Infectious Disease Diagnosis Using Point of Care platform

The development of a rapid, cost-effective,specific and sensitive Point-of-care tests (POC) for the early diagnosis of infectious diseases.

Infectious diseases continue to cause an enormous burden of death and disability in developing countries. Increasing access to appropriate treatment for infectious diseases could have a major impact on disease burden. Some common infections can be managed syndromically without the need for diagnostic tests, but this is not appropriate for many infectious diseases, in which a positive diagnostic test is needed before treatment can be given. 

By reviewing  all the problem of the people for diagnosis, our team has concluded that the diagnosis should be made at the point of care, so that treatment can be started without delay, and should not depend on the availability of a laboratory or of highly trained staff. This review will focus on point-of-care (POC) tests for infectious diseases that could be used to improve clinical management in resource-limited settings.

A point-of-care (POC) test is performed at or near the site where a patient initially encounters the health care system, has a rapid turnaround time (approximately 35 min), and provides actionable information that can lead to a change in patient management. Rapid results reduce the need for multiple patient visits, enable timely treatment, and facilitate the containment of infectious disease outbreaks. 

            Today the requirement is for the development of a rapid, cost-effective,specific and sensitive Point-of-care tests (POC) for the early diagnosis of infectious diseases. Truelab™ workstation is one such platform meeting all these requirements. Truelab™ Uno Dx/Truelab™ DUO/Truelab™ Quattro is a hand held, battery operated, easy to carry nucleic acid amplification workstation consisting of lightweight, portable, mains / battery operated Truelab™ Uno Dx Real Time micro PCR Analyzer, Trueprep™ AUTO Sample Prep Device, room temperature stable Truenat™ micro PCR chips and Trueprep™ AUTO Sample Prep kits.  It is a portable system and results are reported in less than an hour. It is enables accurate and specific disease diagnosis at Point-of-care (PoC) or near-care settings, and is suited especially for resource limited settings.

Our development is rapid, cost-effective, specific and sensitive Point-of-care tests (POC) for the early diagnosis of infectious diseases.Truelab™ Uno Dx/Truelab™ DUO/Truelab™ Quattro is a hand held, battery operated, easy to carry nucleic acid amplification workstation consisting of lightweight, portable, mains/battery operated Truelab™ Uno Dx Real Time micro PCR Analyzer. The physian can run more than one sample in Truelab™ DUO/Truelab™ Quattro. It is a portable system and results are reported in less than an hour. It is enables accurate and specific disease diagnosis at Point-of-care (PoC) or near-care settings, and is suited especially for resource limited settings.

Infectious diseases continue to cause millions of deaths every year,the vast majority of them in developing countries,and a huge burden of disability.Because many of the deaths caused by infection are in young children,the burden of disease attributable to infectious diseases, in terms of healthy life-years lost,is high.Strategies for reducing the burden of disease caused by infectious disease.Since many people in developing countries do not have access to laboratory services,diagnosis depends on the availability of point of care (POC) tests.The treatment can be started without delay, and should not depend on the availability of a laboratory or of highly trained staff. 

The goal of diagnostic POC tests is to improve access to care. Our solution is mainly focussed on diagnosis of more diseases like,Truenat™HLA-B27,Truenat™MTB-FQ,Truenat™MTB-INH,Truenat™Influnzae AB, Truenat™HPV,Truenat™MTB-NTM.Truenat™Staphylococcus aureus, Truenat™Pseudomonas aeroginosa, Truenat™ MRSA,Truenat™ HIV-1, Truenat™ Zika, Truenat™ Nipha,Truenat™ GBS,Truenat™ Trichomonas, Truenat™ Rabies,Truenat™ Chlamydia, Truenat™ Neisseria gonorrhea, Truenat™ Neisseria meningitides,Truenat™H3N2, Truenat™H1N1, Truenat™Salmonella,Truenat™MTB, Truenat™Klebsiella, Truenat™Bordetella pertusis, Truenat™Bordetella parapertusis, Truenat™HCV, Truenat™ Haemophilus influenza type B, Truenat™Leptospira,Truenat™HPV, STDs,Truenat™ Streptococcal and Staphylococcal pneumonia,  Truenat™Hepatitis A virus, Truenat™Hepatitis E virus, Truenat™Group B Streptococcus, HIV-2, Truenat™Epstein-Barr  virus(EBV), Truenat™Visceral Leishmaniasis, Truenat™Cytomegalovirus(CMV),Human herpesvirus 6 (HHV-6), Truenat™Herpes simplex viruses 1 & 2,Human Leukocyte Antigen B27( HLAB27), Truenat™ Rotavirus, Truenat™Rubella,Truenat™Rubeola, RTruenat™ubula, and Truenat™Clostridium Difficile.

The emphasis of care is shifting toward prevention and early detection of disease.Point-of-care testing gives immediate results in non-laboratory settings to support more patient-centered approaches to healthcare delivery. These instruments combine multiple analytical functions into self-contained, portable devices that can be used by non-specialists to detect and diagnose disease, and can enable the selection of optimal therapies through patient screening and monitoring of a patient’s response to a chosen treatment.With the development of miniaturized devices and wireless communication,the way in which doctors care for patients will change dramatically and the role patients take in their own health care will increase. 

Successful business models are created when the entrepreneur or executive team is hyper-focused on serving and delighting a customer. Keep solving problems for our customers and they’ll stay with us, which in turn ensures our financial sustainability. The problem is, our customer and our beneficiary may not be the same person.

Truenat is installed in 400 labs/sites across India as well as in some other developing countries. For instance, in India 2.7 million people are infected with TB according to TBFACTS.ORG. However being developing country, not everyone can afford to go for expensive tests. Truenat is being portable, less expensive test which everyone can afford to use the platform. Truenat provide support not only for care related medical conditions but also for disease prevention. Truenat is designed for use outside formal healthcare settings by the general publics or lab technicians, because of its simplicity.

By 2020,we are expecting to serve about 10 times more than the current installations which we have across the globe. Truenat is installed in a lab facility where no.of patients(suspected TB) are higher,than it might require more time to perform the test since Truenat has one sample processing system at a time.To decrease this burden, we are integrating Duo(2) and Quattro(4) slots in the system, where it can process 2 or 4 samples at the same amount of time.In the coming years, we are researching on MDR/XDR assays for Tuberculosis, which could greatly improve the way of treatment for TB.

Our team is mainly focused on research and development of Biological Sciences and Biotechnology is based on development of sensitive,  rapid, cost-effective, point of care diagnostic devices for infectious disease screening.Its an R&D company involved in basic research and has multi-disciplinary capability in MEMS( Micro Electromechanical Systems ), chemistry, molecular biology, biochemistry, fermentation, electronics and software and product development.

Patients in rural areas may have to walk for hours to reach a clinic where laboratory services are available.So our Point of care diagnosis is suited especially for resource limited settings. Since Truenat is battery operated, it can be used anywhere. Truenta now can run 2-4 tests and provide results in one hour for panel of tests run at smaller amount of time. Looking to increase Truenat usage in India, our strategy from operating through distributors to engage directly with doctors and institutions.

Point-of-care (POC) diagnostics provide rapid actionable information for
patient care at the time and site of an encounter with the health care system. Emerging molecular diagnostics have met requirements for speed, low cost, and ease of use for POC applications. A major driver for POC development is the ability to diagnose infectious diseases at sites with a limited infrastructure. 

Researching existing molecular diagnostics kits and identifying the market gaps and opportunities to play.

The volume of point-of-care testing (PoCT) has steadily increased over the 40 or so years since its widespread introduction. That growth is likely to continue,driven by changes in healthcare delivery which are aimed at delivering less costly care closer to the patient’s home.In the developing world there is the challenge of more effective care for infectious diseases and PoCT may play a much greater role here in the future.Through this application we want increase the awareness of Point-of-care diagnosis(PoC) testing among all groups of populations. POCT uses efficient work flow process.

The development of the device which can lead to diagnosis of all type of diseases in less than an hour. Due to unavailability of clinical samples the various types of diseases is limited. We aim to develop assays for a vast disease types provided we have clinical samples to work with. If we receive more of clinical samples it will make us easier to develop assaysfor more of diseases. Secondly validation of each of assay at the end of development,which enables us to efficiently perform in the field.