Wenhui Wang, Linlin Liu, Zhongping Ning, Lin Che, Xinming Li
Introduction: Inflammation is closely related to adverse outcomes of acute myocardial infarction (AMI). This study aimed to evaluate whether neutrophil-lymphocyte ratio (NLR) can predict poor prognosis of critical AMI patients.
Materials and methods: We designed a retrospective cohort study and extracted AMI patients from the "Medical Information Mart for Intensive Care-III" database. The primary outcome was 1-year all-cause mortality. The secondary outcomes were 90-day and in-hospital all-cause mortalities, and acute kidney injury (AKI) incidence. The optimal cut-offs of NLR were picked by X-tile software according to the 1-year mortality and patient groups were created: low-NLR (< 4.8), high-NLR (4.8 - 21.1), and very high-NLR (> 21.1). Cox and modified Poisson regression models were used to evaluate the effect of NLR on outcomes in critically AMI patients.
Results: Finally, 782 critical AMI patients were enrolled in this study, and the 1-year mortality was 32% (249/782). The high- and very high-NLR groups had a higher incidence of outcomes than the low-NLR group (P < 0.05). The multivariate regression analyses found that the high- and very high-NLR groups had a higher risk of 1-year mortality (Hazard ratio (HR) = 1.59, 95% CI: 1.12 to 2.24, P = 0.009 and HR = 1.73, 95% CI: 1.09 to 2.73, P = 0.020), 90-day mortality (HR = 1.69, 95% CI: 1.13 to 2.54, P = 0.011 and HR = 1.90, 95% CI: 1.13 to 3.20, P = 0.016), in-hospital mortality (Relative risk (RR) = 1.77, 95% CI: 1.14 to 2.74, P = 0.010 and RR = 2.10, 95% CI: 1.23 to 3.58, P = 0.007), and AKI incidence (RR = 1.44, 95% CI: 1.06 to 1.95, P = 0.018 and RR = 1.34, 95% CI: 0.87 to 2.07, P = 0.180) compared with low-NLR group. NLR retained stable predictive ability in sensitivity analyses.
Conclusion: Baseline NLR is an independent risk factor for 1-year mortality, 90-day mortality, in-hospital mortality, and AKI incidence in AMI patients.
{"title":"The neutrophil-lymphocyte ratio to predict poor prognosis of critical acute myocardial infarction patients: a retrospective cohort study.","authors":"Wenhui Wang, Linlin Liu, Zhongping Ning, Lin Che, Xinming Li","doi":"10.11613/BM.2023.010702","DOIUrl":"https://doi.org/10.11613/BM.2023.010702","url":null,"abstract":"<p><strong>Introduction: </strong>Inflammation is closely related to adverse outcomes of acute myocardial infarction (AMI). This study aimed to evaluate whether neutrophil-lymphocyte ratio (NLR) can predict poor prognosis of critical AMI patients.</p><p><strong>Materials and methods: </strong>We designed a retrospective cohort study and extracted AMI patients from the \"Medical Information Mart for Intensive Care-III\" database. The primary outcome was 1-year all-cause mortality. The secondary outcomes were 90-day and in-hospital all-cause mortalities, and acute kidney injury (AKI) incidence. The optimal cut-offs of NLR were picked by X-tile software according to the 1-year mortality and patient groups were created: low-NLR (< 4.8), high-NLR (4.8 - 21.1), and very high-NLR (> 21.1). Cox and modified Poisson regression models were used to evaluate the effect of NLR on outcomes in critically AMI patients.</p><p><strong>Results: </strong>Finally, 782 critical AMI patients were enrolled in this study, and the 1-year mortality was 32% (249/782). The high- and very high-NLR groups had a higher incidence of outcomes than the low-NLR group (<i>P</i> < 0.05). The multivariate regression analyses found that the high- and very high-NLR groups had a higher risk of 1-year mortality (Hazard ratio (HR) = 1.59, 95% CI: 1.12 to 2.24, P = 0.009 and HR = 1.73, 95% CI: 1.09 to 2.73, P = 0.020), 90-day mortality (HR = 1.69, 95% CI: 1.13 to 2.54, P = 0.011 and HR = 1.90, 95% CI: 1.13 to 3.20, P = 0.016), in-hospital mortality (Relative risk (RR) = 1.77, 95% CI: 1.14 to 2.74, P = 0.010 and RR = 2.10, 95% CI: 1.23 to 3.58, P = 0.007), and AKI incidence (RR = 1.44, 95% CI: 1.06 to 1.95, P = 0.018 and RR = 1.34, 95% CI: 0.87 to 2.07, P = 0.180) compared with low-NLR group. NLR retained stable predictive ability in sensitivity analyses.</p><p><strong>Conclusion: </strong>Baseline NLR is an independent risk factor for 1-year mortality, 90-day mortality, in-hospital mortality, and AKI incidence in AMI patients.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"33 1","pages":"010702"},"PeriodicalIF":3.3,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9807232/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10869822","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Lieselot Dedeene, Marie Stockman, Sophie Steels, Pieter Vermeersch, Glynis Frans
Introduction: The presence of macroenzymes in blood can cause diagnostic confusion. Therefore, confirming the presence of macroenzymes is important to reduce unnecessary (non-)invasive investigations. Polyethylene glycol (PEG) precipitation is a simple and fast first-line method for the detection of macroenzymes. However, there is no consensus on the upper reference limit for the PEG-precipitable activity (%PPA) of monomeric enzymes. The aim of this study was to verify a PEG precipitation protocol for the detection of macroenzymes in our laboratory by establishing upper reference limits (URLs) and determining imprecision for eight enzymes after PEG precipitation. In addition, we aimed to clinically verify the URLs using samples containing macroenzymes as identified by electrophoresis.
Materials and methods: Per enzyme, at least 40 leftover blood samples from adult patients with either normal or increased enzyme activities were diluted 1:1 with 25% PEG 6000 and 1:1 with 0.9% NaCl. Mixtures were incubated for 10 min at 37°C and centrifuged. Supernatant enzyme activity was measured on Cobas c702 and the %PPA was calculated.
Results: The following URLs were obtained: 26% PPA for amylase, 29% PPA for alkaline phosphatase (ALP), 61% PPA for alanine aminotransferase, 48% PPA for aspartate aminotransferase, 24% PPA for creatine kinase (CK), 55% PPA for gamma-glutamyltransferase, 65% PPA for lactate dehydrogenase, and 56% PPA for lipase. The within-lab imprecision was < 15%. Regarding the clinical verification, the two historical samples with proven macroCK showed a %PPA of 69% and 43%, respectively, and a sample with proven macroALP had a %PPA of 52%.
Conclusion: In this study, URLs for monomeric enzyme activities after PEG precipitation for eight different enzymes were established. The URLs are suitable for clinical use, but are only partially in line with other studies. Therefore, our data highlight the importance of establishing laboratory-specific upper reference limits for %PPA to allow a correct interpretation.
{"title":"Detection of macroenzymes: establishing upper reference limits for eight enzymes after polyethylene glycol precipitation.","authors":"Lieselot Dedeene, Marie Stockman, Sophie Steels, Pieter Vermeersch, Glynis Frans","doi":"10.11613/BM.2023.010705","DOIUrl":"https://doi.org/10.11613/BM.2023.010705","url":null,"abstract":"<p><strong>Introduction: </strong>The presence of macroenzymes in blood can cause diagnostic confusion. Therefore, confirming the presence of macroenzymes is important to reduce unnecessary (non-)invasive investigations. Polyethylene glycol (PEG) precipitation is a simple and fast first-line method for the detection of macroenzymes. However, there is no consensus on the upper reference limit for the PEG-precipitable activity (%PPA) of monomeric enzymes. The aim of this study was to verify a PEG precipitation protocol for the detection of macroenzymes in our laboratory by establishing upper reference limits (URLs) and determining imprecision for eight enzymes after PEG precipitation. In addition, we aimed to clinically verify the URLs using samples containing macroenzymes as identified by electrophoresis.</p><p><strong>Materials and methods: </strong><i>Per</i> enzyme, at least 40 leftover blood samples from adult patients with either normal or increased enzyme activities were diluted 1:1 with 25% PEG 6000 and 1:1 with 0.9% NaCl. Mixtures were incubated for 10 min at 37°C and centrifuged. Supernatant enzyme activity was measured on Cobas c702 and the %PPA was calculated.</p><p><strong>Results: </strong>The following URLs were obtained: 26% PPA for amylase, 29% PPA for alkaline phosphatase (ALP), 61% PPA for alanine aminotransferase, 48% PPA for aspartate aminotransferase, 24% PPA for creatine kinase (CK), 55% PPA for gamma-glutamyltransferase, 65% PPA for lactate dehydrogenase, and 56% PPA for lipase. The within-lab imprecision was < 15%. Regarding the clinical verification, the two historical samples with proven macroCK showed a %PPA of 69% and 43%, respectively, and a sample with proven macroALP had a %PPA of 52%.</p><p><strong>Conclusion: </strong>In this study, URLs for monomeric enzyme activities after PEG precipitation for eight different enzymes were established. The URLs are suitable for clinical use, but are only partially in line with other studies. Therefore, our data highlight the importance of establishing laboratory-specific upper reference limits for %PPA to allow a correct interpretation.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"33 1","pages":"010705"},"PeriodicalIF":3.3,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9807236/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10520550","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Adnan Haşimi, Özlem Doğan, Ceyhan Ceran Serdar, Muhittin A Serdar
Introduction: This study determines and compares the concentrations of arginine and methylated arginine products ((asymmetric dimethylarginine (ADMA), symmetric dimethylarginine (SDMA), n-monomethyl-1-arginine (L-NMMA) and homoarginine (HA)) for assessment of their association with disease severity in serum samples of COVID-19 patients.
Materials and methods: Serum arginine and methylated arginine products of 57 mild-moderate and 29 severe (N = 86) COVID-19 patients and 21 controls were determined by tandem mass spectrometry. Moreover, the concentrations of some of the routine clinical laboratory parameters -neutrophil lymphocyte ratio (NLR), C-reactive protein, ferritin, D-dimer, and fibrinogen measured during COVID-19 follow-up were also taken into consideration and compared with the concentrations of arginine and methylated arginine products.
Results: Serum ADMA, SDMA and L-NMMA were found to be significantly higher in severe COVID-19 patients, than in both mild-moderate patients and the control group (P < 0.001 for each). In addition, multiple logistic regression analysis indicated L-NMMA (cut-off =120 nmol/L OR = 34, 95% confidence interval (CI) = 3.5-302.0, P= 0.002), CRP (cut-off = 32 mg/L, OR = 37, 95% CI = 4.8-287.0, P < 0.001), and NLR (cut-off = 7, OR = 22, 95% CI = 1.4-335.0, P = 0.020) as independent risk factors for identification of severe patients.
Conclusions: The concentration of methylated arginine metabolites are significantly altered in COVID-19 disease. The results of this study indicate a significant correlation between the severity of COVID-19 disease and concentrations of CRP, NLR and L-NMMA.
前言:本研究测定并比较了COVID-19患者血清样本中精氨酸和甲基化精氨酸产物(不对称二甲基精氨酸(ADMA)、对称二甲基精氨酸(SDMA)、n-单甲基-1-精氨酸(L-NMMA)和同型精氨酸(HA))的浓度,以评估其与疾病严重程度的相关性。材料与方法:采用串联质谱法测定57例轻中度、29例重度(N = 86) COVID-19患者及21例对照组的血清精氨酸和甲基化精氨酸产物。此外,还考虑了在COVID-19随访期间测量的一些常规临床实验室参数-中性粒细胞淋巴细胞比率(NLR)、c反应蛋白、铁蛋白、d -二聚体和纤维蛋白原的浓度,并与精氨酸和甲基化精氨酸产物的浓度进行了比较。结果:重症患者血清ADMA、SDMA、L-NMMA均显著高于轻、中度患者和对照组(P < 0.001)。此外,多元logistic回归分析显示,L- nmma (cut- cut =120 nmol/L OR = 34, 95%可信区间(CI) = 3.5 ~ 302.0, P= 0.002)、CRP (cut- cut = 32 mg/L OR = 37, 95% CI = 4.8 ~ 287.0, P < 0.001)和NLR (cut- cut = 7, OR = 22, 95% CI = 1.4 ~ 335.0, P= 0.020)是鉴定重症患者的独立危险因素。结论:甲基化精氨酸代谢物浓度在COVID-19疾病中发生显著改变。本研究结果表明,COVID-19疾病严重程度与CRP、NLR和L-NMMA浓度存在显著相关性。
{"title":"Association of serum ADMA, SDMA and L-NMMA concentrations with disease progression in COVID-19 patients.","authors":"Adnan Haşimi, Özlem Doğan, Ceyhan Ceran Serdar, Muhittin A Serdar","doi":"10.11613/BM.2023.010701","DOIUrl":"https://doi.org/10.11613/BM.2023.010701","url":null,"abstract":"<p><strong>Introduction: </strong>This study determines and compares the concentrations of arginine and methylated arginine products ((asymmetric dimethylarginine (ADMA), symmetric dimethylarginine (SDMA), n-monomethyl-1-arginine (L-NMMA) and homoarginine (HA)) for assessment of their association with disease severity in serum samples of COVID-19 patients.</p><p><strong>Materials and methods: </strong>Serum arginine and methylated arginine products of 57 mild-moderate and 29 severe (N = 86) COVID-19 patients and 21 controls were determined by tandem mass spectrometry. Moreover, the concentrations of some of the routine clinical laboratory parameters -neutrophil lymphocyte ratio (NLR), C-reactive protein, ferritin, D-dimer, and fibrinogen measured during COVID-19 follow-up were also taken into consideration and compared with the concentrations of arginine and methylated arginine products.</p><p><strong>Results: </strong>Serum ADMA, SDMA and L-NMMA were found to be significantly higher in severe COVID-19 patients, than in both mild-moderate patients and the control group (P < 0.001 for each). In addition, multiple logistic regression analysis indicated L-NMMA (cut-off =120 nmol/L OR = 34, 95% confidence interval (CI) = 3.5-302.0, P= 0.002), CRP (cut-off = 32 mg/L, OR = 37, 95% CI = 4.8-287.0, P < 0.001), and NLR (cut-off = 7, OR = 22, 95% CI = 1.4-335.0, P = 0.020) as independent risk factors for identification of severe patients.</p><p><strong>Conclusions: </strong>The concentration of methylated arginine metabolites are significantly altered in COVID-19 disease. The results of this study indicate a significant correlation between the severity of COVID-19 disease and concentrations of CRP, NLR and L-NMMA.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"33 1","pages":"010701"},"PeriodicalIF":3.3,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9807234/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10525965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Blood samples having inappropriate volume are a substantial part of preanalytical errors. Inadequate sample volume for glycated haemoglobin (HbA1c) test may be a common problem of patients with diabetes mellitus having vascular changes. In this study, we compared HbA1c concentrations of underfilled and appropriately filled blood collection tubes.
Materials and methods: To compare HbA1c concentrations, blood samples were collected into 2 mL tubes containing K3-EDTA from 109 subjects. Two blood samples (underfilled and appropriately filled) were drawn from a patient by the same personnel and materials. HbA1c measurements were assayed on a Cobas 6000 analyser module c 501 (Roche Diagnostics, Mannheim, Germany). The HbA1c% results were compared by t-test and Wilcoxon's signed-rank statistical methods (SPSS Inc., Chicago, USA). Bias analysis was performed using Microsoft Excel 4.0.
Results: Underfilled samples were classified three groups (group 1, N = 44; group 2, N = 36; and group 3, N = 29) according to the filling ratio of the samples; 0.5 mL and below (< 25%), 0.5-1.0 mL (25-50%), and 1.0-2.0 mL (> 50%), respectively. When we compared underfilled tubes with pairing filled tubes, there was a statistically significant difference only with tubes filled less than 25% (P = 0.030). Furthermore, we have done bias analysis between paired tubes according to the diagnostic cut-off value of 6.5%. The bias was more prominent in up to 50% underfilled blood tubes (1.1%), when HbA1c concentrations were below the diagnostic cut-off of 6.5%.
Conclusions: We suggest that the blood tubes with EDTA for HbA1c measurement should be filled with at least 50% to avoid clinical variations.
{"title":"Undefilled blood tube containing EDTA: Is it an inappropriate sample for HbA1c assay?","authors":"Berrak Guven, Ismail Benice, Murat Can","doi":"10.11613/BM.2023.010901","DOIUrl":"https://doi.org/10.11613/BM.2023.010901","url":null,"abstract":"<p><strong>Introduction: </strong>Blood samples having inappropriate volume are a substantial part of preanalytical errors. Inadequate sample volume for glycated haemoglobin (HbA1c) test may be a common problem of patients with diabetes mellitus having vascular changes. In this study, we compared HbA1c concentrations of underfilled and appropriately filled blood collection tubes.</p><p><strong>Materials and methods: </strong>To compare HbA1c concentrations, blood samples were collected into 2 mL tubes containing K3-EDTA from 109 subjects. Two blood samples (underfilled and appropriately filled) were drawn from a patient by the same personnel and materials. HbA1c measurements were assayed on a Cobas 6000 analyser module c 501 (Roche Diagnostics, Mannheim, Germany). The HbA1c% results were compared by t-test and Wilcoxon's signed-rank statistical methods (SPSS Inc., Chicago, USA). Bias analysis was performed using Microsoft Excel 4.0.</p><p><strong>Results: </strong>Underfilled samples were classified three groups (group 1, N = 44; group 2, N = 36; and group 3, N = 29) according to the filling ratio of the samples; 0.5 mL and below (< 25%), 0.5-1.0 mL (25-50%), and 1.0-2.0 mL (> 50%), respectively. When we compared underfilled tubes with pairing filled tubes, there was a statistically significant difference only with tubes filled less than 25% (P = 0.030). Furthermore, we have done bias analysis between paired tubes according to the diagnostic cut-off value of 6.5%. The bias was more prominent in up to 50% underfilled blood tubes (1.1%), when HbA1c concentrations were below the diagnostic cut-off of 6.5%.</p><p><strong>Conclusions: </strong>We suggest that the blood tubes with EDTA for HbA1c measurement should be filled with at least 50% to avoid clinical variations.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"33 1","pages":"010901"},"PeriodicalIF":3.3,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9927728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9663357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Alexandre Raynor, Carmen Stefanescu, Arnaud Bruneel, Hervé Puy, Katell Peoc'h, Hana Manceau
Herein, we report the case of a 42-year-old woman, hospitalized in a French tertiary hospital for a relapse of a chronic enteropathy, who was found on admission to have no detectable serum transferrin. Surprisingly, she only exhibited mild anaemia. This atransferrinemia persisted for two months throughout her hospitalization, during which her haemoglobin concentration remained broadly stable. Based on her clinical history and evolution, we concluded to an acquired atransferrinemia secondary to chronic undernutrition, inflammation and liver failure. We discuss the investigations performed in this patient, and hypotheses regarding the relative stability of her haemoglobin concentration despite the absence of detectable transferrin.
{"title":"Reversible atransferrinemia in a patient with chronic enteropathy: is transferrin mandatory for iron transport?","authors":"Alexandre Raynor, Carmen Stefanescu, Arnaud Bruneel, Hervé Puy, Katell Peoc'h, Hana Manceau","doi":"10.11613/BM.2023.010801","DOIUrl":"https://doi.org/10.11613/BM.2023.010801","url":null,"abstract":"<p><p>Herein, we report the case of a 42-year-old woman, hospitalized in a French tertiary hospital for a relapse of a chronic enteropathy, who was found on admission to have no detectable serum transferrin. Surprisingly, she only exhibited mild anaemia. This atransferrinemia persisted for two months throughout her hospitalization, during which her haemoglobin concentration remained broadly stable. Based on her clinical history and evolution, we concluded to an acquired atransferrinemia secondary to chronic undernutrition, inflammation and liver failure. We discuss the investigations performed in this patient, and hypotheses regarding the relative stability of her haemoglobin concentration despite the absence of detectable transferrin.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"33 1","pages":"010801"},"PeriodicalIF":3.3,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9807235/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9308042","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: The aim of the study was to calculate reference intervals (RIs) for thyroid stimulating hormone (TSH), free thyroxine (fT4) and free triiodothyronine (fT3) and evaluate the clinical significance of these intervals by use of reference change values (RCV) of the analytes.
Materials and methods: Laboratory patient data between August and December 2021 were evaluated for the study. A total of 188,912 patients with TSH, fT4, fT3, anti-thyroid peroxidase antibodies (Anti-TPO) and anti-thyroglobulin antibodies (Anti-Tg) results were evaluated. All measurements were performed on Cobas c801 (Roche Diagnostics, Penzberg, Germany) using electrochemiluminescence immunoassay technology. Estimated RIs were compared with manufacturer's by means of RCVs of analytes.
Results: Thyroid stimulating hormone values didn't differ significantly by gender and age. The combined RIs for whole group (N = 28,437) was found as 0.41-4.37 mIU/mL. Free T4 values (11.6-20.1 pmol/L, N = 13,479 in male; 10.5-19.5 pmol/L, N = 17,634 female) and fT3 values (3.38-6.35 pmol/L, N = 2,516 in male; 3.39-5.99 pmol/L, N = 3,348 pmol/L in female) significantly differed by gender (P < 0.050). Both fT4 and fT3 values also showed significant differences in age subgroups comparisons. So, male and female RIs were represented separately for age subgroups. When compared with manufacturer's RIs, TSH whole group and fT4 subgroups RIs didn't exceed the analytes' RCVs, but this difference was greater for fT3.
Conclusions: Reference interval estimation by use of indirect method out of laboratory data may be more accurate than manufacturer provided RIs. This population based RIs evaluated using RCV of analytes may provide useful information in clinical interpretation of laboratory results.
{"title":"Reference intervals for thyroid disorders calculated by indirect method and comparison with reference change values.","authors":"Zeynep Yildiz, Lale Köroğlu Dağdelen","doi":"10.11613/BM.2023.010704","DOIUrl":"https://doi.org/10.11613/BM.2023.010704","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of the study was to calculate reference intervals (RIs) for thyroid stimulating hormone (TSH), free thyroxine (fT4) and free triiodothyronine (fT3) and evaluate the clinical significance of these intervals by use of reference change values (RCV) of the analytes.</p><p><strong>Materials and methods: </strong>Laboratory patient data between August and December 2021 were evaluated for the study. A total of 188,912 patients with TSH, fT4, fT3, anti-thyroid peroxidase antibodies (Anti-TPO) and anti-thyroglobulin antibodies (Anti-Tg) results were evaluated. All measurements were performed on Cobas c801 (Roche Diagnostics, Penzberg, Germany) using electrochemiluminescence immunoassay technology. Estimated RIs were compared with manufacturer's by means of RCVs of analytes.</p><p><strong>Results: </strong>Thyroid stimulating hormone values didn't differ significantly by gender and age. The combined RIs for whole group (N = 28,437) was found as 0.41-4.37 mIU/mL. Free T4 values (11.6-20.1 pmol/L, N = 13,479 in male; 10.5-19.5 pmol/L, N = 17,634 female) and fT3 values (3.38-6.35 pmol/L, N = 2,516 in male; 3.39-5.99 pmol/L, N = 3,348 pmol/L in female) significantly differed by gender (P < 0.050). Both fT4 and fT3 values also showed significant differences in age subgroups comparisons. So, male and female RIs were represented separately for age subgroups. When compared with manufacturer's RIs, TSH whole group and fT4 subgroups RIs didn't exceed the analytes' RCVs, but this difference was greater for fT3.</p><p><strong>Conclusions: </strong>Reference interval estimation by use of indirect method out of laboratory data may be more accurate than manufacturer provided RIs. This population based RIs evaluated using RCV of analytes may provide useful information in clinical interpretation of laboratory results.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"33 1","pages":"010704"},"PeriodicalIF":3.3,"publicationDate":"2023-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9807239/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10520547","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-10-01Epub Date: 2022-08-05DOI: 10.11613/BM.2022.030802
Massimo Daves, Andrea Piccin, Cristina Vicidomini, Antonia De Luisi, Andrea Mega
Screening and measurement of monoclonal (M) proteins are commonly performed using capillary zone electrophoresis (CZE). The identification of M-protein or monoclonal component (CM) is an essential requirement for diagnosis and monitoring of monoclonal gammopathies. The detection of CM has been largely improved by CZE. Capillary electrophoresis estimates CM more accurately, because absence of variation due to different dye binding affinities of proteins as instead seen with agarose gel electrophoresis. However, interferences can be present in CZE. This occurs because all substances absorbing at 200 nm can be identified. Recognition and handling of specimens exhibiting such interferences is essential to ensure accurate diagnostic and patient safety. We herein report on an unusual case of serum protein electrophoresis, to highlight that laboratory staff must be aware of and familiarise with the information provided by laboratory instruments. For example, in the case of serum indices, about specimen quality.
{"title":"Utility of serum indices in a particular case of serum protein electrophoresis.","authors":"Massimo Daves, Andrea Piccin, Cristina Vicidomini, Antonia De Luisi, Andrea Mega","doi":"10.11613/BM.2022.030802","DOIUrl":"https://doi.org/10.11613/BM.2022.030802","url":null,"abstract":"<p><p>Screening and measurement of monoclonal (M) proteins are commonly performed using capillary zone electrophoresis (CZE). The identification of M-protein or monoclonal component (CM) is an essential requirement for diagnosis and monitoring of monoclonal gammopathies. The detection of CM has been largely improved by CZE. Capillary electrophoresis estimates CM more accurately, because absence of variation due to different dye binding affinities of proteins as instead seen with agarose gel electrophoresis. However, interferences can be present in CZE. This occurs because all substances absorbing at 200 nm can be identified. Recognition and handling of specimens exhibiting such interferences is essential to ensure accurate diagnostic and patient safety. We herein report on an unusual case of serum protein electrophoresis, to highlight that laboratory staff must be aware of and familiarise with the information provided by laboratory instruments. For example, in the case of serum indices, about specimen quality.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":" ","pages":"030802"},"PeriodicalIF":3.3,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9344864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40696906","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2022-10-01Epub Date: 2022-08-05DOI: 10.11613/BM.2022.030705
Rabia Tan, Mustafa Yilmaz, Yusuf Kurtulmuş
Introduction: Measurement uncertainty is a non-negative parameter that characterizes the distribution of all values appropriate to the measured size and is associated with the measured result. In this study, we aimed to compare the results with various suggestions and produce more qualified results by calculating the measurement uncertainties of the immunoassays like fertility hormones, drug concentration tests, cardiac markers, thyroid function tests and tumour markers.
Materials and methods: Uncertainty calculation was made in accordance with the top-down approach according to Nordtest guide. The 12-month study of internal and external quality assessment results were used. The parameters of drug concentration tests were performed on the Abbott Architect c8000, other hormones/markers on the i2000 of the same brand.
Results: Factors that increased the measurement uncertainty of a test were due to external quality control data. The calculations showed that 13 of 26 parameters satisfied quality requirements. The highest uncertainty value, with 28% belonged to cancer antigen 19-9 test. The lowest value was calculated for prolactin with 8.3%. Dehydroepiandrosterone sulfate and phenytoin performed poorly in terms of measurement uncertainty, although internal and external quality control assessment results were considered favourable for both.
Conclusion: It is recommended that the concept of measurement uncertainty, which plays an important role in the total quality performance of the laboratory, should be followed up by the clinical laboratory experts at certain time intervals and should be increased the awareness of clinicians about the subject.
{"title":"A practical approach example to measurement uncertainty: Evaluation of 26 immunoassay parameters.","authors":"Rabia Tan, Mustafa Yilmaz, Yusuf Kurtulmuş","doi":"10.11613/BM.2022.030705","DOIUrl":"https://doi.org/10.11613/BM.2022.030705","url":null,"abstract":"<p><strong>Introduction: </strong>Measurement uncertainty is a non-negative parameter that characterizes the distribution of all values appropriate to the measured size and is associated with the measured result. In this study, we aimed to compare the results with various suggestions and produce more qualified results by calculating the measurement uncertainties of the immunoassays like fertility hormones, drug concentration tests, cardiac markers, thyroid function tests and tumour markers.</p><p><strong>Materials and methods: </strong>Uncertainty calculation was made in accordance with the top-down approach according to Nordtest guide. The 12-month study of internal and external quality assessment results were used. The parameters of drug concentration tests were performed on the Abbott Architect c8000, other hormones/markers on the i2000 of the same brand.</p><p><strong>Results: </strong>Factors that increased the measurement uncertainty of a test were due to external quality control data. The calculations showed that 13 of 26 parameters satisfied quality requirements. The highest uncertainty value, with 28% belonged to cancer antigen 19-9 test. The lowest value was calculated for prolactin with 8.3%. Dehydroepiandrosterone sulfate and phenytoin performed poorly in terms of measurement uncertainty, although internal and external quality control assessment results were considered favourable for both.</p><p><strong>Conclusion: </strong>It is recommended that the concept of measurement uncertainty, which plays an important role in the total quality performance of the laboratory, should be followed up by the clinical laboratory experts at certain time intervals and should be increased the awareness of clinicians about the subject.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":" ","pages":"030705"},"PeriodicalIF":3.3,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9344870/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40697868","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Overactive bladder (OAB) is the most common urinary disorder and the leading cause of functional daytime intermittent urinary incontinence in children. The aim of this study was to determine whether urinary brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) concentrations, normalized to urine creatinine, could be used as biomarkers for diagnosis and treatment monitoring of OAB in children.
Materials and methods: Urine samples of 48 pediatric patients with OAB were collected at the start of anticholinergic therapy (baseline), at follow-up visits (3 and 6 months), and from 48 healthy controls. Urinary BDNF and NGF concentrations were determined by ELISA method (Merck, Darmstadt, Germany) and Luminex method (Thermo Fisher Scientific, Waltham, USA). Differences of frequency between quantifiable analyte concentrations between subject groups were determined using Fisher's exact test.
Results: There was no statistically significant difference between quantifiable analyte concentrations between patients at baseline and the control group for BDNF and NGF by either the ELISA or Luminex method (P = 1.000, P = 0.170, P = 1.000, and P = N/A, respectively). There was a statistically significant difference between quantifiable BDNF by the ELISA method between patients at baseline and complete success follow-up (P = 0.027), while BDNF by Luminex method and NGF by both methods were not statistically significant (P = 0.078, P = 0.519, and P = N/A, respectively).
Conclusions: This study did not demonstrate that urinary BDNF and NGF concentrations, can be used as biomarkers for diagnosis and therapy monitoring of OAB in children.
膀胱过动症(OAB)是最常见的泌尿系统疾病,也是儿童日间功能性间歇性尿失禁的主要原因。本研究的目的是确定尿脑源性神经营养因子(BDNF)和神经生长因子(NGF)浓度与尿肌酐归一化是否可以作为儿童OAB诊断和治疗监测的生物标志物。材料和方法:收集48例OAB患儿在抗胆碱能治疗开始(基线)、随访(3个月和6个月)和48例健康对照者的尿液样本。采用ELISA法(Merck, Darmstadt, Germany)和Luminex法(Thermo Fisher Scientific, Waltham, USA)测定尿液BDNF和NGF浓度。使用Fisher精确检验确定受试者组间可量化分析物浓度之间的频率差异。结果:ELISA法和Luminex法测定基线时患者BDNF和NGF可量化分析物浓度与对照组比较,差异均无统计学意义(P = 1.000, P = 0.170, P = 1.000, P = N/A)。基线时和完全成功随访时,ELISA法可量化BDNF差异有统计学意义(P = 0.027),而Luminex法BDNF和两种方法的NGF均无统计学意义(P = 0.078, P = 0.519, P = N/ a)。结论:本研究并未证明尿BDNF和NGF浓度可作为儿童OAB诊断和治疗监测的生物标志物。
{"title":"Urinary brain-derived neurotrophic factor and nerve growth factor as noninvasive biomarkers of overactive bladder in children.","authors":"Merima Colic, Dunja Rogic, Jasna Lenicek Krleza, Ana Kozmar, Lorna Stemberger Maric, Slaven Abdovic","doi":"10.11613/BM.2022.030706","DOIUrl":"https://doi.org/10.11613/BM.2022.030706","url":null,"abstract":"<p><strong>Introduction: </strong>Overactive bladder (OAB) is the most common urinary disorder and the leading cause of functional daytime intermittent urinary incontinence in children. The aim of this study was to determine whether urinary brain-derived neurotrophic factor (BDNF) and nerve growth factor (NGF) concentrations, normalized to urine creatinine, could be used as biomarkers for diagnosis and treatment monitoring of OAB in children.</p><p><strong>Materials and methods: </strong>Urine samples of 48 pediatric patients with OAB were collected at the start of anticholinergic therapy (baseline), at follow-up visits (3 and 6 months), and from 48 healthy controls. Urinary BDNF and NGF concentrations were determined by ELISA method (Merck, Darmstadt, Germany) and Luminex method (Thermo Fisher Scientific, Waltham, USA). Differences of frequency between quantifiable analyte concentrations between subject groups were determined using Fisher's exact test.</p><p><strong>Results: </strong>There was no statistically significant difference between quantifiable analyte concentrations between patients at baseline and the control group for BDNF and NGF by either the ELISA or Luminex method (P = 1.000, P = 0.170, P = 1.000, and P = N/A, respectively). There was a statistically significant difference between quantifiable BDNF by the ELISA method between patients at baseline and complete success follow-up (P = 0.027), while BDNF by Luminex method and NGF by both methods were not statistically significant (P = 0.078, P = 0.519, and P = N/A, respectively).</p><p><strong>Conclusions: </strong>This study did not demonstrate that urinary BDNF and NGF concentrations, can be used as biomarkers for diagnosis and therapy monitoring of OAB in children.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"32 3","pages":"030706"},"PeriodicalIF":3.3,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9562800/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9647504","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Leonor Guiñón, Anna Soler, Rosa María López, Sonia Pajares, José Manuel González de Aledo, Ana Argudo-Ramírez, José Luis Marín, Judit García-Villoria, Ángeles Sahuquillo, Luisa Alvarez
Introduction: To ensure the quality of the new-born screening (NBS), our laboratory reviewed the analytical procedure to detect subjective steps that may represent a risk to the patient. Two subjective activities were identified in the extra-analytical phases: the classification of dried blood spots (DBS) according to their quality and the assignment of haemoglobin patterns. To keep these activities under control, inter-rater studies were implemented. This study aimed to evaluate the inter-rater reliability and the effectiveness of the measures taken to improve the agreement between observers, to assure NBS results' quality.
Materials and methods: Dried blood spots specimens were used for the inter-rater studies. Ten studies were performed to assess DBS quality classification, and four to assess the assignment of haemoglobin patterns. Krippendorff's alpha test was used to estimate inter-rater reliability. Causes were investigated when alpha values were below 0.80.
Results: For both activities, the reliability obtained in the first studies was inadequate. After investigation, we detected that the criterion to classify a DBS as scant was not consolidated, and also a lack of consensus on whether or not to report Bart's haemoglobin depending on its percentage. Alpha estimates became higher once the training was reinforced and a consensus about the appropriate criteria to be applied was reached.
Conclusion: Inter-rater reliability assessment helped us to ensure the quality of subjective activities that could add variability to NBS results. Furthermore, the evolution of the alpha value over time allowed us to verify the effectiveness of the measures adopted.
{"title":"Inter-rater reliability assessment for the new-born screening quality assurance.","authors":"Leonor Guiñón, Anna Soler, Rosa María López, Sonia Pajares, José Manuel González de Aledo, Ana Argudo-Ramírez, José Luis Marín, Judit García-Villoria, Ángeles Sahuquillo, Luisa Alvarez","doi":"10.11613/BM.2022.030901","DOIUrl":"https://doi.org/10.11613/BM.2022.030901","url":null,"abstract":"<p><strong>Introduction: </strong>To ensure the quality of the new-born screening (NBS), our laboratory reviewed the analytical procedure to detect subjective steps that may represent a risk to the patient. Two subjective activities were identified in the extra-analytical phases: the classification of dried blood spots (DBS) according to their quality and the assignment of haemoglobin patterns. To keep these activities under control, inter-rater studies were implemented. This study aimed to evaluate the inter-rater reliability and the effectiveness of the measures taken to improve the agreement between observers, to assure NBS results' quality.</p><p><strong>Materials and methods: </strong>Dried blood spots specimens were used for the inter-rater studies. Ten studies were performed to assess DBS quality classification, and four to assess the assignment of haemoglobin patterns. Krippendorff's alpha test was used to estimate inter-rater reliability. Causes were investigated when alpha values were below 0.80.</p><p><strong>Results: </strong>For both activities, the reliability obtained in the first studies was inadequate. After investigation, we detected that the criterion to classify a DBS as scant was not consolidated, and also a lack of consensus on whether or not to report Bart's haemoglobin depending on its percentage. Alpha estimates became higher once the training was reinforced and a consensus about the appropriate criteria to be applied was reached.</p><p><strong>Conclusion: </strong>Inter-rater reliability assessment helped us to ensure the quality of subjective activities that could add variability to NBS results. Furthermore, the evolution of the alpha value over time allowed us to verify the effectiveness of the measures adopted.</p>","PeriodicalId":9021,"journal":{"name":"Biochemia Medica","volume":"32 3","pages":"030901"},"PeriodicalIF":3.3,"publicationDate":"2022-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9344869/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9284079","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}