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MELS301 > QC > Flashcards

QC Flashcards

1
Q

What is quality management

A

The act of overseeing all activities and tasks needed to maintain excellence
This includes quality assurance and QC

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2
Q

What is quality assurance

A

Policies, training, equipment maintenance

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3
Q

What is quality control

A

Positive and negative controls
Inspecting quality through checks and tests

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4
Q

What does calibration determine

A

It determines the relationship between analyte concentration and instrument signal

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5
Q

How should a calibration curve be prepared

A

In the same biological matrix as the samples

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6
Q

What are QCs

A

Samples of known acceptable values are measured to ensure acceptable system performance

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7
Q

What are the different types of WC available

A

Liquid stable
Lyophilized- freeze dry
Assay/unassayed
Qualitative
Bi/Tri level

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8
Q

What is an assay vs unassayed QC

A

Assay control is made by a manufacturer with given ranges and guides
Unassay control you establish your own ranges

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9
Q

Internal vs external QC

A

Internal - in labs, quick, daily
External - sample given by third party which is analysed in lab and reported, takes month

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10
Q

What is analytical accuracy

A

Closeness of mean test result to true value of the analyte

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11
Q

Accuracy equation

A

Percentage difference : (result-actual)/actual x100

Correlation plots made
r=1 is perfect, Pearsons correlation

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12
Q

What is analytical precision

A

How reproducible your results are

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13
Q

Precision equation

A

Coefficient of variation % = SD/mean x100

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14
Q

What is the coefficient of variation

A

Standardised measure of spread that describes the variability relative to the mean
It is a percentage, ideally less than 5 and good to compare sets of data with

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15
Q

What is intra-run precision and what does it detect

A

Repeated analysis of the same sample under the same conditions in a small amount of time (20 tests in a day)
Detects short term variation

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16
Q

What is inter-run precision and what does it detect

A

Repeated analysis of the same sample over days/weeks/months
Detects long term variation

17
Q

What is analytical specificity

A

The ability to measure only the target analyte in a population of interfering substances
How good is the assay for specifically identifying the analyte

18
Q

What is analytical sensitivity

A

The ability to detect small variations in concentration

19
Q

What is the limit of detection

A

The lowest concentration that can be reliably detected above the background noise of the matrix
3SD above min

20
Q

What is the linear range

A

The analytical measurement range where there is a proportional relationship between measured and expected values

21
Q

Allowable limits of performance set by who

A

RCOA
Set of specifications for allowable error for different analyte S
Bland-Altman plots show difference between test and reference method

MELS301 (6 decks)

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