In the Name of God

1
In the Name of God
2
Method Validation in Clinical Laboratories

• Dr. F.Razi
• Reference Health Lab
• Mordad 87

3
(No Transcript)
4
????? ???????
???????????? ??????????? ????? ???????
????????? ?????
???????????
5
(No Transcript)
6
Verification of Performance specifications

• Accuracy
• Precision
• Reportable range for test system
• Verification of reference Intervals

7
Tests Modified or Developed In-House

• Accuracy
• Precision
• Reportable range
• Reference Intervals
• Analytical sensitivity
• Analytical specificity
• Any other performance characteristic required for
  test performance

8

• Mean , SD , CV
• F- test
• Paired t-test
• Linear regression or Least squares
• Correlation coefficient

9

• A comparison of methods experiment to estimate
  inaccuracy or bias

• Accuracy
• Precision
• Reportable range for test system
• Verification of reference Intervals

A replication experiment to estimate imprecision
A linearity type experiment to determine the
reportable range
Collecting reference values to verify the
reference range
10
Replication experiment

• A minimum of 20 replicate determinations On at
  least two levels of control materials are
  recommended to estimate the imprecision or random
  error of the method.

11
CV SD100/mean
12
linearity type experiment

• A minimum of 5 specimens with known
• or assigned values should be analyzed
• in to assess the reportable range.

13
(No Transcript)
14
Recovery Experiment
15

• Example calcium method, if 0.1 ml of a 20 mg/dL
  standard is added to 1.0 ml of serum, the amount
  added is 20(0.1/1.1) or 1.82 mg/dL.
• Sample A addition (11.4 11.6)/2 11.5 mg/dL
• Sample A dilution (9.7 9.9)/2 9.8 mg/dL
• Sample B addition (11.2 11.0)/2 11.1 mg/dL
  
• Sample B dilution (9.5 9.5)/2 9.5 mg/dL
• Sample A addition 11.5, Sample A dilution
  9.8, diff 1.7mg/dL
• Sample B addition 11.1, Sample B dilution
  9.5, diff 1.6 mg/dL
• (1.7 mg/dL/1.82 mg/dL)100 93.4 recovery
• (1.6 mg/dL/1.82 mg/dL)100 87.9 recovery
• Average the recoveries from all the
  specimens tested.
• (93.4 87.9)/2 90.6 average recovery
• 100 - 90.6 9.4 proportional error

16
(No Transcript)
17
A CV of 2.0 and bias of 0.0
B CV of 2.0 and bias of 0.2
CV of 3.0 and bias of 3.0
CV of 4.0 and bias of 3.0
18

• Ongoing (at least semi-annual) assessment of
  accuracy is required .

19
Method Validation in Iran ?
20
??????? ???
?????????
?????????? ?? ?????????
??? ????? 1
????? ?? ???????????? ???? ????? ( ????? ??????
?? ???? ????????? ) ??? ??? RHL
??? ????? 2
????? ???? ???????????? ???????
???? GMP ? GDP ????? ????????
??????? ?????? ??
?????????? ?? ?????????
???? ??????
???? ????????? ??? ??? ????
?????????? ????? ?????????? ???????? ??????
?????? ??? ...
???? ?????? ???? ???????????? ????
21

????? ?? ????????? ???? ????? ????? ??????
?? ???? ??????????
??? ????? 1 ????? ?????? ????? ?? ??????? ?? ?
??????? ????? ?????????? ?? ????????? ?? ?????
???? ???????????? ???????
??? ?????????
??? ????? ???
????? ????
??? ??????? ?? ????? ??????????
??? ?????????? / ?????? ??????
??? ????? ?????
????? ??? ???? ?????? ??????

??? ???? ?? ??? ???? ???
??????? ????? ????
22
????? ?? ????????? ???? ????? ????? ??????
?? ???? ??????????
??? ????? 2 ????? ?????? ?????? ????? ??
??????? ?? ? ??????? ????? ?????????? ?? ?????
????????????? ??? ??????? ??
????? ?? ????????? ???? ?????
??? ??????? ???? ?????

?????
???? ??? ??????? ?? ????? ?????????? ??? ?????????? / ?????? ?????? ??? ????? ????? ????? ??? ???? ?????? ?????? ????? ???????????? ?????







??????? ????? ????
23
????? ??????? ? ???

• ????? ???? / ????? ???
• ???? ???? (?????? ?? ??? ??????)
• ?????? ???????
• ????? ????? ??? ???? ????? ?????
• ????? ????? ??????? ?? ?????????

24
????? ????? ?????

• ????? ???? ?????
• ??? ????? ???? ???????
• ?????? ?? ? ??????? (???????????)
• ?????????? ???? ??? ?????? ?????????? ???
• ??? ???????????
• ???
• ??? ????
• ????? ?????? ??? ??? ? ????? ???????????

25
Thank you for your attention