In Vitro Diagnostics (IVD)
In vitro diagnostic (IVD) tests analyse patient-derived samples including blood, tissue and other body fluids to detect disease, guide treatment and monitor health. Meaning “in glass”, in vitro testing is performed outside the body, unlike in vivo testing, which takes place within a living organism.
IVDs play a critical role in modern healthcare, supporting decision-making across the continuum of care from screening and early diagnosis through to prognosis, personalised treatment and long-term monitoring. Despite influencing as many as 70% of clinical decisions, IVDs account for less than 1% of healthcare expenditure across the EU27, UK and EFTA, highlighting the substantial clinical information they provide relative to healthcare spending (1).
IVDs can be performed in laboratories or in near-patient settings through point-of-care and at-home testing. Different diagnostic approaches are used depending on the clinical question, sample type and biological target being measured:
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Immunoassays such as ELISA, lateral flow assays and radioimmunoassays use antibody–antigen interactions to detect or quantify proteins, antigens or antibodies.
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Immunohistochemistry uses antibodies to identify and localise specific biomarkers within tissue.
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Molecular diagnostics use techniques such as PCR and sequencing to detect specific DNA or RNA sequences.
Together, these approaches support everything from rapid infectious disease testing to more detailed molecular and tissue-based analysis in areas such as oncology and personalised medicine.
The IVD workflow
Although individual tests vary, most IVD workflows follow four broad stages:
- Sample collection: An appropriate patient specimen is collected to accurately reflect the person’s health status.
- Sample preparation: The sample may be separated, diluted, filtered or otherwise processed to make the target suitable for analysis.
- Testing: The target analyte is detected or measured using the appropriate diagnostic method, with controls helping confirm assay performance.
- Analysis: Results are assessed against reference ranges, thresholds or other clinical information to support a meaningful clinical interpretation.
2BScientific Limited provides a range of IVD products and diagnostic reagents from specialist suppliers, supporting workflows from assay development and sample analysis through to detection and quality control.
Our IVD Ranges
Before an IVD can generate a reliable result, it needs reliable components. Many diagnostic assays are built around carefully characterised antibodies, antigens, controls, calibrators and detection reagents. Choosing high-quality, well-characterised reagents from specialist suppliers is therefore critical to assay sensitivity, specificity and consistency.
Medix Biochemica is a leading supplier of raw materials for IVD development, including antibodies and antigens used in immunoassays, alongside processed plasma and serum that can be used as starting materials for IVD controls and calibrators. Its portfolio supports diagnostic areas ranging from infectious disease and cardiovascular testing to tumour markers and metabolic disease.
Immunoassay IVDs are a cornerstone of modern diagnostics, combining the specificity of antibody–antigen recognition with highly adaptable test formats to detect or quantify specific targets in patient samples including proteins, antigens and patient antibodies.
ELISA
The enzyme-linked immunosorbent assay (ELISA) is a biochemical assay that converts specific antibody–antigen binding into a measurable signal (2). ELISAs are particularly useful when clinicians need to detect or quantify a defined target with high specificity. Their sensitivity can support low-level detection, while the microplate format enables multiple samples to be processed in parallel using a simple and well-established laboratory workflow.
Lateral flow assays
Lateral flow assays (LFAs) use antibody-antigen recognition in a simple strip-based format to deliver rapid results (3). As the sample moves along the strip, any target present is captured at the test line to produce a visible signal. Their speed, simplicity and minimal equipment requirements make LFAs particularly useful for point-of-care and at-home testing.
VIDIA offers a broad range of diagnostic immunoassays across ELISA kits and rapid lateral flow formats. Its ELISA portfolio supports infectious serology, including IgG, IgM and IgA testing for viral, bacterial and parasitic pathogens, with many 96-well assays supporting parallel sample processing. For faster testing, VIDIA also offers Rapid VIDITEST lateral flow assays across gastrointestinal and respiratory infections, inflammatory and tumour markers and mononucleosis, providing qualitative results within around 15 minutes.
Immunohistochemistry (IHC) uses antibodies to detect specific proteins in tissue sections. Once an antibody binds its target, a chromogenic or fluorescent system produces a visible signal, displaying where the biomarker is located within the tissue (4). This combination of protein-level and spatial information makes IHC particularly valuable in diagnostic pathology, where it can help classify tumours, identify the likely tissue or cell of origin and assess prognostic or predictive biomarkers.
Zeta Corporation offers more than 375 primary antibodies for diagnostic pathology and IHC, including mouse monoclonal, rabbit monoclonal and rabbit polyclonal antibodies. Its antibodies are developed and validated for use on formalin-fixed, paraffin-embedded (FFPE) tissue, with options suitable for both manual and automated staining workflows
Molecular diagnostics encompass a range of methods that detect and analyse DNA, RNA or other molecular biomarkers to help diagnose disease, classify conditions, guide treatment decisions and monitor patient responses over time (5). Notably, molecular methods can offer high analytical sensitivity and specificity while revealing genetic information that protein-based tests cannot directly provide. Common approaches include:
- Polymerase chain reaction (PCR): rapidly amplifies predefined DNA or RNA sequences, making it useful for detecting known pathogens, genetic variants and other disease-associated targets.
- Next-generation sequencing (NGS): analyses large numbers of DNA or RNA fragments in parallel, enabling high-throughput molecular profiling across multiple genes and the detection of complex or low-frequency variants.
- Microarray analysis: examines large panels of predefined genetic markers simultaneously, making it useful for multiplex genotyping and expression profiling.
Zytomed Systems supports molecular pathology through several complementary technologies. Its AmoyDx real-time PCR assays support targeted detection of clinically relevant oncology mutations, fusions and copy-number changes, including EGFR, KRAS and BRAF. VisionArray DNA chips provide sensitive, multiplex detection of pathogens such as HPV, fungi and mycobacteria, with built-in positive controls.
Featured IVD Supplier
Medix Biochemica is a Finnish biotechnology company, established in 1985, focusing on high-quality raw materials and diagnostic tests for global markets. We develop, produce, and market critical raw materials, including antibodies, antigens and biologicals for the IVD companies and rapid diagnostic tests for human healthcare worldwide. Recently joined Lee BioSolutions and EastCoast Bio are complementing our offering of critical raw materials to the IVD industry.
References
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1. MedTech Europe. European IVD Market Statistics Report 2025
[Internet]. Brussels: MedTech Europe; 2025 [cited 2026 Sep 8]. Available from: https://www.medtecheurope.org/wp-content/uploads/2025/12/ivd-m-report-2025_final.pdf
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2. Aydin S, Emre E, Ugur K, Aydin MA, Sahin İ, Cinar V, Akbulut T. An overview of ELISA: a review and update on best laboratory practices for quantifying peptides and proteins in biological fluids.
Journal of International Medical Research. 2025 Feb;53(2):03000605251315913.
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3. Koczula KM, Gallotta A. Lateral flow assays.
Essays in biochemistry. 2016 Jun 30;60(1):111-20.
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4. Jayagopal D, Kantharaju KH, Shekhar H, Gopinath A, Thekdi PI, Babu PK. Immunohistochemistry as a diagnostic tool in pathology.
Bioinformation. 2025 Oct 31;21(10):3595.
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5. Liu Q, Jin X, Cheng J, Zhou H, Zhang Y, Dai Y. Advances in the application of molecular diagnostic techniques for the detection of infectious disease pathogens.
Molecular Medicine Reports. 2023 Apr 3;27(5):104.