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Diagnosis of chylous abdominal effusions: what is the triglyceride threshold value? 乳糜腹腔积液的诊断:甘油三酯阈值是什么?
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-06-15 DOI: 10.11613/BM.2023.020902
Bertrand Lefrère, Emmanuel Curis, Randa Bittar, Antoine Levasseur, Pierre Grès, Zoé Guilbert, Belkacem Zenati, Corinne Cherfils, Mehdi Sakka, Dominique Bonnefont-Rousselot

Introduction: Chylous abdominal effusions are serious complications that can be triggered by various aetiologies. The biochemical diagnosis of chyle leakage in ascites or in peritoneal fluid capsules relies on the detection of chylomicrons. Assaying the fluid's concentration of triglycerides is still the first-line tool. Given that only one comparative study has sought to quantify the value of the triglyceride assay for diagnosing chylous ascites in humans, our objective was to provide practical triglyceride thresholds.

Materials and methods: We conducted a 9-year, retrospective, single-centre study of adult patients and compared a triglyceride assay with lipoprotein gel electrophoresis for the analysis of 90 non-recurring abdominal effusions (ascites and abdominal collections) of which 65 were chylous.

Results: A triglyceride threshold of 0.4 mmol/L was associated with a sensitivity > 95%, and a threshold of 2.4 mmol/L was associated with a specificity > 95%. According to Youden index, the best threshold was 0.65 mmol/L with a sensitivity of 88 (77-95)%, a specificity of 72 (51-88)%, and, in our series, a positive predictive value of 89 (79-95)% and a negative predictive value of 69 (48-86)%.

Conclusions: In our series, cut-off of 0.4 mmol/L could be used for ruling-out diagnosis of chylous effusions, while cut-off of 2.4 mmol/L could be used for reasonably confirming diagnosis.

腹腔乳糜积液是由多种病因引起的严重并发症。腹水或腹膜液囊中乳糜漏的生化诊断依赖于乳糜微粒的检测。检测液体中甘油三酯的浓度仍然是一线工具。鉴于只有一项比较研究试图量化甘油三酯测定在诊断人类乳糜腹水中的价值,我们的目标是提供实用的甘油三酯阈值。材料和方法:我们对成年患者进行了一项为期9年的回顾性单中心研究,并将甘油三酯测定法与脂蛋白凝胶电泳法进行了比较,分析了90例非复发性腹腔积液(腹水和腹腔积液),其中65例为乳糜。结果:0.4 mmol/L的甘油三酯阈值与敏感性> 95%相关,2.4 mmol/L的阈值与特异性> 95%相关。根据约登指数,最佳阈值为0.65 mmol/L,敏感性为88(77-95)%,特异性为72(51-88)%,阳性预测值为89(79-95)%,阴性预测值为69(48-86)%。结论:本研究中,0.4 mmol/L的临界值可用于乳糜积液的排除诊断,2.4 mmol/L的临界值可用于乳糜积液的合理确诊。
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引用次数: 0
Analytical verification of the Dymind D7-CRP automated analyser. Dymind D7-CRP 自动分析仪的分析验证。
IF 3.8 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-06-15 DOI: 10.11613/BM.2023.020703
Merima Čolić, Bojana Magdić, Monika Kolundžić, Jasna Leniček Krleža

Introduction: The aim of this study was to perform a verification of the Dymind D7-CRP automated analyser and compare it with established analysers.

Materials and methods: Analytical verification included estimation of repeatability, between run precision, within-laboratory precision, and bias in control samples with low, normal and high levels. The acceptance criteria for analytical verification were defined using the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) 2019 Biological Variation Database. Method comparison between the Dymind D7-CRP and the Sysmex XN1000 for haematological parameters and the Dymind D7-CRP and the Beckman Coulter AU680 for CRP values was performed on 40 patient samples.

Results: Analytical verification criteria were adequately met with the exception of monocyte count for repeatability and within-laboratory precision (13.4% and 11.5%, respectively, acceptance criteria 10.1%) and measurement uncertainty (23.0, acceptance criteria 20.0%) at low level, eosinophil count for BIAS at the low level (37.7%, acceptance criteria 25.2%), basophil count (BAS) for BIAS at the high level (14.2%, acceptance criteria 10.9%), and mean platelet volume (MPV) for repeatability (4.2% and 6.8%), between run precision (2.2% and 4.7%), within-laboratory precision (4.0% and 7.3%) (acceptance criteria 1.7%), and measurement uncertainty (8.0 and 14.6%, acceptance criteria 3.4%) at both the low and high concentrations. Method comparison showed no clinically significant constant or proportional differences for all parameters except BAS and MPV.

Conclusion: The analytical verification of the Dymind D7-CRP showed adequate analytical characteristics. The Dymind D7-CRP can be used interchangeably with the Sysmex XN-1000 for all parameters tested, except BAS and MPV, and with the Beckman Coulter AU-680 for the determination of CRP.

简介本研究旨在对Dymind D7-CRP自动分析仪进行验证,并将其与现有分析仪进行比较:分析验证包括对重复性、运行间精密度、实验室内精密度以及低、正常和高水平对照样本的偏差进行估计。利用欧洲临床化学和实验室医学联合会(EFLM)2019 年生物变异数据库确定了分析验证的接受标准。对40份患者样本进行了Dymind D7-CRP与Sysmex XN1000血液学参数的方法比较,以及Dymind D7-CRP与贝克曼库尔特AU680 CRP值的方法比较:重复性(4.2% 和 6.8%)、运行间精密度(2.2% 和 4.7%)、实验室内精密度(4.0% 和 7.3%)(接受标准为 1.7%)和测量不确定性(8.0% 和 14.6%,接受标准为 3.4%)在低浓度和高浓度时均相同。方法比较显示,除BAS和MPV外,所有参数的常数或比例差异均无临床意义:结论:Dymind D7-CRP的分析验证显示出足够的分析特性。除BAS和MPV外,Dymind D7-CRP可与Sysmex XN-1000互换使用,也可与Beckman Coulter AU-680互换使用。
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引用次数: 0
Post-treatment neutrophil to lymphocyte ratio as a prognostic tool in patients treated with tocilizumab for severe COVID-19 pneumonia - a single center experience. 治疗后中性粒细胞与淋巴细胞比率作为接受托西珠单抗治疗的严重新冠肺炎肺炎患者的预后工具-单中心经验。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-06-15 DOI: 10.11613/BM.2023.020704
Gomerčić Palčić Marija, Matijaca Hana, Kruljac Ivan, Vusić Lucija, Hostić Vedran, Vrbanić Luka, Fanika Mrsić, Zrilić Radovan, Ćelap Ivana, Gaćina Petar

Introduction: Tocilizumab is used in patients with severe COVID-19 pneumonia and high concentration of IL-6. We studied potential prognostic role of neutrophil and lymphocyte count regarding tocilizumab treatment.

Materials and methods: We enrolled 31 patients with severe COVID-19 pneumonia and higher serum IL-6 concentration. The samples were taken on the day of tocilizumab administration and five days later. We used ROC analysis to investigate the association between the analysed parameters and 30-day mortality in order to determine the best pre-treatment and post-treatment prognostic factor. Kaplan-Meier curves and log-rank test were used to present and to analyse the difference in survival.

Results: Patients had a median age of 63 (55-67) years and were treated with a median tocilizumab dose of 800 mg. During the 30-day follow-up period, 17 patients died (30-day mortality 54%). Among pre-treatment variables, neutrophil count had the best prognostic accuracy (AUC 0.81, 95%CI: 0.65-0.96, P = 0.004), while neutrophil to lymphocyte ratio (NLR) had the highest accuracy among post-treatment variables in predicting 30-day mortality (AUC 0.94, 95%CI: 0.86-1.00, P < 0.001). Among post-treatment parameters, neutrophil count and NLR were equally good prognostic factors. Post-treatment NLR cut-off of 9.8 had the sensitivity of 81% and specificity of 93%. Patients with NLR ≥ 9.8 had the median survival of 7.0 (3-10) days vs. median survival not reached in patients with NLR < 9.8 (P < 0.001).

Conclusion: Pre-treatment and post-treatment neutrophil count with post-treatment NLR may represent prognostic tools for patients with higher IL-6 concentration in severe COVID-19 pneumonia treated with tocilizumab.

简介:托奇利珠单抗用于重症新冠肺炎肺炎和高浓度IL-6患者。我们研究了中性粒细胞和淋巴细胞计数对tocilizumab治疗的潜在预后作用。材料和方法:我们纳入了31例严重新冠肺炎肺炎患者,他们的血清IL-6浓度较高。样品在托西利珠单抗给药当天和五天后采集。我们使用ROC分析来研究所分析的参数与30天死亡率之间的相关性,以确定最佳的治疗前和治疗后预后因素。Kaplan-Meier曲线和对数秩检验用于呈现和分析生存率的差异。结果:患者的中位年龄为63岁(55-67岁),接受了中位剂量为800 mg的托珠单抗治疗。在30天的随访期内,17名患者死亡(30天死亡率54%)。在治疗前变量中,中性粒细胞计数具有最佳的预后准确性(AUC 0.81,95%CI:0.65-0.96,P=0.004),而中性粒细胞与淋巴细胞比率(NLR)在治疗后变量中预测30天死亡率的准确性最高(AUC 0.94,95%CI:0.86-1.00,P<0.001)。在治疗后参数中,中性白细胞计数和NLR同样是良好的预后因素。治疗后NLR截止值9.8的敏感性为81%,特异性为93%。NLR≥9.8的患者的中位生存期为7.0(3-10)天,而NLR<9.8的患者中位生存率未达到(P<0.001)。
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引用次数: 0
Kimura disease as an uncommon cause of persistent hypereosinophilia: a diagnostic challenge. 木村病是持续性嗜酸性粒细胞增多症的罕见病因:诊断挑战。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-06-15 DOI: 10.11613/BM.2023.020801
Javier Laguna, María Rodríguez-García, Angel Molina, Anna Merino

Kimura disease (KD) is an unusual inflammatory disease of unknown etiology. Despite being described many years ago, KD might cause diagnostic difficulty or be confused with other conditions. Here, we present a 33-year-old Filipino woman who was referred to our hospital for evaluation of persistent eosinophilia and intense pruritus. Blood analysis and peripheral blood smear review showed high eosinophil counts (3.8 x109/L, 40%) that did not show morphological abnormalities. Besides, high serum IgE concentration was detected (33,528 kU/L). Serological tests were positive for Toxocara canis and treatment with albendazol was initiated. Nevertheless, increased eosinophil counts were still present after several months, alongside with high serum IgE concentrations and intense pruritus. During her follow-up, an inguinal adenopathy was detected. The biopsy revealed lymphoid hyperplasia with reactive germinal centers and massive eosinophil infiltration. Proteinaceous deposits of eosinophilic material were also observed. All these findings, together with peripheral blood eosinophilia and high IgE concentrations, confirmed the diagnosis of KD. The diagnosis of KD should be considered in the differential diagnosis of long-standing unexplained eosinophilia in association with high IgE concentrations, pruritus and lymphadenopathies.

木村病是一种病因不明的罕见炎症性疾病。尽管在许多年前就被描述过,但KD可能会导致诊断困难或与其他疾病混淆。在这里,我们提出一个33岁的菲律宾妇女谁被转介到我们医院评估持续嗜酸性粒细胞增多和强烈的瘙痒。血液分析和外周血涂片检查显示高嗜酸性粒细胞计数(3.8 x109/L, 40%),未显示形态异常。血清IgE浓度较高(33,528 kU/L)。犬弓形虫血清学检测呈阳性,于是开始用阿苯达唑治疗。然而,几个月后,嗜酸性粒细胞计数仍然增加,同时血清IgE浓度高,瘙痒强烈。在随访中,发现腹股沟腺病。活检显示淋巴增生伴生发中心反应性增生和大量嗜酸性粒细胞浸润。还观察到嗜酸性物质的蛋白质沉积。所有这些结果,加上外周血嗜酸性粒细胞增多和高IgE浓度,证实了KD的诊断。KD的诊断应考虑在鉴别诊断长期不明原因嗜酸性粒细胞增多症与高IgE浓度,瘙痒和淋巴结病。
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引用次数: 0
Fibrin clot interference in a human chorionic gonadotrophin assay causing a false Down syndrome screening result. 纤维蛋白凝块干扰人绒毛膜促性腺激素测定导致假唐氏综合征筛查结果。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.011001
Arzu Etem Akagac, Hatice Bozkurt Yavuz

Serum samples are generally used for the measurement of human chorionic gonadotrophin (hCG) to calculate second-trimester maternal screening results. Lower hCG concentrations correlate with a lower calculated risk of Down syndrome (DS). Hence, erroneously low hCG results due to fibrin clot may lead to misinterpretation. We present a 23-year-old woman with a pregnancy of 17+3 weeks. Blood was taken into the Becton-Dickinson (BD) vacutainer SST-II Advance tube (Ref: 367955). The hCG test was performed on Immulite 2000 XPi analyser (Siemens Healthcare Diagnostics Inc, Tarrytown, USA) with original reagents. The results of the same sample were found as 2566 U/L, 18,153 U/L, and 7748 U/L. Three consecutive results after removal of the small fibrin clot and recentrifugation were 18,878, 20,255, and 22,339 U/L. The risk of DS and MoM for the concentration of 2556 U/L hCG was < 1/10,000 and 0.14, respectively. For a hCG concentration of 20,255 U/L, these values were 1/5632 and 1.13, respectively. Laboratory professionals and technicians should be aware that erroneously low hCG results can be measured with the Immulite 2000 XPi due to interference from small fibrin clots. Falsely underestimated hCG values reduce the MoM values and thus the calculated risk of DS.

血清样本一般用于测定人绒毛膜促性腺激素(hCG),以计算孕中期产妇筛查结果。较低的hCG浓度与较低的唐氏综合征(DS)计算风险相关。因此,由于纤维蛋白凝块导致的错误的低hCG结果可能导致误解。我们报告一位怀孕17+3周的23岁女性。血液被带入Becton-Dickinson (BD)真空容器SST-II先进管(参考:367955)。hCG检测在Immulite 2000 XPi分析仪(Siemens Healthcare Diagnostics Inc, Tarrytown, USA)上使用原厂试剂进行。同一样品的结果分别为2566 U/L、18153 U/L和7748 U/L。去除小纤维蛋白凝块再离心后连续3次的结果分别为18,878、20,255和22,339 U/L。hCG浓度为2556 U/L时发生DS和MoM的风险分别< 1/ 10000和0.14。当hCG浓度为20,255 U/L时,这些值分别为1/5632和1.13。实验室专业人员和技术人员应该意识到,由于小纤维蛋白凝块的干扰,使用Immulite 2000 XPi可能会测量出错误的低hCG结果。错误低估hCG值会降低MoM值,从而降低DS的计算风险。
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引用次数: 0
False positive result of human chorionic gonadotropin caused by human anti-mouse antibodies. 人类抗小鼠抗体导致的人类绒毛膜促性腺激素假阳性结果。
IF 3.8 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010802
Jaroslav Racek, Ivana Potočová, Daniel Rajdl, Ladislav Trefil, Marie Šolcová

Immunochemical reactions are fast, can be automated, and generally do not require pretreatment of biological material. Based on these advantages, they are widely used. On the other hand, they are susceptible to analytical interference that can lead to inaccurate results. These factors include the presence of anti-mouse antibodies, causing false positive (or sometimes false negative) results. Although the anti-mouse antibodies over many decades have been repeatedly identified to be the causative source but due to the rarity of such encounters they remain insufficiently considered. Here we show a case, a 45 year-old female who was mis-diagnosed with pregnancy due to falsely elevated human chorionic gonadotropin (hCG) due to anti-mouse antibodies. This led to the patient undergoing two ultrasound examinations and laparoscopy before the hCG was repeated on alternative assays which showed negative results, preventing the patient from methotrexate treatment. Here we describe the details of the case, outline the assay principal, supporting the finding from literature and outlining a process on how to identify such interferences in timely manner.

免疫化学反应速度快,可自动进行,一般不需要对生物材料进行预处理。基于这些优点,它们被广泛使用。但另一方面,它们也容易受到分析干扰,导致结果不准确。这些因素包括抗小鼠抗体的存在,从而导致假阳性(有时是假阴性)结果。虽然几十年来抗小鼠抗体已被反复确认为致病源,但由于这种情况很少发生,因此仍未得到充分考虑。这里我们展示了一个病例,一位45岁的女性因抗小鼠抗体导致人绒毛膜促性腺激素(hCG)假性升高而被误诊为怀孕。这导致患者接受了两次超声波检查和腹腔镜检查,然后在其他检测方法上重复检测 hCG,结果显示为阴性,患者因此无法接受甲氨蝶呤治疗。在此,我们描述了该病例的细节,概述了检测原理,支持文献中的发现,并概述了如何及时发现此类干扰的流程。
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引用次数: 0
Laboratory medicine in arterial hypertension. 动脉高血压的实验室医学。
IF 3.8 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010501
Merica Aralica, Vesna Šupak-Smolčić, Lorena Honović, Lucija Franin, Pavica Šonjić, Maja Šimac, Mihovil Horvat, Nina Poropat

In the initial diagnostics of arterial hypertension (AH) laboratory medicine is a cornerstone, along with a blood pressure (BP) measurement and an electrocardiogram. It mainly refers to routine blood and urine tests for diagnosis and monitoring primary hypertension and its associated conditions such as asymptomatic hypertension-mediated organ damage, chronic kidney disease and hypertensive disorders of pregnancy. In addition, long term non-fatal and fatal risks for cardiovascular (CV) events in hypertension are assessed based on clinical and laboratory data. Furthermore, laboratory medicine is involved in the management of hypertension, especially in monitoring the disease progression. However, antihypertensive drugs may interfere with laboratory test results. Diuretics, especially thiazides, can affect blood and urine sodium concentrations, or angiotensin-converting enzyme inhibitors and angiotensin receptor blockers can affect the blood biomarkers of the renin-angiotensin-aldosterone system (RAAS). It's dysfunction plays a critical role in primary aldosteronism (PA), the most common endocrine disorder in secondary hypertension, which accounts for only small proportion of AH in relative terms but substantial proportion of hypertensives in absolute terms, affecting younger population and carrying a higher risk of CV mortality and morbidity. When screening for PA, aldosterone-to-renin ratio still contributes massively to the increased incidence of the disease, despite certain limits. In conclusion, laboratory medicine is involved in the screening, diagnosis, monitoring and prognosis of hypertension. It is of great importance to understand the preanalytical and analytical factors influencing final laboratory result.

在动脉高血压(AH)的初步诊断中,实验室医学与血压(BP)测量和心电图是基石。它主要是指用于诊断和监测原发性高血压及其相关疾病(如无症状高血压介导的器官损害、慢性肾病和妊娠期高血压疾病)的血常规和尿常规检查。此外,还根据临床和实验室数据评估高血压引发心血管(CV)事件的长期非致命和致命风险。此外,实验室医学也参与了高血压的管理,尤其是在监测疾病进展方面。然而,降压药可能会干扰化验结果。利尿剂,尤其是噻嗪类药物,会影响血液和尿液中的钠浓度,血管紧张素转换酶抑制剂和血管紧张素受体阻滞剂也会影响肾素-血管紧张素-醛固酮系统(RAAS)的血液生物标志物。原发性醛固酮增多症(PA)是继发性高血压中最常见的内分泌失调症,它的功能障碍在原发性高血压中起着至关重要的作用,PA 在高血压患者中所占的比例相对较小,但在高血压患者中所占的绝对比例却很大,它影响着年轻人群,并具有较高的心血管疾病死亡和发病风险。在筛查 PA 时,醛固酮-肾素比值尽管有一定的限制,但仍会导致该病发病率的增加。总之,实验室医学参与了高血压的筛查、诊断、监测和预后。了解影响最终化验结果的分析前和分析因素非常重要。
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引用次数: 0
Elimination of lipaemic interference by high-speed centrifugation. 高速离心消除血脂干扰。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010703
Gemma Solé-Enrech, Ruth Cano-Corres, Maria Isabel Aparicio-Calvente, Nino Spataro

Introduction: In order to deliver high quality results, detection and elimination of possible analytical interferences, such as lipaemia, is crucial. The aim of this study is to evaluate the efficacy of high-speed centrifugation in eliminating lipaemic interference and to define own lipaemic index (LI) for the studied biochemical analytes.

Materials and methods: Evaluated analytes were: albumin, alkaline phosphatase, alanine-aminotransferase (ALT), aspartate-aminotransferase (AST), calcium, creatinine, gamma-glutamyltransferase (GGT), glucose, phosphates, total proteins, urea and total bilirubin. Those analytes and LIs have been analysed in duplicate in the Roche Diagnostics-c8000 analyser in samples centrifuged at 3000 rpm/10 minutes in the SL16 (Thermo Scientific, Waltham, USA) centrifuge and according to an own high-speed centrifugation protocol (12,900 rpm/15 minutes) in the MicroCL17R (Thermo Scientific, Waltham, USA) centrifuge. Lipaemia has been measured in each sample. The efficiency of high-speed centrifugation is verified by the Wilcoxon test (P < 0.05). In cases where significant differences are observed, our own LI is calculated. For ALT and AST, it is verified by McNemar test (P < 0.05). For creatinine, both Wilcoxon and McNemar test were applied.

Results: There were statistically significant differences in analyte concentration before and after high-speed centrifugation for: albumin, creatinine, GGT, glucose, phosphates, urea and total bilirrubin. Own LI is calculated. McNemar test shows statistically significant diferences in the proportion of delivered results before and after high-speed centrifugation in ALT, AST and creatinine.

Conclusions: This study confirms the efficacy of high-speed centrifugation protocol for all the considered analytes, excepting calcium, alkaline phosphatase and total proteins.

为了提供高质量的结果,检测和消除可能的分析干扰,如血脂,是至关重要的。本研究的目的是评价高速离心对消除脂化干扰的效果,并为所研究的生化分析物定义自身的脂化指数(LI)。材料与方法:评价物为:白蛋白、碱性磷酸酶、丙氨酸转氨酶(ALT)、天冬氨酸转氨酶(AST)、钙、肌酐、γ -谷氨酰转移酶(GGT)、葡萄糖、磷酸盐、总蛋白、尿素和总胆红素。这些分析物和LIs在Roche Diagnostics-c8000分析仪中,在SL16 (Thermo Scientific, Waltham,美国)离心机中以3000 rpm/10分钟的速度离心,在MicroCL17R (Thermo Scientific, Waltham,美国)离心机中按照自己的高速离心方案(12,900 rpm/15分钟)进行分析。在每个样本中都测量了血脂。采用Wilcoxon检验验证高速离心的效率(P < 0.05)。在观察到显著差异的情况下,计算我们自己的LI。ALT和AST经McNemar检验证实(P < 0.05)。肌酐采用Wilcoxon试验和McNemar试验。结果:白蛋白、肌酐、GGT、葡萄糖、磷酸盐、尿素、总胆红素高速离心前后分析物浓度差异有统计学意义。计算自己的LI。McNemar检验显示高速离心前后ALT、AST、肌酐的送检比例差异有统计学意义。结论:本研究证实了高速离心方案对除钙、碱性磷酸酶和总蛋白外的所有考虑的分析物的有效性。
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引用次数: 0
The relationship of melatonin concentration in preterm infants and adverse outcomes in the late neonatal period. 早产儿褪黑素浓度与新生儿后期不良结局的关系。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010706
Нalyna Pavlyshyn, Iryna Sarapuk, Kateryna Kozak

Introduction: The aim of research was to assess the melatonin concentrations in the early neonatal period as a predictor of adverse outcomes of late neonatal period in preterm infants and to estimate its optimal predictive cut-off values.

Materials and methods: A total of 115 preterm infants admitted to the neonatal intensive care unit were screened for eligibility, five did not meet the criteria, six parents declined the participation. So, a total of 104 preterm infants with gestational age 25-34 weeks were included in research. The concentration of melatonin in urine was determined by the Enzyme Immunoassay method (Human Melatonin Sulfate ELISA kit, Elabscience, China). The Mann-Whitney U-test and analysis of the receiver operating characteristic (ROC) curve were used in statistical analysis.

Results: Analysis of the ROC curves has revealed optimal cut-off values for urinary melatonin concentration to predict late outcomes. Melatonin concentration below 3.58 ng/ml with sensitivity of 72% can predict development of retinopathy of prematurity (ROP) (AUC = 0.73; 95% confidence intervals (CI) 0.61-0.86). Good diagnostic accuracy (AUC = 0.80; 95% CI 0.67-0.93) has been shown for bronchopulmonary dysplasia (BPD). The optimal cut-off value for melatonin concentration in BPD prediction is 3.71 ng/ml (sensitivity 80%, specificity 64%). Urinary melatonin concentration below 3.79 ng/ml can be associated with late-onset sepsis (AUC = 0.76; 95% CI 0.64-0.87; sensitivity 72%; specificity 62%). There were no significant associations between melatonin concentration and necrotizing enterocolitis (P = 0.912).

Conclusion: Urinary melatonin concentration below the certain cut-off values in the early neonatal period may serve as one of the predictors of adverse outcomes such as BPD, ROP, and late-onset sepsis in the late neonatal period in preterm infants.

研究的目的是评估新生儿早期褪黑激素浓度作为早产儿新生儿晚期不良结局的预测因子,并估计其最佳预测临界值。材料与方法:对新生儿重症监护病房收治的115例早产儿进行资格筛选,其中5例不符合标准,6例家长拒绝参与。因此,共有104名胎龄为25-34周的早产儿被纳入研究。尿中褪黑素浓度采用酶免疫法测定(人硫酸褪黑素ELISA试剂盒,Elabscience,中国)。统计学分析采用Mann-Whitney u检验和受试者工作特征(ROC)曲线分析。结果:ROC曲线分析揭示了尿褪黑激素浓度预测晚期预后的最佳临界值。褪黑素浓度低于3.58 ng/ml,预测早产儿视网膜病变(ROP)的敏感性为72% (AUC = 0.73;95%置信区间(CI) 0.61-0.86)。诊断准确率高(AUC = 0.80;95% CI 0.67-0.93)被证实为支气管肺发育不良(BPD)。褪黑激素浓度预测BPD的最佳临界值为3.71 ng/ml(敏感性80%,特异性64%)。尿褪黑素浓度低于3.79 ng/ml可与晚发性脓毒症相关(AUC = 0.76;95% ci 0.64-0.87;灵敏度72%;特异性62%)。褪黑素浓度与坏死性小肠结肠炎无显著相关性(P = 0.912)。结论:新生儿早期尿褪黑素浓度低于一定临界值可作为早产儿新生儿晚期BPD、ROP、晚发性脓毒症等不良结局的预测因素之一。
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引用次数: 0
On determining the sensitivity and specificity of a new diagnostic test through comparing its results against a non-gold-standard test. 通过与非金标准试验结果的比较,确定一种新的诊断试验的敏感性和特异性。
IF 3.3 3区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2023-02-15 DOI: 10.11613/BM.2023.010101
Farrokh Habibzadeh

Diagnostic tests are important clinical tools. To assess the sensitivity and specificity of a new test, its results should be compared against a gold standard. However, the gold-standard test is not always available. Herein, I show that we can compare the new test against a well-established diagnostic test (not a gold-standard test, but with known sensitivity and specificity) and compute the sensitivity and specificity of the new test if we would have compared it against the gold-standard test. The technique presented is useful for situations where the gold standard is not readily available.

诊断测试是重要的临床工具。为了评估一项新检测的敏感性和特异性,应将其结果与金标准进行比较。然而,金标准测试并不总是可用的。在这里,我展示了我们可以将新测试与一个完善的诊断测试(不是金标准测试,但具有已知的灵敏度和特异性)进行比较,并计算新测试的灵敏度和特异性,如果我们将其与金标准测试进行比较的话。所提出的技术对于金标准不容易获得的情况很有用。
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引用次数: 0
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Biochemia Medica
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