Validation of Hematology Analyzers

Perhaps the most common laboratory procedure performed for hospital patients and outpatients is complete blood count (CBC) or CBC with differential. CBC serves as a screening and diagnostic test for a wide range of conditions and diseases as well as a monitoring tool for treatment and disease status. Given its foundational nature and despite its relative simplicity, the veracity of this basic blood testing is essential. Therefore, thorough validation testing on all new hematology analyzers must be performed to ensure patient safety.

It is reasonable to assume that a newly acquired piece of diagnostic equipment would run as intended, as manufacturers perform their own validation testing to prove intended use and to fulfill regulatory requirements prior to launching a product in the market. However, the ultimate responsibility of verifying instrument performance specifications and characteristics prior to the patient testing falls to the end-user laboratory.

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Source: MedLabMag

Is Fully Integrated LC-MS/MS The Future For The Routine Clinical Lab?

Liquid chromatography-mass spectrometry (LC-MS/MS) is an analytical chemistry technique that combines the physio-chemical separation capabilities of liquid chromatography (via conventional chromatography within a column) with the analytic power of mass spectrometry. It allows the user to properly ascertain the individual mass/charge ratio of analytes present in a chromatographic peak. 

The high throughput capabilities of this technique will bring value to the clinical lab, where time taken to analyze samples is paramount. Bringing LC-MS/MS testing into the clinical setting has been a slow process, however, the medical device industry is on the verge of a fundamental breakthrough that could help drive the adoption of this technique.

Read more: Is Fully Integrated LC-MS/MS The Future For The Routine Clinical Lab?

Source: ClinicalChemistryInternational

Biomedical Laboratory Automation

Improve safety and efficiency in various types of clinical laboratories with Thermo Scientific™ TCAutomation™ Laboratory Automation Solutions. This expandable and scalable, fully-featured laboratory automation solution allows labor-intensive tasks in pre- and post-analytical phases of sample management to be automated in different combinations. Depending on the floor plan and efiiciency requirements, the TCAutomation™ systems can be expanded step-by-step.

TCAutomation™ systems throughput can range from 250 up to 1000 tubes per hour. Because solutions are modular, they are easy to expand. Automating can be started from a certain function and built up towards total laboratory automation. Samples are transported in the system within dual-lane conveyors in a multitube carrier which accommodates several tube sizes. The carrier includes an embedded microchip, based on RFID technology, making sample identification fast and reliable, and enabling excellent real-time sample tracking possibilities.

Read more: Biomedical Laboratory Automation

Download: Thermo Scientific TCAutomation Laboratory Automation Solution

Source: ThermoFisherScientific

Data Analytics in the Clinical Laboratory

Managing test utilization reveals opportunities for improved laboratory performance and better patient care

The laboratory reimbursement market is shifting away from consumption-, fee-for-service-, and transaction-based paradigms to models based on the quality and value of the services provided by clinical labs. Payors are increasingly asking health systems and their providers to respond by providing high-quality care while being mindful of financial performance.

In turn, the move away from fee-for-service payments in favor of other models of reimbursement—especially bundled payment models—is causing lab managers to take a hard look at how they can reduce unnecessary testing.

Read more: Data Analytics in the Clinical Laboratory

Source: clpmag

Medical Laboratory Technology

A medical laboratory scientist (MLS), also referred to as a clinical laboratory scientist (Honors) or Medical laboratory technologist (Old name for simple Bsc degree holder) is a laboratory based healthcare professional who performs complex chemical, hematological, immunologic, histopathological, cytopathological, microscopic, and bacteriological diagnostic analyses on body fluids such as blood, urine, sputum, stool, cerebrospinal fluid (CSF), peritoneal fluid, pericardial fluid, and synovial fluid, as well as other specimens.

Medical laboratory scientists work in clinical laboratories at hospitals, physician's offices, reference labs, biotechnology labs and non-clinical industrial labs.

Video Link: Medical Laboratory Technology

Source: SaskatoonHealthReg

Diabetes Testing on High-Throughput Analyzer Files for FDA Approval

The cobas c513 analyzer has been submitted to the US Food and Drug Administration (FDA) for approval as a dedicated, high-throughput HbA1c testing solution to help laboratories meet increasing testing needs for people with diabetes.

The cobas c513 analyzer from Roche (Basil, Switzerland) is based on the proven, trusted cobas technology developed in cooperation with Hitachi High-Technologies (HHT). The HbA1c test is a longer term measurement of blood sugar levels used to determine if a person has or is at risk of developing diabetes. Set to run on the established Tina-Quant HbA1c A1cDx Gen.3 test, which is also used across the Roche laboratory HbA1c portfolio, the cobas c513 will ensure high-quality results and comply with current guidelines and recommendations for HbA1c testing and measures A1c as defined by the IFCC.

cobas c513 features direct results reporting, thereby minimizing risk of result misinterpretation and eliminating the need to perform time-consuming, manual result interpretation. This feature will help save valuable time and laboratory resources, while ensuring high-quality results. Furthermore, cobas c513 will provide a higher on-board test capacity, enabling laboratories to load the analyzer with more tests at a time, save lab space, minimize resources, and ensure a smooth workflow.

Read more: Diabetes Testing on High-Throughput Analyzer Files for FDA Approval

The cobas c513 analyzer provides throughput of up to 400 HbA1c patient results/hour, closed

tube sampling (CTS), and is standardized according to IFCC transferable to DCCT/NGSP

Source: Roche

What Does a Medical Laboratory Technician Do?

You’ve heard about the exciting career opportunity in the healthcare industry, but you don’t exactly picture yourself as a nurse. It’s important to know that not all healthcare careers involve direct patient care. There are in-demand opportunities in the field that allow you to work behind-the-scenes while still having a positive impact on people’s health.

Becoming a medical lab tech (MLT) is one of those opportunities. The bright future of this field is indicated by the 30 percent projected increase in jobs through 2022, according to the Bureau of Labor Statistics (BLS).

That stat alone should pique your interest about this career. But it’s not enough to make up your mind. Before choosing to pursue this profession, you need to be able to answer the following question: What does a medical lab tech do?

So what does a medical lab tech do? They work in laboratory settings that aid in disease and illness diagnosis – but that is merely the tip of the iceberg. The variety of duties that an MLT performs makes it an ever-changing position that demands creativity and problem-solving skills.

But before you can realize you want to become a medical lab technician, you should be able to answer the following question: what does a medical lab technician do, anyway? Keep reading to find your answer!

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What Does a Medical Laboratory Technician Do?

Source: Rasmussen College