(Registration certificate NФС 032б2004/0889-04)
The "TB-BIOCHIP" developed in the Engelhardt Institute of Molecular Biology are able to detect over 95% of TB-strains resistant to rifampin and above 80% of those resistant to isosniazid, which are the most effective anti-TB drugs available today. The analysis requires less than one day, and it provides exact data on the type of mutation responsible for the drug-resistance.
The benefits of the "TB-BIOCHIP"-based diagnostics
* Cost of one-day stay in hospital is above 800 roubles
||Final diagnosis is made within days
||Cost per analysis (roubles)
||Resulting anti-TB therapy
||selective therapy is prescribed at an early stage
|Traditional testing of drug resistance
||The patient receives a standard mixture of anti-TB drugs, even though he/she is afflicted with a drug-resistant form of TB.
Bacteriological diagnostics based on liquid media (B&D, BioMerieux)
||30 day or more*
The benefit value of application of biochips appears to be higher that 25000 roubles per one patient with drug-resistant TB form.
Sensitivity and specificity of the test-system
- sampling (blood drawing)
- destruction of TB-bacilli in phlegm leading to release of DNA.
- PCR-amplification for subsequent genetic analysis of DNA fragments responsible for resistance towards anti-TB drugs.
- Hybridization between DNA fragments extracted from micobacteria and the probes immobilized on the biochip
- Analysis of the fluorescence patterns obtained from different pads of the biochip by means of "Chip-Detector-01".
- The method allows detecting not less than 500 genome-equivalents of mico-bacteria (100-300 CFU in 1 ml of sputum)
- The method allows one to detect DNA of micobacteria of TB complex in a sample under study (sputum) and to determine the presence/absence of resistance against rifampicin and isoniazid with 95% specificity.
Reports in the specialized ImageWare computer program
Comments for non-specialists:
- Tuberculosis is detected.
- Resistance against first-line anti-TB drugs (rifampicin and isoniazid that are commonly used for TB treatment) is revealed.
- The patient should be treated with other anti-TB drugs.
Comments for non-specialists:
Composition of "TB-BIOCHIP" test-system
- Standard form of tuberculosis is detected.
- The patient should be treated with common anti-TB drugs.
At present, 'TB-Biochips' have been introduced in the medical practice of 12 anti-TB Centers in Russia. They have also been tested in the South Korea, Kirgizia and they are currently under evaluation in two clinical laboratories of the USA.
Micobacteria tuberculosis is the causative agent of
( x3000 )
In case of an active form of TB, micobacteria are quickly multiplied in the lungs or other tissues resulting in severe intoxication of the organism.
According to the World Health Organization , 10 mln "new"TB patients are registered annually
in the world, and above 3 million people die from this disease.
In 1995 the WHO declared TB a global emergency.
Strains that are resistant to multidrug treatments afflict on average from 2 to 30 percent of victims, and they are particularly dangerous.
In 2004, TB caused death of nearly 85% among all victims of infectious and parasitic diseases in Russia.
TB in Russia:
Morbidity data (per 100.000 people)
TB in different regions of the Russian Federation (per 100.000 people)
DNA - desoxyribonucleic acid - carrier of genetic information in living cells.
Biochip - a matrix of microscopic gel pads arranged on glass or other support. Each pad can operate as a miniature test tube.
M. tuberculosis - TB causative agent
Rifampin, isoniazid - most common anti-Tb drugs routinely prescribed to all primary patients.
TB MDR (tuberculosis with multiple drug-resistance) - the form of disease when TB micobacteria in the body of a patient are not sensitive to the first line (most commonly used) anti-TB drugs.
PCR - polymerase chain reaction allows to obtain gene copies in unrestricted numbers.
Hybridization method allows to identify the tested DNA by reaction between the latter and the molecular probes immobilized on the chip.