| Antibody Test Manufacturer | An antibody test manufacturer develops and produces diagnostic tests that detects antibodies in human or animal blood samples. Antibody tests can use different technologies with lateral flow being one common type.
Abingdon Health is an lateral flow antibody test manufacturer having developed and produced tests for multiple industries. |
| Antigen Test | Like antibody tests, most people will think COVID-19 when talking about an antigen test. However, an antigen test is a lateral flow rapid test or other type of test that detects antigens in a sample. These tests can be configured to work with a variety of antigens. See below for more information about antigens. Visit our Coronavirus Hub for information about antigen tests. |
| Antigens | Antigens are proteins, peptides (amino acid chains) and polysaccharides (chains of monosaccharides/simple sugars). They normally trigger an immune response and cause the body to produce antibodies in the presence of an unknown substance. There can be self-antigens that from within the body and are present on body tissues or cells. Or there are non-self antigens meaning from the environment such as toxins, viruses or bacteria. |
| Coronavirus | In 2020, the term coronavirus became synonymous with COVID-19 or SAR-CoV-2 (severe acute respiratory syndrome 2). But there are several common coronaviruses such as 229E (alpha coronavirus), NL63 (alpha coronavirus), OC43 (beta coronavirus) and HKU1 (beta coronavirus). Other coronaviruses include MERS-CoV (the beta coronavirus that causes Middle East Respiratory Syndrome, or MERS) and SARS-CoV (the beta coronavirus that causes severe acute respiratory syndrome, or SARS). The National Institute of Allergy and Infectious Diseases in the USA define coronaviruses as a ‘large family of viruses that usually cause mild to moderate upper-respiratory tract illnesses, like the common cold’. Coronaviruses are zoonotic diseases and can cause mild or moderate disease in humans whereas some cause serious and widespread illness or death. SARS-CoV (disappeared in 2004), SARS-CoV-2 and MERS-CoV being examples. |
| FDA | The FDA is the U.S. Government department responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of food supply. FDA stands for the Food and Drug Administration. |
| GMP | GMP stands for Good Manufacturing Practice and is “a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.” Source: https://ispe.org/initiatives/regulatory-resources/gmp. |
| ISO | ISO stands for International Organization for Standardization. ISO is an independent, international organization that develops standards to ensure the quality, safety, and efficiency of products, services, and systems. |
| ISO Standards | ISO Standards are ‘formula that describes the best way of doing something’ within an industry area or sector such as Quality Management, Environmental Management, Health and Safety, Energy Management, Food safety and IT security standards Source: https://www.iso.org/standards.html. |
| ISO 13485 | An ISO standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices and related services that consistently meet customer and applicable regulatory requirements. Abingdon Health is certified to ISO 13485. |
| ISO 9001 | An ISO standard that demonstrates a structured approach to quality management, to ensure that a company meets the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service. Abingdon Health is certified to ISO 9001. |
| IVDR | In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is new EU legislation applicable to in vitro diagnostic (IVD) medical devices. Manufacturers wishing to apply for a conformity assessment of their IVD medical device have until May 2022 to meet the requirements of the new Regulation. Abingdon Health wrote a blog on protecting lateral flow assays and businesses in readiness for IVDR changes. |
| Lateral flow assay | Easy to use diagnostic devices that produce results in minutes from a variety of samples to confirm the presence or absence of a target analyte, such as pathogens or biomarkers. These tests are used in a variety of industries. Common terms: Lateral flow test (LFT), lateral flow device (LFD), lateral flow assay (LFA), lateral flow immunoassay (LFIA), lateral flow immunochromatographic assay, dipstick, express test, pen-side test, quick test, rapid test and test strip. Learn more about lateral flow assays at https://www.abingdonhealth.com/services/what-is-lateral-flow-immunoassay/. |
| Lateral flow assay development | The process of taking a lateral flow assay from a concept into a test ready for scale-up and transfer into routine manufacturing. Development follows a process of planning, feasibility and optimisation. View the site for Abingdon Health’s approach to rapid test development. |
| Lateral flow assay manufacture | The process of routinely manufacturing lateral flow rapid tests for use across multiple industries. Leading rapid test manufacturers combine in-house manufacturing and regulatory expertise with start-of-the-art automation and established material suppliers to assure the production of reliable tests. Visit our site to see how Abingdon Health manufactures lateral flow assays. |
| Lateral flow readers | Lateral flow readers are portable or desktop electronic devices used to reader rapid tests to capture qualitative, semi-quantitative or quantitative data for the purpose of producing enhanced results to support faster decision making and treatment solutions. Data taken in real-time can also support research. Smartphones can also be converted into latera flow readers using state-of-the-art app technology that integrates with Smartphone camera technology. See Smartphone readers below for more details. |
| Medical device | The World Health Organisation defines a medical device as ‘any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s)’. See the full definition at https://www.who.int/medical_devices/full_deffinition/en/. |
| mHealth | An abbreviation for mobile health, a term used for the practice of medicine and public health supported by mobile devices. An example of such a device is Abingdon Health App software that turns a Smartphone in to lateral flow reader. |
| MHRA | MHRA stands for Medicines and Healthcare products Regulatory Agency and is an executive agency of the Department of Health and Social Care within the UK Government. MHRA regulates medicines, medical devices and blood components for transfusion in the UK. |
| NALFIA | NALFIA means nucleic acid lateral flow immunoassay: a companion diagnostic device that works alongside molecular testing tools such as PCR, LAMP or RPA to determine the presence of nucleic acids post RNA or DNA amplification. An example can be found here: www.abingdonhealth.com/pcrd/ |
| Near patient testing | Near patient testing is an analytical process that is performed in a decentralised location outside of a laboratory. |
| Neutralising antibodies | In the case of COVID-19, neutralising antibodies bind to the SARS-CoV-2 Spike protein and interfere with the coronavirus’ ability to enter human cells. IgG neutralising antibodies are the most common antibody in blood and have the largest part to play in conferring immunity to bacteria or viruses. |
| Neutralising antibody rapid tests (COVID-19) | Neutralising antibody rapid tests use lateral flow technology to detects SARS-CoV-2 IgG antibodies in blood. These are point of care tests and produce results in minutes. Neutralising antibody tests differ from other antibody tests as they detect the antibody key in ‘neutralising’ the effects of COVID-19. This is key in confirming who has produced an immune response post-infection or vaccination. Read our blog entitled What are COVID-19 neutralising antibody rapid tests? to learn more. |
| Nitrocellulose membrane | Nitrocellulose membranes in lateral flow assays store binding reagents at the test and control lines that bind to a target or the control. |
| Nucleic acids | Nucleic acids are information-carrying molecules in cells and determine the inherited characteristics of every living thing. The two main classes of nucleic acids are deoxyribonucleic acid (DNA) and ribonucleic acid (RNA). |
| Point of care testing | An analysis that is performed close or near to a patient and outside of a laboratory. In animal health these types of diagnostic devices or referred as pen-side tests, among other names. |
| Rapid Test | A rapid test is a common name for lateral flow assay. The term has been well known within diagnostics organisations and their clients for years. However, the SARS-CoV-2 (COVID-19) pandemic in 2020 brought the use of rapid test into use by the general public, further increasing the use of the technology. See lateral flow assay for more information about the technology. |
| Reagents | A reagent is a substance or compound that can facilitate a reaction. When talking about reagents in the context of lateral flow rapid tests, a reagent can be an antibody, antigen or aptamer, to name a few examples. |
| SaMD | SaMD means Software as a Medical Device and is software that is part of a medical device and needs to be classified, assessed, trialled and approved by notified bodies and regulators before the software can be used for medical purposes. Abingdon Health wrote a blog about why understanding ‘Software as a Medical Device’ regulation is vital for success in the US mHealth market: https://www.abingdonhealth.com/grasp-software-as-a-medical-device-regulation-for-success-in-the-us-mhealth-market/ |
| Seroconversion | Wikipedia defines seroconversion as ‘the development of specific antibodies in the blood serum as a result of infection or immunization. After seroconversion has occurred, the antibodies can be detected by blood tests for the disease.’ |
| Lateral flow Smartphone readers | Readers that use app software to integrate with camera and connectivity technology within Smartphones to capture qualitative, semi-quantitative or quantitative data from rapid tests to be shared securely to data hubs and connected devices for viewing and analysis by stakeholders. |
| Transfer to manufacture | Transfer to manufacture (in lateral flow manufacturing terms) is the process of taking a rapid test that has successfully completed the feasibility, optimisation and prototyping phases of assay development through scale-up with validation batches at small, medium and delivery batch scale. |
| Zoonotic diseases | A zoonotic disease (zoonoses – plural) or a zoonosis is an infectious disease that is transmitted between species from animals to humans. Zoonotic pathogens may be bacterial, viral or parasitic, or may involve unconventional agents and can spread to humans through direct contact or through food, water or the environment. (Source: WHO). Examples of zoonotic diseases include coronavirus, Salmonella, Rabies, Lyme Disease to name a few. |
