The coagulation laboratory is in an ever-changing environment, populated by automated analyzers that offer advances in both volume and variety of tests. There are several general' considerations around which the next generation of hemostasis instrumentation might be designed. Indeed, an issue is represented by the evolution of laboratory diagnostics as a whole. Modern clinical laboratories are increasingly consolidated within networks or large facilities. This tangible revolution carries notable implications in the way laboratory resources are organized and tests ultimately delivered. The foremost consequence is that the layout of the future coagulation analyzers may be designed to fit small, medium, and large laboratories.
To put it simply, rather than creating a vast array of different models of analyzers that can individually fit highly heterogeneous volumes of testing in different geographical environment, the use of modular instrumentation enables simple connection of separate analyzers, with substantial savings in both human and economic resources. Automation has pre-potently revolutionized workflow and sample management in modern laboratories. Several technical solutions exist that can be customized around specific needs of organization and testing volume.
Indian Market Dynamics
The Indian market for coagulationreagents and instruments in 2015-16 was valued at 122 crore, with reagents dominating at 107.36 crore. This includes 16 percent customs duty and 10 percent freight.
The instruments at 14.64 crore have a contribution of 9.66 crore from fully automated instruments. The market for semi-automated instruments constituting single-channel, 2-channel, and 4-channel were valued at 4.98 crore in 2015-16.
Stago is represented by five distributors – Syndicate Diagnostic P Ltd, Bio Medica, Nisha Sales, Labex, and Imperial Biotech. 2015-16 was a good year for the company. Metropolis awarded its exclusive order to the vendor and it replaced most of the instruments in the Apollo Group.
Werfen India was not far behind. Its major customers included SRL Diagnostics, Dr Lal Pathlabs, CMC, Max, Gangaram, PGI Chandigarh, AIIMS, SGPGI, the Global Group, the Care Group and St Johns, and the Indian Army.
In August 2016, Sysmex Corporation received the 14th Annual Merit Award for Collaborative Achievement between Industry, Academia, and Government of Japan for the practical realization of a system for diagnosing hepatic fibrosis using glycosylation, developed in collaboration with the National Institute of Advanced Industrial Science and Technology.
Advances in Coagulation Technology
Significant advances have been made in the capability and flexibility of coagulation instrumentation. Instruments previously required manual pipetting, recording, and calculating the results, which necessitated significant operator expertise, intervention, and time. Current technology allows a walkaway environment in which, after specimens and reagents are loaded and the testing sequence is initiated, the operator can move on to perform other tasks.
Clot detection methods have remained consistent but with the advent of chromogenic- and immunologic-based assays, other instrumentation needed to be incorporated into the coagulation laboratory. Multiple methodologies became incorporated into single analyzers to expand their test menu options. From instruments that performed only clot-based assays, clinical laboratory instruments were developed that could perform both clot-based and chromogenic-based assays on one platform. The next step was the development of a single instrument that could perform clotting and chromogenic and immunologic assays. Additional advances have included improved specimen and reagent storage and processing, increased throughput, and enhanced data management and result traceability.
Random access testing. Automated coagulometers now provide random access testing. Through simple programming, a variety of tests can be run in any order on single or multiple specimens within a testing sequence. Previous automated analyzers were capable of running only one or two assays at a time, so batching was necessary. The disadvantage was that specimens with multiple orders had to be handled multiple times. For current automated analyzers, the ability to run multiple tests is limited only by the number of reagents that can be stored in the analyzer and the instrument's ability to interweave tests requiring different end-point detection methodologies simultaneously, such as clot-based, chromogenic, and immunologic methods. Random access promotes profiling.
Open reagent systems. A variety of reagents from numerous distributors are available for coagulation testing, and laboratory directors want the flexibility of selecting the reagents that best suit their needs without being restricted in their choices by the analyzers being used. Recognizing that the ability to select reagents independently of the test system is a high priority, instrument manufacturers have responded by developing systems that provide optimal performance with alternative manufacturers' reagents, provided that the reagents are compatible with the instrument's methodology.
Expanded computer capabilities. The computer circuitry of analyzers now incorporates internal data storage and retrieval systems. Hundreds of results can be stored, retrieved, and compiled into cumulative reports. Multiple calibration curves can be stored and accessed. Quality control files can be stored, which eliminates the time-consuming task of manually logging and graphing quality-control values. Westgard rules can be applied, and failures are automatically flagged. Some analyzers feature automatic repeat testing when failures occur on the initial run. The quality control files can be reviewed or printed on a regular basis to meet regulatory requirements.
The programming flexibility of modern analyzers has enhanced the laboratory's opportunities to provide expanded test menus. Most advanced analyzers are preprogrammed with several routine test protocols ready for use. Specimen and reagent volumes, incubation times, and other testing parameters do not need to be predetermined by the operator but can be changed easily, when necessary. Additional tests can be programmed into the analyzer by the user, whenever needed, which allows for enhanced flexibility of the analyzer and reduces the need for laboratories to have multiple instruments.
Instrument interfacing to laboratory information systems and specimen bar coding capabilities have become a priority as facilities of all sizes endeavor to reduce dependence on manual record keeping. Bidirectional interfaces improve efficiency through the ability of the instrument to send specimen bar code information to the laboratory information systems and receive a response listing the tests that have been ordered. This eliminates the need for the operator to program each specimen and test.
Indian Market Dynamics is based on market research conducted by Medical Buyer in November 2016.