Schemes and Performance Evaluation Criteria of Korean Association of External Quality Assessment (KEQAS) for Improving Laboratory Testing
2021; 41(2): 230-239
Ann Lab Med 2021; 41(2): 221-224
Published online March 1, 2021 https://doi.org/10.3343/alm.2021.41.2.221
Copyright © Korean Journal of Laboratory Medicine.
1Department of Parasitology and Tropical Medicine, Chonnam National University Medical School, Gwangju, Korea; 2Department of Laboratory Medicine, Chonnam National University Medical School, Gwangju, Korea; 3College of Pharmacy, Chonnam National University, Gwangju, Korea
Correspondence to: Eun Jeong Won, M.D., Ph.D.
Department of Parasitology and Tropical Medicine, Chonnam National University Medical School, 42 Jebongro, Dongku, Gwangju 61469, Korea
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Stool examination is the gold standard for the detection of intestinal parasites. We assessed the performance of a newly developed AVE-562 analyzer (AVE Science & Technology Co., Hunan, China) for the vision-based detection of eggs of Clonorchis sinensis—the most common intestinal parasite in Korea—in stool samples. In total, 30 stool samples with a high or low egg count or without eggs (as negative control samples) (N=10 each) were prepared and analyzed. The performance of the AVE-562 analyzer was compared with that of the formalin-ether concentration (FEC) method. The overall correct identification rate of the AVE-562 analyzer based on FEC results was 66.6%. The sensitivity, specificity, positive predictive value, and negative predictive value of the AVE-562 analyzer for detecting C. sinensis eggs were 36.4%, 100.0%, 100.0%, and 73.1%, respectively. The average time required to run five tests simultaneously was 27 min using the AVE-562 analyzer and 58 min using the FEC method. Although the AVE-562 analyzer enables rapid and convenient stool examination, its sensitivity needs to be improved, particularly considering the prevalence of low-burden C. sinensis infection in Korea.
Keywords: AVE-562 analyzer, Performance, Parasite, Clonorchis sinensis, Eggs
Infection with intestinal parasites occurs worldwide and represents a widespread and serious public health concern in developing countries . In Korea, intestinal parasitic infections were highly prevalent , but their prevalence has drastically declined . Currently,
There is an increasing demand for low-complexity, highthroughput, and cost-effective tools to replace labor-intensive microscopic examinations. Accordingly, digital imaging diagnosis based on the morphometric characteristics of parasite eggs has been proposed [13-15]. The first study to use an automated stool examination system suggested that an adjusted algorithm should be created for the correct classification of helminth eggs . Recently, a cuvette-based automated microscopy analyzer, sediMAX 1 (77 Elektronika, Budapest, Hungary), was evaluated for the detection of intestinal parasites, helminths, and protozoa . The sediMAX 1 analyzer showed perfect performance for the detection of
In total, 30 stool samples with a high or low egg count or without eggs (as negative control samples; N= 10 each) were prepared and analyzed. Then, the amount of eggs in high-count formalinized stool samples collected for laboratory quality-control purposes at Chonnam National University Hospital, Gwangju, Korea, from January 2018 to December 2019 was adjusted to 150 eggs/mL. Stool samples were collected with the approval provided by the Institutional Review Board of Chonnam National University Hospital (IRB CNUH-2015-052). All data obtained were anonymized, and no information was used that could lead to patient identification. The need for written consent was waived due to minimal risk to the subjects.
Formalized stool samples within a month from subjects not infected with
Of the 10 high-egg-count samples, only four tested positive using the AVE-562 analyzer, whereas all 10 tested positive by the FEC method (Table 1). Of the 10 low-egg-count samples, none tested positive using the AVE-562 analyzer, and only one tested positive using the FEC method. All negative control samples tested negative using both methods. The overall correct identification rate of the AVE-562 analyzer based on the FEC results was 66.6% (14/21) (
Our study had several limitations. First, eggs of intestinal parasites prevalent in Korea other than
This work was partly supported by the AVE Science & Technology Co. The opinions expressed in this paper are those of the authors and do not necessarily represent those of AVE Science & Technology Co.
Eun Jeong Won conceived the study, participated in study design and data analysis and was responsible for the writing and submission of the final manuscript. Yu Jeong Lee carried out the experimental study and participated in writing the manuscript. Young-Chang Cho, Soo Hyun Kim, Myung Geun Shin, and Jong Hee Shin analyzed and interpreted data. All authors were involved in revising the manuscript critically for important intellectual content, and all authors approved the final version to be published.
No potential conflicts of interest relevant to this article were reported.
This study was financially supported by Chonnam National University (grant number: 2018-3309), Chonnam National University Hwasun Hospital Institute for Biomedical Science (HCRI 19026), and the Basic Science Research Program through the National Research Foundation of Korea (NRF) funded by the Ministry of Education (NRF-2019R1C1C1004605 and NRF2019M3E5D1A02067953).