Yıl 2017, Cilt 18, Sayı 1, Sayfalar 65 - 69 2017-04-17

MİKROBİYOLOJİK TEST METOTLARININ DOĞRULANMASI (VALİDASYONU)
VALIDATION OF MICROBIOLOGICAL TESTING METHODS

Dilek DUYGU [1] , Abel Udo UDOH [2]

341 3180

Metot doğrulanması, amaca en uygun ve kabul edilebilir nitelikte sonuçları üretecek analitik metodun ortaya çıkarılması sürecidir. Doğrulanmış metodun hedefi bu metotla yapılmış sonuçlara güvenirlik sağlamaktadır. Laboratuvar, standart olmayan metotları, laboratuvar tarafından geliştirilen veya tasarlanan metotları geçerli kılmalıdır. Doğrulama çalışmaları yeni bir cihaz devreye girdiğinde ya da yeni kimyasallarda önemli bir değişiklik olduğunda da yapılmalıdır. Yöntem yeni bir personel tarafından uygulanır. Uzun süredir kullanılmayan ancak kullanılmasına gereksinim duyulan bir doğrulama yönteminin laboratuvar sonuçlarını etkilediği düşünülür. Laboratuvarların, analitik metotların seçimi ve kullanımı için bir yöntem ve prosedür belirlemeleri gereklidir. Metot, kesinlik, doğruluk, seçicilik, hassasiyet, tekrar edilebilirlik ve kararlılık için gerekli minimum standartları başarılı bir biçimde karşılamalı ya da aşmalıdır.

 Method-validation is a method which proofs that a given analytical process, when applied well, produces findings which are suitable for a purpose and of acceptable standard. A process whereby an authentic information is given on an analytical method duly applied and enough to meet the needs and acceptable standards, is known as method-validation. The goal to validate a method therefore, is to make the findings of the method-validation reliable throughout the course of the study. With the above in mind, validating a method therefore, is for the purpose of making the obtained results reliable in the study. A laboratory should authenticate non-standard methods and laboratory-designed/developed methods. Validation studies should also be done when new equipment steps into the work or an important change occurs along the new chemicals. The method is carried out by a new personnel. A validation method that has not been used for a long time, demanded to be used during a study, is thought to affect the laboratory results. Laboratories need to make a policy and procedures for the selection and the use of analytical methods. The method will successfully meet or exceed the minimum standards recommended for accuracy, precision, selectivity, sensitivity, reproducibility, and stability.

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Konular Fen
Dergi Bölümü Derleme/Review
Yazarlar

Yazar: Dilek DUYGU
Kurum: GAZI UNIV
Ülke: Turkey


Yazar: Abel Udo UDOH
Kurum: GAZİ ÜNİVERSİTESİ, GAZİ EĞİTİM FAKÜLTESİ
Ülke: Turkey


Bibtex @derleme { trkjnat271725, journal = {Trakya University Journal of Natural Sciences}, issn = {2147-0294}, eissn = {2528-9691}, address = {Trakya Üniversitesi}, year = {2017}, volume = {18}, pages = {65 - 69}, doi = {10.23902/trkjnat.271725}, title = {VALIDATION OF MICROBIOLOGICAL TESTING METHODS}, key = {cite}, author = {DUYGU, Dilek and UDOH, Abel} }
APA DUYGU, D , UDOH, A . (2017). VALIDATION OF MICROBIOLOGICAL TESTING METHODS. Trakya University Journal of Natural Sciences, 18 (1), 65-69. DOI: 10.23902/trkjnat.271725
MLA DUYGU, D , UDOH, A . "VALIDATION OF MICROBIOLOGICAL TESTING METHODS". Trakya University Journal of Natural Sciences 18 (2017): 65-69 <http://dergipark.gov.tr/trkjnat/issue/30632/271725>
Chicago DUYGU, D , UDOH, A . "VALIDATION OF MICROBIOLOGICAL TESTING METHODS". Trakya University Journal of Natural Sciences 18 (2017): 65-69
RIS TY - JOUR T1 - VALIDATION OF MICROBIOLOGICAL TESTING METHODS AU - Dilek DUYGU , Abel Udo UDOH Y1 - 2017 PY - 2017 N1 - doi: 10.23902/trkjnat.271725 DO - 10.23902/trkjnat.271725 T2 - Trakya University Journal of Natural Sciences JF - Journal JO - JOR SP - 65 EP - 69 VL - 18 IS - 1 SN - 2147-0294-2528-9691 M3 - doi: 10.23902/trkjnat.271725 UR - http://dx.doi.org/10.23902/trkjnat.271725 Y2 - 2017 ER -
EndNote %0 Trakya University Journal of Natural Sciences VALIDATION OF MICROBIOLOGICAL TESTING METHODS %A Dilek DUYGU , Abel Udo UDOH %T VALIDATION OF MICROBIOLOGICAL TESTING METHODS %D 2017 %J Trakya University Journal of Natural Sciences %P 2147-0294-2528-9691 %V 18 %N 1 %R doi: 10.23902/trkjnat.271725 %U 10.23902/trkjnat.271725
ISNAD DUYGU, Dilek , UDOH, Abel . "MİKROBİYOLOJİK TEST METOTLARININ DOĞRULANMASI (VALİDASYONU)". Trakya University Journal of Natural Sciences 18 / 1 (Nisan 2017): 65-69. http://dx.doi.org/10.23902/trkjnat.271725