Chapt 5

Question 1

a system of ensuring accuracy and precisions in the laboratory

a process ensuring that analytical results are correct by testing known samples tat are resemble patient sample

Answer 1

quality control

Question 2

involves in the process of monitoring the characteristics of the analytical process and detect analytical errors during testing and ultimately prevent the reporting of inaccurate patient test results

Answer 2

quality control

Question 3

measures the smallest concentration of an analyte of interest

Answer 3

sensitivity

Question 4

determines only the analyte of interest

Answer 4

specificity

Question 5

the nearness or closeness of the assayed value to the tru or target value

Answer 5

accuracy

Question 6

the capacity of the assay to give repeated results on the same sample that agree with one another

Answer 6

precision or reproductibility

Question 7

the degree by which a method is easily repeated

Answer 7

practicability

Question 8

achieved when the assay is able to maintain accuracy and precisions over an extended period of time during which equipment, reagents, personnel may change

Answer 8

reliability

Question 9

detects the proportion of an individuals WITH the disease

Answer 9

diagnostic/assay sensitivity

Question 10

detects the proportion of an individuals WITHOUT the disease

Answer 10

diagnostic/assay specificity

Question 11

the method to differentiate correctly whose individual with the disease against healthy cases utilizing the proportion of true positive and true negative in all evaluated cases

Answer 11

diagnostic/assay accuracy

Question 12

define the parameters in the calculation

Answer 12

True Positive (T+): CORRECTLY identifies as a PATIENT
False Positive (F+): INCORRECTLY identifies as a PATIENT
True Negative (T-): CORRECTLY identifies as a HEALTHY
False Negative (F-): INCORRECTLY identifies as HEALTHY

Question 13

what are the objectives of quality control

Answer 13

1. to check the stability of the machine
2. to check the quality of the reagents
3. to check technical errors

Question 14

the analysis of control samples together with the patient specimens

Answer 14

Intralab QC

Question 15

detects changes in performance between the present operation and the stable operation

Answer 15

Intralab QC

Question 16

involves proficiency testing programs that periodically provide samples of unknown concentration to participating clinical laboratories

Answer 16

Interlab QC

Question 17

maintains long-term accuracy of the analytical methods

Answer 17

Interlab QC

Question 18

differentiate commutable reference sample and non-commutable reference sample

Answer 18

commutable: relates to the closeness of agreement between the results for an RM and results for clinical samples when measured by more than or equal to two measured procedures
non-commutable: will have a measurement bias for clinical samples and results will not be compared across all processes

Question 19

achieved by an unknown sequence of calibrations, using reference that must be commutable

Answer 19

Traceability

Question 20

these are errors encountered in the collection, preparation and measurement of samples, including transcription an release of laboratory results

Answer 20

variation

Question 21

an error present in all measurement, is due to chance
the bias for varying differences between repeated measurements

Answer 21

Random error

Question 22

an error that influences observations consistently in one direction

detects either positive or negative bias

Answer 22

systemic error

Question 23

and error refers to the difference between the target value and the assayed value

exist when there is a continual difference between the comparative method and the test method regardless of the concentration

Answer 23

constant error

Question 24

and error that results in greater deviation from the target value due to higher sample concentration

exist when the difference between test method and comparative method is proportional to the analyte concentration

Answer 24

proportional/slop/percent error

Question 25

activities that takes place before testing

Answer 25

pre-analysis

Question 26

comprises patient reporting and result interpretation

Answer 26

post-analysis