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31 Cards in this Set

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Calibration



Review


We calibrate an instrument to relate instrument measurement signal to _____________

analyte concentration

Calibration



We calibrate an instrument to relate ____________ to analyte concentrate

instrument signal

Calibration



What is the upper end?

The highest value we can reliably report without sample manipulation.

The _________ _____ we can ____ ______ without ____ ___.

Calibration



What is the upper end?

The highest value we can reliably report without sample manipulation.

The ________ we can ___________ without ________.

Calibration



WHAT IS THE UPPER END?

The highest value we can reliably report without sample manipulation



What happens if a result exceeds upper end?

Dilution

Calibration



Upper end



What happens if a result exceeds the upper end?

Dilution



What is the low end?

Lowest value we can reliably report

Calibration



Low end



Def.

Lowest value we can reliably report.

______ _____ we can ____ _____.

Calibration



Low end

Lowest value we can reliably report.



This is not necessary _____.


What must be assessed?

zero


LoB, D, Q

Calibration



Low end


Lowest value we can reliably report.



This is not ________ zero.


We must ______LoB, __, ____.

necessarily


assess


D


Q

Calibration



Low end



This is not necessarily _____.


We must assess ___________

zero


LoB,D, Q



Def of low end

Lowest value we can reliably report

Define LoB

It represents the 95th percentile of analytical noise for the assay.

It _____ the ____ ______ of ____ ____ for the ____.

Define LoB

It _______ the __________ of __________ for the _____.

represents


95th percentile


analytical noise


assay

DEFINE LOB

It represents the 95th percentile of analytical noise for the assay.



Formula

LoB=mean of the blank + 1.645 (SD of blank)

Formula for LoB

LoB=______ of the blank + 1.645 (___ of blank)

mean


SD

Formula for LoB


Test

LoB= Mean of the blank +1.645 (SD of blank)



Why 1.645 is used?

z-score of one-sided tail at 5%

LoB



Def.


Formula

It represents the 95th percentile of analytical noise for the assay.



LoB=Mean of the blank+1.645 (SD of blank)



1.645 is used because it is the ___-score of ____-sided tail at _____.

z


one


5%

LoD



Def.

The lowest concentration of an analyte that can be distinguished from LoB/0

The _____ ______ of an _____ that can be _____ from ____/___

LoD



Def.

The _________________ of an _____ that can be ______ from ________.

Lowest concentration


analyte


distinguisdhed


LoB/0

LoD



Def.

The lowest concentration of an analyte that can be distinguished from LoB/0



if the analyte is really present LoD___LoB

>

LoD



Notes

____ of samples at the LoD will fal below the LoB by design and chance distribution.

5% see slide 34 in lecture 8 for more

LoD



Formula

LoD=LoB+1.645(SD low concentration sample)

LoD


LoD=____+1.645(SD _____________)

____=LoB+______ (____ low concentration sample)

LoD


1.645


SD

LOD



Formula

LoD=LoB+1.645(SD low concentration sample)

LoQ ____ LoD

>

LoQ canot be ___ LoD, but the two could be ______.

<


equal

LoQ



Formula

Total analytical error=bias+(2*SD)

_________________=_____+ (__*___)

LoQ



Formula


Total ______ error = ______ + (2*____)

analytical


bias


SD

LoQ


Formula



_____ analytical ______= _______+ (___*______)

Total


error


bias


2


SD

LoQ



Formula

Total analytical error=Bias + 2*SD

LoQ



Notes

The lowest concentration at which a test analyte can be reliably measured based on total analytical error



2nd def.

Imprecision of 20% CV or better at low analyte level

Notes

See Lecture 8 slide 25-45