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End-user verification results of two serum separator tubes for clinical chemistry analytes according to CLSI GP34-A and CLSI GP41-A6. 根据 CLSI GP34-A 和 CLSI GP41-A6 对两种血清分离管进行临床化学分析的最终用户验证结果。
IF 2.1 4区 医学 Q3 Biochemistry, Genetics and Molecular Biology Pub Date : 2024-05-01 Epub Date: 2024-05-03 DOI: 10.1080/00365513.2024.2344681
Sedat Abusoglu, Busra Ecer, Halil Guven, Ahmet Emre Yorulmaz, Muhittin Abdulkadir Serdar, Ali Unlu, Fikret Akyurek, Bahadir Ozturk, Gulsum Abusoglu

Tube manufacturers use different composition of gels and blood clot activator formulations in serum tube production. Our aim was to investigate the within-tube (repeatability) and between-tube variation, concordance between comparison results of BD and VacuSEL tubes. Blood samples were collected from control subjects (n = 20) and patients (n = 30) in accordance with the CLSI GP41-A6 and CLSI GP34-A guidelines. Twenty-three clinical chemistry parameters were analysed via Roche Cobas C702 Chemistry Analyzer on T0 (0 hour) and T24 (24 hour). Mean differences % were compared with Wilcoxon matched pair test. Clinical significance was evaluated based on desirable bias according to total allowable error (TEa). VacuSEL tubes demonstrated acceptable performance for the results of 20 parameters with regards to desirable bias % limits. Lactate dehydrogenase (LD) [mean difference % (%95 confidence intervals (CI) values of BD and VacuSEL tubes at T0 [6.41% (4.80-8.01%)]; sodium (Na) and total protein (TP) at T24 [-0.27% (-0.46 to -0.07%) and -1.39% (-1.87 to -0.91), respectively] were over the desirable bias limits (LD: 4.3%, Na: 0.23% and TP: 1.36%, respectively) but not exceeding total biological variation CV % [Na: 0.5 (0.0-1.0) % and TP: 2.6 (2.3-2.7) %). %95 confidence intervals (CI) of T0 LD values overlap with within-subject biological variation % (CI) limits (LD: 5.2 (4.9-5.4) %). The differences between two tubes were not medically significant and necessarily conclusive. VacuSEL serum tubes presented comparable performance with BD serum tubes.

试管制造商在生产血清试管时使用不同的凝胶和血凝块活化剂配方。我们的目的是研究 BD 和 VacuSEL 血清试管的管内(重复性)和管间差异以及对比结果的一致性。根据 CLSI GP41-A6 和 CLSI GP34-A 指南,我们采集了对照组(20 人)和患者(30 人)的血样。在 T0(0 小时)和 T24(24 小时)期间,通过罗氏 Cobas C702 化学分析仪分析了 23 项临床化学参数。采用 Wilcoxon 配对检验比较平均差%。临床意义根据总允许误差(TEa)的理想偏差进行评估。VacuSEL 管在 20 个参数的结果中表现出了可接受的性能,达到了理想的偏差百分比限值。乳酸脱氢酶 (LD) [T0 时 BD 和 VacuSEL 管的平均差% (%95 置信区间 (CI) 值 [6.41% (4.80-8.01%)];T24 时钠 (Na) 和总蛋白 (TP) [-0.27% (-0.46 至 -0.07%) 和 -1.分别为-0.27%(-0.46 至-0.07%)和-1.39%(-1.87 至-0.91)]超过了理想偏差限(分别为 LD:4.3%、Na:0.23% 和 TP:1.36%),但未超过总生物变异 CV % [Na:0.5 (0.0-1.0) % 和 TP:2.6 (2.3-2.7) %]。T0 LD 值的 95%置信区间 (CI) 与受试者内生物变异% (CI) 限值重叠(LD:5.2 (4.9-5.4) %)。两种试管之间的差异不具有医学意义,也不一定是结论性的。VacuSEL 血清管与 BD 血清管的性能相当。
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引用次数: 0
Reproducibility and stability of the immature platelet fraction using Sysmex XN-10. 使用 Sysmex XN-10 检测未成熟血小板部分的可重复性和稳定性。
IF 2.1 4区 医学 Q3 Biochemistry, Genetics and Molecular Biology Pub Date : 2024-04-01 Epub Date: 2024-02-29 DOI: 10.1080/00365513.2024.2321590
Usman Ali, Gavin Knight, Mridula Chopra, Dimitris A Tsitsikas

Background: The Immature Platelet Fraction (IPF) is an indicator of thrombopoiesis which is a useful parameter in thrombocytopenia. It demonstrates compensatory mechanisms in production of platelets, but currently not implemented in routine clinical practice. The aim of this study was to establish the reproducibility and stability of IPF, for both percentage (%-IPF) and absolute (A-IPF) measurements.Material/methods: A total of 71 samples, of which 45 for reproducibility and 26 for stability analysis, were assayed for full blood count using the Sysmex XN-10 analyser at room temperature (RT:19-25 °C). For reproducibility analysis, IPF measurements were analysed 11 times by different appraisers using the same sample, while for stability analysis, IPF was measured over fourteen hourly-intervals up to 24 h (n = 21) and then separately extended beyond the point of stability to 72 h (n = 5).

Results: Reproducibility analysis of %-IPF and A-IPF (n = 45) showed very reliable results, with the range of mean CV% values between 1.25-8.90% and 1.70-9.96%, respectively. On the other hand, overall, stability analysis of %-IPF and A-IPF (n = 21) at RT over 24 h showed reliable results, with pooled mean CV% values of 1.32% and 1.43%, respectively, with no significant difference between %-IPF and A-IPF (p = 0.767 and p = 0.821). All %-IPF and A-IPF values had exceeded the set acceptance criterion of stability (CV% ≥ 10.0%) before 72 h.

Conclusions: Overall, %-IPF and A-IPF reproducibility and storage at RT for 24 h predominantly demonstrates the suitability of their usage for testing on the Sysmex XN-series analysers.

背景:未成熟血小板比例(IPF)是血小板生成的一个指标,是血小板减少症的一个有用参数。它显示了血小板生成的代偿机制,但目前尚未在常规临床实践中应用。本研究旨在确定 IPF 百分比(%-IPF)和绝对值(A-IPF)测量的可重复性和稳定性:使用 Sysmex XN-10 分析仪在室温(RT:19-25 °C)下对 71 份样本进行了全血细胞计数分析,其中 45 份用于重现性分析,26 份用于稳定性分析。在重现性分析中,由不同的鉴定人员使用同一样本进行了 11 次 IPF 测量分析;而在稳定性分析中,IPF 的测量时间间隔为每小时 14 次,直至 24 小时(n = 21),然后在稳定点之后分别延长至 72 小时(n = 5):结果:%-IPF 和 A-IPF 的重现性分析(n = 45)显示结果非常可靠,平均 CV% 值范围分别为 1.25-8.90% 和 1.70-9.96%。另一方面,总体而言,RT 24 小时内 %-IPF 和 A-IPF(n = 21)的稳定性分析结果可靠,汇总平均 CV% 值分别为 1.32% 和 1.43%,%-IPF 和 A-IPF 之间无显著差异(p = 0.767 和 p = 0.821)。所有 %-IPF 和 A-IPF 值在 72 小时前都超过了设定的稳定性接受标准(CV% ≥ 10.0%):总体而言,%-IPF 和 A-IPF 的重现性和在 RT 条件下保存 24 小时的稳定性表明,它们适合在 Sysmex XN 系列分析仪上进行测试。
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引用次数: 0
Red blood cell distribution width (RDW) reflects disease severity in patients with carbon monoxide poisoning: systematic literature review and meta-analysis. 红细胞分布宽度 (RDW) 反映一氧化碳中毒患者的疾病严重程度:系统文献综述和荟萃分析。
IF 2.1 4区 医学 Q3 Biochemistry, Genetics and Molecular Biology Pub Date : 2024-04-01 Epub Date: 2024-03-28 DOI: 10.1080/00365513.2024.2332998
Giuseppe Lippi, Brandon M Henry, Camilla Mattiuzzi

No definitive prognostic biomarkers for carbon monoxide (CO) poisoning have been proposed. The aim of this study is to investigate, through a systematic literature review and pooled analysis, whether red blood cell distribution width (RDW) can predict disease severity in CO-poisoned patients. We performed an electronic search in Scopus and PubMed using the keywords: 'red blood cell distribution width' OR 'RDW' AND 'carbon monoxide' AND 'poisoning,' with no time or language restrictions (i.e. through August 2023) to find clinical studies that examined the value of RDW in patients with varying severity of CO poisoning. The analysis was performed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) 2020 reporting checklist. We identified 29 articles, seven of which were included in our analysis, with a total of 1979 CO-poisoned patients, 25.9% of whom were severely ill. In all but one of the studies, the RWD mean or median value was higher in CO-poisoned patients with severe disease. The weighted mean difference (WMD) of RDW was 0.36 (95% confidence interval (CI), 0.26-0.47)%. In the three articles in which the severity of illness in CO-poisoned patients was defined as cardiac injury, the WMD of the RDW was 1.26 (95%CI, 1.02-1.50)%. These results suggest that monitoring RDW in CO-poisoned patients may help to determine the severity of disease, particularly cardiac injury.

目前尚未提出一氧化碳(CO)中毒的明确预后生物标志物。本研究旨在通过系统性文献综述和汇总分析,探讨红细胞分布宽度(RDW)能否预测一氧化碳中毒患者的疾病严重程度。我们使用关键字在 Scopus 和 PubMed 上进行了电子检索:红细胞分布宽度 "或 "RDW"、"一氧化碳 "和 "中毒",没有时间或语言限制(即截止到 2023 年 8 月),以查找在不同严重程度的一氧化碳中毒患者中检测 RDW 价值的临床研究。分析按照 PRISMA(系统综述和元分析首选报告项目)2020 报告清单进行。我们共发现了 29 篇文章,其中 7 篇纳入了我们的分析,共涉及 1979 名一氧化碳中毒患者,其中 25.9% 的患者病情严重。除一项研究外,其他所有研究中,病情严重的一氧化碳中毒患者的 RWD 平均值或中位值均较高。RDW 的加权平均差 (WMD) 为 0.36(95% 置信区间 (CI),0.26-0.47)%。在将一氧化碳中毒患者的病情严重程度定义为心脏损伤的三篇文章中,RDW 的加权平均差值为 1.26(95%CI,1.02-1.50)%。这些结果表明,监测一氧化碳中毒患者的 RDW 可能有助于确定疾病的严重程度,尤其是心脏损伤。
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引用次数: 0
LC-MS/MS analysis of 11-nor-9-carboxy-hexahydrocannabinol (HHC-COOH) and 11-hydroxy-hexahydrocannabinol (HHC-OH) for verification of hexahydrocannabinol (HHC) intake. 对 11-去甲-9-羧基六氢大麻酚(HHC-COOH)和 11-羟基六氢大麻酚(HHC-OH)进行 LC-MS/MS 分析,以核实六氢大麻酚(HHC)的摄入量。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-04-01 Epub Date: 2024-03-26 DOI: 10.1080/00365513.2024.2333023
Paul Pettersson-Pablo, Joakim Oxelbark

Natural and semi-synthetic cannabinoid analogs are getting increasing media attention for their recreative use as an alternative to traditional cannabis, in Sweden as well as internationally. To investigate an increasing number of urine samples incoming to our clinical laboratory that were screening positive, using a CEDIA THC-COOH immunoassay from ThermoFisher Scientific, but then testing negative using GC-MS based verification analysis, we developed an LC-MS/MS-method for verification of hexahydrocannabinol (HHC) and Δ8-tetrahydrocannabinol. Assessment of HHC intake was based on identification of the following four metabolites: 11-nor-9(R)-carboxy-hexahydrocannabinol (R-HHC-COOH), 11-nor-9(S)-carboxy-hexahydrocannabinol (S-HHC-COOH), 11-hydroxy-9(R)-hexahydrocannabinol (R-HHC-OH) and 11-hydroxy-9(S)-hexahydrocannabinol (S-HHC-OH). Out of 46 urine samples analysed in this study, 44 showed presence of HHC-metabolites, which indicate HHC as the main explanation for an increased number of negative verifications for THC-COOH. In these samples, the HHC-OH metabolites occurred at a higher concentration than R-HHC-COOH while S-HHC-COOH was only detected in few samples at low concentrations. R-HHC-COOH and S-HHC-COOH can easily be added to a pre-existing verification method for THC-COOH, and still show acceptable results, while HHC-OH requires an enzyme capable of hydrolysing the ether glucuronide bond.

在瑞典和国际上,天然和半合成大麻素类似物因其作为传统大麻替代品的娱乐用途而日益受到媒体关注。我们的临床实验室收到越来越多的尿样,使用 ThermoFisher Scientific 公司的 CEDIA THC-COOH 免疫测定法检测结果呈阳性,但使用基于 GC-MS 的验证分析法检测结果呈阴性。HHC 摄入量的评估基于以下四种代谢物的鉴定:11-去甲-9(R)-羧基六氢大麻酚(R-HHC-COOH)、11-去甲-9(S)-羧基六氢大麻酚(S-HHC-COOH)、11-羟基-9(R)-六氢大麻酚(R-HHC-OH)和 11-羟基-9(S)-六氢大麻酚(S-HHC-OH)。在本研究分析的 46 份尿样中,44 份显示存在 HHC 代谢物,这表明 HHC 是导致 THC-COOH 阴性验证数量增加的主要原因。在这些样本中,HHC-OH 代谢物的浓度高于 R-HHC-COOH,而 S-HHC-COOH 仅在少数样本中检测到,且浓度较低。R-HHC-COOH 和 S-HHC-COOH 可以很容易地添加到已有的 THC-COOH 检验方法中,并仍然显示出可接受的结果,而 HHC-OH 则需要一种能够水解醚葡萄糖醛酸键的酶。
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引用次数: 0
Pediatric reference intervals for serum folate and cobalamin based on a European population without exposure to folic acid fortification. 基于未接触叶酸强化剂的欧洲人口的儿科血清叶酸和钴胺素参考区间。
IF 1.3 4区 医学 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-04-01 Epub Date: 2024-03-21 DOI: 10.1080/00365513.2024.2330918
Peter Ridefelt, Johan Saldeen, Mandy Vogel, Uta Ceglarek, Wieland Kiess, Anders Larsson

The aim of the present study was to define pediatric reference intervals for serum cobalamin and folate utilizing data generated from a population not exposed to food fortified with folic acid. Folate and cobalamin results analyzed by electrochemiluminescence immunoassay (Roche Cobas) were obtained from 2375 children (2 months to 17.99 years of age). The serum samples were collected between 2011 and 2015 as part of the LIFE (Leipzig Research Centre for Civilization Diseases) Child cohort study in Germany, where folic acid fortification of food is not mandated. These results were used to generate age- and gender-specific reference intervals presented as non-parametric 2.5 and 97.5 percentiles. Because of a subsequent restandardisation of the Roche folate assay in 2016, folate values were recalculated accordingly for adaptation to results obtained using the present calibration. In both genders, folate concentrations decreased continuously with age, whereas cobalamin concentrations peaked at five years of age and then declined. Teenage females had higher concentrations of cobalamin in the age group 12-17.99 years.

本研究旨在利用未接触叶酸强化食品人群的数据,确定儿科血清钴胺素和叶酸的参考区间。通过电化学发光免疫分析法(罗氏 Cobas)对 2375 名儿童(2 个月至 17.99 岁)的叶酸和钴胺素结果进行了分析。这些血清样本是在 2011 年至 2015 年期间收集的,是德国 LIFE(莱比锡文明病研究中心)儿童队列研究的一部分。这些结果被用来生成特定年龄和性别的参考区间,以非参数的 2.5 和 97.5 百分位数表示。由于罗氏叶酸测定法随后于2016年重新标准化,因此叶酸值也相应地重新计算,以适应使用本校准法获得的结果。在男女两性中,叶酸浓度随着年龄的增长而持续下降,而钴胺素浓度则在五岁时达到峰值,然后下降。在 12-17.99 岁年龄组中,青少年女性的钴胺素浓度较高。
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引用次数: 0
Preinterventional pan-immune-inflammation value as a tool to predict postcontrast acute kidney injury among acute coronary syndrome patients implanted drug-eluting stents: a retrospective observational study. 将介入前泛免疫炎症值作为预测植入药物洗脱支架的急性冠脉综合征患者造影后急性肾损伤的工具:一项回顾性观察研究。
IF 2.1 4区 医学 Q3 Biochemistry, Genetics and Molecular Biology Pub Date : 2024-04-01 Epub Date: 2024-03-20 DOI: 10.1080/00365513.2024.2330904
Alparslan Kurtul, Murat Gok

We evaluated the value of pan-immune-inflammation value (PIV) in predicting the risk for postcontrast acute kidney injury (PCAKI), an important complication following percutaneous coronary intervention (PCI) in acute coronary syndrome (ACS) patients. Medical records of 839 ACS patients underwent PCI between June 2019 and December 2022 were retrospectively analyzed. Patients were divided into two groups: PCAKI (-) and PCAKI (+). PCAKI was defined as a ≥ 0.5 mg/dL and/or a ≥ 25% increase in serum creatinine within 72 h after PCI. The PIV was computed as [neutrophils × platelets × monocytes]÷lymphocytes. The mean age was 60.7 ± 12.9 years. PCAKI was detected in 105 (12.51%) patients. PIV was higher in the PCAKI (+) group compared to PCAKI (-) group (median 1150, interquartile range [IQR] 663-2021 vs median 366, IQR 238-527, p < 0.001). Receiver operating characteristic curve analysis showed that the best cutoff of PIV for predicting PCAKI was 576 with 81% sensitivity and 80% specificity. PIV was superior to neutrophil-lymphocyte ratio and platelet-lymphocyte ratio for the prediction of PCAKI (area under curve:0.894, 0.849 and 0.817, respectively, p < 0.001 for all). A high PIV was independently correlated with PCAKI (≤576 vs. >576, odds ratio [OR] 12.484, 95%confidence interval [CI] 4.853-32.118, p < 0.001) together with older age (OR 1.058, p = 0.009), female gender (OR 4.374, p = 0.005), active smoking (OR 0.193, p = 0.012), left ventricular ejection fraction (OR 0.954, p = 0.021), creatinine (OR 10.120, p < 0.001), hemoglobin (OR 0.759, p = 0.019) and c-reactive protein (OR 1.121, p = 0.002). In conclusion, a high PIV seems to be an easily assessable tool that can be used in clinical practice for predicting the risk of PCAKI in ACS patients implanted drug-eluting stents.

我们评估了泛免疫炎症值(PIV)在预测急性冠状动脉综合征(ACS)患者经皮冠状动脉介入治疗(PCI)后的重要并发症--造影后急性肾损伤(PCAKI)风险方面的价值。研究人员对2019年6月至2022年12月期间接受PCI治疗的839名ACS患者的病历进行了回顾性分析。患者被分为两组:PCAKI(-)组和PCAKI(+)组。PCAKI定义为PCI术后72小时内血清肌酐升高≥0.5 mg/dL和/或≥25%。PIV计算公式为[中性粒细胞×血小板×单核细胞]÷淋巴细胞。平均年龄为 60.7 ± 12.9 岁。105例(12.51%)患者检测到PCAKI。与 PCAKI (-) 组相比,PAKI (+) 组的 PIV 更高(中位数 1150,四分位数间距 [IQR] 663-2021 vs 中位数 366,IQR 238-527,p p 576,几率比 [OR] 12.484,95% 置信区间 [CI]4.853-32.118,p p = 0.009)、女性性别(OR 4.374,P = 0.005)、主动吸烟(OR 0.193,P = 0.012)、左室射血分数(OR 0.954,P = 0.021)、肌酐(OR 10.120,P = 0.019)和 c 反应蛋白(OR 1.121,P = 0.002)。总之,高 PIV 似乎是一种易于评估的工具,可在临床实践中用于预测植入药物洗脱支架的 ACS 患者发生 PCAKI 的风险。
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引用次数: 0
Secondary polycythemia in acutely ill COVID-19 patients is associated with higher mortality but not markedly higher thrombotic risk. COVID-19急症患者的继发性多血症与较高的死亡率有关,但血栓风险并不明显升高。
IF 2.1 4区 医学 Q3 Biochemistry, Genetics and Molecular Biology Pub Date : 2024-04-01 Epub Date: 2024-02-27 DOI: 10.1080/00365513.2024.2321589
Marko Lucijanic, Ivan Krecak, Ena Soric, Anica Sabljic, Tamara Vasilj, David Cicic, Anamarija Vrkljan Vuk, Zvonimir Kremer, Ivo Dilber, Anton Glasnovic, Ozren Jaksic, Rajko Kusec

Secondary polycythemia is commonly observed among patients with chronic pulmonary diseases. However, its significance in the context of Coronavirus disease 2019 (COVID-19) is unknown. We retrospectively evaluated a total of 5872 hospitalized COVID-19 patients with mostly severe and critical symptoms, and without prior or subsequently diagnosed myeloproliferative neoplasm. Patients were stratified based on admission hemoglobin into four subgroups: anemia (hemoglobin <120 g/L for females and 130 g/L for males), normal hemoglobin, mild (hemoglobin 160-165 g/L for females and 165-185 g/L for males) and severe polycythemia (hemoglobin >165 g/L for females and >185 g/L for males). Among 5872 patients, a total of 158 (2.7%) had mild and 25 (0.4%) severe polycythemia. Polycythemia was significantly associated with higher respiratory and functional impairment, reduced plasma volume, higher serum osmolarity and comorbidity burden specific to the degree of polycythemia. Patients presenting with mild (odds ratio (OR) = 1.63, p = .003) and severe polycythemia (OR = 4.98, p < .001) had increased risk of death in comparison to patients with normal hemoglobin, whereas no significant associations with venous thromboembolism, arterial thrombosis nor major bleeding were observed. Anemia was associated with higher risk of death (OR = 1.42, p < .001), venous thromboembolism (OR = 1.34, p < .006) and major bleeding (OR = 2.27, p < .001) in comparison to normal hemoglobin. Associations of polycythemia and anemia with mortality diminished, and anemia with venous thromboembolism and major bleeding persisted, after multivariate adjustments for age, sex, comorbidities, COVID-19 severity and functional status. Secondary polycythemia in hospitalized COVID-19 patients without prior of subsequently diagnosed myeloproliferative neoplasm is rare and is associated with high mortality, increasing with degree of polycythemia, but not markedly higher thrombotic risk.

继发性多血细胞症常见于慢性肺部疾病患者。然而,继发性多血症在冠状病毒病 2019(COVID-19)中的意义尚不清楚。我们对 5872 名住院的 COVID-19 患者进行了回顾性评估,这些患者大多症状严重且危重,之前或之后均未确诊骨髓增生性肿瘤。根据入院时的血红蛋白将患者分为四个亚组:贫血(女性血红蛋白为 165 克/升,男性血红蛋白大于 185 克/升)。在 5872 名患者中,共有 158 人(2.7%)患有轻度多血症,25 人(0.4%)患有重度多血症。多血症与较高的呼吸和功能障碍、血浆容量减少、血清渗透压升高以及与多血症程度相关的并发症负担明显相关。轻度多血症患者(几率比(OR)= 1.63,p = .003)和重度多血症患者(OR = 4.98,p p p p
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引用次数: 0
Correction. 更正。
IF 2.1 4区 医学 Q3 Biochemistry, Genetics and Molecular Biology Pub Date : 2024-04-01 Epub Date: 2024-02-22 DOI: 10.1080/00365513.2024.2321430
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引用次数: 0
Measurement of plasma total calcium before plasma free ionized calcium - a possibility with affordable pitfalls. 先测量血浆总钙,再测量血浆游离离子钙--有可能,也有可能存在负担不起的隐患。
IF 2.1 4区 医学 Q3 Biochemistry, Genetics and Molecular Biology Pub Date : 2024-02-01 Epub Date: 2024-02-21 DOI: 10.1080/00365513.2024.2317756
Tobias Skou Kjøller, Bent S Lind, Peter Schwarz, Henrik L Jørgensen

Free ionized calcium (fCa) is considered the gold standard for assessing calcium status in patients, but it is relatively expensive and is associated with several preanalytical and analytical error sources. We investigated the feasibility of using a reflex test that involves first measuring total calcium (tCa) and if out of reference range, then measure fCa, with expectation of reducing the number of fCa measurements. We used data from 1815 unique patients with concurrent measurement of fCa, tCa and albumin adjusted calcium (aCa). Patients were stratified by albumin level, and the association of fCa to tCa and aCa respectively was assessed with linear regression. The regression analysis showed the best linearity for tCa and aCa at albumin <35 g/L (R2: 0.80-0.90), and the poorest at albumin >40 g/L (R2: tCa 0.58; aCa 0.59). We examined the accuracy of hypo- and hypercalcemia classifications for tCa, aCa and the reflex test. aCa had more misclassifications of hypo- and hypercalcemia than tCa, with respectively 25% and 21%. Implementation of the reflex test would correct any false hypo- or hypercalcemia classified by tCa, leaving only false negative results corresponding to 9% of all tCa measurements. False negative results were on average 0.04 mmol/L above or below the reference range of fCa. Implementation of the reflex test reduces the number of fCa by 68% without major errors diagnosing hyper- or hypocalcemia.

游离离子钙(fCa)被认为是评估患者血钙状况的黄金标准,但其价格相对昂贵,而且与分析前和分析中的一些误差源有关。我们研究了使用反射测试的可行性,即首先测量总钙(tCa),如果超出参考范围,再测量游离钙,从而减少游离钙的测量次数。我们使用了 1815 例同时测量 fCa、tCa 和白蛋白调整钙(aCa)的患者的数据。根据白蛋白水平对患者进行了分层,并通过线性回归评估了 fCa 与 tCa 和 aCa 的关系。回归分析表明,tCa 和 aCa 在白蛋白 R2:0.80-0.90)时,tCa 和 aCa 的线性关系最好,而白蛋白大于 40 g/L 时,线性关系最差(R2:tCa 0.58;aCa 0.59)。我们检查了 tCa、aCa 和反射试验对低钙血症和高钙血症分类的准确性。与 tCa 相比,aCa 对低钙血症和高钙血症分类的误判率更高,分别为 25% 和 21%。采用反射测试可纠正任何由 tCa 分类的错误低钙血症或高钙血症,只留下相当于所有 tCa 测量值 9% 的假阴性结果。假阴性结果平均比 fCa 参考范围高或低 0.04 mmol/L。采用反射测试可将 fCa 的数量减少 68%,而不会出现诊断高钙血症或低钙血症的重大错误。
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引用次数: 0
Reliability of a point of care testing blood gas analyzer for measurement of lactate levels in cerebrospinal fluid. 用于测量脑脊液中乳酸水平的护理点检测血气分析仪的可靠性。
IF 2.1 4区 医学 Q3 Biochemistry, Genetics and Molecular Biology Pub Date : 2024-02-01 Epub Date: 2024-02-20 DOI: 10.1080/00365513.2024.2318619
Alberto Fernández Reina, María Dolores López Abellán, Samir Attaibi Hadri, Ángela Puche Candel, María Isabel Díaz López, Eva Pérez Fernández, Manuel Tomás Orgaz Morales, Luis García de Guadiana-Romualdo

Analysis of cerebrospinal fluid (CSF), including lactate, is key for diagnosis of acute meningitis. Since blood gas analyzers (BGA) enable rapid and safe blood-lactate measurements, we evaluated the reliability of RAPIDPoint 500 BGA to provide a fast and accurate measure of CSF lactate. In this study, CSF lactate levels were measured by a reference assay and on RAPIDPoint 500 BGA. Comparability was evaluated through difference analysis, using Bland Altman test, and linear regression analysis, using the Passing Bablok test. Agreement rate according to CSF lactate (≥3.5 and <3.5 mmol/L) was calculated using kappa (κ) statistic. Population study included 98 CSF samples. Concerning difference analysis, according to Bland-Altman test, bias was 0.13 mmol/L (CI 95%: -0.26 to 0.52 mmol/L. In regression analysis, according to Passing-Bablok equation a systematic difference between both assays was found. In concordance analysis, the interrate realibility was very high (κ: 0.964). According to our resuls, although a systematic difference was detected when lactate levels were measured on RAPIDPoint 500 BGA, the results from Bland-Altman test and the high agreement rate support that this POCT analyzer could be useful for a early and safe detection of patients with high probability of increased CSF lactate level.

包括乳酸在内的脑脊液(CSF)分析是诊断急性脑膜炎的关键。由于血气分析仪(BGA)能快速、安全地测量血乳酸,我们对 RAPIDPoint 500 BGA 快速、准确测量 CSF 乳酸的可靠性进行了评估。在这项研究中,CSF 乳酸盐水平是通过参考测定法和 RAPIDPoint 500 BGA 进行测量的。通过差异分析(使用 Bland Altman 检验)和线性回归分析(使用 Passing Bablok 检验)对可比性进行了评估。根据 CSF 乳酸盐(≥3.5 和
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Scandinavian Journal of Clinical & Laboratory Investigation
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