The enzyme-linked immunosorbent assay (ELISA) is a commonly used analytical biochemistry assay, first described by Eva Engvall and Peter Perlmann in 1971. The assay uses a solid-phase type of enzyme immunoassay (EIA) to detect the presence of a ligand in a liquid sample using antibodies directed against the protein to be measured. ELISA has been used as a diagnostic tool in medicine, plant pathology, and biotechnology, as well as a quality control check in various industries.
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to assure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a shift left since it focuses on quality efforts earlier in product development and production and on avoiding defects in the first place rather than correcting them after the fact.
Walter Andrew Shewhart was an American physicist, engineer and statistician, sometimes known as the father of statistical quality control and also related to the Shewhart cycle.
Control charts are graphical plots used in production control to determine whether quality and manufacturing processes are being controlled under stable conditions. The hourly status is arranged on the graph, and the occurrence of abnormalities is judged based on the presence of data that differs from the conventional trend or deviates from the control limit line. Control charts are classified into Shewhart individuals control chart and CUSUM(CUsUM)(or cumulative sum control chart)(ISO 7870-4).
An assay is an investigative (analytic) procedure in laboratory medicine, mining, pharmacology, environmental biology and molecular biology for qualitatively assessing or quantitatively measuring the presence, amount, or functional activity of a target entity. The measured entity is often called the analyte, the measurand, or the target of the assay. The analyte can be a drug, biochemical substance, chemical element or compound, or cell in an organism or organic sample. An assay usually aims to measure an analyte's intensive property and express it in the relevant measurement unit.
Statistical process control (SPC) or statistical quality control (SQC) is the application of statistical methods to monitor and control the quality of a production process. This helps to ensure that the process operates efficiently, producing more specification-conforming products with less waste scrap. SPC can be applied to any process where the "conforming product" output can be measured. Key tools used in SPC include run charts, control charts, a focus on continuous improvement, and the design of experiments. An example of a process where SPC is applied is manufacturing lines.
The Western Electric rules are decision rules in statistical process control for detecting out-of-control or non-random conditions on control charts. Locations of the observations relative to the control chart control limits and centerline indicate whether the process in question should be investigated for assignable causes. The Western Electric rules were codified by a specially-appointed committee of the manufacturing division of the Western Electric Company and appeared in the first edition of a 1956 handbook, that became a standard text of the field. Their purpose was to ensure that line workers and engineers interpret control charts in a uniform way.
Nelson rules are a method in process control of determining whether some measured variable is out of control. Rules for detecting "out-of-control" or non-random conditions were first postulated by Walter A. Shewhart in the 1920s. The Nelson rules were first published in the October 1984 issue of the Journal of Quality Technology in an article by Lloyd S Nelson.
A real-time polymerase chain reaction is a laboratory technique of molecular biology based on the polymerase chain reaction (PCR). It monitors the amplification of a targeted DNA molecule during the PCR, not at its end, as in conventional PCR. Real-time PCR can be used quantitatively and semi-quantitatively.
Sensitivity and specificity mathematically describe the accuracy of a test that reports the presence or absence of a condition. If individuals who have the condition are considered "positive" and those who do not are considered "negative", then sensitivity is a measure of how well a test can identify true positives and specificity is a measure of how well a test can identify true negatives:
Medical Laboratory Assistants (MLAs) prepare, and in some cases process samples within a pathology laboratory. They also utilise pre-analytical systems in order for biomedical scientists (BMS) or Medical Laboratory Scientific Officers to process the biochemical tests requested on the sample. The majority of an MLA's time is spent in processing specimens. As such, the MLA has to have excellent knowledge of their particular sample acceptance policy, whilst obeying the data protection act, patient confidentiality, COSHH and the Caldicott rules.
Analyse-it is a statistical analysis add-in for Microsoft Excel. Analyse-it is the successor to Astute, developed in 1992 for Excel 4 and the first statistical analysis add-in for Microsoft Excel. Analyse-it provides a range of standard parametric and non-parametric procedures, including Descriptive statistics, ANOVA, ANCOVA, Mann–Whitney, Wilcoxon, chi-square, correlation, linear regression, logistic regression, polynomial regression and advanced model fitting, principal component analysis, and factor analysis.
The combination of quality control and genetic algorithms led to novel solutions of complex quality control design and optimization problems. Quality is the degree to which a set of inherent characteristics of an entity fulfils a need or expectation that is stated, general implied or obligatory. ISO 9000 defines quality control as "A part of quality management focused on fulfilling quality requirements". Genetic algorithms are search algorithms, based on the mechanics of natural selection and natural genetics.
A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical medical laboratories are an example of applied science, as opposed to research laboratories that focus on basic science, such as found in some academic institutions.
In statistical quality control, the CUsUM is a sequential analysis technique developed by E. S. Page of the University of Cambridge. It is typically used for monitoring change detection. CUSUM was announced in Biometrika, in 1954, a few years after the publication of Wald's sequential probability ratio test (SPRT).
Molecular diagnostics is a collection of techniques used to analyze biological markers in the genome and proteome, and how their cells express their genes as proteins, applying molecular biology to medical testing. In medicine the technique is used to diagnose and monitor disease, detect risk, and decide which therapies will work best for individual patients, and in agricultural biosecurity similarly to monitor crop- and livestock disease, estimate risk, and decide what quarantine measures must be taken.
The Westgard rules are a set of statistical patterns, each being unlikely to occur by random variability, thereby raising a suspicion of faulty accuracy or precision of the measurement system. They are used for laboratory quality control, in "runs" consisting of measurements of multiple samples. They are a set of modified Western Electric rules, developed by James Westgard and provided in his books and seminars on quality control. They are plotted on Levey–Jennings charts, wherein the X-axis shows each individual sample, and the Y-axis shows how much each one differs from the mean in terms of standard deviation (SD). The rules are:
A compact disk/digital versatile disk (CD/DVD) based immunoassay is a method for determining the concentration of a compound in research and diagnostic laboratories by performing the test on an adapted CD/DVD surface using an adapted optical disc drive; these methods have been discussed and prototyped in research labs since 1991.
Clinical metagenomic next-generation sequencing (mNGS) is the comprehensive analysis of microbial and host genetic material in clinical samples from patients by next-generation sequencing. It uses the techniques of metagenomics to identify and characterize the genome of bacteria, fungi, parasites, and viruses without the need for a prior knowledge of a specific pathogen directly from clinical specimens. The capacity to detect all the potential pathogens in a sample makes metagenomic next generation sequencing a potent tool in the diagnosis of infectious disease especially when other more directed assays, such as PCR, fail. Its limitations include clinical utility, laboratory validity, sense and sensitivity, cost and regulatory considerations.
