Cc lab

Question 1

Includes maneuvers encountered in the pre-analytic, analytic and post analytic phases of laboratory testing.
Monitors performance starting from the ordering of a laboratory determination to its reporting, the interpretation of results, and application to patient care

Answer 1

Quality Assurance

Question 2

Concerned with the analytic phase of a QA
* Monitors the overall reliability of laboratory results in terms of accuracy and precision.

Answer 2

Quality Control

Question 3

2 Major types of Quality control

Answer 3

External QC ( Inter-laboratory QC)
Internal QC ( Intra-laboratory )

Question 4

involves proficiency testing programs that periodically provide sample of unknown concentration of analytes to participating laboratories.

Answer 4

External QC ( Inter-laboratory QC)

Question 5

involves the analyses of control samples together with the patient specimens.
Detects changes in performance between the present operation and “stable” operation.
Important for the daily monitoring of accuracy and precision of analytical methods.
Detects both random and systemic errors

Answer 5

Internal QC ( Intra-laboratory )

Question 6

closeness of the result compared with the true or actual value.

Answer 6

Accuracy

Question 7

Ability to produce a series of results that agree closely with each other; commonly expressed in terms of standard deviation ( SD ); called reproducibility.

Answer 7

Precision

Question 8

solutions with a known amount of a substance and are used to calibrate an assay method ( e.g. standards & calibrators ); vital in a procedure to determine the most “true “ value of an analyte.

Answer 8

Reference Material

Question 9

The range of values for a given constituent in healthy individuals; determined by performing a specific measurement on a large number of healthy individuals often grouped by age and sex; important factors should be standardized

Answer 9

Reference range

Question 10

Solution known characteristics and of known value; composed of one known constituent only and used as a basis or reference for the calculation of the value of unknown.

Answer 10

Standard Solution

Question 11

Solution (either commercially or non- commercially prepared) composed of several known constituents which can be run simultaneously with the test to check for the accuracy of the results.
● Human control materials are preferred but because of limited sources and Bovine-Based QC materialisnot the choice for immunochemistry, dye-binding, and certain bilirubin assays

Answer 11

Control solution

Question 12

ability of a method to detect the smallest concentration of a given analyte.

Answer 12

Analytic sensitivity

Question 13

ability of a method to detect only the analyte it is designed to determine

Answer 13

Analytic specificity

Question 14

Ability of a test to detect a given disease or condition

Answer 14

Diagnostic Sensitivity

Question 15

ability of a test to detect the absence of a given disease or condition

Answer 15

Diagnostic Specificity

Question 16

probability that a positive test indicates disease

Answer 16

Positive predictive value

Question 17

probability that a negative test indicates absence of disease

Answer 17

Negative Predictive value