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KETIDAKPASTIAN PEMERIKSAAN HEMATOLOGI 2 komponen ketidakpastian standard bias (uB) pemeriksaan hematologi XE-2100 & XT-2000i : 1. SD relatif pengukuran berulang kalibrator SCS-1000 (SEM) 2. Ketidakpastian standard kalibrator dari perusahaan (uCref)
Pengukuran Berulang Kalibrator SCS-1000 XE-2100 Parameter
Target
1 s t 2nd run
3rd run
4th run
5th run
Mean
SD
run Leukosit
6,888
6,800
6,850
6,890
6,910
6,890
6,868
0,045
Eritrosit
4,589
4,590
4,600
4,590
4,580
4,540
4,580
0,023
Hemoglobin 14,4
14,4
14,5
14,3
14,4
14,4
14,4
0,071
Hematokrit
40,57
40,7
40,7
40,6
40,5
40,2
40,54
0,207
Trombosit
178,1
181,0
182,0
179,0
175,0
178,0
179,0
2,739
XT-2000i Parameter
Target
1st run
2nd run
3rd run
4th run
5th run Mean
Leukosit
6,783
6,720
6,670
6,900
6,800
6,820
6,782
0,090
Eritrosit
4,513
4,510
4,510
4,540
4,520
4,510
4,518
0,013
Hemoglobin
14,11
14,1
14
14,1
14,1
14,1
14,08
0,045
Hematokrit
39,32
39,3
39,2
39,6
39,4
39,3
39,36
0,152
SD
Perhitungan ketidakpastian pengukuran Hb XE-2100 Tanggal 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30
Kontrol Level-1 5.80 5.90 5.80 5.80 5.90 5.80 5.80 5.80 5.80 5.90 5.80 5.80 5.90 5.80 5.80 5.90 5.90 6.00 6.00 6.00 6.10 6.10 6.00 6.10 6.00 6.00 6.10 6.10 6.10 6.10
Kontrol Level-2 12.30 12.40 12.40 12.50 12.30 12.40 12.30 12.30 12.30 12.30 12.30 12.20 12.30 12.30 12.30 12.40 12.30 12.60 12.60 12.50 12.60 12.70 12.60 12.70 12.50 12.60 12.60 12.60 12.60 12.60
Kontrol Level-3 17.30 17.50 17.10 17.20 17.30 17.40 17.40 17.40 17.50 17.40 17.20 17.20 17.30 17.30 17.30 17.40 17.30 17.20 17.20 17.20 17.30 17.30 17.10 17.20 17.20 17.30 17.30 17.30 17.30 17.40
Standar deviasi dan Mean bulan Juni 2013
Perhitungan ketidakpastian pengukuran Hb XE-2100 Standar deviasi parameter hemoglobin bulan Januari-Juni 2013 Bulan
Kontrol
(2013)
Level 1
Level 2
Level 3
Januari
0.07
0.08
0.14
Februari
0.06
0.13
0.31
Maret
0.08
0.12
0.15
April
0.06
0.13
0.38
Mei
0.05
0.08
0.09
Juni
0.12
0.15
0.1
0.07
0.12
0.20
Total
Standar deviasi
0.1374
Ketidakpastian pengukuran (U) hemoglobin: uSDqc = {[(SDqc2)L1 + (SDqc2)L2 + (SDqc2)L3] /3}1/2 = {[(0,07)2 + (0,12)2 + (0,2)2] /3}1/2 = 0,1374 g/dL uc = {(uSDqc)2 + (uB)2}1/2 uc = {(uSDqc)2 + (SEM)2 +(uCref)2}1/2 uc = [(uSDqc)2 + {1/N x (SD kalibrator) 2} +(uCref)2] uc = [(0,1374)2 + {1/5 x (0,071) 2}+ (0,11) 2] 1/2 uc = 0,1788
1/2
U = uc x 1,96 (CI 95%) = 0,35 g/dL Nilai ketidakpastian pengukuran Hb ± 0,35 g/dL Contoh: Hasil pemeriksaan hemoglobin pasien = 10 g/dL Maka hasilnya berkisar 10 ± 0,35 g/dL (9,65 – 10,35 g/dL)
