BD ProEx™ C Reagent

Aberrant S-Phase Induction: Deviating from the usual or normal progression into the S-Phase (synthesis phase where dna/chromosome replication occurs) of the cell cycle. The BD ProEx™ C Antibody reagent is highly sensitive and specific to aberrant S-Phase induction.

Adjunctive: Joined or added to another, but not necessarily a part of it (e.g. ICC adjunctive cytology diagnosis- BD ProEx C™ ICC test result is adjunctive to the Pap result to provide additional diagnostic information).

Algorithm: A step-by-step problem solving procedure, especially an established procedure with a finite number of steps.

ASR (Analyte Specific Reagent): Antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acids sequences, and similar reagents which, through specific binding or chemical reactions with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens.

Antibody (Ab): An immunoglobulin molecule that has a specific amino acid sequence by virtue of which it interacts only with the antigen that induced its synthesis in cells of the lymphoid series or with an antigen closely related to it.

Antigen (Ag): Any substance which is capable, under appropriate conditions, of inducing a specific immune response and of reacting with the products of that response.

Apoptosis: Cell death; Fragmentation of a cell into membrane-bound particles that are then eliminated by phagocytosis.

Buffer: A buffer is a substance capable in solution of neutralizing both acids and bases to maintain the original acidity or basicity of the solution.

Cell Cycle: Sequence of events at the cellular level during which cell reproduction occurs. Cell reproduction entails replication of the DNA (S-Phase) followed by division of the nuclear components and partitioning of the cytoplasm into two daughter cells (M-Phase).

Cell Cycle Checkpoint: Mechanism by which the cell actively halts progression through the cell cycle until it can ensure that an earlier process, such as DNA replication or mitosis, is complete. G1 and G2 are the two cell cycle checkpoints.

Chromosome: In animal cells, a structure in the nucleus containing a linear thread of DNA, which contains and transmits genetic information and is associated with RNA and histones.

CLIA (Clinical Laboratory Improvement Amendment): Law establishing quality standards for all laboratory testing (except research) to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test is performed. Lab tests are categorized as waived testing, moderately complex, and highly-complex. Laboratories performing these tests must meet certain criteria to perform tests in a particular category.

CPT (Current Procedural Terminology): Codes that are assigned to all laboratory tests reimbursed by Medicare. CPT 88342 is the code for ICC/IHC procedures.

Cyto (cyt): (Prefix)- Cell.

Cytochemistry: The study of the chemical composition of cells.

Cytology: The study of cells; their origin, structure and function.

Cytoplasm: A colloidal viscous matrix that is external to the nucleus in a cell. The protoplasm of a cell, excluding the nucleus.

Diagnosis: The act or process of identifying or determining the nature and cause of disease or injury through evaluation of patient history, examination and review of laboratory data.

Diagnostic device: An instrument or test used in medical diagnosis.

Differentiate: To become distinct or specialized; acquire a different character. Cells differentiate during development to become specialized in structure and function.

DNA (deoxyribonucleic acid): The genetic material of all cellular organisms. Genetic material is replicated during the S-Phase of the cell-cycle.

Dysplasia: Abnormality of development; in pathology alteration in size, shape and organization of adult cells. Dysplasia is defined in morphological terms by a loss of normal orientation of epithelial cells, accompanied by alterations in cellular and nuclear size, shape and staining characteristics.

Epithelial: Cells forming the covering of most internal and external surfaces of the body and its organs.

G1 Phase: Gap 1- Phase of the cell cycle between nuclear/cytoplasmic division (M-Phase) and DNA synthesis (S-Phase). The G1 Phase is a cell-cycle checkpoint. Repairs to damaged DNA normally occur in the G1 Phase. During the G1 Phase the cell makes further decisions regarding whether to self-renew, differentiate, or die.

G2 Phase: Gap 2-Phase of the cell cycle between the S-Phase and the M-Phase. The G2 cell cycle checkpoint prevents cells from initiating mitosis when they experience DNA damage during G2, or when they progress into G2 with some unrepaired damage inflicted during previous S or G1 Phases.

General Purpose Reagents (Also known as a General Use Reagent): A chemical reagent that has general laboratory applications, that is used to collect, prepare, and examine specimens from the human body for diagnostic purposes, and that is not labeled or otherwise intended for a specific diagnostic application.

Histo-: Prefix; meaning tissue.

Histochemistry: The branch of science that deals with the chemical composition of the tissues of the body.

Histology: The study of the structure, composition and function of human tissues.

Histone: Any of various simple water-soluble proteins that yield a high proportion of basic amino acids on hydrolysis and are found associated with DNA in cell nuclei.

Home-Brew Test (In-house test): Home-brew tests combine an ASR with general use reagents to form an assay or in vitro diagnostic test used to evaluate clinical specimens. Laboratories developing home-brew tests must be CLIA certified for High-Complexity testing and must validate the performance characteristics of the test.

Immunochemistry: The application of antibodies as chemical reagents to cells or tissues.

Immunocytochemistry (ICC): The application of immunochemical techniques (e.g. immunoperoxidase staining) to cytochemistry.

Immunohistochemistry (IHC): The application of immunochemical techniques to histochemistry techniques.

IVD: In vitro diagnostic; an in vitro diagnostic is a medical test performed outside the body or a device used outside the body and is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals.

MCM 2 (Minichromosome Maintenance Proteins): Proteins that function in the early stages of DNA replication. The MCM 2 proteins are over-expressed in aberrant S-Phase induction. The over-expression of MCM proteins has been observed in dysplastic and malignant tissues. Two MCM 2 clones are included in the BD ProEx™ C Antibody Reagent.

M-Phase: Mitotic Phase- Portion of the cell cycle when cell division occurs.

Microsomes: A tiny granule in the cytoplasm where protein synthesis takes place under the direction of RNA.

Mitogenic: An agent that induces mitosis.

Mitosis: The entire process of cell division, including division of the nucleus and cytoplasm.

Mutation: A change in form, quality, or some other characteristic. In genetics, mutation is a permanent transmissible change in genetic material.

Nucleus: A large, membrane-bound, usually spherical protoplasmic structure within a living cell, containing the cell’s hereditary material and controlling the growth, metabolism, and reproduction. (pleural is nuclei)

Nuclear: Pertaining to the nucleus. Cells staining positive for aberrant S-Phase induction using BD ProEx™ C in an ICC method has a nuclear staining pattern (brown color appears in the nucleus, not cytoplasm of the cell).

Oncogene: A gene found in the chromosomes of tumor cells whose interaction is associated with the initial and continuing conversion of normal cells into cancer cells.

Oncogenic: Giving rise to tumors or causing tumor formation (e.g. tumor inducing viruses such as HPV).

Phagocyte: A cell that characteristically engulfs foreign material and consumes debris and foreign bodies.

Phagocytosis: The engulfing and destruction of particulate matter by phagocytes.

Polymer: A naturally occurring or synthetic compound consisting of large molecules made up of a linked series of repeated monomers.

Proliferation: To grow or multiply by rapidly producing new tissue, parts, cells, or offspring.

Proteins: Fundamental components of all living cells. Proteins are necessary for the proper functioning of an organism.

Protoplasm: The living substance of a cell including the cytoplasm and nucleus.

Quiescent: Being at rest; inactive.

RNA (Ribonucleic Acid): A long linear polymer of nucleotides found in the nucleus but mainly in the cytoplasm of a cell where it is associated with microsomes; it transmits genetic information from DNA to the cytoplasm and controls certain chemical processes in the cell; ribonucleic acid is the genetic material of some viruses.

S-Phase (Synthesis Phase): Part of the cell cycle when DNA synthesis occurs (chromosome replication).

Synthesis: To put together; the composition or combination of parts or elements so as to form a whole.

TOP2A (Topoisomerase II-alpha): A nuclear enzyme involved in DNA replication. TOP2A is over-expressed in aberrant S-Phase induction. TOP2A is one of three antibodies included in the BD ProEx™ C Antibody Reagent. (alpha is sometimes represented by the symbol a)

Topoisomerase: An enzyme that helps to maintain the correct conformation of DNA in the cell nucleus.

Transcription: The process of constructing a messenger RNA molecule using a DNA molecule as a template with resulting transfer of genetic information to the messenger RNA.