In Vitro Diagnostics
Clinical diagnostics, particularly in vitro diagnostic (IVD) testing, analyzes patient samples like blood, saliva, or urine using IVD devices to detect diseases. Proper sample handling, storage, and traceability are essential for safe, accurate results. Automating IVD workflows reduces errors and improves efficiency across pre-analytical, analytical, and post-analytical phases, with Total Laboratory Automation (TLA) and Laboratory Information Management Systems (LIMS) supporting full traceability and accurate diagnoses.
How Hamilton Supports In Vitro Diagnostics Workflows
A symptomatic patient visits a physician or hospital, and samples are collected for diagnostics. These samples are transported to a laboratory, where they are identified and then prepared for short-term routine storage. Automated processes in this pre-analytical phase include decapping, fraction identification (e.g. blood samples), aliquoting, and recapping, freeing lab personnel to focus on quality and throughput.
During the analytical phase, the samples are processed for the relevant diagnostic test within the specific departments.
Key steps of the post-analytical phase include validating and approving the generated results for release and transmitting them back to the physician or hospital for medical diagnosis and treatment. During this phase, the samples are often archived and can even be retrieved for retesting or disposed of from an automated storage system according to regulatory requirements.
Explore Hamilton Products for Key In Vitro Diagnostics Applications
Good to Know About In Vitro Diagnostics
This section provides a selection of additional resources related to the application described on this page. It includes helpful articles, videos, and blogs that offer deeper insights into the topic.
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What Is In Vitro Diagnostics?
IVD testing involves analyzing samples such as blood, tissue, or other bodily fluids taken from the human body. These tests are conducted outside the body, typically in a laboratory setting—hence the term "in vitro," which means "in glass."
IVD tests are used to detect diseases, conditions, or infections and play a crucial role in supporting physician decision-making and monitoring patient health. Around two-thirds of all medical diagnoses are based on IVD tests.
What Are Typical Automated Workflows in In Vitro Diagnostic Laboratories?
Clinical laboratories are highly automated facilities. Routine diagnostic of blood samples for clinical chemistry and immunoassays is typically processed via a TLA track that automatically directs samples to the specific analyzers.
Automated workflows for specialized diagnostics such as microbiology, molecular diagnostics, or allergology testing have become more and more important as pressure to enhance efficiency increases. These automated processes support faster, more consistent data that physicians rely on to make timely clinical decisions.
What Automated Solutions Exist for In Vitro Diagnostic Sample Preparation?
Nucleic acid extraction, protein extraction, centrifugation, and blood fractionation are typical sample preparation steps that can be easily automated.
What Type of Fully Automated Instruments Are Used in Clinical Laboratories?
Fully automated instruments perform end-to-end processing, from sample intake to results reporting. In routine diagnostics, those analyzers are connected to TLA tracks. Pre-analytic steps of sample preparation prior to the fully automated instruments are necessary and depend on the sample matrix.
The sample preparation consists of isolating the specific analytes via fractionation, dilution, or extraction steps. Those steps can be integrated into the TLA system (e.g., centrifugation & blood fractionation), be part of the workflow on the fully automated system, like nucleic acid extraction for genetic diagnostic testing, or as a semi-automated step prior to the analyzer. These flexible workflow options allow clinical teams to customize automation to fit their sample types, throughput demands, and diagnostic goals.
How Do Clinical Laboratories Efficiently Store Samples?
Sample storage plays an important role in the intermediate storage of samples between analyses. Serum banks and DNA storage are examples of intermediate storage. Besides intermediate storage, post-analytical storage, used for sample retrieval, retesting, or regulatory compliance, is equally critical.
Automated storage solutions help laboratories reduce manual handling, improve traceability, and ensure consistent sample integrity across teams and testing phases.
How to Automate Post-Analytical Processing?
Integration of automated storage solutions to TLA tracks can facilitate and speed up proper storage and easier retrieval.
Independent automated storage solutions are equally effective for storing samples tested outside of TLA systems, offering flexibility across workflows. Full traceability, automated retrieval for retesting, and automated disposal of samples significantly reduce the time laboratory staff need to spend on these steps.
How Can We Guarantee Sample Traceability from Sample to Result?
Samples are typically traced via a barcode managed by LIMS. Instrumentation identifies samples via barcode scan prior to processing to guarantee that the right sample is processed.
Overview of Common Techniques Used in In Vitro Diagnostics
In clinical diagnostic laboratories, various techniques are applied to analyze biological samples and assist in diagnosing medical conditions. These techniques can be broadly categorized based on the type of test being performed, the technology used, and the nature of the analysis.
Molecular Diagnostics
Analyzes genetic material (DNA or RNA) to detect genetic disorders, infectious diseases, or mutations.
Immunodiagnostics
Relies on the interaction between antibodies and antigens to detect biomarkers, pathogens, or specific proteins (e.g. from the immune system).
Microbiology
Identifies and characterizes microorganisms (bacteria, viruses, fungi, or parasites) in clinical samples.
Clinical Chemistry
Measures the chemical components of biological fluids to assess organ function or diagnose diseases.
Hematology and Blood Analysis
Study of blood components, including red blood cells, white blood cells, platelets, and plasma, to identify pathologies.
Where In Vitro Diagnostics Is Used (Industries and Purposes)
In vitro diagnostic workflows are widely applied across a range of clinical settings, supporting laboratories in delivering timely, high-quality results that inform patient care. These environments include:
- Private clinical laboratories (independent of hospitals)
- Private clinical hospital laboratories
- Governmental clinical hospital laboratories
- Private in vitro diagnostic service providers
In Vitro Diagnostics Case Studies and Application Notes
Other In Vitro Diagnostics Resources
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
Browse app notes, user guides, specification documents, and more in our Knowledge Center.
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