“ImDi” innovative products

“ImDi” LLC develops immune chips which allow detecting 8-10 different causative agents of human diseases in a sample tested simultaneously. Main advantage of this method is that it gives opportunity to examine a patient for all infections causing similar disease symptoms with only one assay.

The test proposed is based on a protein matrix (immune chip), which looks like a small solid substrate with discretely marked in certain order antigens of different infectious diseases causative agents on its surface.

The matrixes dot-immunoassay results are decoded by signal presence in the precisely spatially determined antigens application areas. Applying the technology of protein matrixes allows developing simple-to-operate and fully completed tests. Diversified test is autonomous, can be accomplished within 1 hour by personnel without specific skills and that is why it can be used everywhere both for individual analyses and mass screening of serum, plasm or whole blood. At the same time it is more efficient, informative and is much cheaper, than ELISA. If a sample tested contains one or several antibodies from a studied range, as a result of analysis dark flecks appear on the corresponding antibodies application areas – positive result. If specific antibodies lack, corresponding antigen areas do not differ from substrate background – negative result. Each matrix has built-in controls: positive (K+) – human antigens application area and negative (K-) – clear substrate area. Results can be recorded visually. But by the large scales a special computer program which analyses digitized matrix image, is used.

Diversified analysis possesses susceptibility and specificity equal to the modern monospecific immune-enzyme test-kits, but differs through more informativeness (simultaneous complex examination), efficacy and usability.

Test-kits based on protein immune chips can be used in laboratory diagnostics to detect:

1. TORCH-infections;
2. Helminthiasis (lambliosis, opisthorchiasis, ascaridiasis, toxocariasis);
3. Zoonotic infections (brucellosis, leptospirosis, yersiniosis, listeriosis).

Immune chips have several competitive advantages in comparison with ELISA test-kits. The most important of them is a quality of infections determined in 1 test – 8 against 1. That is why you can use only 1 immune chip to make test for 1 patient, while regarding immune-enzyme test-kits you need to use 1 strip (i.e. 8 holes) from 8 test-kits to make a test for a one patient. Thereby the cost of determining 8 infections using immune chip is 1,5-2 times lower, than using ELISA test-kit.

Besides it takes 2-3 times less time you need to make analyses using immune chips in laboratory in comparison with immune-enzyme test-kits. This is due to the fact that many preparatory operations with reagents must be carried out for immune-enzyme analysis. Thereby there is 2-4 times less necessity in personnel (trained laboratory assistants) to make analyses with immune chips.

The following basic differences of new diagnosticums from immune-enzyme test-kits used nowadays should be noted:

• A group of human infections is diagnosed simultaneously;
• Immune chips based test-kit reagents are poured out at a factory and are ready to be used for analyses (ELISA kits require additional manipulations to prepare process solutions of reagents which are contained in a kit);
• You don’t need additional laboratory equipment for diagnosis which allows using them in small labs and even in the field conditions.

Immune chips advantages

Undisputable merits of this immune diagnostic are:

• 7-8 analyses on one biochip: for toxoplasmosis, syphilis, clamidiosis, German measles, mycoplasmosis, ureaplasmosis, cytomegalovirus infection, herpes;
• Simple-to-operate analysis, it is possible to use in small labs or outside;
• Analysis time – 1,5 hours;
• A cost in terms of 1 analysis is not less than 2 times lower;

Susceptibility and specificity of immune chips analyses is not worse than plate option of monospecific ELISA.

Other diversified tests’ advantages:

• Simple-to-operate;
• Possibility to apply them in small labs, in doctor’s consulting room, at the bedside or outside;
• Efficient analysis performance;
• Moderate price.

The technology of protein immune chips production is simple, allows getting reproducible results an provides stability of immune chip characteristics by long-term storage, as well as by higher temperatures. Susceptibility and specificity of immune chips analyses is not worse than plate option of monospecific ELISA.

Immune chips methodology implementation will make patients examination simpler, faster, cheaper and more available.

Immune chips can be widely used in clinical medicine and veterinary science, as well as in sanitary-and-epidemiological and scientific researches.

Since one immune chips analysis is equal to several monospecific kits analyses, and since their prices are close, immune chips implementation in wide practice can result in significant economic effect, which is made up not only of kit’s cost price, but also includes reduction of instrumentation and manhours needed for analysis.

Applying immune chips for different human infections diagnostics will be needed by different clinicians – obstetricians-gynecologists, urologists, dermatovenerologists, infectious diseases specialists etc (for example, biochips necessity for urogenital infections diagnostics in the capital of Russia makes up at least 1 Mio per year).

Conclusions:

1. Immune chips have a wide field of application (medicine, veterinary science, sanitation, ecology, scientific researches);
2. Susceptibility and specificity of immune chips analyses is not worse than plate option of monospecific ELISA;
3. Introducing this methodology will make patients examination simpler, faster, cheaper, and more available; it allows saving much time for both doctors and patients;
4. This method can be applied and used in small labs, which are not fully equipped, and even outside labs;
5. Diversified immune chip technology brings clinician closer to hospital patients at most (urgent, so-called “bedside” diagnosis);
6. This method provides a considerable economic effect for both costs on producing immune-enzyme test-kits and purchasing test-kits, and on labor inputs for carrying out assays, that makes immune chips more attractive not only for end user, but also for diagnostic lab itself;
7. Applying immune chips for different human infections diagnostic will be needed by clinicians of different professions;
8. Equipment constructed on the base of immune chips can fit in small suitcase, replacing today’s labs with their complicated biochemical tests – it all will make medical examination extremely fast, cheap, and, what is most important, very accurate.
9. New immune chips technology allows moving public health to the new level and high-level diagnostics based on immune chips will be available on farms, in mountains, and even in tundra.