?????? ???? ?? ????????? ????? ??? Reference Interval

1
?????? ???? ??
????????? ????? ???Reference Interval
??? ????

• ???? ????
• ???? ??????? ???????????? ??????
• ????????? ???????
• ?????87

2
?????? ????
REFERENCE INTERVAL

• ?????? ?? ???????? ?? ?? ????? ????? ???? ?????
  ( ????? - ?????? ) ????? ?????? ???? ???? ??
  ?????? ????
• ?? ????????? ? ??????????.

??? ?????? ????? ????? ????? ..................
..................................................
.......

Test Result
Unit Normal Range Glucose
100 mg/dL

REFERENCE INTERVAL
3
????? Range ???? ????? ?????? ?? ?? ???? ??
??????? ??? ? ??? ?????? ?? ?? ???? ??? ???? ???
? ???? ?? ?? ??????.

• ????? Normal
• ?????? ????? ???? ????? ??????? ????? ?? ?????
  ???? ??????? ????? ????? ??? . ( ????? ????? ) ?
  ????? ???????? ??? ?????? ?????? ??? ????.

4
????? ?????? ????? ?????? WHO ?? ?????

• ????? ?? ?????? ????? ????? ???????????? ?
• ??????? ????? ????? ??? ??? ?? ????? ??????

5
REFERENCE INTERVAL ? ?????
???? ?????? ?? ???? ????? ???? ?? ?????????.
????? ??? ??????? (????? ??? ...) ?????
??? ???? ????(???? ???? ??????...)

• ??? ?????? ?????
• ????? ????? .....................................
  ......................................
  
  
  
• Test Result Unit
  REFRENCE INTERVAL
• Glucose 100 mg/dL
  
• 
  ?

???? ????
- ?? - ???
??????? ?? ??????? ??????
- ???? ??? ????
-
??????? ???????? ????? ???
- ???? ?????
????????? ?? ?????
- ?????? ?????????

- ???????
- ?????????
????? ?????? ???? ??? ??? ????? ???? ???????
?????? ???? ?????? ???????????????


6

• Reference Individual
• Reference sample group
• ???? ????
• ????????? ?? ????? ????? ? ?? ???? ????? ????
  ?????
• Reference population
• ??? ?????? ?? ?????? ??????? ??????? ? ?????? ???
  ???

7

• ?????? ???? ???? ...
• ???? ???? 95 Reference Value
  
• 98 100
• 82 85
• ??????? ???? Reference Values

8

• 100
• 102 ? 100? 98
• 106 103? 102 ? 100 ? 97? 96 90
• 103 96
• ????? ???? (Reference Distribution)
• ????? ???? ??? ???? ???? ??
  ???? ????

?? ???? Reference Limit
?? ???? Reference Limit
?????? ???? Reference Interval ????? ??????? ??
??? ?? ?? ???? ???????????
9
??? ??? ??????? ?? ?????? ???? ????? ?? ?????????
Full Reference Interval study
Transference and validation
10
????? ?????? ????

• 1- ???? ???? ??????? ???????? ? ??????? ?? ?????
  ?????
• 2- ???? ????? ??? ?????? ? ????? ???? ? ????????
  ?????
• 3- ???? ????? ???? ???? ?? ????? ???? ? ?? ????
  ????????
• 4- ???? ???? ????? ???? ?????? ????????
• 5- ??????? ?????? ?? ?????? ????? ??? ????? ???
  ???? ??????? ??? ???? ?????
• 6- ????? ???? ????? ?????????? ????? ????
  (????? 120 ???)
• ?????? ?? ?????? ??????? ???? ???
• 7-????? ???? ????? ???? ????? ???? ????? ?????
  ????(??????????? ??? ????? )
• 8- ??? ???? ? ??? ???? ????? ??
• 9- ?????? ??????? ???? ? ????? ??????? ????
• 10- ???? ????????? ? ??????? ????? ????
• 11- ????? ????? ??? ?????? (????? (D/R
• 12- ????? ? ????? ??????? ????? ??? ??????? ?
  ????? ?????? ????

11
????? ??? ?? ??????? ? ?????? ?????? ????

• ?????? ???? ?????
• ????? ??? ?????? ???? ???? ???????

12
????? ??? ?? ??????? ? ?????? ?????? ???? ?????
????? ???

• ???? ??? - ?????? ?????? ???? ?? ???? ?? ??
  ????????? ?? ????????? ???? ??????? ?? ?????
  ?????? ???? ( ??? ? ?????) ????? ??????? ?????
• ????? ????? ???? ? ????? ????? ???? ?? ????
  ????? ????????? ? ???????? ? ????? ????? ??? ??
  ????? ????? ????? ????? ???? ? ??? ???? ????
  ???? ????? ???? ????.

13
?????? ????? ???? ???? ???? ?????? ?????? ????

• 1- ??????? ?? ?????? ???? ?? ??? ????? ??? ?
  ???? ??????? ??????? ???? ?? ?????????
• ?????????
• ???? ??????? ????????? ? ????????? ????? ?? ??
  ????? ???? ? ???? ?????? ????? .?????? ??????
  ????????????? ??? ? ??? ????? ? ???????? ???????
  ? ?????? ???? ??????? ???? ? ?????? ?????? ??????
  ???? ???? ??? ???? ?????? ? ?????? ? ??? ????
  ????? ????? ????????? ???? ???? .

14

• 2- ?????? ????? ????? ?? 20 ????? ?????? ?????
  ????? ????????? ? ???????? ????? ??????? ????
  ???? ??????

????? ?? 2 ????? ???? ?? ??????
???? ?? 2 ????? ???? ?? ??????
?????? 20 ????? ? ?????? ????
????? ?? 2 ????? ???? ?? ??????
??????? ?????? ???? ???? ???
??????? ?????? ???? ???? ????
15
Validation with 60 sample

• ?????? 60 ??? ?? ???????? ????? ???? ?????.
• ????? ?????? ???? ????? ???
• ????? ????? ?? ?????? ???? ????? ?????????? ???
  ????????? ???? ????? ?? ?????????? ??????? ???
  ???? ??
• ?? ??????? ????? ???? ???? ??? ????? ?? ???
  ?????? ?? ?????? ????? ????? ?? ?????? ????
  ?????? ???? ?????? ???? ????? ???.

16
Y a bX x150 U/l a1
b2 Y12150301 U/l
17
???? ??? ?????? ?????? ???? ??????? ????? ????
????? ?? ????? ???? ????? ?????? ????? ??? ??
????? ??? ?????? ???? ( ??? ? ?????) ?????
??????? ????? ???? ?? ??? ?????? ??? ??????? ???
.
18
????? ??? ????? ?? ?????????
1-??????? ?? ????? ??? ( ????? ???? ????
) 2-?????? ????? ???? ( ?????? ?? ????? ????? ?
????) 3- ???? ?? ?????? ??????? ????? ?????
19
.

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

• 1- 40 ????? ??? ????? ?? ????? ?????? ???? ?????
  ?????? ???
• 2- ?? ??? 5 ??? ? ?????? 8 ????? ?? ?????? ?????
  ????? ?? ???? ?? ??????? ???? ?????? ???? ????
  ???? .
• 3- ????? ????? ?? ???????? ????? ??????????
  ??????? ????? ???? ???? ????? ????? ?????? ??????
  ??? ?? ?????? ?????? ????? ????.
• 4- ??? ????? ????? ???? ??? ???? ???? ????? 5 ???
  ???? ????? ??????.
• 5- correlation / coefficient ????? ??? ? ??? 9
  9 0. lt r ??? ??????? ??? ???? ????? ??? ? ????
  ????????? ?? ?????? ????? ???? ????? ??? ?????.
• 6- ??? 9 9 rlt0. ???? ???? ??????? ?????? ???? ??
  ???? t-test ?????? ???? ???? ???? ??? ?? ??????
  ????? ???? ????? ??? ?????.

20
difference between the test minus comparative
results on the y-axis
difference between the test minus comparative
results on the y-axis
21
(No Transcript)
22
Y a bX SE (systematic error) Y - X
cholesterol comparison study chol 200
mg/dl a2 slope1.03 Y 2.0 1.03X
208 systematic error 208-200 8
23
Criteria for acceptable performance

• TE SE RE TE biasmeas 3Smeas
• Biasmeas average difference or difference
  between averages from t-test calculations or the
  difference between Y-X
• Smeas the estimate of the method standard
  deviation
• TETAE ?

24
???2 (0-0.4) T.bil. ???1 (0.5-0)
0.35 0.9
0.27 0.62
0.13 0.35
0.2 0.48
0.28 0.37
0.32 0.74
0.2 0.35
0.25 0.64
0.23 0.42
0.21 0.49
0.28 0.44
0.19 0.35
25
???2 (8.1-10.4) ca ???1 (8.8-10.2)
8.9 8.6
8.9 8.6
14.2 12.9
14.2 12.8
12.5 10.5
6 5.2
11.3 10.7
5.4 5.3
12 10.8
5.9 5.4
10.6 9.9
5.1 4.9
12.3 11.2
5.9 5.6
26
???2 (0-40) AST. ???1 (0-40)
38 25
35 30
39 32
41 28
45 38
44 23
50 20
37 19
35 18
38 21
39 26
27

• ?? ???? ?? ???? ???