immunohematology - alternatives to tube tests

FDA

commercial blood banking reagents are licensed by the center for biologics evaluation and research of the _____

code of federal regulations

the FDA’s criteria can be found in the _____

specificity

reagents must have recognition of the antigenic determinant and its corresponding antibody

potency

reagents must have the strength of the reaction

quality control

testing to determine the accuracy and precision of equipment, reagents, and procedures

microplate

a 96 well microtiter plate replaces tube tests; applies the same principle as test tube method as a concentrated button indicates a reaction and dispersed cells indicate no reaction

dextran acrylamide gel

gel technology uses _____ particles to trap agglutinated cells where they combine with reagents and predispensed in microtubes of plastic cards

gel technology

RBCs or plasma/serum added to microtube and allowed to incubate before centrifugation; large agglutinates are trapped at the top (4+) and nonagglutinated cells travel to the bottom of the microtube

gel technology

can be both automated, semiautomated and manual uses 0.8% cell concentrations rather than 3-5%

solid phase

uses microplate wells with immobilized reagent; cells that adhere to the sides and bottom of the wells are positive and cells that settle to the bottom of the wells are negative

erythrocyte magnetization

magnetic particles are either absorbed onto RBC surfaces, or bound via antibody, antisera is added to wells, a strong magnet is used to bring the cells into close proximity and trigger agglutination to replace centrifugation; a button at the bottom indicates a positive reaction

ortho diagnostics

vision systems that use gel card system

beckman-coulter

PK 7400 that utilizes a microplate agglutination

werfen

capture systems that utilize SPRCA

biorad

IH-500/IH-1000 that utilizes gel card systems

grifols

erytra/erytra eflexis that utilizes a gel card system

diagast

QWALYS systems that utilizes erythrocyte magnetization

vendor assessment

determine vendor’s experience with customer support, training, and service

base technology assessment

investigate the reliability and accuracy of technology

instrument assessment

consider the adaptability, availability, and cost effectiveness of the automation to assess the instrument’s performance