Single molecule counting or detection technology, linked with traditional immunoassay technology, has made it possible to realize the holy grail of immunoassay development – specifically, improving the S/N ratio of an assay by up to a thousandfold.
The Indian diagnostics sector has been witnessing immense progress. Major technological advancements and higher efficiency systems have taken the sector to new heights. Advanced cutting-edge technologies are being used to understand disease diagnosis and prognosis, thereby strengthening the sophistication level of the participants in the sector. Immunochemistry is one of the most rapidly growing fields in the Indian in vitro diagnostics (IVD) market. The factors which are fueling this growth are increasing overall healthcare expenditure, rising healthcare spend from Indian government, decreasing morality rate, increasing aging population, and lifestyle related diseases. This has led to a breed of products which are faster, with better technology, offer advance parameters, are modular, and take-up minimum bench space, and most importantly ensure excellent return on investment and affordability.
Immunochemistry analyzers are becoming more and more popular in the clinical chemistry and immunoassay laboratories as these are proving to be an effective tool to diagnose cancer, illegal drugs, infertility, sodium levels, endocrine functions, and blood clots. The analyzers are highly sophisticated as different analyzers have different analysis times, and need different reagents. Over the years, the testing menus across various formats have seen a sea change. In the current scenario, there is an increasing trend for testing of hormone levels and other non-infectious biomarkers like assays for autoimmune diseases, oncology and cardiac markers, and tests for vitamins. This is in addition to the focus on diagnosis of infectious diseases like hepatitis, HIV, dengue, and malaria.
An ongoing challenge for these analyzers has always been their relative lack of the sensitivity needed for accurate diagnosis and rule-out of disease. The limits of sensitivity have mainly been the result of high background noise blocking the measurement of analytes signals at low concentrations. Thus, the holy grail of development has been to enhance analytes signal while decreasing the background noise, commonly measured as the signal-to-noise (S/N) ratio. Today, these platforms are capable of automatized analysis allowing high-throughput testing and are a mainstay in clinical laboratories. In addition, the development of lateral-flow tests has brought the technology from healthcare facilities to decentralized settings. The discovery of the enzyme-multiplied immunoassay technique (EMIT) and other homogeneous immunoassays simplified the technology and allowed for automation. The application of chemiluminescent labels further improved analytical sensitivity. With single molecule counting technologies now making ultrasensitive immunoassays possible, however, a paradigm shift is under way.
Indian Market Dynamics
The Indian immunochemistry market in 2017 is estimated at Rs. 2170 crore. The instruments and reagents are estimated at Rs. 1550 crore, ELISA kits at Rs. 330 crore, and rapid tests at Rs. 290 crore. The reagents in 2017 earned revenues of Rs. 1385 crore, and the instruments Rs. 165 crore.
Roche and Abbot continue to dominate this segment. On October 3, 2017, Alere became a subsidiary of Abbott. Siemens, J Mitra, and bioMérieux are equally aggressive, and have a considerable market share. Ortho, Tosoh, Beckman Coulter, Transasia, and Bio-Rad have presence in this segment.
Immunochemistry is the fastest growing area in the Indian IVD market. The segment’s growth is being fueled by the growing demand for automated diagnostics. The key contributory factors are increase in overall healthcare expenditure; rising healthcare spend from the government, decreasing morality rate, increasing aging population and lifestyle related diseases.
The growth has also percolated down to Tier II and Tier III cities, as they too have started to move toward better medical and testing facilities. This is evident by the growing number of standalone hospitals and laboratories in smaller cities and towns, and the recent expansion of corporate hospital chains and chain labs from metros and A-towns to these areas. Small to medium privately owned laboratories of Tier-II and Tier-III cities make up 65–70 percent of India’s vast clinical diagnostic laboratory network, yet most IVD products have traditionally been designed for consolidated centers. Any approach to improving laboratory quality in India must include the implementation of reagents and instruments specifically designed to improve quality in Tier-II and Tier-III cities with ease-of-use, reduced consumption of consumables.
Responding to this development, the market over the last couple of years has become increasingly competitive. Vitality in this scenario is being ensured with clear understanding of the segment and the ability to provide products and services that fit. A breed of products which are faster, with better technology, have been launched. They offer advanced parameters, are modular and take up minimum bench space, and importantly ensure excellent return on investment and affordability.
Globally, the immunochemistry market represents approximately 40.1 percent of the global IVD market. Immunochemistry is by far the largest segment by volume, mostly due to routine testing. It is primarily driven by growing access to healthcare. With the rapid technological advancement in healthcare industry the immunochemistry analyzer market is expected to grow at a single digit healthy CAGR from 2018 to 2025.
Increasing focus on drug monitoring, rising prevalence of cardiovascular disorders and cancer, increasing research and development activities and government initiatives, rising awareness of new diagnostics tools among medical professionals are the major factors driving the market growth. However, stringent government regulations to produce the immunochemistry products and high cost of the products, act as an inhibitor for this market.
North America followed by Europe dominates the global immunochemistry market due to increasing number of patients with cardiovascular disorder and cancers, growing aging population, developed healthcare infrastructure, and growing demand for immunoassay technologies in these regions. Asia-Pacific is the fastest emerging market owing to a growing patient population with cardiac diseases, increasing awareness about advanced immunochemistry products available in the market, developing healthcare infrastructure, and rising government spending in the healthcare industry.
Some of the key market players in global market include F. Hoffmann-La Roche, Siemens Healthcare, Danaher Corporation, ImmunoChemistry Technologies LLC, Beckman Coulter, Ortho Clinical Diagnostics, and Thermo Fisher Scientific.
Manufacturers are designing new instruments to incorporate many additional capabilities and features, and are also actively engaged in discovering and validating new biomarkers, creating assays for those biomarkers to extend the menus of their instruments. Factors like the available laboratory space for placing an instrument, throughput needs, and a range of workflows are considered in designing and including the components for providing a fully automated instrument. The design and functionality of new instruments are predominantly customer-driven.
Automation. Over the past several decades, laboratories have observed a significant evolution in not only the immunoassays that are available, but also the technology that is used and the potential to automate testing and increase sample throughput. A number of semiautomated and fully automated analyzers are now commercially available for the performance of a variety of bacterial, viral, fungal, and parasitic antibody and/or antigen detection tests. The available automated platforms are either compact benchtop units that take up a limited amount of space in the laboratory, or free-standing units with larger footprints which require more space. The vast majority of the automated analyzers provides walk-away simplicity to perform assays from sample processing through interpretation and reporting of results.
The majority of manufacturers of automated instruments also provide software for the analysis and management of patient data and for monitoring the quality of the testing being performed. Most of the instruments can also interface with computer-based, hospital laboratory information systems for seamless and accurate reporting of results. The number and selection of automated instruments used depends primarily on the volume of specimens being tested and the number of individual tests to be performed. Some instruments will run only assay protocols developed and preset by the manufacturer, while others will permit the incorporation of user-defined protocols or are completely open systems that can be programmed to perform all analytical steps of a wide variety of manufacturers’ kits.
CLIA technology. Regardless of its current optimal analytical performance, CLIA (chemiluminescence immunoassay) technology is destined for further development. The new flow-injection CLIA (FI-CLIA) technology which is based on the fast injection of micro-bubbles into the reaction system with the aim of ensuring a more efficient reagent mixture and of reducing incubation times and increasing temperature control is able to improve the immunoreaction kinetics and therefore significantly reduce analysis time. Further improvements are expected in the coming years with the development of new analytical platforms such as the two-dimensional resolution for chemiluminescence multiplex immunoassay and the magnetic nanoparticles CLIA, which will likely result in additional increases in the clinical efficacy of antibody tests.
Multiplexed assays. Recent advances have been made in the development of multiplex immunoassays, which allow for the simultaneous detection of multiple analytes in a single reaction by combining immunoassay chemistries with flow cytometric analysis. Part of the benefit of this technology arises from its ability to measure as many as 500 targets in a 50–100 µL sample. Moreover, multiplexing allows for a simple and easily automated, marker-guided tissue segmentation, and provides more information from each tissue section, which may be critically important for small samples, such as needle biopsies of tissues or small metastatic tumor samples. Although multiplexing aims primarily to get more from less, there is growing need to expand the technology even further by measuring not only multiple analytes present in a sample, but also the per cell output of each analyte.
Single molecule counting. A proprietary single molecule counting technology aims to take immunodiagnostics to the next level by offering sensitivity up to a thousand times greater than contemporary immunoassay platforms. The current microparticle immunoassays are powered by single molecule counting technology, wherein the microparticles improve binding efficiency while minimizing nonspecific binding. The ultrasensitive, fully automated, quantitative, fluorescent, sandwich immunoassay allows for detection of analytes down to femtogram-per-milliliter levels.
Ultrasensitive immunoassays. The recent development of high-sensitivity immunoassays ushers in a new era for immunodiagnostics. Single molecule counting or detection technology, linked with traditional immunoassay technology, has made it possible to realize the holy grail of immunoassay development – specifically, improving the S/N ratio of an assay by up to a thousandfold. The evolution of high-sensitivity immunoassays has enabled detection of low-abundance molecules, approaching the clinical sensitivity accomplished with PCR.
Newly developed capabilities for detecting and quantifying biomarkers at low concentrations are changing clinical practice and patient management. With a wide range of diagnostic opportunities, high-sensitivity immunoassays have the potential for a great and growing clinical impact. Their ability to rule out disease is critical for an accurate, safe, and cost-effective diagnostic workup. High-sensitivity immunoassays may allow for such a paradigm shift, not only in detecting and diagnosing disease, but also in ruling-out disease, thereby eliminating unnecessary testing, and ultimately improving patient care.
Manufacturers are committed to contribute to the improvement of public health. Scientific and technological innovation is at the heart of advancement strategy and has thus enabled to extend the field of immunology through innovative chemiluminescence technology and the compact automated design of new immunoassay systems offering increased number of simultaneously measured parameters and processing capacity as well as enhanced usability that has been specifically designed to fulfill the requirements across segments, and paving the way for affordable and high-quality immunochemistry testing. Manufacturers are now also focusing on meeting the laboratory needs for innovative test formats and systems that can adapt to the workflow of their setup, ensure reliable results consistently, and are affordable.
The evolution from Berson and Yalow’s first radioimmunoassay to today’s ultrasensitive single molecule counting technology spans nearly six decades. With unprecedented sensitivity, the single molecule counting technology will transform immunodiagnostics across multiple disease areas in both acute and chronic disease management, and change patient care from reactive disease treatment to proactive health management. Immunoassays fundamentally changed clinical practice, and with the advancement of ultrasensitive immunoassays, the next disruption in healthcare will follow.
Moreover, the evolutionary process of the CLIA method is, in all likelihood, merely beginning. In the coming years, new and more efficient analytical methods based on the principle of chemiluminescence will be introduced into autoimmune diagnostics, at a steadily reduced cost.
This transformation will align antibody diagnostics with already consolidated biochemistry and immunoassay methods, with noticeable advantages in terms of both diagnostic accuracy and expediency, to great clinical benefit.
Immunochemistry – What to Watch Out for in 2018
The Indian IVD market is valued at more than USD 500 million, and is expected to surpass USD 1.5 billion by 2018 growing at a steady CAGR of 15–16 percent annually. Availability of disease-specific tests and an increasing test menu, among other factors are contributing to this growth. In the current scenario, there is a rising demand for testing of hormone levels and other noninfectious bio-markers such as assays for autoimmune diseases, oncology and cardiac markers, and tests for vitamins. This is in addition to the focus on diagnosis of emerging and re-emerging infectious diseases like hepatitis, HIV, dengue, malaria, leptospirosis, and chikungunya using both ELISA technique and rapid tests.
With the latest advancements, third-generation immunoassays for transfusion transmitted infections are now giving way to fourth-generation assays, which are designed on parameters such as early detection, better sensitivity and specificity, reduction in infection rates, affordability, and others. The chemiluminescence immunoassays (CLIA) seem to be on a growth trajectory with their broad menu and excellent sensitivity and specificity. Manufacturers need to work on making these affordable in order to ensure a deep reach.
Besides this, emergence of new concepts such as point-of-care testing, testing formats such as microarrays are further contributing to the growth of this segment.
Rapid testing kits are becoming a preferred choice for their ease of usage and time taken to report results. Even this arena has seen a lot of development, with manufacturers now focusing on addressing issues of false positivity and negativity.
Screening for transfusion transmitted infections is now being regularly conducted by corporate and chain labs, private hospitals, and blood banks. Further, the government and private bodies are penetrating Tier III and IV cities and towns, through public–private partnerships.
Laboratories rely on factors such as a wide test menu, reliability of results, turnaround time, innovative technologies, and affordability while choosing an immunochemistry testing system. Another important factor to consider is the after-sales support offered by the IVD companies. This is especially true in remote areas, where prevalence of infectious diseases leads to an increased workload and in-turn frequent breakdowns.
India’s leading in-vitro diagnostic company, Transasia Bio-Medicals Ltd. continues to focus on timeless ELISA and IFAs, while introducing newer platforms like CLIA to cater to the growing needs of the labs and blood banks.
Sr. Business Development Manager, Immunology,
Transasia Bio-Medicals Ltd.
The Trend of CLIA Application in Special Sex Hormones Detection
In recent years, chemiluminescence immunoassay (CLIA) methods are increasingly getting used by major laboratories for their routine hormone tests, including FSH, LH, testosterone, and others because of the higher sensitivity and shorter time to get the test results. However, some special sex hormones test, which is mainly tested by ELISA or RIA is getting popular day by day.
Testosterone is a kind of sex hormone (androgen) that helps develop male features. The majority of testosterone in the human body attaches to two proteins: albumin and sex hormone binding globulin (SHBG). However, only free testosterone, unbound by SHBG, can enter and activate androgen receptors in cells, resulting in testosterone-mediated effects. It is reported that advanced age and obesity may alter SHBG concentrations, which will lead to low concentration of total testosterone. Some of these cases may be misdiagnosis of hypogonadism when the free testosterone is in fact normal. Since the amount of free testosterone is small compared with total testosterone, it is necessary to use a high-sensitivity method to detect it.
17α-hydroxy progesterone (17α-OHP) is an endogenous progestogen steroid hormone related to progesterone and is mainly produced in the adrenal glands. The 17α-OHP test is mainly used to screen and monitor treatment for congenital adrenal hyperplasia (CAH) in infants and children. This test can also be used when a female has increased growth of facial and body hair or other symptoms that could be related to elevated male sex hormones. Consequently the 17α-OHP test is getting popular in the laboratory.
In the human body, androstenedione is the common precursor of androgen and estrogen sex hormones. Androstenedione is produced in the adrenal glands and the gonads. The androstenedione test is usually used to evaluate adrenal gland function or detect adrenal tumors and is also used for hirsutism in women.
Currently most laboratories use ELISA or RIA for the above testing. In recent years, some immunoassay manufacturers have started to develop these assays using higher sensitivity CLIA methods, which may be chosen by some higher requirement laboratory in the future.
Overseas Technical Director,
Snibe Co., Ltd.
Immunoturbidimetry Reagents - Ease of Use with Innovation in Future
Immunoturbidimetry is an important technique in the broad diagnostic field of clinical chemistry. It is used to determine serum proteins which are not detectable with classical clinical chemistry methods and antigen-antibody reaction. Immunoturbidimetry is based on specific and sensitive reactions between an antigen and an antibody. Each antibody binds to a specific antigen (like a key and lock). Antigens are substances that induce an immune response (production of antibodies). The immunoturbidimetry is further classified into two types namely direct immunoturbidimetry and particle enhanced turbidimetric immuno assay (PETIA). The principle of precipitation reaction is the interaction of antigen with antibody leading to the production of antigen-antibody complexes.
The prozone security is an optimal antibody-antigen ratio that leads to maximal precipitation. If the antigen concentration exceeds a certain level, antibody saturation occurs, followed by decreased precipitation and, in turn, lowers measuring signals. This effect is described as high dose hook or antigen excess effect.
The advantages of immunoturbidimetry versus the conventional slide agglutination method are the high sensitivity, quantitative result, high prozone security, and independency of manual application. The disadvantages of agglutination slide tests are the differing drop size of sample or latex reagent, the contamination of reagent or use by splattering, visual interpretation (depends on user), time-consuming and labor intense, qualitative (+ or -) or semi-quantitative results (+,++,+++,++++), and false differentiation of borderline cases.
DiaSys immunoturbidimetric tests are provided in various kits for multi-purpose or automated use on common clinical chemistry analyzers. DiaSys offers a broad range of human matrix based calibrators and controls for general clinical chemistry, lipid parameters, specific proteins, etc., with a variety of interesting analytes. DiaSys immunoturbidimetry has a wide measuring range in combination with high prozone security, no sample dilution, and reliable results for all normal and pathological samples due to high prozone limit. It also provides extremely sensitive results (LOD as low as zeptomole level), due to the absence of interfering emissions (i.e. high specificity) leaving no doubt in immunoturbidimetry test.
Dr Rajesh Rengarajan
Product Manager-Clinical Chemistry,
DiaSys Diagnostic India Pvt. Ltd.
Integrated Modular Automation and Diagnostic Immunology
IVD has witnessed several changes and additions to its gamut of offerings in the recent past. Automation and integration are driving the analyzers market which offers a broad assay menu. There has been a paradigm shift from traditional to automation and integration analyzers. India is witnessing growth in number of total laboratory automation.
While diagnostic immunology is the fastest growing segment in the Indian IVD market, the diagnostics lab services are also growing at the fastest pace both in the public and private sector. The segment’s growth is expected to be fuelled by growing demand for integrated or modular systems. Integrated and modulated laboratory automation has now begun to impact diagnostic immunology also. The potential advantages of total automation include decreased personnel and operating costs, less human intervention and fewer laboratory errors, more rapid processing of samples and recording of results, increased safety, better control of the entire process, and decreased need for laboratory space.
Completely integrated fully automated systems have gained impetus across all segments of the industry for the different types of end users ranging from standalone labs to corporate laboratories to multi-specialty hospital’s laboratories. Mindray being a leading developer, manufacturer, and marketer in the field of IVD, we understand the market needs and requirements and by keeping the vision of better healthcare for all by working with the mission of advanced medical technologies to make healthcare more accessible and with core values of aligning with our customers are committed to contribute to the improvement of public health through our scientific and technological innovation.
Mindray being a recognized brand in immunology is meeting the increasingly sophisticated needs by offering varying solutions from small laboratories (CL-1000i and CL-1200i) to medium laboratories (CL-2000i) to core laboratories (SAL 6000 and SAL 8000) with highly functional and unique reagents and instruments that deliver high clinical value and enhance the quality of testing, as well as instilling its customers with confidence.
Product Manager – Immunoassay,
Mindray Medical India Private Limited
Integrated Modular Growth in the Indian Clinical Chemistry Market
This is a very exciting time to be involved in the diagnostic market in India. The clinical chemistry market has witnessed great growth and expansion in recent years and we can expect this to continue for the foreseeable future. India is an extremely important market for Randox and we are delighted to be involved, providing high-quality diagnostic solutions to meet this demand. There are between 30,000 and 40,000 clinical laboratories across India, covering a diverse market consisting of private laboratories, chains, hospitals run by governments, charities and non-profit organizations, and several major private world-class hospital groups. We have witnessed huge improvements in Indian healthcare and these are being driven by the demand for accurate diagnostics with a major focus on consolidation and cost-effective testing. Patient care is the primary focus of clinical chemistry testing and Randox has developed a versatile range of high-quality clinical chemistry analyzers to meet this demand.
One of the key focuses in India is on diabetes and heart disease due to its prevalence. It has become even more important for diagnostic companies to effectively predict the likelihood of individuals developing these diseases. Offering innovative solutions and early diagnosis helps prevent, combat, and treat these conditions economically at the earliest possible opportunity. Randox offers a complete diabetes profile including Adiponectin, for early detection of diabetes, as well as a comprehensive cardiac profile to provide the clinician with the opportunity to accurately diagnose a range of cardiac-related diseases and optimize patient therapy.
Reduction of outsourcing and consolidation of routine and specialized tests onto a single platform should be a major consideration when purchasing laboratory instruments. This approach allows laboratories to reduce their costs and also have complete ownership of their testing and patient results. This approach not only increases efficiencies but also brings with it a quicker turnaround time of results which further enhances the laboratory’s offering to patient care. Our extensive, dedicated RX test menu is optimized for use on the RX series analyzers, ensuring precision and accuracy of results. In addition to the complete range of calibrators, controls, and RIQAS – our EQA program, Randox provides a complete cost-effective solution for a variety of laboratory types.
Global Manager-RX Series,
Randox Laboratories Limited
Poised for Rs. 2700 Crore by Year 2020
Indian immunochemistry market in India is expected to be reach Rs. 2700 crore by year 2020.
Being the largest segment in the IVD industry, the immunochemistry reagents and instruments market is estimated at `2100 crore in the year 2018.
Thyroid hormones, fertility hormones, tumor markers, infectious disease testing are the major parameters followed by specific protein testing. Reagent business is having the highest share at 90 percent of the total value.
Innovation and affordability are the two key growth factors and manufacturers are moving toward development of compact and affordable solutions. Cartridge-based immunology testing systems are gaining momentum because of the simple operation, compact hardware, and smaller pack sizes. On the other hand, many such systems are also finding their way into the emergency rooms as a POCT system for critical parameters in cardiac testing like troponin-I, NT-proBNP, CKMB, and myoglobin. The thyroid panel is still dominating the immunology market with a share of more than 50 percent in the testing volume. The huge growth in thyroid testing resulted in considerable reduction in the cost of testing as compared to the last decade. Sepsis marker is gaining importance and at present many POCT instruments are available in the market with lateral flow immunofluorescence systems for sepsis marker testing. Vitamin-D is another fastest growing test in the immunochemistry segment. There are multiple platforms for vitamin-D testing starting from lateral flow based system with visual comparison to fully automated CLIA-based testing. Only few players are there in the vitamin-D testing and at present the cost of testing is not suitable for the rural population in India. From standalone high cost floor model systems, the customers are moving toward highly affordable bench top systems with very low recurring cost. More systems are entering into the market to capture the entry level segment with throughput as low as 60 tests per hour. One of the limiting factors for the immunology testing is the fact that the reagents and instruments are highly dependent on import and hence cost of testing is still on the higher side. On an average, around 800 immunology systems are installed annually where more than 70 percent of the systems are placed on rental.
Specific protein testing is one of the major segments in immunochemistry that has shown exponential growth. The common specific proteins tests which involve qualitative or semi-quantitative testing are performed earlier using latex-based reagents. With the advancement in technology, now the fourth-generation latex enhanced reagents, having high sensitivity and linearity as compared to earlier reagents, are used for specific protein estimation. Introduction of a semiautomated nephelometry system into the industry nearly a decade ago was one the key factors for growth in specific protein testing in India. With one of the highest population of diabetic patients in India, HbA1c testing was on a rise which led to an installation base of more than 3500 semiautomated nephelometry platforms in India. At present the highest number of Hba1c and CRP tests are performed in nephelometric platforms which itself is a proof of the acceptance of technology. The total nephelometry testing market in India is estimated at `50 crore in the year 2018. One of the key growth factors in the specific protein testing segment is the indigenization of the reagents and instruments and there are few manufacturers in India pioneering the segment with a wide range of reagents and hardware. More parameters are added year on year (Y-o-Y) and it is also expected to have tests like vitamin-D and PSA in the nephelometry platform in the near future along with cardiac markers like Troponin-I and CKMB. It is also expected to have combination systems to enter into the market which can perform general clinical chemistry tests and specific protein tests using cartridge-based reagent systems.
With more parameters being added Y-o-Y, the immunochemistry market in India is expected to be reach Rs.
2700 crore by year 2020.
Rajesh M Patel
Agappe Diagnostics Ltd.
Procurement Plans and Market Trends
For the proper functioning of an organization or institution there are major factors which should be considered namely men, money, and material.
Finance is the elixir that helps in the formation of new ventures, and also allows these ventures to take advantage of opportunities to grow. The organization hires local workers as employees, in turn to support the venture in local and state levels. The strategic use of financial backing, such as investments, is a key to the success of every venture. In the above classification, we also note the importance of materials for which the following points should be considered. The strategy for procurement includes a market survey, in turn analyzing the real need by consolidating with the user department and technical team.
We also have to consider analyzing the market regularly to know the recent trends before finalizing. While planning for purchase it is also important for considering the legal requirement and also analyzing the after sales service in terms of warranty etc. Consideration of time limit has to be fixed otherwise a competitor may install the same before us.
A priority list should be prepared with respect to budget allocation for various departments. A cost profit analysis should be done to determine how changes in costs, time, and volume affect a company’s net and operating income. Preplanning is obligatory to achieve about 90 percent of the task in the procurement process.
While planning, the procurement of resources for any hospital can be achieved only by a definite budgeting and financial forecasting process. For a hundred-bedded hospitals, we should consider the basic equipment and further consider necessity for further equipment. In short the process of procuring resources for any organization will help in its prosperity or adversity of the same.
Enigma Behind Immunoassays
The thyroid is a small gland in our body, which together with two other parts of our brain (pituitary gland and hypothalamus), work as a well-orchestrated triad, controlling the level of thyroid stimulating hormone (TSH) in our blood. However, in spite of a large body of knowledge in the medical fraternity, functioning of this very important gland has thrown up new mysteries. This is because of new findings in recent years that have highlighted simplification in our prevalent understanding of the way the triad of organs produce and release TSH in our blood. If levels of TSH go up or down beyond the normal range, a wide array of abnormalities show up, so much so that thyroid function tests (TFTs) form a very important set of tests in a pathology laboratory.
However, it is this very set of tests that have come into question. First, what is the normal and acceptable range (upper and lower limits) of TSH in a particular population has been debated in different scientific fora.
A second problem which the doctors and technicians have to grapple with is the variability of test-results in itself; even a broadly similar set of instruments and methods can give up to 40 percent more or less values in TSH levels. A third concern is the mounting evidence about the variability of the TSH molecule itself, from one patient to another.
Standardization of TSH and other TFTs is therefore still a formidable challenge, due to the lack of proper reference intervals and standardized measurement procedures. The laboratory medicine community the world over has realized that variability in TSH results in different platforms can create a lot of confusion to clinicians and the general population; harmonization of procedures is therefore the need of the hour.
International Federation of Clinical Chemistry’s (IFCC) Committee for Standardization of Thyroid Function Test (C-STFT) has been formed to address these issues. IFCC is encouraging a lot of awareness-channels – organizing events, research publications, and news articles. The committee is in discussions with IVD industry, kit manufacturers, clinicians, hospitals, and laboratories to formulate guidelines for assisting in correct measurement, diagnosis, and management of thyroid diseases.
As a corresponding member of IFCC Committee for Reference Interval and Decision Limit, I have established reference interval for many chemistry and immunochemistry parameters in our laboratory, based on the our own population demographic variation. The reference interval (90 percent confidence interval) of the Indian population for TSH by non-parametric procedure (bootstrap) is 0.48–4.52, and by the parametric one (after transformation of the data) is 0.45–4.27 based on our laboratory data.
Dr Barnali Das
Consultant, Biochemistry and Immunology,
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Corresponding Member, IFCC Committee for Reference Interval & Decision Limit,
College of American Pathologist Inspector and NABL Assessor
Market Trends – Need of the Hour
Immunochemistry analyzers are becoming more and more popular in global clinical chemistry. Increasing number of patient with various diseases such as cardiovascular diseases and cancer, rising demand for technological advances in immunochemistry techniques, increasing research and development activities, government initiatives, increasing disease-specific immunoassays, test volumes, and growing aging population are some of the factors that drive the growth of the immunochemistry market in healthcare. MALDI-TOF is the fastest growing sub-segment in the global mass spectrometry market widely used in the clinical diagnostic field. Globally, immunochemistry represents approximately 40.1 percent of the IVD market.
Nowadays, most of the super-specialty hospital laboratories are well-equipped with automated equipment, NABL accreditation, and insurance coverage. At the same time there is also heavy pressure for quality, error-free results to ensure patient satisfaction. But with limited workforce and multilevel HIS needs in the clinical lab, it is difficult to manage turnaround time (TAT), quality of reporting to the huge inflow of patients. In this scenario we look for the laboratory industry to come up with solutions in providing equipment with the best interface/information system, customized training program for lab technicians, so that laboratories can strengthen their technical skills and HIS needs.
This in turn ensures continuous dispatch of accurate reports to manage high growing volumes which enables the improvised patient satisfaction and timely management.
Knowing that stringent government regulations have led to the high cost of the products, hospitals are still ready to procure them as they do not want to compromise on quality which enables efficient patient care. In recent times, government spending on life science research and increased R&D are major drivers of global mass spectrometry market; we expect that they can provide best services in terms of providing more reagents and stand-by equipment at the hospital laboratories to surpass the technical difficulties arising in the functioning of the equipment in the mid hours of the clock and distracting the nursing team in delivering effective patient care.
Hence we are very much interested to shake hands with the immunochemistry, mass spectrometry market which comes up with a better solution in providing the reagents or the equipment, delivering them in the need of hour, understanding the necessity of saving patient lives as we treat our customers as a highly esteemed part in the healthcare industry.
Dr KS Sridharan
Deputy Chief of Laboratory Services,
Professor of Microbiology,
Sri Ramachandra Medical College and Research Institute
Immunochemistry Instruments and Reagents – Latest Trends
An immunochemistry analyzer can be used by medical laboratories for a variety of substances to detect anti-arrhythmic, antibiotic, anticonvulsant, or cardiac glycoside, drug interaction determination, infectious diseases, allergy testing, cardiac markers, endocrine hormone testing, and others. Immunochemistry analyzers run patient samples to detect any number of biologically active substances. When choosing an immunochemistry analyzer, it is important to look at several factors to determine which analyzer is best for your needs.
Different immunochemistry analyzers have different analysis times, required tests and reagents, ability to do parallel processing or automatic dilutions, and number of tests that can be run per hour.
There is a rising focus on biomarkers development across the globe as they help in detection of various diseases in their initial stage. Immunochemistry plays a crucial role in the development of biomarkers, thus with the growing demand of biomarkers, the market for immunochemistry instruments and reagents will also flourish. Furthermore, government support in terms of funds and grants has also provided the much needed impetus to this market.
Moreover, increasing focus on drug monitoring and growing incidences of various diseases are other factors driving the growth of the market. In addition to this, technological advancements due to which automated and more accurate instruments are present in the market is another major factor propelling the growth of the market.
In 2016, the hospitals and diagnostic laboratories segment accounted for the largest share of immunochemistry and immunohistochemistry market, by end user. Growing prevalence of cancer and rapidly increasing geriatric population across the globe are the major factors driving the growth of the immunochemistry market.
Other important factors driving market growth include increasing healthcare spending and improving healthcare infrastructure resulting in an increase in the number of hospitals and diagnostic laboratories.
Furthermore, technological advancements such as automated sample preparation and digital pathology and its greater utilization in the diagnosis of many chronic and life-threatening diseases are expected to contribute to the growth of the immunohistochemistry market.
Dr Neelima Verma
Senior Consultant Clinical Biochemistry,
NABL Medical Lead Assessor,