In the realm of diagnostics, clinical chemistry has been at the forefront of the technological revolution to create automated environments that enable fast, cost-efficient, and high-quality testing. While great strides have been made in chemistry testing technology, today's clinical laboratories continue to face emerging complexities, owing largely to industry growth, an ever-changing healthcare landscape, and network consolidations. Effective and advancing rapidly, innovation has succeeded in bringing significant relief to over-burdened laboratories carrying the weight of increasing test volumes, stricter cost controls, labor shortages, and multifaceted network operations.

Industry advancements have enabled most manufacturers to produce high-quality products with Six-Sigma assay performance. But the availability of these products may be only part of the equation. For laboratories seeking to improve turnaround times (TATs), lower cost of ownership, and addressing the need for standardization throughout the organization, the other part of the equation may be to optimize available technology. In the fast-paced laboratory environment, however, the benefits of technology are not always fully realized.

Owing to various technological advancements in the field of professional diagnostics, the applications of biochemistry analyzers that were initially restricted to the detection of infectious diseases are now venturing into other areas as well such as drug testing. As a result of this technological evolution, the diagnostics tests are now witnessing a boost in their demand. This has led to the rapid growth of the biochemistry instruments and reagents market worldwide, which is expected to grow at a CAGR of 6 percent from 2017-2021, according to Technavio. The rising demand for automation and integration of multiple processes is one of the primary growth factors for this market.

Technology Trends

In 1978, the industry was changed with the introduction of an automated system that allowed a number of critical routine chemistry tests to be performed using one consolidated unit. This initial system made it possible to complete these tests, commonly ordered as a STAT, in less than one minute using a single small sample. This technology became a foundation for the future of automated chemistry testing.

Automation in clinical chemistry labs reduces errors and delivers properly checked results in reduced turnaround time. This is crucial in the clinical test process as it determines diagnosis and treatment.The use of automated analyzers with the ability to incorporate different tests, assay types, reagents, software, and accessories provides a comprehensive package for improving clinical effectiveness and outcomes. Washing and rinsing is also a mundane and tedious task. To overcome this issue, advanced automated systems are designed to even wash automatically.

Adoption of point-of-care testing (POCT) is currently a popular trend in the market since it provides faster results and supports patient-centered approaches to health care delivery. The sensoryPOCTtechnology enables rapid analysis of blood samples, with devices designed to address the challenges faced in the diagnosis and treatment of cancer and stroke. The high cost of clinical diagnostic devices has triggered their adoption rate.

Manufacturers are developing biochemistry analyzers with multiplexing analyzers. Such type of analyzers possess the feature of positive identification that reduces the process of repeated pathogen testing. This becomes a critical feature in cases of samples that have low volume such as neonatal units. These types of systems with shorter turnaround time give advantages of high clarity and result in accuracy. The feature of positive identification helps acquire accurate results in shorter run time by avoiding the inclusion of too many targets. On the other hand, besides pathogen testing, biochemistry analyzers are used for drug monitoring, drug abuse detection and many more applications.

Initially, biochemistry analyzers were used for repetitive analysis that consumed a lot of reagents. This has now changed, and due to replacement by discrete working systems low volume reagents are now being used. The new instruments are able to automate repetitive sample analysis steps that would have otherwise been done manually. Moreover, as a result of the convergence of system engineering, automation and IT technology, a significant change has been brought in the market. The shift from enzyme-linked immunosorbent assay (ELISA) technique to an automated biochemistry method increases time and personnel efficiency considerably, and leads to cost effectiveness as well.

 

Road Ahead

One of the latest trends that will gain traction in the clinical chemistry market in the coming years is the complete focus on fully automated clinical chemistry analyzers. These help to integrate both analytical and pre-analytical processes. Additionally, they can also perform immunoassays and chromogenic assays by using a smaller sample and reagent volume and can perform 500-800 tests per hour.

Moreover, the greatest improvement to clinical chemistry automation will be in taking advantage of the further integration of middleware capabilities into automated instruments. If given the ability to conduct QC management and auto-verification in a middleware environment, in the event of a QC failure, patient testing can be stopped immediately and withhold results can be released after the problem is addressed. Once the problem is resolved, samples could be re-run automatically, thereby improving technologist efficiency as well as the quality of our results.However, despite technological advancements, today's laboratories continue to feel the pressure to deliver accurate and timely results while managing the costs. While high-quality products can greatly improve the efficiency and effectiveness of laboratory operations, these systems can be further optimized in the future.

Every change made in the instrument has a clear purpose and improvement in mind, and each one, no matter how little, is a step forward in the evolution of the lab, and gives patients and physicians greater confidence in the quality of lab results.

Edward Hill
Industry Speak
Measurement Uncertainty in the Clinical Laboratory

What is measurement uncertainty?

Measurement Uncertainty (MU) relates to the doubt that exists for the result of any measurement. There is always a margin of doubt for any measurement, and the clinical lab needs to ascertain the width of the margin and the significance of the doubt. Two values are needed in order to quantify uncertainty; the width of the margin and the confidence level, which states how sure we are that the true value is within that margin.

In a hospital or healthcare environment the clinician must be certain that any change identified in a patient's test result is not due to the laboratory test system, but a change in the patient's status. This is especially critical at clinical decision levels.

How do we calculate measurement uncertainty using QC Data?

The first step in calculating Uncertainty is to look at intra-assay precision and the inter-assay precision of QC data. Intra-assay precision refers to measurement precision within a run. It is normally measured by running 20 or more replicates of the same sample at the same time. Inter-assay precision on the other hand refers to precision over a number of different runs. It is normally measured by running 20 or more replicates of the sample over several days e.g. run one replicate every day for 20 days.

Calculation

To measure Uncertainty (u), the lab must first calculate the Standard Error of the Mean (SEM) of the Intra-assay precision (A) and the SD of the Inter-assay precision (B). Once we have calculated A and B, we need to square them, add them and calculate the square root:

 

As Uncertainty is calculated as SD, and 1SD is equal to 68 percent confidence on the Gaussian curve, it is reasonable to multiply the Uncertainty by a coverage factor (K) of 2 to attain a 2SD confidence level of 95 percent. This is known as Expanded Uncertainty (U).

Why is measurement uncertainty useful in the laboratory?

In addition to helping meet ISO 15189:2012 requirements, Measurement Uncertainty has a range of added benefits for the clinical laboratory:

  • lIt provides quantitative evidence that measurement results adhere to the clinical requirements for reliability.
  • lIt provides labs with an indication of potential sources of Uncertainty. Efforts can then be taken to reduce or eliminate these sources, thereby improving overall efficiency.
  • lIt allows for accurate comparison of results with reference values using the same measurement procedure.
  • lIt is an essential component for achieving standardized and harmonized measurement results through metrological traceability.

Conclusions and Recommendations

Due to increasingly tight budgets, cost-cutting practices are becoming routine in the laboratory.Laboratory professionals need to utilize every available method of saving money in order to maintain high quality outputs while remaining within budget.

Six Sigma and Measurement Uncertainty can be used to increase efficiency in QC practices. Both of these statistical calculations however can involve time-consuming and labor-intensive data analysis. The ideal solution would be for labs to utilize a peer group program with automatic QC data upload and advanced statistics such as Six Sigma and Measurement Uncertainty calculated automatically.

Edward Hill
QC Product Specialist,
Randox Laboratories

Sachin Singh
Industry Speak
Growing Need of Fully Automated Systems

Laboratories designed for processing specimens have specialized machinery designed to measure different chemicals in a number of many biological samples and tests. The first biochemistry analyzers were mainly used for routine repetitive analyses. Over the years, they have been replaced by discrete working systems, which use lower reagent consumption. These new instruments automate repetitive sample analysis steps which would otherwise have been done manually by a technician.

In vitro diagnostics market has showcased several emerging trends over the past few years. Some of the most definitive trends have been the advent of decentralized testing, mounting automation in laboratories, increasing consolidation, and preference for early detection of diseases. Several pathological labs have resorted to invest heftily and have been adopting fully automated systems for diseases diagnosis. In light of this, the accuracy of test results has increased, while the turnaround times have been reduced significantly.

Automating the process used in biological samples is extremely advantageous especially in high throughput laboratories. In general, automation improves throughput, decreases error within and between tests, and generates a report of the steps performed. As today's assays require smaller and smaller volumes, Doctors require accuracy and CV data to be available for an increasing number of tests. Nowadays, aim is to give a fast and reliable result with minimal human assistance.

These new technologies have enabled a better understanding of disease processes. The introduction of user-friendly automated devices has minimized human effort and increased the efficiency of diagnostic procedures.

Automated instruments are expanding system capabilities and introducing technological advancements to provide comprehensive testing solutions that facilitate efficient, accurate, and streamlined laboratory procedures. The factors contributing to the growth of automated instruments and reagents market in India include the consolidation of diagnostic laboratory chains, major hospitals, and laboratory chains opening new centers in Tier II and Tier III cities, increasing government/private sector expenditure in healthcare, public awareness, and affordability.

Laboratory management in India is a super-specialized arena. The need of the hour is to make dedicated investments in terms of sophisticated analytical technologies, skilled human resources, instruments, and reagents; comply with stringent accreditation guidelines; and provide excellent customer service such as exhaustive test menu, along with short and accurate reporting times.

In order to overcome these challenges, the market is moving toward automated systems. Upgrading the laboratories to totally computerized fully automated systems has made a big difference in the bottom lines of many laboratories, by cutting down the cost of consumables and less requirement of qualified and trained technicians. These factors have prompted lab managers to go in for automation.

Customers are placing a lot of weightage on the quality of service backup they receive. The emphasis is on getting complete solutions from a single company. High-end laboratories opt for automated integrated systems. Developments of software programs have also allowed the integration of various workflows of biochemistry analyzers for better control and operational efficiency.

One of the major factors driving the growth of the market is the advancement in technology. The increase in automation of biochemistry instruments is the key advancement in technology for high-throughput analyses of biochemical entities. High-throughput analyses consume less time and generate results quickly.

The use of automation in clinical labs has progressed significantly, from the first random-access analyzer to total lab automation (TLA). Laboratories now desire complete solutions from a single provider, like closed system reagents with calibrators and controls, and viable software.

Additionally, the fully automated analyzers market is moving toward testing consolidation, which is creating demand for integrated systems with expanded capabilities, thereby securing the future of next-generation laboratory analyzers. Given the trends being observed among biochemistry labs today, automation will play an even larger role in the future, going beyond operational effectiveness to also positively impact clinical effectiveness and ultimately help improve patient outcomes.

Sachin Singh
Head: Strategic and Operational Marketing,
DiaSys Diagnostics India Pvt. Ltd.

Dr Vijay S. Bhat
Second Opinion
The Future of Clinical Laboratory Immunology

In the last decade, there have been striking changes in the practice of clinical laboratory immunology, as diagnostic testing for infection is no longer the major activity now. Technological advances have come in various immunochemical methodologies. Now cytokines (e.g. TNF-alpha and IFN-gamma) receptors (sTNF-r) and soluble immune activation markers (e.g. Neopterin and B2M) can be measured in blood and within stimulated lymphocyte subsets (T-cell, B-cell, NK-cell etc.) to assess the capacity of the immune system to respond to specific stimuli. Therefore autoimmune diseases, allergy and asthma, organ and bone marrow transplantation, lymphoid and plasma cell malignancies, primary and secondary immune deficiencies, are being brought under the umbrella of clinical laboratory immunology testing.

Modern immunology relies heavily on the use of antibodies as highly specific laboratory reagents. The diagnosis of infectious diseases, successful outcome of transfusions and transplantations, and the availability of biochemical and hematologic assays with specificity and sensitivity capabilities all attest to the value of antibody detection. So advances in diagnostic immunology are now driven by instrumentation, automation, and implementation of less complex and standardized procedures. Such processes can be either amplified immunoassays (chemiluminescent ELISA), flow cytometry with monoclonal antibodies, immunoglobulins, or molecular methods (polymerase chain reactions).

Outlook

Predictive immunology from single biomarkers to the "omics" is in vogue now, as predictive, preventive, and personalized medicine (PPPM) occupies a key position in assisting diagnostics towards the estimation and correlation between genetic polymorphism and risk of a disease. Subclinical stages are also determined by identification of highly specific proteomic related biopredictors. To name a few, type 1 diabetes, multiple sclerosis, strategic avenues, and global tools are being developed toward its related care, using highly specific immunological biomarkers, in the process using genomics and "ex vivo" generated cell-based therapies. Thus, as each disease has individual fingerprints, goal of modern technology would be to implement the latest immunological assays in laboratory, in solving problems related to the disease.

Dr Vijay S. Bhat
ConsultantBiochemist, HOD-Laboratory Medicine,
Manipal Hospitals, Bangalore


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