Hematology – Inclining Toward Highly Sensitive and Efficient Analysis

Hematology analyzers can now use computer vision technologies to recognize, enumerate, differentiate, and count blood cells.

The hematology analyzer has witnessed fierce technological evolutions because of the introduction of new methods for cellular analysis and the rapid development of software. There has been a marked improvement in data management and analytic efficiency. Moreover, there is increasing adoption of technological innovative products such as the expansion of high throughput analyzers and introduction of basic cytometry techniques.

Several companies are manufacturing and marketing miniature instruments with high accuracy. Analyzers are converging multiparameter tests into single platforms through these miniaturized instruments, thereby helping labs and hospitals to save on heavy investments. All these processes go a long way in reducing manual reviews, thereby boosting the efficiency in the hematology analyzer market.

Indian Market
The Indian hematology instruments and reagents market in 2016 is estimated Rs. 952 crore, with reagents constituting a 63 percent market share.

The six-part high-end automated slide-sharing stainers are being bought by some discerning premium institutes. The slide stainer is directly connected to the analyzer, and when set up and loaded with slides, it offers walkaway capabilities. In general, it takes 5–10 minutes to stain a batch of slides. Only a handful of leading players offer this top-of-the-line product. In 2016, this automated analyzer was procured by Amrita Institute of Medical Sciences, Wadia Hospitals, KLE Hospital, BLK Super Specialty Hospital, Christian Medical College Vellore, Tata Memorial Hospital, and Green Cross Hospital, among others.

Some of the government procurement was made by Directors, Medical Education and Research, Mumbai, Kerala, Gujarat, Uttar Pradesh, and the Defense Services. In June 2016, the department of pathology and blood bank at AIIMS, Jodhpur, procured Sysmex reagents and consumables for hematology analyzer system models XN 1000 B3 and XP-100 from Transasia Bio-Medicals.

While all the segments are facing an increase in demand, the three-part instruments are gradually being replaced by five-part entry-level instruments. The five-part analyzers, which dominate this segment with a 63 percent share may be segmented as high-end, mid-end, and entry level. While the mid-end segment, with a share of 21 percent features 100-sample capacity autoloaders, the high-end models, with a volume-wise share of 16 percent, extend the analyzer’s output in the form of reticulocytes, nucleated RBCs, and fluorescent platelet counts for wider clinical application and research.

The three-part analyzer continues to be the backbone of this segment. It dominates with an 88 percent market share in volume terms and a 64 percent in value terms. The single-chamber models are estimated to have a 40 percent share, the balance being contributed by double-chamber analyzers. Competitively priced, unlike its five-part and six-part counterparts, the three-part analyzer is not sought to be placed, and all the models are purchased outright. It is estimated that in 2016, an additional 95 units (to the sales of 855 units) five-part analyzers were placed and only 290 units of six-part analyzers were sold, which include the premium, automated slide stainer models too.

Semiautomated instruments are gradually making their exit.

Over the last couple of years, the number of companies representing imported brands in India, especially the Chinese, have increased, bringing more competition to the market. Also, some Indian companies have started focusing on manufacturing reagents in India, thereby importing the analyzers from established brands as original equipment, under their own brand name, and marketing the instruments along with the reagents they manufacture. This is creating a more intense demand for open systems and making servicing and prompt availability of spare parts a major differentiator.

Technology Trends
The ongoing revolution of diagnostic testing, squeezed between reduced funding and increasing volumes, carries notable implications in the way laboratory resources are organized and coagulation tests delivered. It is, therefore, predictable that the newer generation of hematology analyzers may be designed to face these emerging needs whilst maintaining a high degree in the quality of testing.

Automation and computer vision technology. Most modern hematology analyzers are fully automated, allowing the user to place the samples at the start, press a button, and wait for a result to be produced at the end of the analysis. The ongoing revolution in technologies has led to the development of hematology analyzers that can use computer vision technologies to recognize, enumerate, differentiate, and count blood cells. The devices automatically perform analysis of a captured digital image, create a report file, and send it to a printer.

Six-part and seven-part analyzers. After the replacement of three-part analyzers by five-part analyzers over the years, now nucleated red blood cell counts and immature granulocytes are emerging as sixth and seventh parameters owing to increasing demand for automation to deliver reliable red blood cell counts, platelet counts, and five-part differentials of white blood cells. The analyzers today combine both bioelectrical impedance and light-scattering detection techniques along with integrated flow cytometry.

Outlook
A noticeable shift in the hematology laboratories has been seen from manual counting toward 100 percent automation owing to growing preference toward high-sensitivity hematology testing. The touchscreen and silent design concept are well-suited to meet the requirements in the hematology labs. The future is predicted to have more advancement because of the large R&D funds available. Next-generation analyzer technology will be created with advanced clinical parameters to improve 3D imaging and clinical utility.