Blessing Kenechi Myke-Mbata, Bruno Basil, Jeremiah John Oloche, Amarachukwu Igbom
Diabetes mellitus with cardiovascular diseases is often a multi-systemic disease that requires a multi-therapeutic approach which mostly poses a challenge to laboratory result interpretation. The non-availability of information on many patients due to poor referral, documentation and record keeping has resulted in isolated interpretation of laboratory result of diabetic patients with multisystemic complications. This has led to both analytical and post-analytical errors which has a negative impact on total quality of results. Therefore, this review showed the possible therapeutic treatment of a diabetic patient with cardiovascular disease and how their pharmacological role could affect laboratory result.
{"title":"Pharmacological Considerations in the Interpretation of Biochemical Results in Diabetic Patients with Cardiovascular Complications.","authors":"Blessing Kenechi Myke-Mbata, Bruno Basil, Jeremiah John Oloche, Amarachukwu Igbom","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Diabetes mellitus with cardiovascular diseases is often a multi-systemic disease that requires a multi-therapeutic approach which mostly poses a challenge to laboratory result interpretation. The non-availability of information on many patients due to poor referral, documentation and record keeping has resulted in isolated interpretation of laboratory result of diabetic patients with multisystemic complications. This has led to both analytical and post-analytical errors which has a negative impact on total quality of results. Therefore, this review showed the possible therapeutic treatment of a diabetic patient with cardiovascular disease and how their pharmacological role could affect laboratory result.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 4","pages":"305-316"},"PeriodicalIF":0.0,"publicationDate":"2023-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10828539/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139673057","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aman Elwadhi, Neha Kc, Kamal Joshi, G Krishna Charan
Visceral leishmaniasis is a common tropical infection presenting with a myriad of hematological abnormalities. We report an unusual case of an 11-year-old girl suffering from a febrile illness with hepatosplenomegaly and anemia. Laboratory findings included pancytopenia and hyperbilirubinemia. The leishmania antigen rK39 was positive and bone marrow examination revealed hemophagocytosis and amastigote forms of Leishmania donovani. Direct Coombs' test was positive (warm type, IgG) and LDH was elevated. Tests for other infections were negative. A diagnosis of visceral leishmaniasis with autoimmune hemolytic anemia (warm antibody type, IgG) with hemophagocytic lymphohistiocytosis was made. Patient showed response with anti-leishmanial treatment with improvement in clinical condition.
{"title":"Suspect the Unexpected: A Rare Association of Autoimmune Hemolytic Anemia and Hemophagocytic Lymphohistiocytosis with Visceral Leishmaniasis: A Case Report and Review of Literature.","authors":"Aman Elwadhi, Neha Kc, Kamal Joshi, G Krishna Charan","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Visceral leishmaniasis is a common tropical infection presenting with a myriad of hematological abnormalities. We report an unusual case of an 11-year-old girl suffering from a febrile illness with hepatosplenomegaly and anemia. Laboratory findings included pancytopenia and hyperbilirubinemia. The leishmania antigen rK39 was positive and bone marrow examination revealed hemophagocytosis and amastigote forms of Leishmania donovani. Direct Coombs' test was positive (warm type, IgG) and LDH was elevated. Tests for other infections were negative. A diagnosis of visceral leishmaniasis with autoimmune hemolytic anemia (warm antibody type, IgG) with hemophagocytic lymphohistiocytosis was made. Patient showed response with anti-leishmanial treatment with improvement in clinical condition.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 4","pages":"330-333"},"PeriodicalIF":0.0,"publicationDate":"2023-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10828534/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139674050","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bisalbuminemia is a rare, benign, protein anomaly presenting with two distinct peaks of albumin on serum protein electrophoresis. It reflects the presence of a normal albumin and a modified albumin in the same individual. This condition can be either hereditary or acquired. Bisalbuminemias are more frequently encountered when serum protein electrophoresis is performed with capillary technique, because this offers better resolution compared to the conventional gel electrophoresis. There are very few case reports available in the literature, showing the presence of a bifid albumin peak along with a distinct paraprotein peak in the globulin region in serum protein electrophoresis. Here we are reporting two cases, a 46-year-old male and a 48 year-old male, diagnosed with multiple myeloma, revealing the presence of an extra peak in the albumin region along with a distinct paraprotein band, when the electrophoresis was performed using capillary mode. From these case reports, we wish to reveal the extremely rare nature of this entity and also to acquaint the clinicians and laboratory personnel with this pattern of electrophoretogram.
{"title":"Bisalbuminemia: A Rare Incidental Finding in Monoclonal Gammopathy.","authors":"Sanjay Bagade, Arshiya Anjum","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Bisalbuminemia is a rare, benign, protein anomaly presenting with two distinct peaks of albumin on serum protein electrophoresis. It reflects the presence of a normal albumin and a modified albumin in the same individual. This condition can be either hereditary or acquired. Bisalbuminemias are more frequently encountered when serum protein electrophoresis is performed with capillary technique, because this offers better resolution compared to the conventional gel electrophoresis. There are very few case reports available in the literature, showing the presence of a bifid albumin peak along with a distinct paraprotein peak in the globulin region in serum protein electrophoresis. Here we are reporting two cases, a 46-year-old male and a 48 year-old male, diagnosed with multiple myeloma, revealing the presence of an extra peak in the albumin region along with a distinct paraprotein band, when the electrophoresis was performed using capillary mode. From these case reports, we wish to reveal the extremely rare nature of this entity and also to acquaint the clinicians and laboratory personnel with this pattern of electrophoretogram.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 4","pages":"325-329"},"PeriodicalIF":0.0,"publicationDate":"2023-12-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10828532/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139673056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Carlos Rodríguez Rojas, Celia Juez Santamaría, Oscar David Pons Belda, Emilia Moreno Noguero
Serum index and macroscopic characteristics of samples can give valuable information and should be interpreted as a result. Following centrifugation of the sample, on gross inspection it was observed that the serum had a brown color. After ruling out the main causes that can cause a brown coloration, such as intravascular hemolysis or high concentrations of methemoglobin, it was noted that the patient was receiving a high-dose of Eltrombopag therapy. Eltrombopag is a non-peptide thrombopoietin receptor agonist approved for the treatment of severe aplastic anemia (SAA). The drug in solution has a brown color and at high concentrations it is capable of changing the color of the serum and may have different effects in different assays of laboratory. This article describes the case of a patient with brown serum due to the consumption of high doses of Eltrombopag that started to cause cutaneous hyperpigmentation.
{"title":"Coffee Colored Serum, Adverse Reaction of Eltrombopag.","authors":"Carlos Rodríguez Rojas, Celia Juez Santamaría, Oscar David Pons Belda, Emilia Moreno Noguero","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Serum index and macroscopic characteristics of samples can give valuable information and should be interpreted as a result. Following centrifugation of the sample, on gross inspection it was observed that the serum had a brown color. After ruling out the main causes that can cause a brown coloration, such as intravascular hemolysis or high concentrations of methemoglobin, it was noted that the patient was receiving a high-dose of Eltrombopag therapy. Eltrombopag is a non-peptide thrombopoietin receptor agonist approved for the treatment of severe aplastic anemia (SAA). The drug in solution has a brown color and at high concentrations it is capable of changing the color of the serum and may have different effects in different assays of laboratory. This article describes the case of a patient with brown serum due to the consumption of high doses of Eltrombopag that started to cause cutaneous hyperpigmentation.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 3","pages":"258-261"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/7b/15/ejifcc-34-258.PMC10588078.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49692756","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Gisela Unger, Silvia Fabiana Benozzi, Raúl Girardi, Graciela Laura Pennacchiotti
Pre-analytical phase external quality assessment programs contribute - through the interlaboratory comparison of quality indicators (QIs) - to the continuous improvement of the clinical laboratory total testing process. The purpose of the present work is to document the results derived from measuring four QIs within the framework of a pre-analytical phase external quality assessment subprogram in Argentina. The laboratories participating in this subprogram measured the following QIs: i) patients recalled for a new blood sample collection due to pre-analytical causes; ii) clotted samples from hemogram and coagulation tests; iii) clinical chemistry hemolyzed samples; and iv) requests with transcription errors entered into the laboratory information system. Results were expressed in percentage value and Sigma value. Databases were anonymized. A minimum acceptable quality level for the four QIs measured was recorded in the majority (75%) of the participating laboratories (Sigma > 3.0). It was nonetheless observed that the QIs of hemolyzed samples and requests with transcription errors entered into the laboratory information system deserve more attention. Through this pioneering experience in Argentina, the participating laboratories - some for the first time - could learn about their performance via interlaboratory comparison of results. This experience also proved to be motivating not only to improve the external assessment subprogram but also to continue working on the measurement of pre-analytical QIs for the continuous improvement of the clinical laboratory total testing process in Argentina.
{"title":"Evaluation of four quality indicators of the Pre-Analytical Phase External Quality Assessment Subprogram of the Fundación Bioquímica Argentina.","authors":"Gisela Unger, Silvia Fabiana Benozzi, Raúl Girardi, Graciela Laura Pennacchiotti","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Pre-analytical phase external quality assessment programs contribute - through the interlaboratory comparison of quality indicators (QIs) - to the continuous improvement of the clinical laboratory total testing process. The purpose of the present work is to document the results derived from measuring four QIs within the framework of a pre-analytical phase external quality assessment subprogram in Argentina. The laboratories participating in this subprogram measured the following QIs: i) patients recalled for a new blood sample collection due to pre-analytical causes; ii) clotted samples from hemogram and coagulation tests; iii) clinical chemistry hemolyzed samples; and iv) requests with transcription errors entered into the laboratory information system. Results were expressed in percentage value and Sigma value. Databases were anonymized. A minimum acceptable quality level for the four QIs measured was recorded in the majority (75%) of the participating laboratories (Sigma > 3.0). It was nonetheless observed that the QIs of hemolyzed samples and requests with transcription errors entered into the laboratory information system deserve more attention. Through this pioneering experience in Argentina, the participating laboratories - some for the first time - could learn about their performance via interlaboratory comparison of results. This experience also proved to be motivating not only to improve the external assessment subprogram but also to continue working on the measurement of pre-analytical QIs for the continuous improvement of the clinical laboratory total testing process in Argentina.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 3","pages":"203-212"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/56/a5/ejifcc-34-203.PMC10588077.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49692768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"The parallel lives of prostate specific antigen in cardiac troponin assays.","authors":"Eleftherios P Diamandis","doi":"","DOIUrl":"","url":null,"abstract":"","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 3","pages":"262-264"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/17/36/ejifcc-34-262.PMC10588081.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49692772","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giuseppe Lippi, Janne Cadamuro, Elisa Danese, Emmanuel J Favaloro, Julien Favresse, Brandon M Henry, Snezana Jovicic, Tomris Ozben, Mario Plebani, Jecko Thachil
Background: The EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) created a survey that has been distributed to its members for gathering information on the key hazards experienced by European medical laboratories during the COVID-19 pandemic.
Methods: The survey was distributed to over 12,000 potential contacts (laboratory workers) via an EFLM newsletter, with responses collected between May 8 and June 8, 2023.
Results: Two hundred replies were collected and examined from European laboratories. 69.7% and 78.1% of all responders said they were short on non-COVID and COVID reagents, respectively. Exactly half of respondents (50.0%) said that they could not complete all laboratory tests required for a specific period, but this figure climbed to 61.2% for COVID tests. Finally, 72.3% of respondents expressed exhaustion during the pandemic, and 61.2% reported increasing patient hostility.
Conclusions: The COVID-19 pandemic had a significant impact on laboratory medicine in Europe. Cultural change, proactive planning, and even re-engineering in some parts of the laboratory industry may thus be necessary to prepare for future challenges.
{"title":"Disruption of laboratory activities during the COVID-19 pandemic: results of an EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) survey.","authors":"Giuseppe Lippi, Janne Cadamuro, Elisa Danese, Emmanuel J Favaloro, Julien Favresse, Brandon M Henry, Snezana Jovicic, Tomris Ozben, Mario Plebani, Jecko Thachil","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>The EFLM Task Force Preparation of Labs for Emergencies (TF-PLE) created a survey that has been distributed to its members for gathering information on the key hazards experienced by European medical laboratories during the COVID-19 pandemic.</p><p><strong>Methods: </strong>The survey was distributed to over 12,000 potential contacts (laboratory workers) via an EFLM newsletter, with responses collected between May 8 and June 8, 2023.</p><p><strong>Results: </strong>Two hundred replies were collected and examined from European laboratories. 69.7% and 78.1% of all responders said they were short on non-COVID and COVID reagents, respectively. Exactly half of respondents (50.0%) said that they could not complete all laboratory tests required for a specific period, but this figure climbed to 61.2% for COVID tests. Finally, 72.3% of respondents expressed exhaustion during the pandemic, and 61.2% reported increasing patient hostility.</p><p><strong>Conclusions: </strong>The COVID-19 pandemic had a significant impact on laboratory medicine in Europe. Cultural change, proactive planning, and even re-engineering in some parts of the laboratory industry may thus be necessary to prepare for future challenges.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 3","pages":"213-219"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/93/22/ejifcc-34-213.PMC10588075.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49692757","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lucio José Pantazis, Gustavo Daniel Frechtel, Gloria Edith Cerrone, Rafael García, Andrea Elena Iglesias Molli
Background: Analyzing longitudinal gene expression data is extremely challenging due to limited prior information, high dimensionality, and heterogeneity. Similar difficulties arise in research of multifactorial diseases such as Type 2 Diabetes. Clustering methods can be applied to automatically group similar observations. Common clinical values within the resulting groups suggest potential associations. However, applying traditional clustering methods to gene expression over time fails to capture variations in the response. Therefore, shape-based clustering could be applied to identify patient groups by gene expression variation in a large time metabolic compensatory intervention.
Objectives: To search for clinical grouping patterns between subjects that showed similar structure in the variation of IL-1β gene expression over time.
Methods: A new approach for shape-based clustering by IL-1β expression behavior was applied to a real longitudinal database of Type 2 Diabetes patients. In order to capture correctly variations in the response, we applied traditional clustering methods to slopes between measurements.
Results: In this setting, the application of K-Medoids using the Manhattan distance yielded the best results for the corresponding database. Among the resulting groups, one of the clusters presented significant differences in many key clinical values regarding the metabolic syndrome in comparison to the rest of the data.
Conclusions: The proposed method can be used to group patients according to variation patterns in gene expression (or other applications) and thus, provide clinical insights even when there is no previous knowledge on the subject clinical profile and few timepoints for each individual.
{"title":"Phenotype similarities in automatically grouped T2D patients by variation-based clustering of IL-1β gene expression.","authors":"Lucio José Pantazis, Gustavo Daniel Frechtel, Gloria Edith Cerrone, Rafael García, Andrea Elena Iglesias Molli","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Analyzing longitudinal gene expression data is extremely challenging due to limited prior information, high dimensionality, and heterogeneity. Similar difficulties arise in research of multifactorial diseases such as Type 2 Diabetes. Clustering methods can be applied to automatically group similar observations. Common clinical values within the resulting groups suggest potential associations. However, applying traditional clustering methods to gene expression over time fails to capture variations in the response. Therefore, shape-based clustering could be applied to identify patient groups by gene expression variation in a large time metabolic compensatory intervention.</p><p><strong>Objectives: </strong>To search for clinical grouping patterns between subjects that showed similar structure in the variation of IL-1β gene expression over time.</p><p><strong>Methods: </strong>A new approach for shape-based clustering by IL-1β expression behavior was applied to a real longitudinal database of Type 2 Diabetes patients. In order to capture correctly variations in the response, we applied traditional clustering methods to slopes between measurements.</p><p><strong>Results: </strong>In this setting, the application of K-Medoids using the Manhattan distance yielded the best results for the corresponding database. Among the resulting groups, one of the clusters presented significant differences in many key clinical values regarding the metabolic syndrome in comparison to the rest of the data.</p><p><strong>Conclusions: </strong>The proposed method can be used to group patients according to variation patterns in gene expression (or other applications) and thus, provide clinical insights even when there is no previous knowledge on the subject clinical profile and few timepoints for each individual.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 3","pages":"228-244"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/cd/1b/ejifcc-34-228.PMC10588079.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49692771","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
With the recent COVID-19 pandemic, point-of-care testing has gained tremendous attention, particularly in acute care settings. The point-of-care testing landscape is rapidly expanding and being contemplated for any crucial test with a central laboratory turnaround time >25% of the clinical decision time. A typical point-of-care testing program within a large hospital system encompasses a multitude of operators utilizing a wide range of devices across multiple testing sites. Thus, managing a large point-of-care testing network remains a daunting task with challenges related to staffing, standardization, quality management, training and competency assessment, and data management. This review will focus on understanding the general organization as well as the roles and responsibilities of various point-of-care testing stakeholders in addressing these challenges. More importantly, it will discuss the strategies and best practices for effective point-of-care testing management based on consensus recommendations from professional societies as well as our experience at Texas Childrens Hospital.
{"title":"Best Practices for Effective Management of Point of Care Testing.","authors":"Anil K Chokkalla, Brandy D Recio, Sridevi Devaraj","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>With the recent COVID-19 pandemic, point-of-care testing has gained tremendous attention, particularly in acute care settings. The point-of-care testing landscape is rapidly expanding and being contemplated for any crucial test with a central laboratory turnaround time >25% of the clinical decision time. A typical point-of-care testing program within a large hospital system encompasses a multitude of operators utilizing a wide range of devices across multiple testing sites. Thus, managing a large point-of-care testing network remains a daunting task with challenges related to staffing, standardization, quality management, training and competency assessment, and data management. This review will focus on understanding the general organization as well as the roles and responsibilities of various point-of-care testing stakeholders in addressing these challenges. More importantly, it will discuss the strategies and best practices for effective point-of-care testing management based on consensus recommendations from professional societies as well as our experience at Texas Childrens Hospital.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 3","pages":"245-249"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/56/5b/ejifcc-34-245.PMC10588082.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49692755","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
I F Ivana Ferrero, D R Deborah Rustichelli, S C Sara Castiglia, L G Loretta Gammaitoni, A P Alessandra Polo, M P Marisa Pautasso, M G Massimo Geuna, F F Franca Fagioli
The Turin Metropolitan Transplant Centre (CIC 305) includes four flow-cytometry laboratories assessing quality control on hematopoietic stem cells (HSC) with different instruments and operators. Therefore, the CD34+ enumeration assay should be validated on a regular basis. We describe here the validation plan to test the inter-laboratory reproducibility of CD34+ enumeration assay, based on the risk analysis. Stabilized blood samples were analysed using Stem-Kit reagent according to manufacturer's instructions and acquired using the Beckman Coulter Navios at Regina Margherita Children's' Hospital (305-1), Beckman Coulter FC500 at Candiolo Cancer Institute FPO-IRCCS (305-2), BD Biosciences FACSLyric™ at S. Luigi Hospital (305-3), and Beckman Coulter Navios EX at Mauriziano Hospital (305-4). The ISHAGE guidelines were followed for estimating % and absolute number of CD34+ cells in single-platform method. For each sample repeatability limit (r), reproducibility error, uncertainty of reproducibility error and coefficient of variation (CV) were reported. The repeated measurements from each laboratory or instrument have a variability, expressed as reproducibility error, lower than the repeatability limit for that single parameter. The corrected reproducibility error is always lower than the repeatability limit except for the percentage value of the "low" count. The analysis of inter-laboratory variance is within the maximum acceptable variance value, and the CV of all measurements for each parameter is less than 8%, indicating low measurement variability among laboratories. Evaluating the overall data, we can conclude that the four laboratories are perfectly aligned and the results are reproducible.
{"title":"Inter-laboratory method validation of CD34+ flow-cytometry assay: the experience of Turin Metropolitan Transplant Centre.","authors":"I F Ivana Ferrero, D R Deborah Rustichelli, S C Sara Castiglia, L G Loretta Gammaitoni, A P Alessandra Polo, M P Marisa Pautasso, M G Massimo Geuna, F F Franca Fagioli","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>The Turin Metropolitan Transplant Centre (CIC 305) includes four flow-cytometry laboratories assessing quality control on hematopoietic stem cells (HSC) with different instruments and operators. Therefore, the CD34+ enumeration assay should be validated on a regular basis. We describe here the validation plan to test the inter-laboratory reproducibility of CD34+ enumeration assay, based on the risk analysis. Stabilized blood samples were analysed using Stem-Kit reagent according to manufacturer's instructions and acquired using the Beckman Coulter Navios at Regina Margherita Children's' Hospital (305-1), Beckman Coulter FC500 at Candiolo Cancer Institute FPO-IRCCS (305-2), BD Biosciences FACSLyric™ at S. Luigi Hospital (305-3), and Beckman Coulter Navios EX at Mauriziano Hospital (305-4). The ISHAGE guidelines were followed for estimating % and absolute number of CD34+ cells in single-platform method. For each sample repeatability limit (r), reproducibility error, uncertainty of reproducibility error and coefficient of variation (CV) were reported. The repeated measurements from each laboratory or instrument have a variability, expressed as reproducibility error, lower than the repeatability limit for that single parameter. The corrected reproducibility error is always lower than the repeatability limit except for the percentage value of the \"low\" count. The analysis of inter-laboratory variance is within the maximum acceptable variance value, and the CV of all measurements for each parameter is less than 8%, indicating low measurement variability among laboratories. Evaluating the overall data, we can conclude that the four laboratories are perfectly aligned and the results are reproducible.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"34 3","pages":"220-227"},"PeriodicalIF":0.0,"publicationDate":"2023-10-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/4e/58/ejifcc-34-220.PMC10588076.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"49692769","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}