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FDA
regulatory agency, enforces regulations
CDC
Makes reccomendations to OSHA for safety of disease transmission
AABB
voluntary accrediting agency, publishes guidelines, standards for blood banks, quality essentials
OSHA
ensures safe and healthy working conditions
EPA
involved in assessing medical waste
QA
comprises the combined activities performed by an organization to ensure quality of products and services
Document Control
should specify and describe acceptable media, types of docs, record-retention intervals
Record Keeping
if it was not recorded then it never happened
Audit Trail
Internal evaluation that recreates every step in the production and distribution of a unit of blood and its components
Computerized Record Guidelines
traces original entry, person making correction, requires backup method
Validation
a process or system that is checked before implementation. Ensures consistency
Personnel Training
provided during poor performance, procedure changes, and new employee orientation
Root-Cause Analysis
investigation and identification of factors contributing to an error
Recalls
issued by manufacturers to remove faulty products
Calibration
standardizes an instrument for accuracy
Quality Control
tests for accuracy and precision
Preventative Maintanence
maintenance to decraese downtime and enhance reliability
CAP
administers proficiency testing to labs
Universal Precautions
applies to blood, bodily fluids, nonintact skin, and mucous membranes. Not sweat
Radiation Safety
nuclear regulatory commission requires training for all using irradiators
Antigens
molecules that bind to antibodies or T cell receptors
Allogeneic
non-self antigen
Autologous
self antigen
Hapten
partial antigen that require a carrier molecule
Antibodies
glycoprotein made of 4 polypeptide chains joined by disulfide bonds. 2 heavy and 2 light chains
Constant region
determines antibody class. heavy chain
Variable Region
binds the antigen on the antibody. Light and heavy chain
IgG
2 binding sites, 4 subclass, monomer
IgM
10 binding sites, pentamer held together by J chain
Primary Response
first exposure to antigen, lag phase of 5-10 days, IgM dominant
Secondary Response
second exposure to antigen, 1-3 days, IgG dominant
IgG
react at 37 C
IgM
react at 22 C
Complement
series of enzymatic reactions, C3 is central to both pathways, end result cell lysis
Classical Pathway
activated by Ag-Ab complexes
Alternative Pathway
activated by foreign cell surface constituents (bactiera)
Sensitization
antibody binds to antigen, no visible agglutination occurs
Lattice Formation
antibody-coated cells cross-link to form visible agglutinaton
Prozone
antibody excess, false negatives
Postzone
antigen excess, false negatives
Reagnet RBC
commercially prepared, known source of antigen
Patient or Donor RBC
usually unknown source of antigen, blank is tested with commercial antisera to determine id
Reagent Antisera
commercially prepared, known source of antibody
Patient or donor serum/plasma
usually unknown, blank tested with commerical RBC
Reagent specificity
recognition of the antigenic determinant and its corresponding antibody
Reagent Potency
strength of the reaction
Polyclonal Antibodies
made from several different clones of B cells, recognize multiple epitopes
Monoclonal Antibodies
made from single clones of B cells that secrete the same specificity
Monoclonal Antibody Examples
Anti-A, Anti-c, and anti-IgG
D antigen Typing
Rh group system contains several antigens, but this is the most important
High Protein Reagents
Anti-D reagent. contains polyclonal antibodies, 20% bovine albumin
Low Protein Reagents
Anti-D Reagent. contains monoclonal antibodies, 6% bovine albumin
Antiglobulin Test
commercial antibody with a specificity toward human globulins is used to agglutinate antibody coated RBC
Antiglobulin Reagents
IgG and Complement
Direct Antiglobulin Test (DAT)
detects IgG or complement bound in vivo. AHG is added after RBC are washed. Agglutination demonstrates attachment
Transfusion Reaction
donor cells coated with IgG
Hemolytic Disease of Newborn
fetal red cells coated with IgG
Autoimmune Hemolytic Anemia
IgG or C3 on patient red cells
Drug-related mechanisms
IgG-drug complex attached to cells
Indirect Antiglobulin Test (IAT)
detects IgG or complement bound to RBC in vitro
Antibody Screening
detects antibodies with specificity to red cell antigens
Antibody identification
identifies specificity of red cell antibodies
Crossmatch
determines serologic compatibility between donor and patient before transfusion
Antigen Typing
identifies a specific red cell antigen in a patient or donor
False Positives
Red cells are agglutinated before washing step, dirty glassware, improper centrifugation
False negatives
faliure to wash cells, testing is delayed, failure to identify weak rxn, loss of reagent, faliure to add reagent, improper centrifugation, inappropriate red cell concentration
Polyspecific AHG
contains both anti-IgG and anti-C3d antibodies. Derived from polyclonal or monoclonal sources
Monospecific AHG
contains either anti-IgG or anti-C3d, not both.
IgG Sensitized Cells
Used to confirm that a test is negative
Low-ionic strength saline (LISS)
increases rate of antibody uptake
Polyethylene glycol (PEG)
concentrates the antibody in the test environment in LISS
Proteolytic enzymes (papain and ficin)
removes negative charges from the cell membrane reducing zeta potential
Bovine Serum Albumin (BSA)
reduces the repulsion between cells but does not shorten incubation time
Lectins
seed extracts that have specificity toward certain RBC antigen
Gel Technology
uses dextran acrylamide gel particles to trap agglutinated cells
Microplate
A 96-well microtiter plate replaces test tubes.
Solid Phase
uses microplate wells with immobilized reagent. Cells adhere to sides and bottom are positive
Blood Group System
one or more antigen governed by a single gene or complex of two or more closely linked genes
Gene
basic unit of inheritance
Locus
specific site where gene is located on a chromosome
Allele
alternative form of a gene found at its locus
Antihetical
antigens produced by opposite alleles
Polymorphic
multiple alleles at a single locus
Rescessive
gene expressed only when inheritied by both parents
Codominant
equal expression of two different alleles, most blood groups
Dominant
gene expressed over another gene
Amorph
gnee that does not express a detectable product
Independent Segregation
occurs when one gene from each parent is passed to offspring in a predictable way
Independent Assortment
different genes are separately resulting in a mix of genetic material
Linkage
two genes that are in proximity are inherited together
Halpotype
a set of linked genes
Linkage disequilibrium
haplotypes occur at higher frequency then unlinked genes
Xg genes
only found on the X chromosome
Cis
alleles on the same chromosome
Trans
alleles on opposite chromosome
Homozygous
a perosn who inherits identical alleles
Heterozygous
a person who inherits different alleles
Phenotype
physical expression of traits
Genotype
actual genetic makeup
Dosage Effect
homozygous results in double dose (stronger rxn) while heterozygous results in singe dose