Clinical Assay
Clinical Assay - Related Videos
13:45
Using a Pan-Viral Microarray Assay (Virochip) to Screen Clinical Samples for Viral Pathogens
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Cited by 84 •
2011
The Virochip is a pan-viral microarray designed to simultaneously detect all known viruses as well as novel viruses on the basis of conserved sequence homology. Here we demonstrate how to run a Virochip assay to analyze clinical samples for the presence of both known and unknown viruses.
08:46
Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
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Cited by 2 •
2015
Drug resistance to targeted therapeutics is widespread and the need to identify mechanisms of resistance--prior to or following clinical onset--is critical for guiding alternative clinical management strategies. Here, we present a protocol to couple derivation of drug-resistant lines in vitro with sequencing to expedite discovery of these mechanisms.
14:45
Enumeration of Major Peripheral Blood Leukocyte Populations for Multicenter Clinical Trials Using a Whole Blood Phenotyping Assay
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Cited by 14 •
2012
In this report, we demonstrate the staining and analysis steps of a phenotyping assay performed on fresh whole blood to enumerate major innate and adaptive leukocyte populations. We emphasize considerations for performing these procedures in the context of a multicenter clinical trial.
14:14
Adaptation of Semiautomated Circulating Tumor Cell (CTC) Assays for Clinical and Preclinical Research Applications
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Cited by 11 •
2014
Circulating tumor cells (CTCs) are prognostic in several metastatic cancers. This manuscript describes the gold standard CellSearch system (CSS) CTC enumeration platform and highlights common misclassification errors. In addition, two adapted protocols are described for user-defined marker characterization of CTCs and CTC enumeration in preclinical mouse models of metastasis using this technology.
09:12
Aortic Ring Assay
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Cited by 42 •
2009
Angiogenesis, the sprouting of blood vessels from pre-existing vasculature, is associated with both natural and pathological processes. Here we demonstrate an aortic ring assay that allows angiogenic potentiators and inhibitors to be directly added to aortic rings in culture. Sprouting and neovessel outgrowth can be determined by inspecting the aortic rings over a period of 6-12 days.
FAQs
Reliability comes from linking several controlled stages rather than relying on target recognition alone. Sample preparation makes the patient specimen suitable for analysis, target recognition identifies the molecule or cellular feature of interest, and signal generation converts that recognition into a measurable result. Defined analytical procedures make these stages consistent enough for comparison across cancer studies and care.
Sensitivity and specificity describe different aspects of assay performance. Sensitivity concerns how effectively a test detects the relevant biological marker, whereas specificity concerns how precisely it distinguishes that marker from other signals. Considering both helps researchers judge whether a measured result is dependable for biomarker characterization, treatment-response evaluation, or disease-monitoring studies.
Quality controls provide an internal check that the analytical procedure is performing as intended. They help researchers assess whether a result reflects the patient specimen and target biology rather than an inconsistency in sample preparation, recognition, or signal generation. Including these controls strengthens confidence when assay findings are compared with tumor features, therapy response, or progression.
Target selection determines what biological question the assay can address. Nucleic acids can support molecular characterization, proteins can provide another biomarker readout, and cellular features can describe properties at the cell level. Choosing among these target types allows investigators to study diagnostic or prognostic biomarkers and track molecular changes relevant to treatment response.
An assay workflow begins with a patient specimen and proceeds through sample preparation, target recognition, signal generation, and quality-control review. The resulting measurement can then be interpreted in the context of the study question, such as whether a biomarker characterizes a tumor or changes during therapy. Keeping these stages standardized supports reproducible evidence across clinical research.
Clinical assays are valuable at several decision points in cancer research and care. They can help identify diagnostic biomarkers, estimate prognostic significance, evaluate whether treatment produces a measurable biological response, and monitor disease progression. In precision oncology, these results connect molecular measurements with patient outcomes, helping translate laboratory discoveries into clinical studies and clinically relevant evidence.