VALIDATION OF MICROBIOLOGICAL TESTING METHODS

Year 2017, , 65 - 69, 17.04.2017

Dilek Duygu Abel Udoh

https://doi.org/10.23902/trkjnat.271725

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)

Abstract

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.

Keywords

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

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