.75 to 5.25 times faster than the 15 to 21 days of conventional culture tests. It is the fastest culture-based test for living TB in existence. Additionaly, recent developments using the BNF technology have proven to detect TB in 1.5 hours.
In addition to these significantly faster test times, NanoLogix technology is simple to use. A lab technician and classical microbiologists who are familiar with basic culturing procedures can conduct a NanoLogix BNP Test. Furthermore, unlike a PCR assay that requires exacting techniques to provide a definitive result, NanoLogix technology can provide accurate results despite errors in sample preparation.
Compared with PCR TB procedures which may cost thousands of dollars just for gene amplification, the NanoLogix technology is extremely cost-effective. This is a critical and deciding factor for developing regions where TB is prevalent and health care resources are very lean. The NanoLogix BNP Test for TB offers the opportunity to rapidly and accurately diagnose patients and provide them with an antibiotic protocol within 4 days. This dramatic reduction in the wait time holds the potential to protect people from contracting the disease, as well as contribute to significantlyto reducing TB prevalence, if not completely eradicating it.