Glossary / Abbreviations

Global Health Labs (GHL): A non-profit organization responsible for development of the Near-Point-of-Care Bead Beater (nPOC-BB) prototypes.
lateral flow assay (LFA): A type of diagnostic format comprising biochemical assay reagents dried into porous materials arranged into a strip. An LFA user will wet the input end of the strip with a liquid sample, such as urine, diluted mucus, or blood, which then transports along the strip, rehydrating and reacting with the reagents in order to yield a visual signal of the presence or absence of a specific analyte in the sample. Also sometimes referred to as a lateral flow test (LFT) or lateral flow immunoassay (LFIA), the latter due to antibodies being common assay reagents for capture and labeling of an analyte on the strip. The canonical example of an LFA is the pregnancy test strip, which is used on human urine to detect human chorionic gonadotropin (hCG).
low- and middle-income countries (LMICs): A partial classification of economic status defined by the World Bank using Gross National Income (GNI) per capita, which is the total income earned by a country's citizens (home and abroad) divided by the country's population. The full World Bank economic classification scheme comprises Low-, Lower-Middle-, and Upper-Middle-Income Countries (collectively, LMIC); and High Income Countries (HIC).
molecular test / nucleic acid amplification test (NAAT): A diagnostic test that can detect the presence of a molecular target, often a nucleic acid sequence specific to a pathogen or other diagnostic target, in very low quantities (down to a single molecule), often through a biochemical amplification of the molecular target. Such testing is often only possible to perform in a well-resourced diagnostic laboratory setting. For an example of an effort to make NAATs more broadly available, see NAATOS.
Mycobacterium tuberculosis (Mtb): A species of pathogenic bacteria in the family Mycobacteriaceae and the causative agent of the infectious disease tuberculosis.
Nucleic Acid Amplification Test On a Strip (NAATOS): A technology developed at Global Health Labs (GHL) that combines the low-cost and availability of lateral flow assay (LFA) testing with nucleic acid amplification (i.e., molecular) testing.
Near-Point-of-Care Bead Beater (nPOC-BB): A portable sample preparation instrument designed to prepare Mycobacterium tuberculosis from human tongue swab specimens for detection of TB via molecular testing in low-resource settings. Will also work with liquified human sputum specimens and may be useful in other sample preparation applications. Originally a component of the Nucleic Acid Amplification Test On a Strip (NAATOS) diagnostic test system developed at Global Health Labs (GHL), it also called the Sample Preparation Module (SPM) in some documentation.
point of care (POC): The location or setting where healthcare services, including diagnostic testing, are delivered to the patient.
Requirements Traceability Matrix (RTM): A document used in the design control of regulated medical devices that tracks the relationship between User Needs and Design Requirements.
Sample Preparation Module (SPM): Another name for the Near-Point-of-Care Bead Beater (nPOC-BB) used in the context of the Nucleic Acid Amplification Test On a Strip (NAATOS) diagnostic test system developed at Global Health Labs (GHL).
Sample Collection Consumable (SCC): A consumable device, such as a nylon-flocked swab, used to collect a sample for preparation in the Near-Point-of-Care Bead Beater (nPOC-BB).
Sample Preparation Tube (STC): A squeezable dropper tube used to contain a sample for preparation in the Near-Point-of-Care Bead Beater (nPOC-BB) and to transfer prepared sample to the consumable of a nucleic acid amplification test.
Tuberculosis: A deadly but curable infectious disease caused by the pathogenic bacteria Mycobacterium tuberculosis (Mtb).