TY - JOUR T1 - Validation study of Hba1c kit to be used in diabetic population TT - Validation study of Hba1c kit to be used in diabetic population AU - Özkan, Elife PY - 2024 DA - September Y2 - 2024 DO - 10.18663/tjcl.1475931 JF - Turkish Journal of Clinics and Laboratory JO - TJCL PB - DNT Ortadoğu Yayıncılık A.Ş. WT - DergiPark SN - 2149-8296 SP - 387 EP - 392 VL - 15 IS - 3 LA - tr AB - Amaç: Hastaneye başvuran Diyabetes Mellitüs tanılı hastalarda taramada kullanılacak olan HbA1c kiti doğrulama çalışması Gereç ve Yöntemler: Rutin analizlerde kullanılan HbA1c kiti internal ve external kontrolleri yanısıra laboratuvar içi doğrulama validasyon çalışmaları testin geçerli kılma basamakları, doğruluk (accuracy) Kesinlik (presizyon) ve rapor aralığı işlemleri yapılmıştır.Sonuç: Hastane tıbbi laboratuvarında HbA1c kitinin bu doğrulama ve geçerli kılma işlemlerini tüm basamakları yapılmış ve kayıt altına alınmıştır. Çalışmalar arası tekrarlanabilirlik (%CV) 0.88, Yöntem / referans materyali karşılaştırma (% Bias)3.94 Hedef: (% Bias + 1.65 (%CV) < TEa) Sonuç olarak TAH:5,40 < TEa:18 (rilibak) olarak hesaplanmıştır ve kit verifiye olmuştur. Diyabetik popülasyon taramasında kullanılacak olan kitin doğruluğu maliyetli ve yaygın bir hastalığın tedavi ve takibinde klinisyen öngörüsünü etkileyeceği için önemlidir.Tüm laboratuvarlar ticari kit olsun olmasın doğrulama işlemlerini laboratuvar güvenirliğini ve kalitesini artırmak adına yapmalıdır. Özellikle toplumu etkileyecek hastalıkların analizlerinde klinisyenlere doğru yön vermek adına yapılması zorunlu olmalıdır. Geniş popülasyonu etkileyecek uzun süreli çalışmalarda kullanılacak kitin doğrulama verilerinin araştırma verilerine eklenmesi de çalışmanın etkinliğini artıracaktır. KW - Validasyon KW - verifikasyon KW - ölçüm belirsizliği KW - doğruluk KW - kesinlik KW - Diyabetes Mellitüs KW - HbA1c N2 - Aim: A validation study of the HbA1c kit to be used in screening patients diagnosed with Diabetes Mellitus admitted to the hospital.Material and Methods: In addition to the internal and external controls of the HbA1c kit used in routine analyses, in-laboratory verification and validation studies, validation steps of the test, accuracy (precision), and report range were carried out.Result: All steps of the verification and validation of the HbA1c kit have been carried out and recorded in the hospital medical laboratory. Inter-study reproducibility (%CV) 0.88, Method / reference material comparison (% Bias) 3.94 Target: (% Bias + 1.65 (%CV) < TEa) As a result, TAH: 5.40 < TEa: 18 (rilibak) was calculated and The kit has been verified.The accuracy of the kit to be used in diabetic population screening is important as it will affect the clinician's prediction in the treatment and follow-up of a costly and common disease. All laboratories, whether commercial kit or not, should carry out verification procedures in order to increase laboratory reliability and quality. It should be mandatory to provide the right direction to clinicians, especially in the analysis of diseases that will affect society. Adding the validation data of the kit to the research data, which will be used in long-term studies that will affect a large population, will also increase the effectiveness of the study. CR - Yücel D. Practical Method Validation and Verification Guide. Turkish Biochemistry Association. Ankara. 2014; 1-26. 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