Harmonisation of TFTs

Transcription

1 Royal Prince Alfred Hospital and University of Sydney Harmonisation of TFTs Harmonisation Workshop May 2015 Paul Williams Harmonisation May 2015

2 Talk Outline IFCC initiatives C-STFT (Committee for standardisation of thyroid function tests). TSH Examples of assays differences TSH Reference interval changes FT4 assay differences and problems Ranges in Pregnancy. Any Consensus?

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4 Paul Williams Harmonisation May 2015 From Beastall, G. C_STFT report UK consensus meeting on thyroid reference intervals (RIs) March 2013

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7 Paul Williams Harmonisation May 2015 From Beastall, G. C_STFT report UK consensus meeting on thyroid reference intervals (RIs) March 2013

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9 From Thienpont report to C-SFT and FDA (APTM AA procedures Trimmed mean)

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14 From Graham Beastall IFCC report

15 TSH Assays in Australia Examples

16 TSH Comparison RPAH Immulite Vs Roche non pregnant samples TSH y = x R² = Immulite Roche Modular

17 Fresh Data from Hobart Immulite vs Roche TSH (last week) Cobas Immulite y = x R² = Series1 Linear (Series1) Cobas 3 2 y = x R² = Series1 Linear (Series1) Linear (Series1) Immulite 4 6 Data provided by Parameswaran, Venkateswaran in Hobart

18 6 TSH Roche TSH 5 4 y = x R² = TSH Linear (TSH) Immulite TSH Data From RPAH Immulite Vs Roche TSH Matched for FT4 Pregnant samples

19 Ann Clin Biochem 2007; 44:

20 Roche Single step assay

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22 Some Background on TSH assays With Thanks for the work of Carol Spencer

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26 Data Provided by Prof. K Sikaris

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28 Harmonised TSH looks to be very promising for TSH Assays Can we implement an All procedures trimmed mean recalibration and harmonise the Reference intervals?

29 What About FT4 and FT3? Do we wait for standardisation to be complete and assays to be recalibrated? This could be slow because of reluctance to re-register assays by the Manufacturers. All assays will increase 30-50% what will be the clinicians reaction?

30 Roche Single step assay

31 15 th IFCC-Conference Clinical Chemistry and Laboratory Medicine Barcelona Spain 2003

32 Just using assay specific Reference ranges, would we diagnose the same patients?

33 Multiple line comparison between Values Thienpont Roche and Abbott THP_M Roche Abbott FT4 pmol/l

34 Data Provided by Prof. K Sikaris

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38 Cobas Recent Data from Hobart Immulite vs Immulite Roche FT4 y = x R² = Series1 Linear (Series1) Immulite FT4 - Cobas FT Mean of Immulite FT4 and Cobas FT SD 3.3 Mean SD Low Free T4 Cobas y = x R² = Series1 Linear (Series1) Immulite_FT4 1 - Cobas_FT SD 2.8 Mean SD Immulite Mean of Immulite_FT4 1 and Cobas_FT4 1 Data provided by Parameswaran, Venkateswaran

39 70% Percentage Elevated ft4 60% 50% 40% 30% 20% 10% Centaur>20 E170>21 DXL>21 Architect>19 0% to 0.03 to 0.3 to 5.0 to 50 to 0.1 to 1.0 to 10 >50 TSH Data Provided by Prof. K Sikaris

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47 Thank You for your attention. Are we able to start the discussion?

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49 FT4 pmol/l FT4 Manufacturers Reference Range A S C S D S V S I R C V B FT4 Low FT4 Mid FT4 High TSH miu/l TSH Manufacturers Reference Ranges A S C S D S V S I R C V B TSH Low TSH MID TSH High FT3 pmol/l FT3 Manufacturers Reference Ranges A S C S D S V S I R C V B FT3 Low FT3 mid FT3 high

50 Data Provided by Prof. K Sikaris

51 Manufacturer Defined RI (MD-RI) Pregnancy Paediatric Abbott No No Siemens Advia Centaur No Yes Siemens Dimensions EXL No Yes Siemens Vista No Yes Siemens Immulite Trimester TSH and FT4 Yes detailed Roche Cobas Elecsys Trimester FT4 Yes Vitros Trimester FT4 and FT3 No Beckman Access Trimester FT4 No 4/8 5/8

52 Differences between FT4 immunoassays FT4 ASSAY Abbott 2-step Siemens Advia Centaur High MW analogue? Siemens Dimensions High MW analogue? Siemens Vista Siemens Immulite High MW analogue? Roche Cobas Elecsys 1-step Vitros Competitive IMA Beckman Access??

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55 From Thienpont report to C-SFT and FDA

56 Table 1. Comparison of TSHs from pregnant women without thyroid disease * Mann-Whitney-Wilcoxon Test Table 2. Comparison of TSHs from 112 real world samples * Mann-Whitney-Wilcoxon Test TSH (miu/l) N=70 results Median (IQR) 2.5 th to 97.5 th centile DPC Immulite 2000 Roche E-170 Comparison * P<0.001 (0.73) (0.84) Table 2. Comparison of TSHs from 112 real world samples * Mann-Whitney-Wilcoxon Test TSH (miu/l) N=112 results DPC Immulite 2000 Roche E-170 Comparison * Median (IQR) 2.5 th to 97.5 th centile (1.66) (2.02) P<0.001

57 Data Provided by Prof. K Sikaris

58 Data Provided by Prof. K Sikaris

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60 TSH Methods E170/ e 601/e 602 (cobas IA) 74 Roche Diagnostics Elecsys 2010/cobas e411 6 Roche Diagnostics Hitachi cobas c501/c502 2 Abbott ARCHITECT (i1000,i2000,i4000) 70 Abbott ARCHITECT c Abbott ARCHITECT i1000sr 7 Abbott AxSYM / AxSYM+ 1 Dimension Vista 4 VITROS ECi /ECi Q 8 VITROS 3600/5600(i ) 17 VITROS 5,1 F S/5600 (c) 1 ADVIA Centaur/ADVIA Centaur XP 52 ADVIA Centaur CP 4 Beckman Coulter Access/Access 2 Beckman Coulter UniCel DxI 600/ Immulite/Immulite Immulite 2000/2000 XPi 1

61 Free T4 Roche Diagnostics Elecsys 2010/cobas e411 6 Roche Diagnostics Hitachi cobas c501/c502 2 E170/ e 601/e 602 (cobas IA) 71 Immulite 2000/2000 XPi 1 Dimension Vista 1 ADVIA Centaur/ADVIA Centaur XP 53 ADVIA Centaur CP 4 Beckman Coulter UniCel DxI 600/ Beckman Coulter Access/Access 2 VITROS ECi /ECi Q 5 VITROS 5,1 F S/5600 (c) 1 VITROS 3600/5600(i ) 13 Abbott ARCHITECT c Abbott ARCHITECT i1000sr 6 Abbott ARCHITECT (i1000,i2000,i4000) 67 Abbott AxSYM / AxSYM+ 1

62 A-Abbott, SC Siemens Centaur, SD Siemens Dimension, SI Siemens Immulite, RC Roche Cobas, V Vitros, B Beckman Coulter.

63 A-Abbott, SC Siemens Centaur, SD Siemens Dimension, SI Siemens Immulite, RC Roche Cobas, V Vitros, B Beckman Coulter.

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