A pilot external quality assurance programme for line-probe assay detection of anti-tuberculosis drug resistance

2013 ◽  
Vol 17 (2) ◽  
pp. 262-266
Author(s):  
K. L. Leung ◽  
C. W. Yip ◽  
H. S. Tang ◽  
Y. W. Lai ◽  
T. K. Lam ◽  
...  
Author(s):  
Cas W Weykamp ◽  
Theo J Penders ◽  
Frits A J Muskiet ◽  
Willem van der Slik

Stable lyophilized ethylenediaminetetra-acetic acid (EDTA)-blood haemolysates were applied in an external quality assurance programme (SKZL, The Netherlands) for glycohaemoglobin assays in 101 laboratories using 12 methods. The mean intralaboratory day-to-day coefficient of variation (CV), calculated from the assay of 12 unidentified pairs over a period of 1 year, was 5·2% (range: 0·2–28·7). Forty-seven per cent of laboratories did not meet the criterion of CV < 5%, whereas 68% did not meet the clinically more desirable 3·3–3·6%. Linearity, as derived from the analysis of five combinations of two haemolysates with low and high glycohaemoglobin percentages over 6 months, was excellent (mean correlation coefficient 0·9953; range: 0·9188–0·9999). Analysis of two samples with high and low glycohaemoglobin percentages gave mean interlaboratory coefficients of variation of 10% for one method performed by several laboratories and 22% for all methods performed by all laboratories. It is concluded that the majority of laboratories do not meet the clinically desirable intralaboratory precision and that an unacceptably high interlaboratory precision exists.


Viruses ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 1456
Author(s):  
Cheryl Jennings ◽  
Neil T. Parkin ◽  
Daniel J. Zaccaro ◽  
Rupert Capina ◽  
Paul Sandstrom ◽  
...  

The National Institute of Allergy and Infectious Diseases (NIAID) Virology Quality Assurance (VQA) established a robust proficiency testing program for Sanger sequencing (SS)-based HIV-1 drug resistance (HIVDR) testing in 2001. While many of the lessons learned during the development of such programs may also apply to next generation sequencing (NGS)-based HIVDR assays, challenges remain for the ongoing evaluation of NGS-based testing. These challenges include a proper assessment of assay accuracy and the reproducibility of low abundance variant detection, intra- and inter-assay performance comparisons among laboratories using lab-defined tests, and different data analysis pipelines designed for NGS. In collaboration with the World Health Organization (WHO) Global HIVDR Laboratory Network and the Public Health Agency of Canada, the Rush VQA program distributed archived proficiency testing panels to ten laboratories to evaluate internally developed NGS assays. Consensus FASTA files were submitted using 5%, 10%, and 20% variant detection thresholds, and scored based on the same criteria used for SS. This small study showed that the SS External Quality Assurance (EQA) approach can be used as a transitional strategy for using NGS to generate SS-like data and for ongoing performance while using NGS data from the same quality control materials to further evaluate NGS assay performance.


2018 ◽  
Vol 71 (11) ◽  
pp. 995-1000 ◽  
Author(s):  
Martyn Peck ◽  
David Moffat ◽  
Bruce Latham ◽  
Tony Badrick

AimsDiagnostic/interpretative accuracy can be challenging in anatomical pathology due to the subjective element of the diagnostic process. This can lead to false-negative or false-positive diagnoses of malignancy, variations in grading and diagnostic misclassification of a condition.It is imperative that an accurate diagnosis is achieved so that an appropriate and timely treatment is administered to the patient, for example, the success of targeted molecular therapeutic options for treatment of cancer is dependent on accurate anatomical pathology diagnoses being issued.MethodsA literature review of diagnostic accuracy in selected specimen categories was undertaken and was compared with data on metropolitan and regional pathologist diagnostic proficiency performance in an external quality assurance programme from surveys provided 2015–2017. For each specimen category, cases having attracted a diagnostic inaccuracy (ie, major discordance) of ≥20% and cases attracting a combined error rate (ie, major and minor discordance) of ≥30% are reviewed and discussed.ResultsThe rate of inaccurate diagnoses (assessed as a major discordance) ranged from 3% to 9% among the different specimen groups, with highest mean percentage of inaccurate diagnoses in gynaecology, dermatopathology and gastrointestinal specimens.ConclusionsIt was possible to ascertain that gynaecology, dermatopathology and gastrointestinal specimens had presented the greatest diagnostic challenge to the participant pathologists, determined as highest rate of diagnostic inaccuracy, that is, major discordance with respective case target diagnoses.Through a combination of routine second opinions, directed retrospective peer review and participation in appropriate external quality assurance schemes, the risk associated with these diagnoses can be minimised.


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