Integration of ISO15189 and external quality assurance data to assist the detection of poor laboratory performance in New South Wales

Pathology ◽  
2018 ◽  
Vol 50 ◽  
pp. S92
Author(s):  
Brett A. Lidbury ◽  
Gus Koerbin ◽  
Alice M. Richardson ◽  
Tony Badrick
Author(s):  
Giuseppe Reina ◽  
Claudio Orlando ◽  
Paola Rebora ◽  
Federico Ambrogi ◽  
Claudia Casini Raggi ◽  
...  

AbstractRecently a revolutionary technique for quantitative PCR determination was introduced in diagnostic laboratories. To determine the influence of technical variability on the reliability of the quantitative assay, it is crucial to use External Quality Assurance (EQA) programs. An EQA program was developed in Italy to check the analytical performance of real-time PCR procedures based on Taq-Man™ probes. This article suggests a new statistical approach to discriminate, using a bivariate technique, laboratory performance that appears to be questionable, by separately considering the two main features of the standard curve: analytical sensitivity and efficiency. Furthermore, specific indexes to evaluate the impact of these two features on the determination of the initial number of molecules are given to help to improve the assay procedure.


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