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Harmonisation of TFTs
Harmonisation Workshop
May 2015
Examples
TSH Comparison RPAH Immulite Vs Roche non pregnant samples
6
Immulite 2000
0
0 2 4 6 8 10
Roche Modular
Fresh Data from Hobart Immulite vs
Roche TSH (last week)
45
40
y = 1.1882x - 0.4003
35 R = 0.9975
30
25
Cobas
20
15
10
5 Series1
0 Linear (Series1)
-5 0 10 20 30 40
Immulite
6
y = 0.9251x + 0.2117
5 R = 0.9688
4 Series1
Linear (Series1)
Cobas
3
Linear (Series1)
2
1
Data provided by Parameswaran,
0
0 2 Immulite 4 6
Venkateswaran in Hobart
TSH
6
5
Roche y = 1.1602x + 0.0921
TSH R = 0.9302
4
3
TSH
2 Linear (TSH)
0
0 1 2 3 4 5 6
Immulite TSH
Data From RPAH Immulite Vs Roche TSH Matched for FT4 Pregnant samples
Ann Clin Biochem 2007; 44: 203208
Roche Single step assay
Some Background on TSH assays
100 THP_M
Roche
90 Abbott
80
FT4
70
pmol/L
60
50
40
30
20
0 2 4 6 8 10 12
Data Provided by Prof. K Sikaris
Recent Data from Hobart Immulite vs
45
Roche FT4 4
+1.96 SD
40 3.3
y = 1.1882x - 0.4003 2
35 R = 0.9975
30
20 Series1
-4
10 -6
5 -8
10 15 20 25 30 35 40
0 Mean of Immulite FT4 and Cobas FT4
-5 0 10 20 30 40
Immulite
25
Low Free T4
4
20 R = 0.8311 2.8
Immulite_FT4 1 - Cobas_FT4 1
1
15
Cobas
Mean
0
-0.1
Series1
10 -1
Linear (Series1) -2
5 -3
-1.96 SD
-2.9
-4
0 10 12 14 16 18
Mean of Immulite_FT4 1 and Cobas_FT4 1
20 22
0 5 10 15 20
Immulite
Data provided by Parameswaran, Venkateswaran
70%
60%
Percentage Elevated fT4
50%
Centaur>20
40%
E170>21
DXL>21
30%
Architect>19
20%
10%
0%
to 0.03 to 0.3 to 5.0 to 50
to 0.1 to 1.0 to 10 >50
TSH
TSH mIU/L
20 4
FT4 pmol/L
15 3
10 2
5 1
0 0
A SC SD SV SI RC V B A SC SD SV SI RC V B
FT4 Low 9 11.5 9.8 9.8 10.3 12 10 7.9 TSH Low 0.35 0.55 0.36 0.36 0.4 0.27 0.46 0.34
FT4 Mid 14 17.1 14.3 14 14.3 17 14.1 11.1 TSH MID 2.7 2.7 2 2 2.2 2.2 2.6 3
FT4 High 19 22.7 18.8 18.8 24.5 22 28.2 14.4 TSH High 4.9 4.8 3.7 3.7 4 4.2 4.7 5.6
6
5
4
3
2
1
0
A SC SD SV SI RC V B
FT3 Low 2.6 3.5 3.4 3.3 2.8 3.1 4.3 3.8
FT3 mid 4.2 5 4.8 4.37 4.7 5 6.2 4.9
FT3 high 5.7 6.5 6.1 6.1 6.5 6.8 8.1 6
Data Provided by Prof. K Sikaris
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
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 ??
From Thienpont report to C-SFT and FDA
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