Clinical Chemistry and Laboratory Medicine (CCLM)最新文献_第5页

The VES-Matic 5 system: performance of a novel instrument for measuring erythrocyte sedimentation rate VES-Matic 5系统:一种测量红细胞沉降率的新型仪器的性能

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-05-11 DOI: 10.1515/cclm-2022-0359

E. Piva, Alice Stoppa, M. Pelloso, M. Plebani

{"title":"The VES-Matic 5 system: performance of a novel instrument for measuring erythrocyte sedimentation rate","authors":"E. Piva, Alice Stoppa, M. Pelloso, M. Plebani","doi":"10.1515/cclm-2022-0359","DOIUrl":"https://doi.org/10.1515/cclm-2022-0359","url":null,"abstract":"Abstract Objectives The VES-Matic 5 is an automated analyzer that assesses erythrocyte sedimentation rate based on a modified Westergren sedimentation technique. Instrument performance was established by addressing the recommendations of the International Council for Standardization in Haematology. Methods Comparison against the reference Westergren method was performed for all samples, and further for the low, middle, and upper third of the analytical range. Intra-run precision, inter‐run precision, and interference studies were further assessed. This study included the evaluation of reference ranges. Results The comparison of methods by Passing–Bablok analysis has shown a good agreement without systematic or proportional differences. The regression equation was y=−0.646 + 0.979x. The mean bias of −0.542 was obtained by Bland–Altman analysis and the upper limit of 8.03 with the lower limit of −9.11 can be considered clinically acceptable. Intra-run and inter-run precision were good for each parameter and interference studies did not show any significant bias with exception of anemia samples, which showed a proportional difference when comparing high erythrocyte sedimentation rate values. Using the local adult reference population, we verified the reference ranges in comparison to those available in the literature, and according to the Clinical Laboratory Standards Institute (CLSI) EP28-A3C document. We determined the upper limit partitioned by gender and the following age groups: from 18 to 50, from 50 to 70, and over 70. Conclusions The VES-Matic 5 analyzer presented good comparability with the reference method. As there are commercial quality control and suitable external quality assessment (EQA) material and programs, the VES-Matic 5 can be employed appropriately for routine purposes.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86119435","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}

引用次数: 2

Lack of analytical interference of dydrogesterone in progesterone immunoassays 孕酮免疫分析缺乏地屈孕酮的分析干扰

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-05-11 DOI: 10.1515/cclm-2022-0174

T. Eggersmann, A. Wolthuis, P. van Amsterdam, G. Griesinger

{"title":"Lack of analytical interference of dydrogesterone in progesterone immunoassays","authors":"T. Eggersmann, A. Wolthuis, P. van Amsterdam, G. Griesinger","doi":"10.1515/cclm-2022-0174","DOIUrl":"https://doi.org/10.1515/cclm-2022-0174","url":null,"abstract":"Abstract Objectives Progesterone, a sex steroid, is measured in serum by immunoassay in a variety of clinical contexts. One potential limitation of steroid hormone immunoassays is interference caused by compounds with structural similarity to the target steroid of the assay. Dydrogesterone (DYD), an orally active stereoisomer of progesterone, is used for various indications in women’s health. Herein, we report a systematic in vitro investigation of potential interference of DYD and its active metabolite 20α-dihydrodydrogesterone (DHD) in seven widely used, commercially available progesterone assays. Methods Routine human plasma samples were anonymized and pooled to create three graded concentration levels of progesterone (P4 high, P4 medium, P4 low). Each pooled P4 plasma sample (6–7 mL) was spiked at high, medium, and “none” concentration with DYD/DHD and was divided into 0.5 mL aliquots. The blinded aliquots were analyzed by seven different laboratories with their routine progesterone assay (six different immunoassays and one liquid chromatography–tandem mass spectrometry assay, respectively) within the Dutch working group on endocrine laboratory diagnostics of the Dutch Foundation for Quality Assessments in Medical Laboratories. Results The sample recovery rate (P4 result obtained for sample spiked with DYD/DHD, divided by the result obtained for the corresponding sample with no DYD/DHD × 100) was within a ±10% window for the medium and high P4 concentrations, but more variable for the low P4 samples. The latter is, however, attributable to high inter- and intra-method variability at low P4 concentrations. Conclusions This study does not indicate any relevant interference of DYD/DHD within routinely used progesterone assays.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90489596","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}

引用次数: 0

Recommendations for IVDR compliant in-house software development in clinical practice: a how-to paper with three use cases 临床实践中符合IVDR的内部软件开发建议:一篇包含三个用例的指南论文

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-05-11 DOI: 10.1515/cclm-2022-0278

Hanneke W. M. van Deutekom, S. Haitjema

{"title":"Recommendations for IVDR compliant in-house software development in clinical practice: a how-to paper with three use cases","authors":"Hanneke W. M. van Deutekom, S. Haitjema","doi":"10.1515/cclm-2022-0278","DOIUrl":"https://doi.org/10.1515/cclm-2022-0278","url":null,"abstract":"Abstract Objectives The In Vitro Diagnostics Regulation (IVDR) will be effective in May 2022 by which in-house developed tests need to apply to the general safety and performance requirements defined in Annex I of the IVDR ruling. Yet, article 16 from Annex I about software can be hard to interpret and implement, particularly as laboratories are unfamiliar with quality standards for software development. Methods In this paper we provide recommendations on organizational structure, standards to use, and documentation, for IVDR compliant in-house software development. Results A practical insight is offered into novel standard operating procedures using three examples: an Excel file with a formula to calculate the pharmacokinetics of tacrolimus and to calculate the new dose, a rule for automated diagnosis of acute kidney injury and a bioinformatics pipeline for DNA variant calling. Conclusions We recommend multidisciplinary development teams supported by higher management, use of ISO-15189 in synergy with IEC-62304, and concise documentation that includes intended purpose, classification, requirement management, risk management, verification and validation, configuration management and references to clinical or performance evidence.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90767535","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}

引用次数: 6

Vitamin D metabolism in living kidney donors before and after organ donation 活体肾脏供者器官捐献前后维生素D代谢的变化

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-05-09 DOI: 10.1515/cclm-2022-0148

D. Enko, A. Meinitzer, S. Zelzer, M. Herrmann, K. Artinger, A. Rosenkranz, S. Zitta

{"title":"Vitamin D metabolism in living kidney donors before and after organ donation","authors":"D. Enko, A. Meinitzer, S. Zelzer, M. Herrmann, K. Artinger, A. Rosenkranz, S. Zitta","doi":"10.1515/cclm-2022-0148","DOIUrl":"https://doi.org/10.1515/cclm-2022-0148","url":null,"abstract":"Abstract Objectives Living kidney donors provide a unique setting to study functional and metabolic consequences after organ donation. Since the lack of data of the homoeostasis of numerous vitamin D metabolites in these healthy subjects, the aim of this study was to assess the vitamin D metabolism before and after kidney donation. Methods We investigated the 25-dihydroxyvitamin D2 (25[OH]D2), 25-dihydroxyvitamin D3 (25[OH]D3), 1,25-dihydroxyvitamin D3 (1,25[OH]2D3), 24,25-dihydroxyvitamin D3 (24,25[OH]2D3), 25,26-dihydroxyvitamin D3 (25,26[OH]2D3), and the native vitamin D2 (ergocalciferol) and vitamin D3 (cholecalciferol) in a well characterized study cohort of 32 healthy living kidney donors before and after organ donation. Results Thirty-two healthy subjects after kidney donation had significantly lower median (interquartile range) 1,25(OH)2D3 serum concentrations (88.6 [62.6–118.8] vs. 138.0 [102.6–152.4] pmol/L, p<0.001) and significantly higher median 25(OH)D2 serum levels (1.80 [1.19–2.19] vs. 1.11 [0.74–1.59] nmol/L, p=0.019) than before donation. Similar serum concentrations of 25(OH)D3 and 25,26(OH)2D3 were observed before and after donation. The 24,25(OH)2D3 blood levels distinctly decreased after organ donation (4.1 [2.3–5.3] vs. 5.3 [2.2–6.9] nmol/L, p=0.153). Native vitamin D2 (0.10 [0.08–0.14] vs. 0.08 [0.06–0.12] nmol/L, p=0.275) was slightly increased and vitamin D3 (1.6 [0.6–7.2] vs. 2.5 [0.9–8.6] nmol/L, p=0.957) decreased after kidney donation. Conclusions Living kidney donors were found with decreased 1,25(OH)2D3 and 24,25(OH)2D3, increased 25(OH)D2 and consistent 25(OH)D3 and 25,26(OH)2D3 serum concentrations after organ donation. The current study advances the understanding on vitamin D metabolism suggesting that altered hydroxylase-activities after donation is accompanied by compensatory elevated dietary-related 25(OH)D2 blood concentrations.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79010833","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}

引用次数: 0

Comparison between polynomial regression and weighted least squares regression analysis for verification of analytical measurement range 多项式回归与加权最小二乘回归分析在分析量程验证中的比较

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-05-09 DOI: 10.1515/cclm-2022-0018

Tae-Dong Jeong, Soo-Kyung Kim, Sollip Kim, C. Lim, J. Chung

{"title":"Comparison between polynomial regression and weighted least squares regression analysis for verification of analytical measurement range","authors":"Tae-Dong Jeong, Soo-Kyung Kim, Sollip Kim, C. Lim, J. Chung","doi":"10.1515/cclm-2022-0018","DOIUrl":"https://doi.org/10.1515/cclm-2022-0018","url":null,"abstract":"Abstract Objectives Recently, the linearity evaluation protocol by the Clinical & Laboratory Standards Institute (CLSI) has been revised from EP6-A to EP6-ED2, with the statistical method of interpreting linearity evaluation data being changed from polynomial regression to weighted least squares linear regression (WLS). We analyzed and compared the analytical measurement range (AMR) verification results according to the present and prior linearity evaluation guidelines. Methods The verification of AMR of clinical chemistry tests was performed using five samples with two replicates in three different laboratories. After analyzing the same evaluation data in each laboratory by the polynomial regression analysis and WLS methods, results were compared to determine whether linearity was verified across the five sample concentrations. In addition, whether the 90% confidence interval of deviation from linearity by WLS was included in the allowable deviation from linearity (ADL) was compared. Results A linearity of 42.3–56.8% of the chemistry items was verified by polynomial regression analysis in three laboratories. For analysis of the same data by WLS, a linearity of 63.5–78.3% of the test items was verified where the deviation from linearity of all five samples was within the ADL criteria, and the cases where the 90% confidence interval of all deviation from linearity overlapped the ADL was 78.8–91.3%. Conclusions Interpreting AMR verification data by the WLS method according to the newly revised CLSI document EP6-ED2 could reduce laboratory workload, enabling efficient laboratory practice.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81870147","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}

引用次数: 1

Comparison of thyroid stimulating hormone, free thyroxine, total triiodothyronine, thyroglobulin and peroxidase antibodies measurements by two different platforms 两种不同平台促甲状腺激素、游离甲状腺素、总三碘甲状腺原氨酸、甲状腺球蛋白和过氧化物酶抗体测定的比较

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-05-06 DOI: 10.1515/cclm-2022-0139

Anis Al Achkar, E. Naous, Christy Salameh, Colin Cordahi, M. Germanos-Haddad, G. Sleilaty, M. Gannagé-Yared

引用次数: 0

Improving D-dimer testing appropriateness by controlling periodicity of retesting: prevention is better than cure 通过控制复检周期提高d -二聚体检测的适宜性:预防胜于治疗

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-05-06 DOI: 10.1515/cclm-2022-0389

Simone Caruso, D. Szoke, S. Birindelli, F. S. Falvella, A. Dolci, M. Panteghini

引用次数: 2

TSH-receptor autoantibodies in patients with chronic thyroiditis and hypothyroidism 慢性甲状腺炎和甲状腺功能减退患者的tsh受体自身抗体

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-05-05 DOI: 10.1515/cclm-2022-0162

Mariella Giannone, M. Dalla Costa, C. Sabbadin, S. Garelli, M. Salvà, S. Masiero, M. Plebani, D. Faggian, N. Gallo, F. Presotto, L. Bertazza, D. Nacamulli, S. Censi, C. Mian, C. Betterle

{"title":"TSH-receptor autoantibodies in patients with chronic thyroiditis and hypothyroidism","authors":"Mariella Giannone, M. Dalla Costa, C. Sabbadin, S. Garelli, M. Salvà, S. Masiero, M. Plebani, D. Faggian, N. Gallo, F. Presotto, L. Bertazza, D. Nacamulli, S. Censi, C. Mian, C. Betterle","doi":"10.1515/cclm-2022-0162","DOIUrl":"https://doi.org/10.1515/cclm-2022-0162","url":null,"abstract":"Abstract Objectives The reported prevalence of TSH-receptor (TSHR) autoantibodies (TRAb) in patients with chronic thyroiditis (CT) range from 0 to 48%. The objective was to study the prevalence of TRAb in patients with CT and hypothyroidism and to correlate it with gender, age, thyroid dimensions, TSH levels, and autoimmune diseases. Methods The study comprised 245 patients with CT and hypothyroidism (median age 42 years, 193 females, 52 males) and 123 Italian healthy subjects matched for sex and age as controls. TRAb were tested with ELISA using a >2.5 IU/L cut off for positivity. TSHR blocking (TBAb) and TSHR stimulating autoantibodies (TSAb) were measured in 12 TRAb-positive patients using bioassays with Chinese hamster ovary (CHO) cells expressing wild-type or R255D-mutated TSHR. Results TRAb positivity was found in 32/245 (13.1%) patients and significantly correlated (p<0.05) with TSH levels. TRAb positivity was significantly higher in males vs. females (p=0.034), in females 16–45 years of age vs. >45 years of age (p<0.05) and in patients with reduced vs. normal/increased thyroid dimensions (p<0.05). Linear regression analysis showed a correlation between TRAb concentrations with age (p<0.05) and TRAb concentrations with TSH (p<0.01). In bioassay with TSHR-R255D all 12 patients tested were TBAb-positive while 33% were also TSAb-positive suggesting the presence of a mixture of TRAbs with different biological activities in some patients. Conclusions TRAb have been found in patients with CT and hypothyroidism. A mixture of TBAb and TSAb was found in some patients and this may contribute to the pathogenesis of thyroid dysfunction during the course of the disease.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89182442","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}

引用次数: 0

Transdermal measurement of cardiac troponins: the future is now 心脏肌钙蛋白的经皮测量:未来就是现在

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-05-05 DOI: 10.1515/cclm-2022-0382

A. Clerico, A. Aimo, M. Zaninotto, M. Plebani

引用次数: 2

Evaluation of serum neurofilament light in the early management of mTBI patients 血清神经丝光在mTBI患者早期治疗中的评价

Clinical Chemistry and Laboratory Medicine (CCLM) Pub Date : 2022-05-05 DOI: 10.1515/cclm-2022-0173

Samy Kahouadji, Jean-Baptiste Bouillon-Minois, Charlotte Oris, Julie Durif, B. Pereira, J. Pinguet, Agathe Rozand, J. Schmidt, V. Sapin, D. Bouvier

{"title":"Evaluation of serum neurofilament light in the early management of mTBI patients","authors":"Samy Kahouadji, Jean-Baptiste Bouillon-Minois, Charlotte Oris, Julie Durif, B. Pereira, J. Pinguet, Agathe Rozand, J. Schmidt, V. Sapin, D. Bouvier","doi":"10.1515/cclm-2022-0173","DOIUrl":"https://doi.org/10.1515/cclm-2022-0173","url":null,"abstract":"Abstract Objectives Serum S100B allows a one-third reduction of computed tomography (CT) scans performed for mild traumatic brain injury (mTBI) patients. In this study, we evaluated the diagnostic performance of serum NF-L in the detection of intracranial lesions induced by mTBI. Methods One hundred seventy-nine adult mTBI patients presenting to the emergency department of Clermont-Ferrand University Hospital with a Glasgow Coma Scale (GCS) score of 14–15 were included. S100B assays were performed for clinical routine while NF-L samples were stored at −80 °C until analysis. CT scans were performed for patients with S100B levels above the decision threshold of 0.10 μg/L. Later, NF-L and S100B levels were compared to CT scan findings to evaluate the biomarkers’ performances. Results The area under the ROC curve (AUC) evaluating the diagnostic ability in the prediction of intracranial lesions was 0.72 (95% CI; 0.58–0.87) for S100B and 0.58 (95% CI; 0.45–0.71) for NF-L, the specificities (at a threshold allowing a 100% sensitivity) were 35.7% for S100B, and 28% for NF-L (p=0.096). AUCs of NF-L and S100B for the identification of patients with neurological disorders were statistically different (p<0.001). The AUCs were 0.87 (95% CI; 0.82–0.93) for NF-L and 0.57 (95% CI; 0.48–0.66) for S100B. There was a poor correlation between NF-L and S100B, and NF-L levels were correlated to patients’ age (Spearman coefficient of 0.79). Conclusions NF-L showed poor performances in the early management of mTBI patients. NF-L levels are strongly correlated to neurodegeneration, whether physiological, age-related, or pathological.","PeriodicalId":10388,"journal":{"name":"Clinical Chemistry and Laboratory Medicine (CCLM)","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2022-05-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89979031","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}

引用次数: 3