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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
IGM IgM +/- 3 SD 1 CLIA, 3
NYS, 6 AAB
IGM IgM, Blood BNII 3 SD 4 CAP
IGM Immunoglobulin M S- 16.8% 5 BV
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
Bahan
Bahan 2 Keterangan
3
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
#DIV/0! #DIV/0!
DATA PERBANDINGAN METODA
40 0 0.000
SUM 0 0 0 0
#DIV/0! #DIV/0! 0.00 0.00
Mean Y Mean X Bias SD Dif
AV(B3:B22) AV(C3:C22) AV(D3:D22) SD(E3:E22)
Confidence Limits t-Critical n upper lower
p=0,01 2.861 40 0.00 0.00
Verivication Limits Manuf. Claim upper lower
p=0,01 2 2.00 2.00
Upper Lower
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
0 0.2
ANALIS
UJI
METODA UJI (Y)
METODA PEMBANDING (X)
TEa
PERHITUNGAN REGRESI
SLOPE #VALUE!
INTERCEPT #VALUE!
R #VALUE!
R #VALUE!
PERSAMAAN GARIS Yc = #VALUE! + #VALUE! Xc
SE = Yc Xc
Jadi SE = #VALUE! SE #VALUE! %
TEcalc= SE + RE
SD saat uji impresisi = CV = #DIV/0! %
RE adalah 3x SD saat uji impresisi = 0.0 RE #DIV/0! %
Jadi TE = #VALUE! TE #VALUE! %
TEa = #DIV/0! TEa 0%
Kinerja Metoda diterima jika TE < TEa
Jadi : #VALUE!
Jadi TEcalc = 0
TEa = 0
Kinerja Metoda diterima jika TE < TEa
Jadi : 0
Patient Manufacturer
Comparisons Claim
N 40 40
Df 39 39
Bias 0.00 -
SD diff 0.00 -
t-value hit
#VALUE! Err:502
/krit
p-value hit
#VALUE! 0.05
/krit
TEa 0
Keputusan
#VALUE!
0.9
0.8
0.7
Unacceptabl e
0.6
Poor
0.5
Margi nal
0.4 Good
0.3 Excel ent
Word Cl ass
0.2
Operating Poi nt
0.1
0
0 0.2 0.4 0.6 0.8 1 1.2
Observed Imprecision, % CV
Diference Plot
1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 33 35 37 39
Diagram Tebar
12
10
8
Metoda Uji
6
4
2
0
0 2 4 6 8 10 12
Metoda Pembanding
0.00
T
etoda di
ara metoda di
ngan
0
0
0
0
0
0
0
Unacceptabl e
0
Poor 0
Margi nal
0
Good
Excel ent
0
Word Cl ass 0
Operating Poi nt
0
0
0
0
0
0
0
0
0
0
0
0
Perbedaan Met Uji dengan Mewt Pembanding (mg/dL)
Diference plo
No Test Result (Y) Comp. Result (X) Yi - Xi
1 0 40
2 0 30
3 0 20
4 0 10
5 0
0
6 0 0 2 4 6 8 10 12
-10
7 0
8 0 -20
9 0 -30
10 0 -40
11 0
12 0
13 0
f(x) =
14 0
15 0
R = 0
Diagram Tebar Me
16 0 12
17 0 10
18 0 8
Metode Uji
19 0
6
20 0
4
21 0
22 0 2
23 0 0
24 0 0
25 0
26 0
27 0 entry data
28 0
29 0 Intercept a
30 0 slope b
31 0 koefisien k r
32 0 Persamaan Garis
33 0 Xc = Medical Decision Concentra
34 0 Maka Yc =
35 0 SE = Yc Xc
36 0 Maka SE =
37 0 TEcalc= SE + RE
38 0 RE adalah 3x SD saat uji impresi
39 0 SD saat uji impresisi =
40 0 Jadi TE calc =
SUM 0 0 0
#DIV/0! #DIV/0! 0.00 Kinerja Metoda diterima jika TE
Mean Y Mean X Bias
AV(B3:B22) AV(C3:C22) AV(D3:D22)
Confidencet-Critical n upper
p=0,01 2.861 40 #REF!
VerivicatioManuf. Claim upper
p=0,01 2 #REF!
TEa 10 5 0
% Bias ### 0 10
12.0
TE ### 0 10
10.0
2.5 0 8.0
Quality Requirement 0 10
Allowable Total Error 10.0 2 0
6.0
Offset 0.0 0 10
Method Performance 1.7 0
4.0
Bias (% diff) #VALUE! 0 10
Imprecision (% CV) 2.8 0 0
0 10 2.0
Sigma Limits s
6 1.67
5 2.00 0.0
0.0 1.0
4 2.50
3
2
3.33
5.00
Ob
Diference plot met uji dng met pembanding
40
30
20
10
0
0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42
10
20
30
40
Nomor Data
#VALUE!
#VALUE!
#VALUE!
Persamaan Garis Yc = a + bXc Yc = #VALUE! + ### Xc
Xc = Medical Decision Concentration = 200
#VALUE!
SE = Yc Xc
#VALUE! atau SE= #VALUE! %
calc
= SE + RE
RE adalah 3x SD saat uji impresisi = 16.83 RE = 8.415 %
5.61 CV = 2.805 %
Jadi TE calc = #VALUE! atau TE calc = #VALUE! %
10.0
8.0
6 Sigma
5 Sigma
6.0 4 Sigma
3 Sigma
4.0 2 Sigma
Operating Point
2.0
0.0
0.0 1.0 2.0 3.0 4.0 5.0 6.0
Observed Imprecision, % CV
Jan Feb Mar Apr May
NO
Li LII Li LII Li LII Li LII Li
1 92 308 96 313 97 315 98 314 91
2 94 314 95 310 98 314 99 309 91
3 96 314 93 308 97 308 98 312 98
4 95 300 91 301 92 310 96 300
5 98 314 93 313 98 313 93
6 98 310 92 307 95 310 91
7 96 314 90 313 98 313 98 306 93
8 93 315 91 304 98 314 99 308 91
9 94 311 90 310 98 314 94 307
10 94 315 91 315 95 310 97 308 98
11 96 312 92 297 99 312 99 300 97
12 97 315 95 308 99 314 95 307 98
13 98 315 91 309 99 307 95 314 98
14 97 313 91 307 98 314 98
15 95 314 92 304 95 310 92 303 96
16 95 300 94 307 96 311 91 301 98
17 98 314 93 307 98 315 97 301 98
18 98 312 90 315 95 308 92 299 95
19 99 314 93 310 98 310 92 298 93
20 96 312 92 306 97 310 95 301
21 96 312 92 308 98 312 93 302 99
22 97 308 92 310 98 300 91 302 93
23 98 314 96 312 98 309 90 296 91
24 99 314 92 311 99 307 95 297 92
25 99 315 93 308 99 309 93 305 91
26 95 315 93 309 98 315 92
27 95 308 99 316 97 313 99 315 94
28 98 315 96 311 93 304 91
29 94 315 97 311 90 296 92
30 95 313 96 308 91 306 98
31 95 312 96 309