EMG owns the exclusive COVID-19 SmartAmp® diagnostic technology.
SmartAmp® has the gold standard sensitivity and specificity properties and, at the same time, does not have any high-cost elements in its design offering a simple-structure device and assays. We hold patents independently from other manufactures and produce all enzymes in Japan.
|Criteria||Real time PCR||SmartAmp|
|STABILITY||Background signal increses over time||Background does not depend on time|
|ANALYSING DEVICE STRUCTURE||Requires high-cost components. Precise control of temperature, precise optics||Cost effective because of one temperature|
|STRUCTURE OF ASSAY||Difficult, more stages||Cost effective, because we get the result at the amplification stage|
|TEMPERATURE OF REACTION||95 / 72 / 57||66|
|SENSITIVITY/SPECIFICITY||98-99% / 98-99%||98-99% / 98-99%|
|SNP DETECTION||Not possible||Available|
SmartAmp is a rapid, high-accuracy PCR diagnostic technology that helps both to identify a foreign agent in any biological material and to determine the mutations of that agent and its sensitivity to treatment.
The SmartAmp technology incorporates several components. First of all, it is an isothermal type PCR, which has a number of advantages over the classic real-time PCR method. It enables the entire reaction to flow at a constant temperature, without temperature cycles, which is a distinctive feature of the technology. Developed in the early 2000s, isothermal PCR has quickly become popular due to its ease of use, relatively low technical equipment requirements, cost-effectiveness, energy efficiency, and quick results, generated within a maximum of 45 minutes. However, the first diagnostic systems based on isothermal PCR were inferior to classic RT-PCR in terms of sensitivity and specificity.
SmartAmp technology has resolved most of the issues related to its isothermal PCR predecessors. Testing sensitivity has reached 50-100 viral copies in a biological sample, while its accuracy has increased to 99.99%, with virtually no risk of cross reactions with other viruses. In addition, the SmartAmp system uses several primers in one reaction, meaning the pathogen (an infectious disease agent) is found and identified even when its DNA (or RNA) had possibly mutated. This feature makes the SmartAmp highly reliable.
SmartAmp additional advantage is its ability to identify genetic polymorphism (versions of genetic rearrangements), somatic mutations, and single-nucleotide polymorphisms (SNPs or single nucleotide substitutions). Due to this capability, the method can determine whether the pathogen is resistant to certain pharmaceutical drugs.
All of the above characteristics of the SmartAmp technology make it a highly specific, extremely sensitive, and swift diagnostic system, with the additional potential to determine sensitivity to drugs.
LifeCase is a cutting-edge, portable laboratory for diagnosis of infectious diseases designed to replace a PCR-laboratory in case of its unavailability. SmartAmp, the newest isothermal polymerase chain reaction (PCR) is the core technology of the laboratory.
LifeCase is a unique solution that helps to diagnose coronavirus and potentially other infections when a fully equipped PCR laboratory is not available. The system’s definite advantages are its mobility, reliability and compact size. Furthermore, combined with the SmartAmp technology, the system enables unprecedented accuracy and sensitivity of virus diagnosis (99.98%) at an early stage of the infectious disease (starting from day one).
The throughput capacity of the mobile laboratory is also noteworthy as the technology enables processing of up to 24 samples per hour. The LifeCase system has no equivalent on the international market. Ideally suited for crowed public spaces, such as airports and railway stations, production facilities and other areas where people gather in large numbers, it can prove essential in situation with no access to an equipped PCR laboratory, but with a need to maintain health and safety of employees or to identify infected people to stop the spread of a virus. This is particularly important for facilities with a continuous manufacturing cycle. LifeCase can help to address these challenges quickly and efficiently.