Molecular Diagnostics in the Microbiology Laboratory

A look at some of the newest generation ‘load and go’ molecular microbiology analyzers.

For decades, pathogens have been isolated and grown in blood cultures, and detected using microscopes, serology and biochemical techniques. However the last few years have seen a revolution in modern microbiology.

The above tests still form the core work of most routine microbiology labs, but modern analytical techniques such as molecular diagnostics and mass spectrometry are increasingly being incorporated, to varying degrees, in laboratories around the world.

Molecular diagnostics refers to the analysis of nucleic acid from DNA or RNA. In the clinical microbiology lab, scientists are looking for the nucleic acid of microorganisms to confirm or exclude a diagnosis.

The molecular diagnostic work undertaken in the lab can vary from a simple, manual monoplex polymerase chain reaction (PCR) based test to complex automated, multiplex testing (testing for multiple pathogens simultaneously). Some of the newest generation ‘load and go’ molecular analyzers are detailed below.

VERIS Mdx Molecular Diagnostics System

The DxN VERIS combines sample prep and sample analysis steps into a single workflow. The automation of DNA extraction, purification, assay set-up and analysis saves the user time and also prevents user error and the risk of contamination. Using real-time PCR, the system is designed for multiplex assays and uses magnetic particle separation for nucleic acid extraction and purification. The initial test menu includes Cytomegalovirus, Hepatitis B, Hepatitis C and HIV-1 ......

Read more: Molecular Diagnostics in the Microbiology Laboratory

Microbiology has traditionally involved use of blood cultures, however molecular methods are
increasingly employed in modern laboratories;
Beckman Coulter's VERIS Mdx Molecular Diagnostics System

Source: SelectScience

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

Clinical Chemistry Analyser: Vitros 5600

An integrated chemistry analyser - Vitros 5600.

Here is an overview of the Vitros 5600 integrated analyser, a next generation system of Ortho Clinical Diagnostics (a JnJ Company).

Highlights:

• capability to add or remove reagents and consumables, and empty solid and liquid waste while operating;
• sample-centered processing integration approach eliminates need to move sample trays or aliquot samples between chemistry and immunoassay processing modules;
• integrates chemistry, immunoassay, and infectious disease testing, and process them in parallel; 
• integrated MicroTip technology expands menu availability, such as DATs, TDMs, specific proteins, %HbA1c, and user-defined channels;
• MicroSensor technology detects interfering levels of hemolysis, icterus, and turbidity;
• e-Connectivity assists with remote diagnostics, software, and test parameter downloads and updates

Video Link: Vitros 5600

Source: www.orthoclinical.com

How about having your DNA analyzed?

Your DNA is a bit like a crystal ball.

It’s strange to think at our core there might be a strand that dictates how much of our life plays out. It can influence a person’s chance of becoming a supermodel, a sufferer of an acute disease, having a sweet tooth or going grey at the age of 21.

So if someone offered to take a look at your DNA for you, would you take them up on the offer?

Life Letters is an Australian company that will analyse your DNA for $540.

The test has been created to let prospective parents know the risk of passing 148 genetic faults on to their children. These include cystic fibrosis, Tay-Sachs, haemophilia, spinal muscular atrophy and fragile X syndrome. In some instances they may find something in your DNA that could affect your personal health in the long term, but the main focus is what you’ll potentially pass on to your children.

The tests can be purchased online, you don’t need a doctor’s referral and at the end you have a consultation with a genetic counsellor over the phone who makes sure you understand the information and can make educated decisions.

Read more: How about having your DNA analyzed?

Do you want to know the story your DNA tells?

Source: news.com.au

Enabling Rapid Results for Effective Neonatal Care

The epoc® Blood Analysis System provides the fast and accurate results that clinicians need to make accelerated treatment decisions

Anyone working with neonates understands the importance of quick and accurate analysis. These tiny patients have different biomarkers from adults, they also have immature immune systems and provide smaller blood samples that are more difficult to acquire. However, with neonatal testing, timing and result quality is often crucial to the wellbeing of the child.

Case Example: London, UK – Gracie*

Gracie was born prematurely. She immediately had trouble breathing, despite the rapid use of an oxygen breathing mask and was whisked off to the NICU. Glucose, oxygen, and electrolytes were quickly analyzed using the epoc® Blood Analysis System and after seeing the results, the doctor was able to give a prompt diagnosis of Persistent Pulmonary Hypertension. Gracie’s rapid results meant that she could receive the treatment she needed and was soon able to be reunited with her parents. 

epoc® Blood Analysis System

Such quick testing is made possible by the advanced Smartcard Technology and wireless communication offered by the epoc® Blood Analysis System. This point-of-care testing solution is able to analyze a small sample of blood (92μL) and transfer the results wirelessly to the epoc® Host2 Mobile Computer, in approximately 30 seconds. This almost instantaneous delivery of blood gas, oxygen, and electrolyte results from the patient’s bedside, allows the clinician to make the accelerated treatment decisions that are necessary when dealing with acute neonatal situations.

Read more: Enabling Rapid Results for Effective Neonatal Care

Clinicians have to make rapid treatment decisions when dealing with acute neonatal situations

Source: Pixabay

Laboratory Developed Tests (LDTs)

An emerging area of FDA regulation

Laboratory developed tests (LDTs) are being increasingly integrated into the standard practice of diagnosing and predicting the risk of developing a disease, as well as informing decisions regarding the management of disease states like cancer, heart disease and diabetes. LDTs are in vitro diagnostic tests that are designed, manufactured and used within a single laboratory. LDT providers typically create the necessary reagents themselves or purchase reagents from outside vendors and then develop their own proprietary tests for in-house pathology and diagnostic purposes, which facilitate the evaluation of alterations in biomarker levels and/or the presence or absence of genetic susceptibility mutations in patients. These diagnostic tests may aid in clinical decision making pertaining to the prevention, treatment and management of an array of common diseases.

Estimates suggest that tens of thousands of diagnostic tests, including the majority of genetic tests, are currently offered as LDTs.1 The growing reliance on diagnostic tests in guiding critical treatment decisions, combined with the dramatic increase in the number and complexity of LDTs, have created legitimate concerns over the safety and effectiveness of new LDTs. Accordingly, regulatory safeguards that ensure the accuracy of LDTs, particularly high-risk LDTs, are warranted so that patients do not seek unnecessary treatments, delay needed treatments or become exposed to inappropriate therapies.

Read more: Laboratory Developed Tests (LDTs)

Source: PersonalizedMedicine

Transforming our lives with laboratory-grown organs

With people living longer than ever, being able to replace bits of the human body as they wear out has become a new frontier in medicine.

Most babies born in 1900 died before the age of 50; 100 years later life expectancy in the UK now exceeds 80 years, with the number of over-65s expected to double by 2030. This trend is radically changing the age demographics of the population and creating a new set of challenges for engineers. One of the most significant of these is to give people a higher quality of life in their old age.

Significant progress has been made; 300,000 hip replacements are now performed annually worldwide, releasing people from pain, and extending the active period of their lives by 20 years or more. The success of these implants has led scientists to develop a new type of biomaterial that is promising to do for medicine what silicon did for computing.

Historically the function of biomaterials has been to replace diseased or damaged tissues. These biomaterials were selected to be as inert as possible while fulfilling mechanical roles such as teeth filling and hip replacement.

Read more: Transforming our lives with laboratory-grown organs

UCL professor Alex Seifalian holds the trachea that was used in the first synthetic organ transplant

Source: RexShutterstock

Visualizing looks of the future lab

Driven forward by improving technologies and increasing demands, the lab of the future could be markedly different in appearance from the laboratories we work in today. From incorporating 3D printing technology to changing the way that lab data is recorded, we take a closer look at how the next generation of laboratories might evolve. 

The paperless lab concept is not a particularly new one, and many laboratories currently operate without physically recording research and development. Tablet devices allow laboratory teams to record their findings electronically, reducing physical waste and optimising storage organisation.

However, Cloud storage tools have made it simpler for laboratory workers to save their findings in a safe and accessible location. This allows laboratories around the world to help and assist each other in real time. The commercial science lab of the future could incorporate Cloud-connected devices to alert the team of relevant updates and developments. Increased connectivity could help ensure less of the budget and less time is wasted, and more is invested in genuine progress. This momentum towards a paperless research laboratory will require labs to obtain access to trusted servers, data centres and secure network connectivity.

The increasing power and availability of 3D printers have made it possible (not to mention affordable) to create pieces of hardware in the laboratory. Specially designed nails, screws and other important components can be created to fit specific requirements. A number of design companies offer open-source hardware printing services, which enable labs with access to 3D printers to immediately develop their own hardware essentials.

Read more: Visualizing looks of the future lab

Source: shutterstock

A personal interpretation

There is a clear move away from a ‘one size fits all’ approach to medicine and instead a new personalized medicine strategy is becoming more important. Mike Furness explains more about multiomics.

It has been known for a while that people with different genotypes respond to drugs differently. Knowledge gained from studying rare genetic disease has improved understanding of important biological pathways, creating the opportunity for more effective treatments.

For early developmental diseases this has meant that each symptom is investigated in isolation, by a specialist in that area. The patient is sent from one clinician to another. On average a child with a rare genetic disease will been seen by seven physicians over a five year period before a diagnosis may be found. For many of these children there will be no diagnosis but recent advances in genomics will address this problem.

It was against this background that the Discovering Development Disease (DDD) project was established between the NHS and the Wellcome Trust Sanger Institute. It has so far genotyped around 14,000 children with undiagnosed conditions and their parents, providing diagnoses for around 40% of these families, and identifying clusters of affected children that had similar clinical characteristics and shared damaging genetic variants in the same gene. Many of these genetic diseases are so rare that a clinician may see only one or two cases in a career; so being able to compare their patient’s genetics to this growing body of knowledge is a major step forward in helping consultants determine a definitive diagnosis.

Read more: A personal interpretation

Source: shutterstock

A clinical look at the future of pathology

Rapid change has become a defining feature of pathology – but can this change power a new generation of laboratory software to shape the role of the clinical laboratory of the future?

It will come as no surprise to those in the clinical laboratory and pathology field that the market is undergoing rapid change. In recent decades health expectations have risen globally, with all member states of the World Health Organisation committed to working towards universal health coverage worldwide.

The proper scaling of pathology services is key to this growth, as pathology is involved in 70% of all healthcare diagnoses. If the pathology market follows the compound annual growth rate of 6.8% from 2014 to 2020 as predicted in a new study by market analysts Grand View Research1, then the global market for clinical laboratories is expected to reach US$149 billion by 2020.

Along with the rise of universal healthcare, other factors are driving change in the pathology market. These include an aging population and the rising prevalence of chronic conditions like obesity and diabetes. We are also seeing an upsurge of new testing methods to support initiatives such as personalized medicine, also known as genomic medicine, and point-of-care testing.

Read more: A clinical look at the future of pathology

Source: shutterstock