Abstract
Amaç: Tıbbi laboratuvarlarda yeni bir yöntemle hasta sonucu verilmeden önce yöntemin performansı değerlendirilerek verileri test edilmelidir. Bu çalışmada, Bilecik Halk Sağlığı Laboratuvarı gözetimindeki entegre hastane laboratuvarlarına kurulması düşünülen kuru sistem biyokimya cihazında çalışılacak testlerin, Klinik ve Laboratuvar Standartları Enstitüsü CLSI tarafından yayımlanan EP15-A2 kılavuzuna göre verifikasyonunun yapılması amaçlanmıştır.Results: The within-run Sr precision value, verification limits are with inside for each two level of glucose, urea, total cholesterol, AST, and TBIL; for first level of ALT and calcium and also verification limits are outside for second levels of calcium and ALT. While the bias value is within the calculated verification limits for glucose, urea, total cholesterol, AST, ALT and TBIL; it is outside of verification limits for calcium.Conclusion: We consider that precision of parameters which were tested in company with EP15-A2 guideline and were studied by dry chemistry system are acceptable, conformity between tests which bias values are outside of verification limits and current autoanalyzer on laboratory is restricted and it will require that these parameters are to be verified by reference method.Key Words: dry chemistry, Spotchem EZ, Bulgular: Çalışma içi within-run, Sr kesinlik değeri glikoz, üre, total kolesterol, AST ve TBIL’nin her iki seviyesi, ALT ve kalsiyumun birinci seviyesi için verifikasyon limitleri içinde iken ALT ve kalsiyumun ikinci seviyeleri için verifikasyon limitleri dışındadır. Glikoz, üre, total kolesterol, AST, ALT ve TBIL için bias değeri, hesaplanan verifikasyon limitleri içinde iken, kalsiyum için verifikasyon limitleri dışındadır.Sonuç: EP15-A2 rehberi temelinde kesinlik ve bias açısından test edilen, kuru kimya cihaz sistemi ile çalışılan parametrelerin kesinliğinin kabul edilebilir olduğu, bias değerleri ise verifikasyon limitleri dışında olan parametrelerin laboratuvarda kurulu olan mevcut otoanalizörle uyumunun sınırlı olduğu ve bu parametrelerin referans yöntemler ile doğrulanması gerekeceği düşünülmektedir
Keywords
References
- Bilić-Zulle L. Comparison of methods: passing and bablok regression. Biochemia Medica, 2011; 21(1):49-52.
- Anonymous. Uluslararası Metroloji Sözlüğü — Temel Ve Genel Kavramlar, İlgili Terimler (VIM). http://www.ume.tubitak.gov.tr/sites/images/ uluslararasi_metroloji_sozlugu.pdf, (Erişim Tarihi: 25/08/2017).
- Anonymous. User Verification of Performance for Precision and Trueness, Approved Guideline EP15-A2. 2nd ed. Wayne, Pa: Clinical and Laboratory Standards Institute, 2005.
- Hanneman SK. Design, analysis and interpretation of method-comparison studies. AACN Adv Crit Care, 2008;19(2): 223-4.
Verification Of Some Biochemistry Tests That To Be Analyzed In Spotchem EZ SP-4430 Dry Chemistry System
Abstract
Objective: The test performance data of the commercial firm should be tested by evaluating the performance of the method before patient is given the result with a new method in medical laboratories. It has been aimed on this study that verification of tests which will work on the equipment of dry system biochemistry which is planned to be established to integrated hospital laboratories in trust of Bilecik Public Health Laboratory is made by EP15-A2 guideline which was published by Clinical and Laboratory Standards Institution CLSI .Methods: Verification study has been made on Spotchem-EZ Arkray device on the base of CLSI, EP15-A2 guidelines for glucose, BUN, AST, ALT, TBIL, total cholesterol, and calcium tests. As a comparative device for the bias calculation, Mindray-BS800M device which is the current autoanalyzer was used. It was studied on Spotchem-EZ device in a way that there were to be 2 two level internal quality control as three times and repetitive for 5 five days, in order to calculate precision on above - designated tests. In order to calculate trueness, 20 patient serums were studied on SpotchemEZ and BS800M autoanalyzer. Verification values were calculated in company with EP15-A2 guidelines
Keywords
References
- Bilić-Zulle L. Comparison of methods: passing and bablok regression. Biochemia Medica, 2011; 21(1):49-52.
- Anonymous. Uluslararası Metroloji Sözlüğü — Temel Ve Genel Kavramlar, İlgili Terimler (VIM). http://www.ume.tubitak.gov.tr/sites/images/ uluslararasi_metroloji_sozlugu.pdf, (Erişim Tarihi: 25/08/2017).
- Anonymous. User Verification of Performance for Precision and Trueness, Approved Guideline EP15-A2. 2nd ed. Wayne, Pa: Clinical and Laboratory Standards Institute, 2005.
- Hanneman SK. Design, analysis and interpretation of method-comparison studies. AACN Adv Crit Care, 2008;19(2): 223-4.
Details
| Primary Language | Turkish |
|---|---|
| Journal Section | Research Article |
| Authors | |
| Publication Date | June 1, 2018 |
| Published in Issue | Year 2018 Volume: 75 Issue: 2 |