附表2能力范围表英文Word下载.docx
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附表2能力范围表英文Word下载.docx
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AnalyticalMethod
AnalyticalInstrument(s)
AnalyticalReagent(s)
Calibrator(s)
Note
AnalyticalPerformance
(1.Trueness;
2.Precision;
3.Reportablerange;
4.OtherPerformances)
1
Alanine
aminotransferase
Serum
B0451********
Rate
method
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA(I)20113401355;
ManufacturerNo.1987-12;
EquipNO.LAB-SH-01
Roche
originalbindedreagent,SFDA(I)20082402207
RocheC.fasCalibraror,SFDA(I)20092402926
1.Accuracy:
bias<
10﹪
Precision:
within-runprecisionCV<
5%,between-precisionCV<
6.67%;
Reportablerange:
4-600U/L
RocheModularP800BiochemistryAnalyzer,Reg.No.SFDA(I)20113401355;
ManufacturerNo.2134-20;
EquipNO.LAB-NFM-205
Rocheoriginalbindedreagent,SFDA(I)20082402207
2.Precision:
6.67%
3.Reportablerange:
Vitors350DryAnalyzerManufacturerNo.27002540,Reg.No.SFDA(I)20092400267,Equip.No.LAB-LJ-33
Vitorsdedicatedreagent,SFDA20092402046
Vitorsdedicatedcalibrator,SFDA20092401611
3-1000U/L
2
Aspartate
B0351********
Ratemethod
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA(I)20033400462;
Rocheoriginalbindedreagent,SFDA(I)20082402208
3.Reportablerange:
4-800U/L
Vitorsdedicatedreagent,SFDA20092402049
Vitorsdedicatedcalibrator,SFDA20092401611
3-750U/L
3
γ-Glutamyltranspeptidase
B0901********
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA(I)20113401355;
GermanDiasysDiagnosticSystemreagent,SFDA(I)20052403246
DiasysCalibraror,SFDA(I)20092401840
3-284.2U/L
RocheModularP800BiochemistryAnalyzer,Reg.No.SFDA(I)20113401355;
ManufacturerNo.2134-20;
EquipNO.LAB-NFM-205
GermanDiasysDiagnosticSystemreagent,SFDA(I)20092402167
10%
Vitorsdedicatedreagent,SFDA20092402044
4
Alkalinephosphatase
B0701********
GermanDiasysDiagnosticSystemreagent,SFDA(I)2092401841
15%
7.5%,between-precisionCV<
1-858U/L
1-858U/L
Vitorsdedicatedreagent,SFDA20092402106
20-1500U/L
5
Totalprotein
A010*********
biuretmethod
Rocheoriginalbindedreagent,SFDA(I)20082401058
1.Accuracy:
bias<
5%
2.Precision:
2.5%,between-precisionCV<
3.33%
2.0-150U/L
colorimetry
Vitorsdedicatedreagent,SFDA20092402107
Vitorsdedicatedcalibrator,SFDA20102401814
20-110U/L
6
ALbumin
3A015135202327101
bromcresolgreenmethod(BCG)
Rocheoriginalbindedreagent,SFDA(I)20082401378
2.Precision:
3.Reportablerange:
10-70g/L
Vitorsdedicatedreagent,SFDA20092402112
3.Reportablerange:
10-60g/L
7
Total
bilirubin
J010*********
Diazo
GermanDiasysDiagnosticSystemreagent,SFDA(I)20092402169
6.66%
1.71-513umol/L
Vitorsdedicatedreagent,SFDA20092402057
1.7-461.7umol/L
8
Glucose
D010*********
Hexokinasemethod
GermanDiasysDiagnosticSystemreagent,SFDA(I)20092402387
0.11-28mmol/L
Hexokinasemethod
Vitorsdedicatedreagent,SFDA20092402150
Vitorsdedicatedcalibrator,SFDA20092402042
1.11-34.69mmol/L
9
Urea
C025*********
Urease/GLDH
Rocheoriginalbindedreagent,SFDA(I)20082400945
4.5%
2.25%,between-precisionCV<
3%
0.83-66.8mmol/L
RocheModularP800BiochemistryAnalyzer,Reg.No.SF
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