Ivana Buttice, Anne Demulder, Corinne De Laet, Aurelie Empain, Laurence Rozen
{"title":"Morphological abnormalities in the white blood cells of a baby with type VI mucopolysaccharidosis.","authors":"Ivana Buttice, Anne Demulder, Corinne De Laet, Aurelie Empain, Laurence Rozen","doi":"10.1684/abc.2024.1915","DOIUrl":"https://doi.org/10.1684/abc.2024.1915","url":null,"abstract":"","PeriodicalId":93870,"journal":{"name":"Annales de biologie clinique","volume":"82 5","pages":"589-591"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142756036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Detection of schistocytes is an important first step in the differential diagnosis of thrombotic microangiopathy. It is however labor intensive and prone to subjectivity. To improve and standardize the detection and quantification of schistocytes, we studied its automated analysis by digital microscopy DM1200 (CellaVision®) on 63 positive and 102 negative smears obtained from SP-50 (Sysmex®). Easy to use and very useful for staff training, it showed a lower between-observer coefficient of variation than usually described for manual counting (25% vs. 50%). Very sensitive (100%) in pre-classification, the detection of schistocytes was highly sensitive (98.4%) and specific (96.8%) after reclassification (AUCROC = 0.9929), showing a good correlation with manual microscopy. TAT was comparable to manual counting. For positive smears, the percentage of schistocytes was similar between pre- and post-classification. However, 29.6% of pre-classified schistocytes were removed and 21.8% were added. For negative smears a significative overestimation of schistocytes (292%) was observed. Except poikilocytosis, on negative smears, the most common error of the software (24.9%) was due to platelets classified in schistocytes. Were also observed for example erroneous divisions of the image (3.2%) or artifactual schistocytes resulting from scratches in the smear (2.6%). Another limit is the high number of red blood cells not analyzed (46.8% for high-density smears), which might false the schistocytes percentage. To conclude, CellaVision® technology showed many benefits, but also limits that the operator needs to know.
检测裂细胞是鉴别诊断血栓性微血管病的重要第一步。然而,它是劳动密集型的,容易产生主观性。为了提高和规范对分裂细胞的检测和定量,我们研究了DM1200 (CellaVision®)对SP-50 (Sysmex®)获得的63份阳性和102份阴性染色的自动分析。易于使用,对员工培训非常有用,它显示出比通常描述的人工计数更低的观察者间变异系数(25% vs 50%)。预分类时非常敏感(100%),重分类后对血吸虫细胞的检测高度敏感(98.4%),特异性(96.8%)(AUCROC = 0.9929),与人工镜检具有良好的相关性。TAT与人工计数相当。对于阳性涂片,分级前和分级后的血吸虫细胞百分比相似。然而,29.6%的预分类血吸虫细胞被去除,21.8%的预分类血吸虫细胞被添加。对于阴性涂片,观察到明显高估了血吸虫细胞(292%)。在阴性涂片上,除异胞增多症外,软件最常见的错误(24.9%)是由于血小板在血吸虫细胞中的分类。也观察到例如图像分裂错误(3.2%)或涂片划痕引起的人造血吸虫细胞(2.6%)。另一个限制是大量红细胞未被分析(高密度涂片为46.8%),这可能会使血吸虫细胞百分比错误。综上所述,CellaVision®技术显示了许多优点,但也有操作员需要了解的限制。
{"title":"[Evaluation of the CellaVision® DM-1200 system for detecting and quantifying schistocytes].","authors":"Sami Zouitina, Frédérique Dubois-Galopin","doi":"10.1684/abc.2024.1921","DOIUrl":"https://doi.org/10.1684/abc.2024.1921","url":null,"abstract":"<p><p>Detection of schistocytes is an important first step in the differential diagnosis of thrombotic microangiopathy. It is however labor intensive and prone to subjectivity. To improve and standardize the detection and quantification of schistocytes, we studied its automated analysis by digital microscopy DM1200 (CellaVision®) on 63 positive and 102 negative smears obtained from SP-50 (Sysmex®). Easy to use and very useful for staff training, it showed a lower between-observer coefficient of variation than usually described for manual counting (25% vs. 50%). Very sensitive (100%) in pre-classification, the detection of schistocytes was highly sensitive (98.4%) and specific (96.8%) after reclassification (AUCROC = 0.9929), showing a good correlation with manual microscopy. TAT was comparable to manual counting. For positive smears, the percentage of schistocytes was similar between pre- and post-classification. However, 29.6% of pre-classified schistocytes were removed and 21.8% were added. For negative smears a significative overestimation of schistocytes (292%) was observed. Except poikilocytosis, on negative smears, the most common error of the software (24.9%) was due to platelets classified in schistocytes. Were also observed for example erroneous divisions of the image (3.2%) or artifactual schistocytes resulting from scratches in the smear (2.6%). Another limit is the high number of red blood cells not analyzed (46.8% for high-density smears), which might false the schistocytes percentage. To conclude, CellaVision® technology showed many benefits, but also limits that the operator needs to know.</p>","PeriodicalId":93870,"journal":{"name":"Annales de biologie clinique","volume":"82 5","pages":"579-588"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142756028","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ahmed Ben Hadj Hassine, Manel Marzouk, Jalel Boukadida
Tuberculosis remains one of the leading causes of mortality worldwide. Microscopy and culture still the references of Tuberculosis diagnosis. Microscopy has a low sensitivity, specificity and culture is time consuming. For this reason, rapid and reliable diagnosis of the disease is required. We describe a retrospective comparison study of tuberculosis diagnosis by PCR IS6110 directly from blood samples of patients with suspected Tuberculosis with Acid-Fast-Bacilli and culture. From 80 patients enrolled, culture results were positive for 25, acid fast bacilli were positive for 15 and blood PCR were positive for 45. Comparing blood PCR result with acid fast bacilli, the sensitivity and specificity were respectively 35% and 87.5% (PPV = 9%, PNV = 21.1%) for PTB. The specificity of blood PCR was 100% (PNV = 72.73%), for EPTB. In comparison with culture blood PCR have a high sensitivity and specificity better than with the acid fast, they were respectively 57.89%, 100% for PTB and 50%, 100% for EPTB. This study is the first established in Tunisia and in Africa aiming to diagnose TB from blood. B-PCR results has shown a high correlation with culture that illustrates the usefulness of B-PCR as a rapid and early diagnostic, combined with others serological results B-PCR can be a solid, rapid and efficient TB diagnostic tools.
{"title":"Rapid diagnosis of tuberculosis by PCR IS6110 from blood in the central region of Tunisia.","authors":"Ahmed Ben Hadj Hassine, Manel Marzouk, Jalel Boukadida","doi":"10.1684/abc.2024.1923","DOIUrl":"https://doi.org/10.1684/abc.2024.1923","url":null,"abstract":"<p><p>Tuberculosis remains one of the leading causes of mortality worldwide. Microscopy and culture still the references of Tuberculosis diagnosis. Microscopy has a low sensitivity, specificity and culture is time consuming. For this reason, rapid and reliable diagnosis of the disease is required. We describe a retrospective comparison study of tuberculosis diagnosis by PCR IS6110 directly from blood samples of patients with suspected Tuberculosis with Acid-Fast-Bacilli and culture. From 80 patients enrolled, culture results were positive for 25, acid fast bacilli were positive for 15 and blood PCR were positive for 45. Comparing blood PCR result with acid fast bacilli, the sensitivity and specificity were respectively 35% and 87.5% (PPV = 9%, PNV = 21.1%) for PTB. The specificity of blood PCR was 100% (PNV = 72.73%), for EPTB. In comparison with culture blood PCR have a high sensitivity and specificity better than with the acid fast, they were respectively 57.89%, 100% for PTB and 50%, 100% for EPTB. This study is the first established in Tunisia and in Africa aiming to diagnose TB from blood. B-PCR results has shown a high correlation with culture that illustrates the usefulness of B-PCR as a rapid and early diagnostic, combined with others serological results B-PCR can be a solid, rapid and efficient TB diagnostic tools.</p>","PeriodicalId":93870,"journal":{"name":"Annales de biologie clinique","volume":"82 5","pages":"519-526"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142756037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Abderrazak Saddari, Said Ezrari, Elmostapha Benaissa, Yassine Ben Lahlou, Mostafa Elouennass, Adil Maleb
Since 1960, Williams and Trotman had dreamed of automating all technical manipulations in bacteriology. However, this switch to automation took several decades to realize. The high cost of instruments and the attachment to classical bacteriology were the main obstacles. Automation began with blood culture incubators, and paved the way for automation in other areas of bacteriology, notably cytology, culture, identification and antibiotic susceptibility testing. Medical laboratories have been quick to recognize the efficiency of these systems and their many advantages. The reduction in turnaround times for bacteriological examinations is one of the changes that have revolutionized laboratory practice. In addition, sensitivity, safety, traceability and quality are more assured with automation. The second revolution is the integration of artificial intelligence into the processing and interpretation of bacteriological analyses. We are currently witnessing the total automation of laboratories and a reduction in human intervention. In this article, we have attempted to address all aspects of bacteriology affected by automation, and the impact of this change on current laboratory practice and quality of healthcare.
{"title":"Robotization in microbiology.","authors":"Abderrazak Saddari, Said Ezrari, Elmostapha Benaissa, Yassine Ben Lahlou, Mostafa Elouennass, Adil Maleb","doi":"10.1684/abc.2024.1922","DOIUrl":"10.1684/abc.2024.1922","url":null,"abstract":"<p><p>Since 1960, Williams and Trotman had dreamed of automating all technical manipulations in bacteriology. However, this switch to automation took several decades to realize. The high cost of instruments and the attachment to classical bacteriology were the main obstacles. Automation began with blood culture incubators, and paved the way for automation in other areas of bacteriology, notably cytology, culture, identification and antibiotic susceptibility testing. Medical laboratories have been quick to recognize the efficiency of these systems and their many advantages. The reduction in turnaround times for bacteriological examinations is one of the changes that have revolutionized laboratory practice. In addition, sensitivity, safety, traceability and quality are more assured with automation. The second revolution is the integration of artificial intelligence into the processing and interpretation of bacteriological analyses. We are currently witnessing the total automation of laboratories and a reduction in human intervention. In this article, we have attempted to address all aspects of bacteriology affected by automation, and the impact of this change on current laboratory practice and quality of healthcare.</p>","PeriodicalId":93870,"journal":{"name":"Annales de biologie clinique","volume":"82 5","pages":"489-499"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142756039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Thomas Tassin, Ludovic Glady, Valérie Moal, Nathalie Oueidat, Isabelle Martinel, Mickael Dubos, Isabelle Benz Bretagne, Laurent Weinmann, Marie-Christine Beauvieux
Hemoglobin (Hb) measurement is a fundamental biological test, especially in emergency situations where rapid medical decisions are required. Portable hemoglobinometers, such as HemoCue®, provide a delocalized solution for capillary whole blood. The SFBC's POCT News and Issues working group designed and conducted two national surveys to assess the use and management of these devices, both on the clinical and biological side, with 306 and 160 responses respectively. The surveys revealed little effective or desired network connection, heterogeneity in management and training, and only 7% of sites fully accredited, although a quality approach is being structured in 45% of cases. Nearly 80% of biologists suggest reclassification as a rapid diagnostic test, citing difficult standards management and inadequate human resources. However, its daily use goes beyond the simple diagnostic orientation of anemia; blood transfusion decisions without laboratory verification are made by 53% of physicians, while 18% of users are unaware of minimum maintenance procedures, underscoring the need for a rigorous quality approach. The SFBC working group proposes a list of tips to help medical biologists implement this approach, a guarantee of reliable results, in the context of medical decision-making. The selected points are fleet mapping, relations with biomedical and clinical departments, quality documents and minimum method verification, user management, QC management and traceability of results.
{"title":"[Use of HemoCue® or portable hemoglobinometer: results of the national surveys carried out by the SFBC POCT working group].","authors":"Thomas Tassin, Ludovic Glady, Valérie Moal, Nathalie Oueidat, Isabelle Martinel, Mickael Dubos, Isabelle Benz Bretagne, Laurent Weinmann, Marie-Christine Beauvieux","doi":"10.1684/abc.2024.1925","DOIUrl":"10.1684/abc.2024.1925","url":null,"abstract":"<p><p>Hemoglobin (Hb) measurement is a fundamental biological test, especially in emergency situations where rapid medical decisions are required. Portable hemoglobinometers, such as HemoCue®, provide a delocalized solution for capillary whole blood. The SFBC's POCT News and Issues working group designed and conducted two national surveys to assess the use and management of these devices, both on the clinical and biological side, with 306 and 160 responses respectively. The surveys revealed little effective or desired network connection, heterogeneity in management and training, and only 7% of sites fully accredited, although a quality approach is being structured in 45% of cases. Nearly 80% of biologists suggest reclassification as a rapid diagnostic test, citing difficult standards management and inadequate human resources. However, its daily use goes beyond the simple diagnostic orientation of anemia; blood transfusion decisions without laboratory verification are made by 53% of physicians, while 18% of users are unaware of minimum maintenance procedures, underscoring the need for a rigorous quality approach. The SFBC working group proposes a list of tips to help medical biologists implement this approach, a guarantee of reliable results, in the context of medical decision-making. The selected points are fleet mapping, relations with biomedical and clinical departments, quality documents and minimum method verification, user management, QC management and traceability of results.</p>","PeriodicalId":93870,"journal":{"name":"Annales de biologie clinique","volume":"82 5","pages":"536-554"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142756031","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Amel Halimi, Zahira Zakia Baba Ahmed-KaziTani, Zahia Boucherit-Otmani
A new direction of research was established due to biofilms' infections caused by a mixture of fungal and bacterial species. Diagnosis of these infections becomes more difficult and high doses of drugs are used in treatment, especially in critically ill patients. The aim of the current study was to examine the effects of amphotericin B, in combination with imipenem or colistin against Candida albicans - Acinetobacter baumannii- Proteus mirabilis and Candida tropicalis - Acinetobacter baumannii -Proteus mirabilis polymicrobial biofilms. According to the microdilution method of the Clinical Laboratory Standards Institute (CLSI) published in documents M27-A3 (2008) and M07-A10 (2015) respectively, the susceptibility of the clinical isolates Candida yeasts to amphotericin B and Gram-negative bacteria to imipenem and colistin was determined. A Checkerboard assay was employed to evaluate the efficacy of drugs combinations. The 3- (4,5-dimethylthiazol-2-yl) -2,5-diphenyl tetrazolium bromide (MTT) reduction assay was used to quantify the biofilms. The combination amphotericin B/colistin and amphotericin B/imipenem did not produce obvious effects against the polymicrobial biofilms formed for 48 hours. Whereas colistin alone produced strong effects against Candida albicans-Acinetobacter baumannii and Candida albicans - Acinetobacter baumannii -Proteus mirabilis compared to Candida tropicalis - Acinetobacter baumannii and Candida tropicalis - Acinetobacter baumannii - Proteus mirabilis polymicrobial biofilms. For mixed Candida spp. bacterial biofilms, these results point to the difficulties in eradicating these biofilms, as well as in preventing their development.
{"title":"In vitro activity of amphotericin B in combination with imipenem/colistin against mixed cultures of Candida spp. and Gram-negative bacteria.","authors":"Amel Halimi, Zahira Zakia Baba Ahmed-KaziTani, Zahia Boucherit-Otmani","doi":"10.1684/abc.2024.1917","DOIUrl":"https://doi.org/10.1684/abc.2024.1917","url":null,"abstract":"<p><p>A new direction of research was established due to biofilms' infections caused by a mixture of fungal and bacterial species. Diagnosis of these infections becomes more difficult and high doses of drugs are used in treatment, especially in critically ill patients. The aim of the current study was to examine the effects of amphotericin B, in combination with imipenem or colistin against Candida albicans - Acinetobacter baumannii- Proteus mirabilis and Candida tropicalis - Acinetobacter baumannii -Proteus mirabilis polymicrobial biofilms. According to the microdilution method of the Clinical Laboratory Standards Institute (CLSI) published in documents M27-A3 (2008) and M07-A10 (2015) respectively, the susceptibility of the clinical isolates Candida yeasts to amphotericin B and Gram-negative bacteria to imipenem and colistin was determined. A Checkerboard assay was employed to evaluate the efficacy of drugs combinations. The 3- (4,5-dimethylthiazol-2-yl) -2,5-diphenyl tetrazolium bromide (MTT) reduction assay was used to quantify the biofilms. The combination amphotericin B/colistin and amphotericin B/imipenem did not produce obvious effects against the polymicrobial biofilms formed for 48 hours. Whereas colistin alone produced strong effects against Candida albicans-Acinetobacter baumannii and Candida albicans - Acinetobacter baumannii -Proteus mirabilis compared to Candida tropicalis - Acinetobacter baumannii and Candida tropicalis - Acinetobacter baumannii - Proteus mirabilis polymicrobial biofilms. For mixed Candida spp. bacterial biofilms, these results point to the difficulties in eradicating these biofilms, as well as in preventing their development.</p>","PeriodicalId":93870,"journal":{"name":"Annales de biologie clinique","volume":"82 5","pages":"527-535"},"PeriodicalIF":0.0,"publicationDate":"2024-11-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142756034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Christian Aussel, Marie-Christine Beauvieux, Stéphane Bermon, Hervé Bisiau, Stéphane Debroczi, Pierre Dupuis, Christoph Ganter, Jérémy Guénezan, Jacques Izopet, Marianne Lafitte, Agnès Mailloux, Sophie Pasini, Pascal Pernet, Xavier Poble, Michel Vaubourdolle
{"title":"[9th International \"Alain Feuillu\" Symposium - Emergency biology and blood gases].","authors":"Christian Aussel, Marie-Christine Beauvieux, Stéphane Bermon, Hervé Bisiau, Stéphane Debroczi, Pierre Dupuis, Christoph Ganter, Jérémy Guénezan, Jacques Izopet, Marianne Lafitte, Agnès Mailloux, Sophie Pasini, Pascal Pernet, Xavier Poble, Michel Vaubourdolle","doi":"10.1684/abc.2024.1919","DOIUrl":"https://doi.org/10.1684/abc.2024.1919","url":null,"abstract":"","PeriodicalId":93870,"journal":{"name":"Annales de biologie clinique","volume":"82 5","pages":"595-603"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"[World lab 2024: a new page in Dubai].","authors":"Katell Peoc'h, Marie Lenski","doi":"10.1684/abc.2024.1918","DOIUrl":"https://doi.org/10.1684/abc.2024.1918","url":null,"abstract":"","PeriodicalId":93870,"journal":{"name":"Annales de biologie clinique","volume":"82 5","pages":"485-487"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142756033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"[Rare genetic diseases in the MENA Region (Middle East and North Africa): Challenges, regional specificities, and future perspectives].","authors":"Merieme Bensalah","doi":"10.1684/abc.2024.1916","DOIUrl":"https://doi.org/10.1684/abc.2024.1916","url":null,"abstract":"","PeriodicalId":93870,"journal":{"name":"Annales de biologie clinique","volume":"82 5","pages":"592-594"},"PeriodicalIF":0.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142756030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Corentin S Lefebvre, Sophie Luneau, Nûn Kalim Bentounes, Laetitia Mauge, Aurélie Dumont, Pascale Gaussem, Dominique Helley, David M Smadja, Nicolas Gendron
Edoxaban is a direct oral anticoagulant available in Europe but not in France. Given the high tourist traffic in France, understanding the pharmacology of edoxaban and the availability of its laboratory testing seemed crucial in emergency situations. The aim of this work was to describe the methodology for measuring the anti-Xa activity of edoxaban, highlighting pre-analytical and analytical aspects, along with essential clinico-biological data for therapeutic guidance. The analysis was performed using the chromogenic method on the STAR-Max analyzer, with the STA®-Liquid ANTI-Xa kit (Diagnostica Stago®). Anti-Xa Edoxaban level measurement has a detection limit of 15 ng/mL, a quantification limit of 20 ng/mL and a linearity limit of 400 ng/mL. Repeatability, intermediate precision, accuracy, and measurement uncertainty studies were conducted to assess method performance, meeting quality requirements. The comparison between two STAR-Max® analyzers showed excellent results with linear regression and a low bias with good precision and no loss of dispersion regardless of edoxaban levels. In conclusion, although the measurement of edoxaban level may be rarely necessary in clinical practice, its implementation is straightforward. The availability of edoxaban in neighboring countries, underscores the importance of having its measurement available in hospital laboratories.
埃多沙班是一种直接口服抗凝剂,在欧洲有售,但在法国没有。鉴于法国游客众多,了解埃多沙班的药理学和实验室检测的可用性在紧急情况下似乎至关重要。这项工作的目的是描述测量埃多沙班抗 Xa 活性的方法,强调分析前和分析方面的问题,以及用于治疗指导的基本临床生物数据。分析是在 STAR-Max 分析仪上使用 STA®-Liquid ANTI-Xa 试剂盒(Diagnostica Stago®)采用显色法进行的。抗 Xa 埃多沙班水平测量的检测限为 15 纳克/毫升,定量限为 20 纳克/毫升,线性限为 400 纳克/毫升。为评估该方法的性能,进行了重复性、中间精度、准确度和测量不确定性研究,以满足质量要求。两台 STAR-Max® 分析仪的比较结果表明,该方法线性回归结果极佳,偏差小,精度高,且无分散损失,与埃多沙班水平无关。总之,尽管在临床实践中可能很少需要测量埃多沙班的水平,但其实施却非常简单。周边国家都能买到埃多沙班,这突出了医院实验室提供埃多沙班测量的重要性。
{"title":"[Implementation of edoxaban anti-Xa activity assay in a hospital laboratory and evaluation of its analytical performance].","authors":"Corentin S Lefebvre, Sophie Luneau, Nûn Kalim Bentounes, Laetitia Mauge, Aurélie Dumont, Pascale Gaussem, Dominique Helley, David M Smadja, Nicolas Gendron","doi":"10.1684/abc.2024.1910","DOIUrl":"10.1684/abc.2024.1910","url":null,"abstract":"<p><p>Edoxaban is a direct oral anticoagulant available in Europe but not in France. Given the high tourist traffic in France, understanding the pharmacology of edoxaban and the availability of its laboratory testing seemed crucial in emergency situations. The aim of this work was to describe the methodology for measuring the anti-Xa activity of edoxaban, highlighting pre-analytical and analytical aspects, along with essential clinico-biological data for therapeutic guidance. The analysis was performed using the chromogenic method on the STAR-Max analyzer, with the STA®-Liquid ANTI-Xa kit (Diagnostica Stago®). Anti-Xa Edoxaban level measurement has a detection limit of 15 ng/mL, a quantification limit of 20 ng/mL and a linearity limit of 400 ng/mL. Repeatability, intermediate precision, accuracy, and measurement uncertainty studies were conducted to assess method performance, meeting quality requirements. The comparison between two STAR-Max® analyzers showed excellent results with linear regression and a low bias with good precision and no loss of dispersion regardless of edoxaban levels. In conclusion, although the measurement of edoxaban level may be rarely necessary in clinical practice, its implementation is straightforward. The availability of edoxaban in neighboring countries, underscores the importance of having its measurement available in hospital laboratories.</p>","PeriodicalId":93870,"journal":{"name":"Annales de biologie clinique","volume":"82 4","pages":"451-460"},"PeriodicalIF":0.0,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142142018","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}