附表2能力范围表英文.docx
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附表2能力范围表英文
附表2
申请检验能力范围（英文）
Lab:
DepartmentofClinicalLaboratory，JiangsuProvincialHospitalintegratedtraditionalandwesternmedicine
Address:
100ShiziStreet，Maigaoqiao，Nanjing，Jiangsu
№
Examina
-tion
Item
Sample
Type
Code
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
Serum
B0451********
Rate
method
RocheModularP800BiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.2134-20;EquipNO.LAB-NFM-205
Rocheoriginalbindedreagent,SFDA（I）20082402207
RocheC.fasCalibraror,SFDA（I）20092402926
1.Accuracy:
bias<10﹪
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.67%
3.Reportablerange:
4-600U/L
Serum
B0451********
Rate
method
Vitors350DryAnalyzerManufacturerNo.27002540,Reg.No.SFDA（I）20092400267,Equip.No.LAB-LJ-33
Vitorsdedicatedreagent,SFDA20092402046
Vitorsdedicatedcalibrator,SFDA20092401611
1.Accuracy:
bias<10﹪
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.67%
3.Reportablerange:
3-1000U/L
2
Aspartate
aminotransferase
Serum
B0351********
Ratemethod
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA（I）20033400462;ManufacturerNo.1987-12;EquipNO.LAB-SH-01
Rocheoriginalbindedreagent,SFDA（I）20082402208
RocheC.fasCalibraror,SFDA（I）20092402926
1.Accuracy:
bias<10﹪
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.67%
3.Reportablerange:
4-800U/L
Serum
B0351********
Ratemethod
RocheModularP800BiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.2134-20;EquipNO.LAB-NFM-205
Rocheoriginalbindedreagent,SFDA（I）20082402208
RocheC.fasCalibraror,SFDA（I）20092402926
1.Accuracy:
bias<10﹪
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.67%
3.Reportablerange:
4-800U/L
Serum
B0351********
Ratemethod
Vitors350DryAnalyzerManufacturerNo.27002540,Reg.No.SFDA（I）20092400267,Equip.No.LAB-LJ-33
Vitorsdedicatedreagent,SFDA20092402049
Vitorsdedicatedcalibrator,SFDA20092401611
1.Accuracy:
bias<10﹪
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.67%
3.Reportablerange:
3-750U/L
3
γ-Glutamyltranspeptidase
Serum
B0901********
Ratemethod
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.1987-12;EquipNO.LAB-SH-01
GermanDiasysDiagnosticSystemreagent,SFDA（I）20052403246
DiasysCalibraror，SFDA（I）20092401840
1.Accuracy:
bias<10﹪
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.67%
3.Reportablerange:
3-284.2U/L
Serum
B0901********
Ratemethod
RocheModularP800BiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.2134-20;EquipNO.LAB-NFM-205
GermanDiasysDiagnosticSystemreagent,SFDA（I）20092402167
DiasysCalibraror，SFDA（I）20092401840
1.Accuracy:
bias<10%
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.67%
3.Reportablerange:
3-284.2U/L
Serum
B0901********
Ratemethod
Vitors350DryAnalyzerManufacturerNo.27002540,Reg.No.SFDA（I）20092400267,Equip.No.LAB-LJ-33
Vitorsdedicatedreagent,SFDA20092402044
Vitorsdedicatedcalibrator,SFDA20092401611
1.Accuracy:
bias<10%
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.67%
3.Reportablerange:
3-284.2U/L
4
Alkalinephosphatase
Serum
B0701********
Rate
method
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.1987-12;EquipNO.LAB-SH-01
GermanDiasysDiagnosticSystemreagent,SFDA（I）2092401841
DiasysCalibraror，SFDA（I）20092401840
1.Accuracy:
bias<15%
2.Precision:
within-runprecisionCV<7.5%,between-precisionCV<10%
3.Reportablerange:
1-858U/L
Serum
B0701********
Rate
method
RocheModularP800BiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.2134-20;EquipNO.LAB-NFM-205
GermanDiasysDiagnosticSystemreagent,SFDA（I）2092401841
DiasysCalibraror，SFDA（I）20092401840
1.Accuracy:
bias<15%
2.Precision:
within-runprecisionCV<7.5%,between-precisionCV<10%
3.Reportablerange:
1-858U/L
Serum
B0701********
Rate
method
Vitors350DryAnalyzerManufacturerNo.27002540,Reg.No.SFDA（I）20092400267,Equip.No.LAB-LJ-33
Vitorsdedicatedreagent,SFDA20092402106
Vitorsdedicatedcalibrator,SFDA20092401611
1.Accuracy:
bias<15%
2.Precision:
within-runprecisionCV<7.5%,between-precisionCV<10%
3.Reportablerange:
20-1500U/L
5
Totalprotein
Serum
A010*********
biuretmethod
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.1987-12;EquipNO.LAB-SH-01
Rocheoriginalbindedreagent,SFDA（I）20082401058
RocheC.fasCalibraror,SFDA（I）20092402926
1.Accuracy:
bias<5%
2.Precision:
within-runprecisionCV<2.5%,between-precisionCV<3.33%
3.Reportablerange:
2.0-150U/L
Serum
A010*********
biuretmethod
RocheModularP800BiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.2134-20;EquipNO.LAB-NFM-205
Rocheoriginalbindedreagent,SFDA（I）20082401058
RocheC.fasCalibraror,SFDA（I）20092402926
1.Accuracy:
bias<5%
2.Precision:
within-runprecisionCV<2.5%,between-precisionCV<3.33%
3.Reportablerange:
2.0-150U/L
Serum
A010*********
colorimetry
Vitors350DryAnalyzerManufacturerNo.27002540,Reg.No.SFDA（I）20092400267,Equip.No.LAB-LJ-33
Vitorsdedicatedreagent,SFDA20092402107
Vitorsdedicatedcalibrator,SFDA20102401814
1.Accuracy:
bias<5%
2.Precision:
within-runprecisionCV<2.5%,between-precisionCV<3.33%
3.Reportablerange:
20-110U/L
6
ALbumin
Serum
3A015135202327101
bromcresolgreenmethod（BCG）
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.1987-12;EquipNO.LAB-SH-01
Rocheoriginalbindedreagent,SFDA（I）20082401378
RocheC.fasCalibraror,SFDA（I）20092402926
1.Accuracy:
bias<5%
2.Precision:
within-runprecisionCV<2.5%,between-precisionCV<3.33%
3.Reportablerange:
10-70g/L
Serum
3A015135202327101
bromcresolgreenmethod（BCG）
RocheModularP800BiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.2134-20;EquipNO.LAB-NFM-205
Rocheoriginalbindedreagent,SFDA（I）20082401378
RocheC.fasCalibraror,SFDA（I）20092402926
1.Accuracy:
bias<5%
2.Precision:
within-runprecisionCV<2.5%,between-precisionCV<3.33%
3.Reportablerange:
10-70g/L
Serum
3A015135202327101
colorimetry
Vitors350DryAnalyzerManufacturerNo.27002540,Reg.No.SFDA（I）20092400267,Equip.No.LAB-LJ-33
Vitorsdedicatedreagent,SFDA20092402112
Vitorsdedicatedcalibrator,SFDA20102401814
1.Accuracy:
bias<5%
2.Precision:
within-runprecisionCV<2.5%,between-precisionCV<3.33%
3.Reportablerange:
10-60g/L
7
Total
bilirubin
Serum
J010*********
Diazo
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.1987-12;EquipNO.LAB-SH-01
GermanDiasysDiagnosticSystemreagent,SFDA（I）20092402169
DiasysCalibraror，SFDA（I）20092401840
1.Accuracy:
bias<10%
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.66%
3.Reportablerange:
1.71-513umol/L
Serum
J010*********
Diazo
RocheModularP800BiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.2134-20;EquipNO.LAB-NFM-205
GermanDiasysDiagnosticSystemreagent,SFDA（I）20092402169
DiasysCalibraror，SFDA（I）20092401840
1.Accuracy:
bias<10%
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.66%
3.Reportablerange:
1.71-513umol/L
Serum
J010*********
colorimetry
Vitors350DryAnalyzerManufacturerNo.27002540,Reg.No.SFDA（I）20092400267,Equip.No.LAB-LJ-33
Vitorsdedicatedreagent,SFDA20092402057
Vitorsdedicatedcalibrator,SFDA20102401814
1.Accuracy:
bias<10%
2.Precision:
within-runprecisionCV<5%,between-precisionCV<6.66%
3.Reportablerange:
1.7-461.7umol/L
8
Glucose
Serum
D010*********
Hexokinasemethod
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.1987-12;EquipNO.LAB-SH-01
GermanDiasysDiagnosticSystemreagent,SFDA（I）20092402387
DiasysCalibraror，SFDA（I）20092401840
1.Accuracy:
bias<5%
2.Precision:
within-runprecisionCV<2.5%,between-precisionCV<3.33%
3.Reportablerange:
0.11-28mmol/L
Serum
D010*********
Hexokinasemethod
RocheModularP800BiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.2134-20;EquipNO.LAB-NFM-205
GermanDiasysDiagnosticSystemreagent,SFDA（I）20092402387
DiasysCalibraror，SFDA（I）20092401840
1.Accuracy:
bias<5%
2.Precision:
within-runprecisionCV<2.5%,between-precisionCV<3.33%
3.Reportablerange:
0.11-28mmol/L
Serum
D010*********
colorimetry
Vitors350DryAnalyzerManufacturerNo.27002540,Reg.No.SFDA（I）20092400267,Equip.No.LAB-LJ-33
Vitorsdedicatedreagent,SFDA20092402150
Vitorsdedicatedcalibrator,SFDA20092402042
1.Accuracy:
bias<5%
2.Precision:
within-runprecisionCV<2.5%,between-precisionCV<3.33%
3.Reportablerange:
1.11-34.69mmol/L
9
Urea
Serum
C025*********
Urease/GLDH
RocheModularSWABiochemistryAnalyzer,Reg.No.SFDA（I）20113401355;ManufacturerNo.1987-12;EquipNO.LAB-SH-01
Rocheoriginalbindedreagent,SFDA（I）20082400945
RocheC.fasCalibraror,SFDA（I）20092402926
1.Accuracy:
bias<4.5%
2.Precision:
within-runprecisionCV<2.25%,between-precisionCV<3%
3.Reportablerange:
0.83-66.8mmol/L
Serum
C025*********
Urease/GLDH
RocheModularP800BiochemistryAnalyzer,Reg.No.SF
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