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Level 1
Jumlah replikasi 3
Jumlah hari 5
Rep.1 Rep.2 Rep.3 Rep.4 Rep.5 Run Mean Run SD
Hari 1 129.1 130 130.4 129.5 129.6 129.8 0.569
Hari 2 128.7 129.9 130.1 129.5 129.8 129.6 0.757
Hari 3 128.4 129.8 130.2 129.5 129.6 129.5 0.945
Hari 4 128.7 130 130.3 129.5 129.9 129.7 0.850
Hari 5 129.1 130 130.4 129.5 130.1 129.8 0.666
Imprecision) UJ
TEST :
METODA :
BAHAN :
Keteran
No Tanggal Waktu
gan
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Rerata
Standar Deviasi (SD)
Coefficien of Varian (CV)
Total Error Allowable (TEa)
long-Term Imprecision
Rep.3 Rep.4 Rep.5 Run Mean Run SD Varian
#DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0!
#DIV/0! #DIV/0! #DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
#DIV/0!
Bahan Keteran
Analis Bahan 1 Bahan 2
3 gan
92 240
94 250
96 235
95 248
98 236
98 234
96 242
93 244
94 243
94 240
96 233
97 237
98 243
97 234
95 241
95 240
98 249
98 232
99 231
96 241
95.95 239.65 #DIV/0!
D) 1.93241055 5.61272051 #DIV/0!
CV) 2.0139766 2.34204904 #DIV/0!
TEa) 10 10
on Impresisi Impresisi #DIV/0!
diterima diterima
EP15 Truness Protocol using Patient Samples
Metode Uji
20 0 6
21 0 4
22 0 2
23 0
0
24 0 0
25 0
26 0
27 0
28 0 ANALIS
29 0 UJI
30 0 METODA UJI (Y)
31 0 METODA PEMBANDING (X)
32 0 TEa
33 0
34 0
35 0 SLOPE
36 0 INTERCEPT
37 0 R
38 0 R²
39 0 PERSAMAAN GARIS
40 0
Xc
Yc
SE
RE
TE
TEa
Kesimpula
Quality Requirement
TEa 10.0
Offset 0.0
Method Performance
Bias (% diff)
Imprecision (% CV)
Sigma Limits s
6 1.67
5 2.00
4 2.50
3 3.33
2 5.00
Perbedaan Met Uji dengan Mewt Pembanding (mg/dL)
(x) =
Diagram Tebar Metode Uji dengan Metode Pembanding
12
10
8
Metode Uji
6
4
2
0
0 1
Metode Pembanding
NALIS
JI
METODA UJI (Y)
METODA PEMBANDING (X)
Ea
PERHITUNGAN REGRESI
SLOPE #VALUE!
INTERCEPT #VALUE!
R #VALUE!
R² #VALUE!
PERSAMAAN GARIS Yc = #VALUE! + #VALUE! Xc
Level 1 Level 2 Level 3
Unit yg
% Unit yg diukur % %
diukur
Medical Decision Concentration (MDC)
MDC Prediksi pers. Regresi #VALUE! #VALUE! #VALUE!
Yc-Xc #VALUE! #VALUE! #VALUE! #VALUE! #VALUE!
Uji Impresisi (RE) 0.497021 #DIV/0!
1.96 x SD atau 1.96 x CV 0.974161 0 #DIV/0! 0 0
SE + 1.96 RE #VALUE! #VALUE! #DIV/0! #VALUE! #VALUE!
Lihat Tabel TEa 10 10
Kesimpulan #VALUE! #DIV/0! #VALUE!
Medical Decisio
12.0
8.0
6.0
4.0
2.0
0.0
0.00 1.00 2.00 3.00 4.00
Observed Imprecision,
0 32 34 36 38 40 42
banding
100
Level 3
Unit yg
diukur
#VALUE!
#VALUE!
0
#VALUE!
#VALUE!
bserved Imprecision, % CV
256 262
303 294
256 262
303 294
127 121
345 348
42 41
154 154
398 388
213 204
99 101
375 375
168 162
240 239
256 262
303 294
29 25
345 348
93 92
436 431
29 25
345 348
42 41
154 154
358 388
93 92
99 101
375 375
168 162
240 239
256 262
303 294
29 25
345 348
93 92
240 239
72 69
312 308
29 25
345 348
No X Y No X Y No X Y No
1
256 262 11 99 101 21 29 25 31
2 303 294 12 375 375 22 345 348 32
3 256 262 13 168 162 23 42 41 33
4 303 294 14 240 239 24 154 154 34
5 127 121 15 256 262 25 358 388 35
6 345 348 16 303 294 26 93 92 36
7 42 41 17 29 25 27 99 101 37
8 154 154 18 345 348 28 375 375 38
9 398 388 19 93 92 29 168 162 39
10 213 204 20 436 431 30 240 239 40
ACID PHOS Acid Phos(Total) 1.5 U/L & ug/L, 15% 7 RCPA
ACMV Anti-CMV Positive or Negative 3 NYS
IGK Immunoglobulins K S- 8% 5 BV
chain
LH LH 2.5 SD 2 WLSH
LH LH +/-25% or 1.5 IU/L 3 NYS
LH LH Centaur 3 SD 4 CAP
LH Luteinizing hormone S- 19.8% 5 BV
LH Luteinizing Hormone 2 mIU/mL or 25% 6 AAB
LH LH 2.0 IU/L, 20% 7 RCPA
LH Luteinizing Hormone 2 SD 8 CFX