Quality Control and Validation
Expert-defined terms from the Masterclass Certificate in ELISA Assays course at London School of Business and Administration. Free to read, free to share, paired with a professional course.
Absorbance is a measure of the amount of light absorbed by a solution, often use… #
Related terms include transmittance and reflectance, which are also measures of light interaction with a solution. In the context of Quality Control, absorbance is an important parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Accuracy refers to how close a measurement is to the true value, and is an impor… #
Related terms include precision, which refers to the consistency of measurements, and trueness, which refers to the closeness of a measurement to the true value. In Quality Control, accuracy is a critical parameter to evaluate in order to ensure the reliability of ELISA assay results.
Additives are substances added to ELISA assay reagents to enhance their p… #
Related terms include excipients, which are inert substances added to reagents to improve their physical or chemical properties. In the context of Validation, additives must be carefully evaluated to ensure they do not interfere with assay performance or results.
Analyte is the substance being measured in an ELISA assay, such as a prot… #
Related terms include antigen, which is a substance that triggers an immune response, and antibody, which is a protein that binds to a specific antigen. In Quality Control, the analyte is a critical parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Antibody is a protein that binds to a specific antigen , and is a key comp… #
Related terms include immunoglobulin, which is a type of antibody, and epitope, which is the specific region of an antigen that an antibody binds to. In the context of Validation, antibodies must be carefully evaluated to ensure they are specific and sensitive for the target analyte.
Antigen is a substance that triggers an immune response , and is a key com… #
Related terms include immunogen, which is a substance that triggers an immune response, and hapten, which is a small molecule that can trigger an immune response when attached to a larger molecule. In Quality Control, antigens must be carefully evaluated to ensure they are pure and stable.
Assay is a laboratory test used to measure the concentration of a specific an… #
Related terms include test, which is a general term for a laboratory test, and method, which is a specific procedure for performing a test. In the context of Validation, assays must be carefully evaluated to ensure they are accurate, precise, and reliable.
Assay validation is the process of evaluating the performance of an ELISA … #
Related terms include method validation, which is the process of evaluating the performance of a laboratory method, and Quality Control, which is the process of monitoring and maintaining the quality of laboratory tests. In Validation, assay validation is a critical step in ensuring the reliability of ELISA assay results.
Binding is the process by which an antibody binds to a specific antige… #
Related terms include affinity, which is the strength of the binding interaction between an antibody and antigen, and avidity, which is the overall binding strength of an antibody-antigen interaction. In Quality Control, binding is an important parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Calibration is the process of configuring an ELISA assay to ensure it is… #
Related terms include standardization, which is the process of configuring an assay to ensure it is consistent with other assays, and Quality Control, which is the process of monitoring and maintaining the quality of laboratory tests. In Validation, calibration is a critical step in ensuring the reliability of ELISA assay results.
Certification is the process of verifying that an ELISA assay has met spe… #
Related terms include accreditation, which is the process of verifying that a laboratory has met specific standards or requirements, and compliance, which refers to the state of meeting specific standards or requirements. In Quality Control, certification is an important step in ensuring the reliability of ELISA assay results.
Coefficient of variation is a measure of the variability of a set of meas… #
Related terms include standard deviation, which is a measure of the spread of a set of measurements, and variance, which is a measure of the average spread of a set of measurements. In Quality Control, the coefficient of variation is an important parameter to monitor in order to ensure the reliability of ELISA assay results.
Concentration is the amount of a substance per unit volume, and is an important… #
Related terms include dilution, which is the process of reducing the concentration of a substance, and titration, which is the process of determining the concentration of a substance by reacting it with a known amount of another substance. In Quality Control, concentration is a critical parameter to evaluate in order to ensure the accuracy and reliability of ELISA assay results.
Control is a sample or standard used to evaluate the performance of an ELISA<… #
Related terms include reference material, which is a sample or standard used to evaluate the performance of an assay, and Quality Control sample, which is a sample used to monitor the quality of an assay. In Validation, controls are critical components of the evaluation process.
Cross #
reactivity is the phenomenon by which an antibody binds to a substance other than the intended antigen, and is a potential source of error in ELISA assays. Related terms include specificity, which refers to the ability of an antibody to bind only to the intended antigen, and interference, which refers to the phenomenon by which a substance other than the intended antigen affects the binding of an antibody. In Quality Control, cross-reactivity is an important parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Detection limit is the minimum amount of a substance that can be detected by an… #
Related terms include limit of quantitation, which is the minimum amount of a substance that can be quantified by an assay, and sensitivity, which refers to the ability of an assay to detect small amounts of a substance. In Validation, the detection limit is a critical parameter to evaluate in order to ensure the reliability of ELISA assay results.
Dilution is the process of reducing the concentration of a substance, and… #
Related terms include titration, which is the process of determining the concentration of a substance by reacting it with a known amount of another substance, and concentration, which is the amount of a substance per unit volume. In Quality Control, dilution is an important parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
ELISA is a laboratory test used to measure the concentration of a specific an… #
Related terms include enzyme-linked immunosorbent assay, which is the full name of the ELISA test, and immunoassay, which is a general term for a laboratory test that uses antibodies or antigens to measure the concentration of a substance. In Validation, ELISA is a critical component of the evaluation process.
Enzyme is a protein that catalyzes a specific chemical reaction, and is often us… #
Related terms include substrate, which is the substance that an enzyme acts on, and cofactor, which is a substance that is required for an enzyme to function. In Quality Control, enzymes are critical components of ELISA assays, and must be carefully evaluated to ensure they are stable and functional.
Epitope is the specific region of an antigen that an antibody bind… #
Related terms include binding site, which is the region of an antibody that binds to an antigen, and antigenic determinant, which is the specific region of an antigen that triggers an immune response. In Validation, epitope is a critical parameter to evaluate in order to ensure the reliability of ELISA assay results.
Error is a deviation from the true value of a measurement, and is an important c… #
Related terms include variability, which refers to the spread of a set of measurements, and uncertainty, which refers to the doubt or uncertainty associated with a measurement. In Quality Control, error is an important parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
False negative is a result that incorrectly indicates the absence of a substance… #
Related terms include false positive, which is a result that incorrectly indicates the presence of a substance, and sensitivity, which refers to the ability of an assay to detect small amounts of a substance. In Validation, false negative is an important parameter to evaluate in order to ensure the reliability of ELISA assay results.
False positive is a result that incorrectly indicates the presence of a substanc… #
Related terms include false negative, which is a result that incorrectly indicates the absence of a substance, and specificity, which refers to the ability of an assay to detect only the intended substance. In Quality Control, false positive is an important parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Heterophile antibody is an antibody that binds to multiple antigens</i… #
Related terms include cross-reactivity, which is the phenomenon by which an antibody binds to a substance other than the intended antigen, and interference, which refers to the phenomenon by which a substance other than the intended antigen affects the binding of an antibody. In Validation, heterophile antibody is an important parameter to evaluate in order to ensure the reliability of ELISA assay results.
Immunoassay is a laboratory test that uses antibodies or antigens … #
Related terms include radioimmunoassay, which is a type of immunoassay that uses radioactive isotopes to detect the binding of an antibody to an antigen, and enzyme-linked immunosorbent assay, which is the full name of the ELISA test. In Quality Control, immunoassay is a critical component of the evaluation process.
Inhibition is the phenomenon by which a substance reduces the binding of an a… #
Related terms include interference, which refers to the phenomenon by which a substance other than the intended antigen affects the binding of an antibody, and cross-reactivity, which is the phenomenon by which an antibody binds to a substance other than the intended antigen. In Validation, inhibition is an important parameter to evaluate in order to ensure the reliability of ELISA assay results.
Interference is the phenomenon by which a substance other than the intended a… #
Related terms include cross-reactivity, which is the phenomenon by which an antibody binds to a substance other than the intended antigen, and inhibition, which refers to the phenomenon by which a substance reduces the binding of an antibody to an antigen. In Quality Control, interference is an important parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Limit of detection is the minimum amount of a substance that can be detected by… #
Related terms include limit of quantitation, which is the minimum amount of a substance that can be quantified by an assay, and detection limit, which is the minimum amount of a substance that can be detected by an assay. In Validation, limit of detection is a critical parameter to evaluate in order to ensure the reliability of ELISA assay results.
Limit of quantitation is the minimum amount of a substance that can be quantifie… #
Related terms include limit of detection, which is the minimum amount of a substance that can be detected by an assay, and detection limit, which is the minimum amount of a substance that can be detected by an assay. In Quality Control, limit of quantitation is an important parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Linearity is the ability of an ELISA assay to produce a linear response t… #
Related terms include calibration, which is the process of configuring an assay to ensure it is accurate and reliable, and standardization, which is the process of configuring an assay to ensure it is consistent with other assays. In Validation, linearity is a critical parameter to evaluate in order to ensure the reliability of ELISA assay results.
Matrix is the substance or medium in which a sample is dissolved or suspended, a… #
Related terms include sample, which is the substance being tested, and buffer, which is a solution used to maintain a stable pH or ionic strength. In Quality Control, matrix is an important parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Method is a specific procedure for performing a laboratory test, such as an E… #
Related terms include protocol, which is a detailed procedure for performing a test, and procedure, which is a general term for a series of steps used to perform a test. In Validation, method is a critical component of the evaluation process.
Non #
specific binding is the phenomenon by which an antibody binds to a substance other than the intended antigen, and is a potential source of error in ELISA assays. Related terms include cross-reactivity, which is the phenomenon by which an antibody binds to a substance other than the intended antigen, and interference, which refers to the phenomenon by which a substance other than the intended antigen affects the binding of an antibody. In Quality Control, non-specific binding is an important parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Optimization is the process of adjusting the parameters of an ELISA assay… #
Related terms include calibration, which is the process of configuring an assay to ensure it is accurate and reliable, and standardization, which is the process of configuring an assay to ensure it is consistent with other assays. In Validation, optimization is a critical step in ensuring the reliability of ELISA assay results.
Precision is the consistency of a set of measurements, and is an important param… #
Related terms include accuracy, which refers to how close a measurement is to the true value, and variability, which refers to the spread of a set of measurements. In Quality Control, precision is a critical parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Quality Control is the process of monitoring and maintaining the quality of labo… #
Related terms include quality assurance, which is the process of ensuring that laboratory tests are performed in accordance with established standards, and validation, which is the process of evaluating the performance of a laboratory test. In Validation, Quality Control is a critical component of the evaluation process.
Reagent is a substance used in a laboratory test, such as an ELISA assay #
Related terms include chemical, which is a substance used in a laboratory test, and buffer, which is a solution used to maintain a stable pH or ionic strength. In Quality Control, reagents are critical components of ELISA assays, and must be carefully evaluated to ensure they are stable and functional.
Reproducibility is the ability of an ELISA assay to produce consistent re… #
Related terms include precision, which refers to the consistency of a set of measurements, and variability, which refers to the spread of a set of measurements. In Validation, reproducibility is a critical parameter to evaluate in order to ensure the reliability of ELISA assay results.
Sample is the substance being tested in an ELISA assay, and is an importa… #
Related terms include matrix, which is the substance or medium in which a sample is dissolved or suspended, and specimen, which is a sample of tissue or fluid used for testing. In Quality Control, sample is a critical component of the evaluation process.
Sensitivity is the ability of an ELISA assay to detect small amounts of a… #
Related terms include specificity, which refers to the ability of an assay to detect only the intended substance, and detection limit, which is the minimum amount of a substance that can be detected by an assay. In Validation, sensitivity is a critical parameter to evaluate in order to ensure the reliability of ELISA assay results.
Specificity is the ability of an ELISA assay to detect only the intended… #
Related terms include sensitivity, which refers to the ability of an assay to detect small amounts of a substance, and cross-reactivity, which is the phenomenon by which an antibody binds to a substance other than the intended antigen. In Quality Control, specificity is a critical parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.
Standard is a substance or material used as a reference in a laboratory test, su… #
Related terms include control, which is a sample or standard used to evaluate the performance of an assay, and reference material, which is a substance or material used as a reference in a laboratory test. In Validation, standards are critical components of the evaluation process.
Standardization is the process of configuring an ELISA assay to ensure it… #
Related terms include calibration, which is the process of configuring an assay to ensure it is accurate and reliable, and optimization, which is the process of adjusting the parameters of an assay to improve its performance. In Quality Control, standardization is a critical step in ensuring the reliability of ELISA assay results.
Substrate is the substance that an enzyme acts on, and is an important pa… #
Related terms include cofactor, which is a substance that is required for an enzyme to function, and inhibitor, which is a substance that reduces the activity of an enzyme. In Validation, substrate is a critical component of the evaluation process.
Titration is the process of determining the concentration of a substance by reac… #
Related terms include dilution, which is the process of reducing the concentration of a substance, and concentration, which is the amount of a substance per unit volume. In Quality Control, titration is a critical step in ensuring the accuracy and reliability of ELISA assay results.
Validation is the process of evaluating the performance of a laboratory test, su… #
Related terms include verification, which is the process of confirming the performance of a laboratory test, and quality control, which is the process of monitoring and maintaining the quality of laboratory tests. In Quality Control, validation is a critical component of the evaluation process.
Variable is a parameter that can be changed or controlled in an ELISA ass… #
Related terms include parameter, which is a characteristic of a laboratory test that can be measured or controlled, and factor, which is a variable that can affect the outcome of a laboratory test. In Validation, variables are critical components of the evaluation process.
Variability is the spread of a set of measurements, and is an important paramete… #
Related terms include precision, which refers to the consistency of a set of measurements, and accuracy, which refers to how close a measurement is to the true value. In Quality Control, variability is a critical parameter to monitor in order to ensure the accuracy and reliability of ELISA assay results.