Utility Evaluation of Two-point Calibration Curve applied for TSH, FT4 Tests

TSH, FT4 검사의 Two-point Calibration Curve 적용의 유용성 평가

  • Park, Hye-Mi (Department of Nuclear Medicine, ASAN Medical Center) ;
  • Yoo, Seon-Hee (Department of Nuclear Medicine, ASAN Medical Center) ;
  • Lee, Seon-Ho (Department of Nuclear Medicine, ASAN Medical Center) ;
  • Kim, Nyun-Ok (Department of Nuclear Medicine, ASAN Medical Center)
  • 박혜미 (서울아산병원 핵의학과) ;
  • 유선희 (서울아산병원 핵의학과) ;
  • 이선호 (서울아산병원 핵의학과) ;
  • 김년옥 (서울아산병원 핵의학과)
  • Received : 2016.09.26
  • Accepted : 2016.10.06
  • Published : 2016.10.29

Abstract

Purpose The ASAN Medical Center, Nuclear Medicine performs TSH (Thyroid stimulating hormone) and FT4 (Free Thyroxine) tests 8 times per day. Accordingly, 70 ~ 80 kit tubes are consumed every day for the measurements and the time consumed for reagent dispensing averages over 170 seconds, where the TAT (turnaround time) may be effected when the number of test samples is larger than expected. Therefore, the following test was conducted with the purpose to reduce the number of kit tubes consumed, and reduce the time for reagent dispensing. Materials and Methods The test is based on applying the same reagent for tests where the number of samples is 30 or less. The test for TSH was conducted 9 times from July $1^{st}$ 2015 to July $10^{th}$ 2015. The test for FT4 was conducted 4 times from June $18^{th}$ 2015 to June $22^{nd}$, 2015. Standard Solution No.2 (0.153 uU/mL) and No.5 (4.96 uU/mL) was selected as the two-point standards for the TSH test, and Standard Solution No.3 (0.777 ng/dL) and No.4 (2.044 ng/dL) was selected as the two-point standards for the FT4 test. 38 test samples were subject to correlation analysis. Results For TSH, the result of the normal test shows ranges of 0.20 ~ 0.37 uU/mL for Control1, 0.53 ~ 0.71 uU/mL for Control2, and 6.77 ~ 7.94uU/mL for Control3, while the result of two-point calibration curve test shows ranges of 0.18 ~ 0.27 uU/mL for Control1, 0.53 ~ 0.71 uU/mL for Control2, and 7.30 ~ 8.52 uU/mL for Control3. For FT4, the result of the normal test shows ranges of 0.85 ~ 0.94 ng/dL for Control1 and 4.23 ~ 4.57 ng/dL for Control2, while the result of two-point calibration curve test shows ranges of 0.61 ~ 0.75 ng/dL for Control1 and 3.88 ~ 5.71 ng/dL for Control2. For TSH, the CV% of the normal test for Control1, Control2 and Control3 are 10.5, 3.3 and 3.6 respectively, while the CV% of the two-point calibration curve test for Control1 and Control1 are 12.4, 8.2 and 5.1 respectively. The result shows an outstanding correlation of TSH: y = 0.9985x - 0.0459 $R^2=0.9986$. For FT4, the CV% of the normal test for Control1 and Control2 are 0.70 and 0.71 respectively, while the CV% of the two-point calibration curve test for Control1 and Control1 are 8.7 and 16.2 respectively. The result shows an outstanding correlation of FT4: y = 1.2674x - 0.1133 $R^2=0.9824$. Conclusion The two-point calibration curve can be efficiently applied for TSH in cases where the number of test samples is not large, since the number of samples to be re-tested increases when the result is abnormal from the calibration curve. The two-point calibration curve test should not be applied for FT4 where the results do not consistently comply with the quality assessment range. Depending on how the two-point calibration curve is applied, up to 5 test tubes can be conserved per test, and the reduced time for reagent dispensing is anticipated to have a positive effect on the TAT (turnaround time).

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