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.

What control types are used in scientific discovery?

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

Applications Common Biospecimens Use of Controls
In-Vitro Diagnostic (IVD) Development Whole Blood
Plasma
Serum
Urine
Saliva
Validation of devices with bulk materials
Calibration of instruments
Determine accuracy, bias, precision, and reproducibility
Bioanalytical Analysis  Plasma
Serum
Measure xenobiotics and biotics
Biomarker Studies Whole Blood
Urine
Saliva
Tissues
Genomic biomarkers
Protein biomarkers
Cell & Gene Therapy/Immuno-oncology Non-Transformed T Cells
Green Fluorescent Cells
Test tumor-killing/therapeutic effect
Test transduction efficacy
Personalized Medicine  Tissues Biofluids Biomarker validation
Verification development
Assay development

 

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

 Diagnostic Criteria Variables
Cohorts Healthy
Diseased
Biospecimens Whole Blood
Plasma
Serum
Urine
Tissue
Saliva
Cerebrospinal Fluid
Anticoagulants EDTA
Heparin
Citrate
Oxalates
ACD
Other commercially available anticoagulants
Inclusion/Exclusion Criteria Age
Gender
Smoking Status
Medication Status
Disease Progression
And more

 

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

Bioanalytics Criteria  Variables
Species Human
Rodent
Canine
Non-Human Primate
Biospecimens Whole Blood
Plasma
Serum
Urine
Cerebrospinal Fluid
Tissues
Anticoagulants EDTA
Heparin
Citrate
Oxalates
ACD
Other commercially available anticoagulants

 

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

Cell & Gene Therapy Criteria Variables
Cohorts Healthy Diseased
Biospecimens Whole Blood
Isolated Cells
PBMCs
T Cells
B Cells
Tissue
Dissociated Tumor Cells
Primary Tissue Associated
Cells
Cell Lines
Inclusion/Exclusion Criteria Age
Gender
Smoking Status
Medication Status
Disease Progression
And more

 

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®.


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Last updated: Feb 1, 2024 at 7:55 AM

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