Nucleus An organelle found in eukaryotic cells that contains genetic material, deoxyribonucleic acid (DNA).
DNA (Deoxyribonucleic acid): A self-replicating material which encodes hereditary information present in all living organisms as the main constituent of chromosomes. DNA encodes hereditary genetic information using four nucleotides; adenine, thymine, cytosine and guanine.
Chromosome A condensed form of the highly organised structure of nucleic acids and proteins found in the nucleus of most living cells, carrying genetic information in the form of genes. Humans have 23 pairs of chromosomes.
Chromatid One of the two threadlike strands (sister chromatids) into which a chromosome divides longitudinally during cell division.
p arm The short arm of the chromosome (with the exception of a metacentric chromosome which has chromosome arms of equal length).
q arm The long arm of the chromosome (with the exception of a metacentric chromosome which has chromosome arms of equal length).
Centromere A primary constriction which separates the p arm from the q arm and holds the pair of sister chromatids together. A region of α satellite DNA sequences. The centromere is the point at which the chromosome is attached to the spindle during cell division.
Telomere A compound structure at the end(s) of a chromosome, consisting of repetitive nucleotide sequences.
Gene A unit of heredity which is transferred from a parent to offspring and is known to determine some characteristics of the offspring. A gene consists of a sequence of nucleotides in DNA that encode the synthesis of a gene product, such as a protein or RNA molecule.
ASR Analyte Specific Reagent. ASRs are “building blocks” of LDTs. [21 CFR 864.4020]
CGMP Current Good Manufacturing Practice. See also QSR. [21 CFR 820]
CLIA Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88, 42 USC 263a). Clinical laboratory testing (except research) in the U.S. is regulated by CMS via the CLIA Regulations. [42 CFR 493]
CMS Centers for Medicare and Medicaid Services.
FDA Food and Drug Administration.
GPR General Purpose Reagent. [21 CFR 864.4010]
IFU Instructions For Use. May also be referred to as a pack insert.
IVD In Vitro Diagnostic Medical Device. [21 CFR 809.3]
LDT Laboratory Developed Test. Sometimes called a “home brew” test or an “in-house” test. Most LDTs in the U.S. are regulated under the CLIA Regulations.
QSR Quality System Regulation. See also CGMP. [21 CFR 820]
RUO For Research Use Only. Not for use in diagnostic procedures.
UDI Unique Device Identification/Identifier. [78 FR 58785, 21 CFR 830]
LPH Hematology probes.
LPS Solid tumor and hematopathology probes.
LPD Dual use probes.
LPE Chromosome enumeration probes.
LPU Microdeletion probes.
LPT Subtelomeric probes.
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