What control types are used in scientific discovery?

In scientific research, controls are employed as standards. By separating the control from the samples exposed to an experimental condition, such as the introduction of an analyte, the effects of the condition can be more easily identified. There is a broad range of controls, all vital to scientific discovery. In this article, Laboratory Control Samples, positive and negative controls, and blank controls are discussed.

Image Credit: BioIVT

Laboratory control samples (LCSs) are used for diagnostic assays and have a known concentration of the analyte of interest for comparison with the experimental sample. LCS duplicates (LCSDs) are analyzed in tandem with the experimental samples. LCSs and LCSDs undergo identical processing as the experimental sample. They demonstrate the accuracy, precision, bias, and reproducibility of a study. LCS and LCSD can be positive or negative or a range, enabling equipment calibration.

In biomarker studies, positive and negative control materials are implemented, including specimens gathered from different cohort groups (such as diseased and healthy) or produced via different treatments and processes (such as incubated with and without a certain chemical).

Positive controls are essential for ensuring that proper results and outcomes are being produced in a study. A positive control specimen should produce the expected experimental result.

The selection of a positive control material involves many considerations, including the mechanism of action and the presence and stability of the biomarker of interest. Lower variance translates to a more efficient and cohesive study with less variability and error.

For biomarker-related studies, negative controls are commonly more difficult to source or create. When used in experiments, negative controls should not change any variables. Blank controls are used to confirm reagents, test for contamination, and set baseline device calibrations. Both negative and blank controls are central to validating the accuracy of experimental results.

Most matrices can be employed as controls, dependent on the stage of research and development and the application under scrutiny. BioIVT supplies several common matrices for a wide range of industries and applications, as shown in Table 1.

Table 1. Source: BioIVT

Controls for diagnostics

A proper negative control and calibration cohort is required for in vitro diagnostics (IVD). For companion diagnostic development, controls must be aligned with personalized therapeutic development and employ ethically collected, well-characterized human specimens. BioIVT sources a plethora of diseased tissues and biofluids for diagnostic development, some of which are listed in Table 2.

Table 2. Source: BioIVT

Controls for bioanalysis

Bioanalysis involves the quantification of substances, like drugs, proteins, and metabolites. The demonstration of preclinical traceability of small and large molecule therapies is of paramount importance and is achieved using ligand-binding ELISAs or LC-MS/MS.

High-quality, traceable matrices with correct documentation for human and animal species in specific anticoagulants are required when sourcing controls and surrogate matrices for bioanalysis. BioIVT provides products such as customized biospecimen anticoagulants, aliquots, volumes, and collection containers (as shown in Table 3).

Table 3. Source: BioIVT

Controls for cell and gene therapy development

The development of a manufacturing process that uses healthy donor cells to ensure the viral vector, environment, and media formulation/supplementation achieves maximum cell expansion is vital for autologous cell and gene therapies.

This process can be tested using a representative material, such as PBMCs from lymphoma or leukemia patients, to ensure its effectiveness. Many such controls are offered by BioIVT, as listed in Table 4.

Table 4. Source: BioIVT

BioITV

BioIVT produces a plethora of ethically sourced, high-quality biospecimens and, with nine global donor centers and in-house processing facilities, can assist with any control biospecimen requirements.

About BioIVT

BioIVT, formerly BioreclamationIVT, is a leading global provider of high-quality biological specimens and value-added services. We specialize in control and disease state samples including human and animal tissues, cell products, blood, and other biofluids. Our unmatched portfolio of clinical specimens directly supports precision medicine research and the effort to improve patient outcomes by coupling comprehensive clinical data with donor samples.

Our Research Services team works collaboratively with clients to provide in vitro hepatic modeling solutions. And as the world’s premier supplier of ADME-Tox model systems, including hepatocytes and subcellular fractions, BioIVT enables scientists to better understand the pharmacokinetics and drug metabolism of newly discovered compounds and the effects on disease processes. By combining our technical expertise, exceptional customer service, and unparalleled access to biological specimens, BioIVT serves the research community as a trusted partner in ELEVATING SCIENCE^®.

Sponsored Content Policy: News-Medical.net publishes articles and related content that may be derived from sources where we have existing commercial relationships, provided such content adds value to the core editorial ethos of News-Medical.Net which is to educate and inform site visitors interested in medical research, science, medical devices and treatments.