附表2能力范围表英文.docx

1、附表2能力范围表英文附表2申请检验能力范围（英文）Lab: Department of Clinical Laboratory，Jiangsu Provincial Hospital integrated traditional and western medicineAddress: 100 Shizi Street，Maigaoqiao，Nanjing，JiangsuExamina-tionItemSampleTypeCodeAnalytical MethodAnalytical Instrument(s)Analytical Reagent(s)Calibrator(s)NoteAnal

2、ytical Performance（1. Trueness；2. Precision；3.Reportable range；4. Other Performances）1AlanineaminotransferaseSerumB0451*RatemethodRoche Modular SWA Biochemistry Analyzer,Reg.No. SFDA(I)20113401355;Manufacturer No.1987-12;Equip NO.LAB-SH-01Rocheoriginal binded reagent, SFDA(I) 20082402207Roche C.fas

3、Calibraror,SFDA(I) 200924029261.Accuracy: bias10Precision: within-run precision CV5%, between-precision CV6.67%;Reportable range: 4-600 U/LSerumB0451*RatemethodRoche Modular P800 Biochemistry Analyzer,Reg.No. SFDA(I)20113401355;Manufacturer No.2134-20;Equip NO.LAB-NFM-205Roche original binded reagen

4、t, SFDA(I) 20082402207Roche C.fas Calibraror,SFDA(I) 200924029261.Accuracy: bias102.Precision: within-run precision CV5%, between-precision CV6.67%3.Reportable range: 4-600 U/LSerumB0451*RatemethodVitors 350 DryAnalyzer Manufacturer No. 27002540,Reg.No.SFDA (I) 20092400267, Equip.No.LAB-LJ-33Vitors

5、dedicated reagent, SFDA 20092402046Vitors dedicated calibrator, SFDA 200924016111.Accuracy: bias102.Precision: within-run precision CV5%, between-precision CV6.67%3.Reportable range: 3-1000 U/L2AspartateaminotransferaseSerumB0351*Rate methodRoche Modular SWA Biochemistry Analyzer,Reg.No. SFDA(I)2003

6、3400462;Manufacturer No.1987-12;Equip NO.LAB-SH-01Roche original binded reagent , SFDA(I) 20082402208Roche C.fas Calibraror,SFDA(I) 200924029261.Accuracy: bias102.Precision: within-run precision CV5%, between-precision CV6.67%3. Reportable range: 4-800 U/LSerumB0351*Rate methodRoche Modular P800 Bio

7、chemistry Analyzer,Reg.No. SFDA(I)20113401355;Manufacturer No.2134-20;Equip NO.LAB-NFM-205Roche original binded reagent , SFDA(I) 20082402208Roche C.fas Calibraror,SFDA(I) 200924029261.Accuracy: bias102.Precision: within-run precision CV5%, between-precision CV6.67%3.Reportable range: 4-800 U/LSerum

8、B0351*Rate methodVitors 350 DryAnalyzer Manufacturer No. 27002540,Reg.No.SFDA (I) 20092400267, Equip.No.LAB-LJ-33Vitors dedicated reagent , SFDA 20092402049Vitors dedicated calibrator , SFDA 200924016111.Accuracy: bias102.Precision: within-run precision CV5%, between-precision CV6.67%3.Reportable ra

9、nge: 3-750 U/L3-Glutamyl transpeptidaseSerumB0901*Rate methodRoche Modular SWA Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manufacturer No.1987-12;Equip NO.LAB-SH-01German Diasys Diagnostic System reagent, SFDA(I)20052403246Diasys Calibraror ，SFDA（I）200924018401.Accuracy: bias102.Precision: wi

10、thin-run precision CV5%, between-precision CV6.67%3.Reportable range: 3-284.2 U/LSerumB0901*Rate methodRoche Modular P800 Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manufacturer No. 2134-20;Equip NO. LAB-NFM-205German Diasys Diagnostic System reagent, SFDA(I) 20092402167Diasys Calibraror ，SFD

11、A（I）200924018401.Accuracy: bias10%2.Precision: within-run precision CV5%, between-precision CV6.67%3.Reportable range: 3-284.2 U/LSerumB0901*Rate methodVitors 350 DryAnalyzer Manufacturer No. 27002540,Reg.No.SFDA (I) 20092400267, Equip.No.LAB-LJ-33Vitors dedicated reagent , SFDA 20092402044Vitors de

12、dicated calibrator , SFDA 200924016111.Accuracy: bias10%2.Precision: within-run precision CV5%, between-precision CV6.67%3.Reportable range: 3-284.2 U/L4Alkaline phosphataseSerumB0701*RatemethodRoche Modular SWA Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manufacturer No.1987-12;Equip NO.LAB-S

13、H-01German Diasys Diagnostic System reagent, SFDA(I) 2092401841Diasys Calibraror ，SFDA（I）200924018401.Accuracy: bias15%2.Precision: within-run precision CV7.5%, between-precision CV10%3.Reportable range: 1-858 U/L SerumB0701*RatemethodRoche Modular P800 Biochemistry Analyzer,Reg.No. SFDA(I) 20113401

14、355;Manufacturer No. 2134-20;Equip NO. LAB-NFM-205German Diasys Diagnostic System reagent, SFDA(I) 2092401841Diasys Calibraror ，SFDA（I）200924018401.Accuracy: bias15%2.Precision: within-run precision CV7.5%, between-precision CV10%3.Reportable range: 1-858 U/LSerumB0701*RatemethodVitors 350 DryAnalyz

15、er Manufacturer No. 27002540,Reg.No.SFDA (I) 20092400267, Equip.No.LAB-LJ-33Vitors dedicated reagent , SFDA 20092402106Vitors dedicated calibrator , SFDA 200924016111.Accuracy: bias15%2.Precision: within-run precision CV7.5%, between-precision CV10%3.Reportable range: 20-1500 U/L5Total proteinSerumA

16、010*biuret methodRoche Modular SWA Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manufacturer No.1987-12;Equip NO.LAB-SH-01Roche original binded reagent , SFDA(I) 20082401058Roche C.fas Calibraror,SFDA(I) 200924029261. Accuracy: bias 5%2. Precision: within-run precision CV2.5%, between-precision

17、 CV3.33%3. Reportable range: 2.0-150 U/LSerumA010*biuret methodRoche Modular P800 Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manufacturer No. 2134-20;Equip NO. LAB-NFM-205Roche original binded reagent , SFDA(I) 20082401058Roche C.fas Calibraror,SFDA(I) 200924029261. Accuracy: bias 5%2.Precisi

18、on: within-run precision CV2.5%, between-precision CV3.33%3. Reportable range: 2.0-150 U/LSerumA010*colorimetryVitors 350 DryAnalyzer Manufacturer No. 27002540,Reg.No.SFDA (I) 20092400267, Equip.No.LAB-LJ-33Vitors dedicated reagent , SFDA 20092402107Vitors dedicated calibrator , SFDA 201024018141. A

19、ccuracy: bias 5%2.Precision: within-run precision CV2.5%, between-precision CV3.33%3. Reportable range: 20-110 U/L 6ALbuminSerum3A015135202327101bromcresol green method(BCG)Roche Modular SWA Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manufacturer No.1987-12;Equip NO.LAB-SH-01Roche original bi

20、nded reagent , SFDA(I) 20082401378Roche C.fas Calibraror,SFDA(I) 200924029261. Accuracy: bias 5%2. Precision: within-run precision CV2.5%, between-precision CV3.33%3.Reportable range :10-70g/LSerum3A015135202327101bromcresol green method(BCG)Roche Modular P800 Biochemistry Analyzer,Reg.No. SFDA(I) 2

21、0113401355;Manufacturer No. 2134-20;Equip NO. LAB-NFM-205Roche original binded reagent , SFDA(I) 20082401378Roche C.fas Calibraror,SFDA(I) 200924029261. Accuracy: bias 5%2.Precision: within-run precision CV2.5%, between-precision CV3.33%3.Reportable range :10-70g/LSerum3A015135202327101colorimetryVi

22、tors 350 DryAnalyzer Manufacturer No. 27002540,Reg.No.SFDA (I) 20092400267, Equip.No.LAB-LJ-33Vitors dedicated reagent , SFDA 20092402112Vitors dedicated calibrator , SFDA 201024018141. Accuracy: bias 5%2.Precision: within-run precision CV2.5%, between-precision CV3.33%3. Reportable range :10-60g/L

23、7TotalbilirubinSerumJ010*DiazoRoche Modular SWA Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manufacturer No.1987-12;Equip NO.LAB-SH-01German Diasys Diagnostic System reagent, SFDA(I) 20092402169Diasys Calibraror ，SFDA（I）200924018401.Accuracy: bias 10%2.Precision: within-run precision CV5%, bet

24、ween-precision CV6.66%3.Reportable range: 1.71-513 umol/LSerumJ010*DiazoRoche Modular P800 Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manufacturer No. 2134-20;Equip NO. LAB-NFM-205German Diasys Diagnostic System reagent, SFDA(I) 20092402169Diasys Calibraror ，SFDA（I）200924018401. Accuracy: bia

25、s 10%2. Precision: within-run precision CV5%, between-precision CV6.66%3. Reportable range: 1.71-513 umol/LSerumJ010*colorimetryVitors 350 DryAnalyzer Manufacturer No. 27002540,Reg.No.SFDA (I) 20092400267, Equip.No.LAB-LJ-33Vitors dedicated reagent , SFDA 20092402057Vitors dedicated calibrator , SFD

26、A 201024018141.Accuracy: bias 10%2.Precision: within-run precision CV5%, between-precision CV6.66%3.Reportable range: 1.7-461.7 umol/L 8GlucoseSerumD010*Hexokinase method Roche Modular SWA Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manufacturer No.1987-12;Equip NO.LAB-SH-01German Diasys Diagn

27、ostic System reagent, SFDA(I) 20092402387Diasys Calibraror ，SFDA（I）200924018401.Accuracy: bias 5%2.Precision: within-run precision CV2.5%, between-precision CV3.33%3.Reportable range : 0.11-28 mmol/LSerumD010*Hexokinase methodRoche Modular P800 Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manuf

28、acturer No. 2134-20;Equip NO. LAB-NFM-205German Diasys Diagnostic System reagent, SFDA(I) 20092402387Diasys Calibraror ，SFDA（I）200924018401.Accuracy: bias5%2.Precision: within-run precision CV2.5%, between-precision CV3.33%3.Reportable range : 0.11-28 mmol/LSerumD010*colorimetryVitors 350 DryAnalyze

29、r Manufacturer No. 27002540,Reg.No.SFDA (I) 20092400267, Equip.No.LAB-LJ-33Vitors dedicated reagent , SFDA 20092402150Vitors dedicated calibrator , SFDA 200924020421.Accuracy: bias 5%2.Precision: within-run precision CV2.5%, between-precision CV3.33%3.Reportable range : 1.11-34.69 mmol/L 9UreaSerumC

30、025*Urease /GLDHRoche Modular SWA Biochemistry Analyzer,Reg.No. SFDA(I) 20113401355;Manufacturer No.1987-12;Equip NO.LAB-SH-01Roche original binded reagent , SFDA(I) 20082400945Roche C.fas Calibraror,SFDA(I) 200924029261.Accuracy: bias 4.5%2.Precision: within-run precision CV2.25%, between-precision CV3%3.Reportable range : 0.83-66.8 mmol/LSerumC025*Urease /GLDHRoche Modular P800 Biochemistry Analyzer,Reg.No. SF