Retrospective Analysis of External Quality Assessment Data of Humoral (Except Feces) Morphology in Guangxi from 2010 to 2022

[Objectives] The study aims to improve the ability of inspectors to recognize humoral morphology and provide data reference for the improvement of EQA work of humoral morphology by Guangxi Clinical Laboratory Center. [Methods] A retrospective analysis was made on the EQA of humoral morphology by Guangxi Clinical Laboratory Center from 2010 to 2022, and the number of participating laboratories, the rate of return, sample types and maps of EQA of humoral morphology such as urine sediment, vaginal secretions and so on(except feces), and the reasons for the high error rate of the results of the participating laboratories were analyzed. [Results] The number of laboratories participating in the assessment of humoral morphology increased from 98 in 2010 to 371 in 2022. Except for 2011(90.98%), the rate of return was more than 94%, and the highest rate of return was up to 100%. A total of 119 pictures of EQA of humoral morphology were studied, including 101 urine sediment smears, 13 vaginal secretions smears and 5 other smears. The types of specimens were relatively comprehensive. The distribution of the maps was basically reasonable. The urinary sediment was mainly composed of crystalline salts, followed by tubes, and cells and fungi ranked third. The coverage was relatively complete. The error rate of return results from high to low were bacteria(error rate was equal to 40%), tubes and crystalline salts(error rate was close to 29%), and cells and fungi(error rate was about 14%). The main cases with high error rate of return results are as follows: the difference between different tubes was not clear, and the diversity of crystal morphology was not understood enough;the phase division of cells in the same system was wrong. [Conclusions] The analysis and summary of the reasons for the high error rate of the data and results of Guangxi's EQA of humoral morphology is helpful for laboratory physicians to improve their awareness of morphological examination and identify clearly the error type and blurred concept, and lays a foundation for Guangxi Clinical Laboratory Center to carry out EQA of humoral morphology more specifically.

External quality assessment on detection of hepatitis C virus RNA in clinical laboratories of China

Background As with many studies carried out in European countries, a quality assurance program has been established by the National Center for Clinical Laboratories in China （NCCL）. The results showed that the external quality assessment significantly improves laboratory performance for quantitative evaluation of hepatitis C virus （HCV） RNA. Methods Serum panels were delivered twice annually to the clinical laboratories which performed HCV RNA detection in China. Each panel made up of 5 coded samples. All laboratories were requested to carry out the detection within the required time period and report on testing results which contained qualitative and/or quantitative test findings, reagents used and relevant information about apparatus. All the positive samples were calibrated against the first International Standard for HCV RNA in a collaborative study and the range of comparison target value （TG） designated as ±0.5 log. Results The numbers of laboratories reporting on qualitative testing results for the first and second time external quality assessment were 168 and 167 in the year of 2003 and increased to 209 and 233 in 2007; the numbers of laboratories reporting on quantitative testing results were 134 and 147 in 2003 and rose to 340 and 339 in 2007. Deviation between the mean value for quantitative results at home in 2003 and the target value was above 0.5 log, which was comparatively high. By 2007, the target value was close to the national average except for the low concentrated specimens （10^3 IU/ml）. The percentage of results within the range of GM±0.5 log10 varied from 8.2% to 93.5%. Some laboratories had some difficulties in the exact quantification of the lowest （3.00 log IU/ml） as well as of the highest viral levels （6.37 log IU/ml） values, very near to the limits of the dynamic range of the assays. Conclusions The comparison of these results with the previous study confirms that a regular participation in external quality assessment （EQA） assures the achievement of a high proficiency level in the diagnosis of HCV infection. During the 5-year external quality assessment, sensitivity and accuracy of detection in most of the clinical laboratories have been evidently improved and the quality of kits has also been substantially improved.

Urgent needs in fostering neglected tropical diseases(NTDs)laboratory capacity in WHO Western Pacific Region:results from the external quality assessment on NTDs diagnosis in 2012-2015

Background:Neglected tropical diseases(NTDs)are a heterogeneous group of mainly chronic,debilitating and often stigmatizing diseases that largely affects low-income and politically marginalized populations,causing a large burden of public health,social and economies in the NTDs endemic countries.NTDs are caused by infections with a range of pathogen,including bacteria,parasites,protozoa and viruses.The accurate diagnosis of NTDs is important for reducing morbidity,preventing mortality and for monitoring of control programs.External Quality Assessment(EQA),a component of laboratory quality assurance,aims to assess the performance of participating laboratories in detecting parasitic infections.The aim of this paper is to report the findings and put forward the recommendations on capacity build from the EQA results of participating NTDs laboratories in selected countries in the WHO Western Pacific Region from 2012 to 2015.Methods:Reference or public health laboratories at national level working on NTDs in 6 countries participated in EQAs organized by the National Institute of Parasitic Diseases(NIPD)of Chinese Center for Disease Control and Prevention(CDC)based in Shanghai,China.Two representatives of each participating laboratory were invited to NIPD to detect NTDs’parasitic infections using the same prepared samples for serological tests(IHA and ELISA)and helminth eggs’morphological tests(Direct smear and Kato-Katz).All of the results were scored and analyzed by using SPSS statistics 19.0 software.Results:The percentage of participants who had EQA score≥60 during 2012-2015 for direct smear test were 80.00%(2012),71.43%(2013),100%(2014)and 75.00%(2015),whereas for Kato-Katz test were 80.00%(2012),57.14%(2013),100%(2014)and 37.50%(2015),respectively.The detection rate of helminth eggs varied in different species,with Ascaris lumbricoides being the highest at 94.07%in average.All laboratories did very well with ELISA tests as shown by the high scores in all four years except Lab A in the first and last EQA.For the positive or negative judgments of serum samples,the total coincidence rates of ELISA between 2012 and 2015 were 90.00%,99.29%,94.29%and 98.75%,respectively.While the total coincidence rates of IHA were respectively 100%,95.00%,90.00%and 97.50%.However,detecting low levels of serum antibody remained problematic for IHA when the titres of samples were taken into consideration.Conclusion:This study demonstrate that EQA scheme have been beneficial to the participating laboratories.The EQA programme identifies certain deficiencies which were needed to overcome and improved the laboratories’performance in helminthiasis diagnosis.However,further optimization of accuracy and uniformity in NTDs diagnosis remains a big challenge.