Immunochemistry analyzers are becoming more and more popular in global clinical chemistry and immunoassay, as these have proved to be very effective tools to diagnose cancer, hepatitis, illegal drugs, fertility problems, sodium levels, endocrine function, and the detection of blood clots.

With the rapid technological advancement in healthcare industry, the immunochemistry analyzers market is expected to grow at a healthy CAGR over the next decade. Globally, the immunochemistry analyzers market represents approximately 40.1 percent
of the global in vitro diagnostics (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.

There are approximately 200,000 immunochemistry analyzers that were installed globally in 2015, out of which only about 17-20 percent are installed in the United States. These statistics suggest that the markets like China, India, and Japan, where lack of basic lab facility prevails, are adopting this new technology. Also it hs been seen that the recurring consumable sales are a strong factor to segment growth.

Immunochemistry analyzers are instruments that automatically run tests on samples from patients to detect any number of biologically active substances. It is very important to know which analyzer to use, as different analyzers have different analysis time, and need different reagents which make these instruments highly sophisticated. These analyzers are mainly being used in infectious disease testing, cancer, cardiac, and autoimmune diseases.

Some of the immunochemistry analyzers are chemiluminescence (CLI) analyzers, immunofluorescence (IFA) analyzers, multiplexed assay systems, enzyme-linked fluorescence assays (ELFAs), enzyme immunoassay (EIA) instruments, and radioimmunoassay (RIA) analyzers.

The immunochemistry market is heavily impacted by rapid replacement trends, which affect the clinical chemistry market. The market is increasingly seeing the entry of CLI analyzers, which are replacing older versions. Smaller labs still opt for IFA or semi-automated CLI analyzers. 
Enzyme-linked immunosorbent assay (ELISA) systems and open systems are exhibiting some growth because of their open platform capabilities and larger test menus and affordability. IFA and CLI analyzers tend to be more expensive, which works in favor of ELISA systems.

ELISA systems will eventually experience erosion because of their lack of sensitivity and low specificities, especially as most laboratories are now consolidating and converting to high-throughput systems. As a result, many vendors are using this opportunity to offer immunoassays or standalone clinical chemistry systems for a high discounted price. Demand for immunochemistry systems seems to work negatively for vendors. Because of this, the retention of the install base is crucial. Some strategies adopted by vendors include offering large discounts/upgrades, adding automation capabilities to existing modules, and having long reagent rental contracts.

Also, the companies operating in immunochemistry are entering into mergers and acquisitions with other companies to expand their immunochemistry business. For instance, F. Hoffmann-La Roche Limited has acquired BioVeris Corporation to expand its leading ECL immunochemistry business into new market segments. In addition, new product launches are also helping to grow the market. Abbott Laboratories has launched new instruments to complete the product line of ARCHITECT immunochemistry analyzers.

Increasing number of patients with various diseases such as cardiovascular disorders and cancer, rising demand for technological advanced immunochemistry technologies, increasing research and development activities, government initiative, increasing disease specific immunoassay test volumes, and growing aging population are some of the factors that drive the growth of the immunochemistry market.

However, stringent government regulations to produce the immunochemistry products and high cost of the products, act as an inhibitor for this market.

Technology Update

Biopharmaceutical development relies heavily on immunoassays to identify, measure, and validate drug candidates from discovery through preclinical and clinical trials and all the way into production. ELISA remains the leading immunoassay method today, enjoying widespread use in many laboratory settings. Nevertheless, the technique is not without its drawbacks. Traditional ELISA assays take a considerable time to complete and the risk of dilution errors and other manual mistakes is always present.

Gyrolab technology. It is an open-technology platform that automates immunoassay workflows by integrating sample addition, washing, and detection in a unique compact disc (CD) format. These CDs contain exact microstructures where centrifugal force, capillary action, and hydrophobic barriers control the parallel processing of up to 112 reactions at nanoliter-scale volumes with short incubation times and minimal matrix effects. As the primary objective of the diagnostic industry is to make new improved diagnostics and therapeutics available to patients as quickly as possible, time is critical to every aspect of product development. Time saved in R&D, validation, and scale-up can significantly contribute to earlier and more conclusive clinical trials, for example.

Diagnostic companies that have successfully reduced development times often attribute their success to automation. Automated immunoassay platforms can speed time to completion, both for new assay development and for routine testing. Walk-away automation also frees up staff to do higher-value work while assays are running.

Generating higher-quality data. Faster product development is not the only reason why laboratories switch from conventional ELISAs to an automated assay platform. They do so because they also acquire higher-quality data that enables data-driven decision making. A robust immunoassay platform with automated workflows avoids handling errors associated with manual methodologies. The results it yields will thus be more precise and more reproducible. In addition, a platform with broad dynamic range, such as Gyrolab systems, can lower the minimum required dilution (MRD), further reducing experimental variability caused by dilution error. Note also that a broad dynamic range can be especially valuable in applications requiring the detection of very low concentrations of analyte.

Switching to an automated immunoassay platform. Switching from an ELISA format to Gyrolab immunoassay technology should not present any major difficulties. Assays that run on Gyrolab can be developed in a variety of matrices, including serum, plasma, synovial fluid, tears, urine, whole blood, sputum, vitreous humor, CSF, and cell culture supernatant. Furthermore, users enjoy full flexibility in choosing assay format. In most cases, the same antibodies currently used in ELISA can be transferred to a Gyrolab assay, thereby ensuring experimental continuity and facilitating regulatory compliance. In addition to having this design freedom, optimized off-the-shelf kits for a range of assays add convenience and boost time saving even further. Finally, the Gyrolab platform is fully scalable from research and discovery phases through preclinical validation to scale-up.

Transferring immunoassays from traditional standard formats such as ELISA onto an automated platform like Gyrolab will save time in assay development and routine assay processing. A robust automation platform will also increase data reproducibility, precision, and dynamic range for a wide range of assays, thereby generating greater confidence in the results obtained.

Drivers and Challenges

Under the strong rules and regulations, laboratories find it difficult to have good revenues. It is very important to find ways to sustain in such a cost-crunched environment. Due to the cost cutting in clinical lab fees, profitability per test is decreasing which makes it necessary for the laboratories to focus on the volume rather than the value. There is also heavy pressure for quality, error-free results to ensure patient satisfaction. This forces labs to lean toward more automated systems with effective workflow solutions.

Laboratories are encouraged for automation due to the heavy influx of patients with insurance coverage. But with limited workforce in the clinical lab, it is difficult to manage the huge inflow of patients. On the other hand, patients need prompt and error-free results. Thus this scenario demands laboratories to seek the help of systems that have a high accuracy, with managing high growing volumes, and also offer remote data-acquisition capabilities.

Eamon Lenehan , Global Marketing Manager, Randox Laboratories Limited
Industry Speak
Growth in Clinical Chemistry Testing

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 us 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 analysers, 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.

Eamon Lenehan
Global Marketing Manager,
Randox Laboratories Limited

Rajesh Patel, Head-Business Operations, Meril Diagnostics
Industry Speak
Changing Trends in Chemiluminescence

Advancements in technology in instruments and adaptation of chemiluminescence technology in various parameters have ensured an inclination of customers toward this technology.

Currently, the total market for immunochemistry is envisaged at Rs.1300 crore.
Reagents continue to contribute two-thirds of the total immunochemistry market accounting for Rs.1000 crore. Chemiluminescence Immunoassay (CLIA) currently contributes to more than 70 percent of the immunochemistry market especially since most of the hormone parameters and routine assays being carried out at chain labs have been shifted to CLIA.

The term chemiluminescence was first coined by Eilhardt Weideman in 1888. Chemiluminescence is the light emitted by a chemical reaction. These reactions are often oxidation reactions. One of the major advantages of chemiluminescence is the limited or no emission of heat energy. Measurement of concentrations of specific molecules in a sample using chemiluminescence-based assays has become very popular in recent years and it is highly useful because the concentration of an unknown substrate can be inferred from the rate at which light is being emitted. The rate of light output is directly proportional to the amount of light emitted and accordingly, proportional to the concentration of the luminescent substrate present. Therefore, light measurement is a comparative indicator of the amount of luminescent substrate present in the sample of interest.

In CLIA, an antibody which specifically recognizes the analyte of interest is tagged to an enzyme Horse Raddish Peroxidase. This enzyme complex then catalyzes the conversion of the enhanced chemiluminescent substrate into a sensitized reagent in the vicinity of the molecule of interest, which on further oxidation by hydrogen peroxide, produces a triplet (excited) carbonyl, which emits light when it decays to the singlet carbonyl. Luminol has been used extensively in CLIA assays in which light emission is triggered by a catalyst. The high sensitivity of detection by means of luminol substrates with HRP enzyme labels has been demonstrated for use in quantifying a variety of analytes with chemiluminescent enzyme immunoassay methods with both sandwich and competitive principles. Immunoassays based on chemiluminescence have substantially greater sensitivity and dynamic range than those based on earlier-generation detection. These systems have developed a wide variety of test menus, performed with both sandwich and competitive heterogeneous immunoassays with the aim of detecting low concentrations of biologically active molecules. Better sensitivity and low background differentiate luminometry from other analytical methods. It is up to 100,000 times more sensitive than spectroscopy and is at least 1000 times more sensitive than fluorometry. The luminescence intensity is usually expressed as photons-per-second and surface area or in arbitrary units often called relative light units (RLUs).

Efficient light emission with low background is coupled with high sensitivity and broad range of photomultiplier detector. For every photon of light striking the surface of the photomultiplier, there is a 106-fold electronic amplification of the signal. PMTs are known for their very low dark currents leading to excellent signal-to-noise ratio for low-intensity samples. PMT-based systems operate in two basic modes - single photon counting and current sensing. There are differing opinions in the chemiluminescence instrumentation field regarding which of the two modes is better. In a modern luminometer, both modes achieve excellent sensitivity and are easy to use. A proper understanding of the characteristics of each mode should allow the user to choose the one best suited to the application.

Chemiluminescence is coming into its own because of technological improvements that have led to higher orders of magnitude leading to better sensitivity.

Meril Diagnostics has always been in the forefront in introducing customer-centric products. The company provides semi-automated CLIA open system to enable even the smallest customer to assay parameters based on CLIA in their laboratory. The system uses reagents in well format and resembles ELISA in protocol, thus making the transition extremely easy. For high-workload customers, Meril provides a unique, one-of-a-kind fully automated processor, capable of performing ELISA and CLIA on the same platform. Such systems substantially decrease customer investment and allow choosing the assay technology for each parameter.

Rajesh Patel
Head-Business Operations,
Meril Diagnostics

Dr Kanchan Gulati, Lab Head, SRL Limited, Faridabad
Second Opinion
Diagnostics of Dengue Viral Infection

Recent scientific advances are enabling the development of new tests that make medical screening, diagnosis, and patient monitoring less invasive, more affordable, and more patient-centered. New and emerging medical tests have the potential to deliver evidence-based medicine that consumers and healthcare professionals have been anticipating.

Dengue virus belongs to the Flavivirus family and comprises four different serotypes. The most important laboratory methods for detecting dengue virus are detection of the highly specific early antigen NS1 and antibodies Ig G and Ig M, anti-dengue virus ELISA, and antibody detection by indirect immunofluorescence.

Direct detection by RT-PCR detects the genetic material of the dengue virus. It provides reliable identification of the infecting virus, but due to the short viraemic phase, it is only effective within the first week after onset of symptoms.

NS1 antigen is detectable on the onset of clinical symptoms in both first and re-infection with dengue virus and remains detectable past the viraemic phase. NS1 detection serves as the first-line screening test for dengue and helps to minimize the diagnostic gap between RT-PCR and antibody positivity.

Serological methods are effective from soon after clinical onset to beyond convalescence. Antibodies against dengue virus appear around day four to seven after symptom onset. Acute infections are generally characterized by the occurrence of IgM, with IgG appearing at the same time or shortly thereafter.

ELISAs also provide fully automated measurement of antibody titers, and are a cost-effective method for screening large numbers of samples. They can be used to determine IgM or IgG antibodies.

Anti-dengue virus ELISAs are based on highly purified virus particles of serotype 2. Due to the high structural similarity between dengue viruses 1 to 4, use of one serotype is sufficient to detect antibodies against all four virus types. Due to use of whole antigen, cross reactions with other Flavivirus antibodies cannot, however, be excluded.

Antibody detection by indirect immunofluorescence is based on cells infected with the corresponding virus, which provide highly sensitive diagnostics. Positive and negative results are evaluated by fluorescence microscopy. It has sensitivities ranging from 96 to 99 percent and specificities of 95 to 100 percent.

Dr Kanchan Gulati
Lab Head,
SRL Limited, Faridabad

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