EISSN: 2980-0749
  Ana Sayfa | Amaç ve Kapsam | Dergi Hakkında | İçindekiler | Arşiv | Yayın Arama | Yazarlara Bilgi | Etik İlkeler | İletişim  
2014, Cilt 12, Sayı 3, Sayfa(lar) 107-114
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Evaluation of Measurement Uncertainty for 25-Hydroxyvitamin D3 Immunoassay Method with
Meltem Demir2, Fatma Demet İnce1
1Tepecik Eğitim ve Araştırma Hastanesi, Tıbbi Biyokimya, İzmir, Türkiye
2Özel Antalya Medikal Park Hastanesi, Biyokimya Laboratuvarı, Antalya, Türkiye
Keywords: 25-Hydroxyvitamin D; uncertainty; immunoassay

Background: It was calculated total uncertainty of measurement using the repeatability and the uncertainty arising from the commercial quality control and calibrator in the method of immunoassay 25-Hydroxyvitamin D3 and was evaluated the potential impact of its on the decision of vitamin D status of patients.

Materials and Methods: The measurement of 25-Hydroxyvitamin D3 was made with electrochemiluminescence immunoassay method. After repeatability, the standard uncertainty arising from the commercial quality control and calibrator were calculated, square of each value were collected and the compound uncertainty was found with the square roots of that value. The expanded uncertainty was obtained by multiplied the combined uncertainty value with a coverage factor (k=2; confidence interval, 95%). Total 7922 results of vitamin D in 1-year was divided into 0-24, 25-49, 50-74, 75-150 nmol/L and the impacts on cut-off value of the measurement uncertainty and patients' vitamin D status was evaluated.

Results: For the serum 25-Hydroxyvitamin D3 test, the total uncertainty of measurement was found as ±24% (confidence interval, 95%). When results were evaluated by adding or removing uncertainty of measurement, the variation of individuals within diagnostic groups were significantly (p<0.001).

Conclusion: We thought that the 25-Hydroxyvitamin D3 immunassay methods provide greater speed, easiness, efficiency and improve work flow in the clinical laboratory. However, the uncertainty of measurement studies should be made if studied results with immunassay methods could significantly affect clinical interpretations and patient management. Adding the value of the uncertainty of measurement to the results of patient will increase the power of physician in the point of clinical decision-making and confidence in the results of laboratory.


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