scholarly journals First external quality assurance program for bloodstream Real-Time PCR monitoring of treatment response in clinical trials of Chagas disease

PLoS ONE ◽  
2017 ◽  
Vol 12 (11) ◽  
pp. e0188550 ◽  
Author(s):  
Juan C. Ramírez ◽  
Rudy Parrado ◽  
Elena Sulleiro ◽  
Anabelle de la Barra ◽  
Marcelo Rodríguez ◽  
...  
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.


1996 ◽  
Vol 42 (9) ◽  
pp. 1478-1482 ◽  
Author(s):  
D Chesher ◽  
L Burnett

Abstract We have investigated the application of Shewhart's p control charts in our external quality-assurance program to monitor the long-term performance of our laboratory's analytical quality. The p control charts have been able to detect long-term changes in our laboratory's analytical performance that would have been difficult to detect by more-conventional techniques. We have explored methods for interpreting these charts as well as some of their limitations, which include minimum subgroup size and dependence on constant specification limits. These charts may be not only a simple method for the long-term monitoring of analytical performance of a laboratory, but also of use to the organizers of external quality-assurance programs.


PLoS ONE ◽  
2019 ◽  
Vol 14 (9) ◽  
pp. e0222290
Author(s):  
Sheila M. Keating ◽  
Wes Rountree ◽  
Eduard Grebe ◽  
Andrea L. Pappas ◽  
Mars Stone ◽  
...  

2017 ◽  
Vol 59 (2) ◽  
pp. e138-e142
Author(s):  
Martyn Peck ◽  
Eleni Yiasemides ◽  
Tony Badrick

2014 ◽  
Vol 30 (S1) ◽  
pp. A176-A177
Author(s):  
Robert Kipyegon Langat ◽  
Jackton Indangasi ◽  
Simon Ogola ◽  
Bashir Farah ◽  
Peter Hayes ◽  
...  

2003 ◽  
Vol 49 (5) ◽  
pp. 782-791 ◽  
Author(s):  
Claudia Casini Raggi ◽  
Pamela Pinzani ◽  
Angelo Paradiso ◽  
Mario Pazzagli ◽  
Claudio Orlando

Abstract Background: External quality assurance (EQA) programs for diagnostic tests based on nucleic acid amplification have not been widely implemented in clinical laboratories and remain limited to few tests. Development of specific EQA programs based on application-based proficiency testing for any diagnostic molecular target is challenging. Development of EQA trials based on methodologic proficiency testing and directed to the evaluation of analytical aspects common to the majority of PCR-based tests may be valuable. Methods: We developed an EQA program for evaluation of DNA extraction and amplification and analysis of products after PCR. Participants received a package containing primers and reference materials to evaluate three specific controls for, respectively, DNA extraction (quality and quantity), PCR performance (specificity and efficiency), and interpretation of results after electrophoresis. Each participant was asked to return to the organizers a form with their numerical results and an aliquot of all amplified samples for joint evaluation. Results: Results varied in all phases of the experimental procedure: preamplification, amplification, and post-PCR interpretation. To give a general estimation on the quality of performances for each laboratory, we designed a score scheme in which the results of any specific action were evaluated on the basis of the distribution around the median consensus values. The maximum possible score was 84. On the basis of total score obtained by each laboratory, we created a qualitative ranking list that provided the final interpretation of results as excellent (>63 points; n = 4 laboratories), good (53–63 points; n = 13), sufficient (42–52 points; n = 15), poor (31–41 points; n = 3), and not acceptable (<31 points; n = 4). Conclusions: This survey demonstrates the importance of EQA trials based on methodologic proficiency testing directed to evaluation of analytical aspects common to the majority of PCR-based tests.


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