VALIDATION OF MICROBIOLOGICAL TESTING METHODS

Abstract

 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.

Keywords

• Accuracy,precision,reproducibility,sensitivity,selectivity,validation

MİKROBİYOLOJİK TEST METOTLARININ DOĞRULANMASI (VALİDASYONU)

Öz

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.

Anahtar Kelimeler

• Doğruluk,kesinlik,tekrar edilebilirlik,hassaslık,seçicilik,validasyon

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