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Comparative Analysis of HbA1c Estimation Using Immunoturbidimetry and High-Pressure Liquid Chromatography Methods in Non-Dialysis Chronic Kidney Disease Patients. 非透析慢性肾病患者使用免疫比浊法和高压液相色谱法估算 HbA1c 的对比分析
Q2 Medicine Pub Date : 2024-10-30 eCollection Date: 2024-10-01
Chanchal Dhingra, Namrata Rao, Shefali Singh, Anumesh K Pathak, Vandana Tiwari, Manish R Kulshrestha, Juhi Verma

Background: Chronic kidney disease (CKD) concomitant with diabetes mellitus (DM), anemia and uremia. Thus, monitoring HbA1c levels presents a complex clinical challenge.

Methods: This analytical cross-sectional study was conducted from May 2022 to April 2023 at Dr. Ram Manohar Lohia Institute of Medical Sciences, Lucknow. We compared HbA1c values obtained by the turbidimetric inhibition immunoassay (TINIA) and high-pressure liquid chromatography (HPLC) methods among non-dialysis CKD patients (n=127).

Results: HbA1c was not detectable among 27 patients by TINIA but measurable with HPLC, all being's anemic. The remaining 100 patients, it was detectable by both the methods. Among these 100 patients, linear regression analysis showed a very strong positive correlation between TINIA-HbA1c and HPLC-HbA1c (R2=0.861; p<0.0001). The agreement between methods was substantial (Cohen's kappa 0.657; p<0.0001). However, HbA1c levels were detected significantly higher with HPLC (Median 7.9, IQR 2.7) than that of TINIA (Median 7.0, IQR 2.9;p=0.025) in diabetics while the difference was not significant in non-diabetic group with both HPLC (Median 5.4,IQR 0.8) and TINIA (Median 5.1,IQR 1.1). Carbamylated Hb (CHb; as detected by HPLC as a side product) was correlated to both HbA1c by HPLC (r=0.299;p=0.007) and TINIA (r=0.336;p=0.006) as well as to serum urea levels (r=0.439;p<0.0001).

Conclusion: HPLC estimates all HbA1c patients in our study group while TINIA failed to do so in around 21.26% cases. The very low hemoglobin levels and high carbamylated hemoglobin were apparent as two most common causes. Also, the values with TINIA are significantly lower in comparison to HPLC among diabetics with CKD.

背景:慢性肾脏病(CKD)伴有糖尿病(DM)、贫血和尿毒症。因此,监测 HbA1c 水平是一项复杂的临床挑战:这项横断面分析研究于 2022 年 5 月至 2023 年 4 月在勒克瑙的拉姆-马诺哈尔-洛希亚博士医学科学研究所进行。我们比较了非透析慢性肾脏病患者(127 人)通过浊度抑制免疫分析法(TINIA)和高压液相色谱法(HPLC)获得的 HbA1c 值:结果:27 名患者用 TINIA 检测不到 HbA1c,但用高压液相色谱法检测到了 HbA1c,他们都是贫血患者。其余 100 名患者两种方法均可检测到 HbA1c。在这 100 名患者中,线性回归分析表明 TINIA-HbA1c 和 HPLC-HbA1c 之间存在很强的正相关性(R2=0.861;p 结论:在我们的研究小组中,HPLC 估算了所有 HbA1c 患者的血红蛋白水平,而 TINIA 估算失败的患者约占 21.26%。血红蛋白水平过低和氨甲酰化血红蛋白过高显然是两个最常见的原因。此外,在患有慢性肾脏病的糖尿病患者中,TINIA 的数值明显低于 HPLC。
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引用次数: 0
An Approach to Include the Cost of Consumables in Biochemistry Analyzer Procurement on the Reagent Rental Model Alleviates Hidden Expenses. 根据试剂租赁模式将消耗品成本纳入生化分析仪采购的方法可降低隐性支出。
Q2 Medicine Pub Date : 2024-10-30 eCollection Date: 2024-10-01
Manish Raj Kulshrestha, Vandana Tiwari, Shivani Singh, Anumesh K Pathak

Background: Clinical biochemistry analyzers are essential for diagnosing and monitoring various diseases and conditions. However, the procurement of these analyzers is often based on the initial purchase cost, which does not reflect the total cost of ownership.

Methods: We applied a novel approach to include all hidden costs to run parameters (consumables and accessories) on a cost-per-reportable test (CPRT) basis. Fixed expenses like water purification plant, HIS connectivity, and electricity backup were assumed to be included in the cost per test itself, while the calibration cost was distributed uniformly in the calculation of CPRT itself. This CPRT was taken to compare the financial results of different bids.

Results: The cost per reportable test received after applying our novel approach in maintenance-free reagent rental basis bid was 47.4% lower than the previous cost per test for the purchased equipment.

Conclusion: This substantial decrease in cost with our novel approach reduced laboratory expenses possible with accurate comparison among analyzers with uniform specifications after eliminating the hidden expenses.

背景:临床生化分析仪对于诊断和监测各种疾病和病症至关重要。然而,这些分析仪的采购通常以初始购买成本为基础,而初始购买成本并不能反映总体拥有成本:我们采用了一种新方法,在每次可报告检测成本(CPRT)的基础上,将运行参数(耗材和配件)的所有隐性成本都计算在内。假定净水设备、HIS 连接和备用电力等固定费用包含在每次测试成本中,而校准成本则统一分配到 CPRT 计算中。计算 CPRT 的目的是比较不同投标的财务结果:结果:在免维护试剂租赁招标中采用我们的新方法后,每次可报告测试的成本比以前购买设备的每次测试成本低 47.4%:结论:我们的新方法大大降低了成本,在剔除隐性开支后,对具有统一规格的分析仪进行精确比较,从而减少了实验室开支。
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引用次数: 0
Cancer Biomarker Concentration Changes During Tumor Progression. 肿瘤进展过程中癌症生物标记物浓度的变化
Q2 Medicine Pub Date : 2024-10-30 eCollection Date: 2024-10-01
Miyo K Chatanaka, Eleftherios P Diamandis

Introduction: Most circulating cancer and other disease biomarker concentrations increase during disease progression, roughly correlating with tumor burden or disease severity. During the biomarker discovery phase, several studies (some published in high-impact journals) report decreases in serum biomarkers at the time of disease diagnosis or during progression (in comparison to control, non-diseased populations). It is suggested these biomarker decreases between normal and diseased populations may have utility in diagnostics.

Methods: We briefly examine if a serum cancer biomarker concentration is likely to decrease as cancer progresses through empirical data.

Results: We propose a simple model, which, if correct, would suggest that in most cases, the biomarker decrease during disease progression could be an artifact or epiphenomenon (thus representing false discovery). Our suggestion is supported by the very few examples of decline of serum biomarkers during cancer development and progression.

Conclusions: The notion that a serum biomarker concentration could be inversely associated with tumor burden seems to be an epiphenomenon.

导言:大多数循环中的癌症和其他疾病生物标志物浓度在疾病进展过程中会增加,与肿瘤负荷或疾病严重程度大致相关。在生物标志物发现阶段,一些研究(其中一些发表在影响力较大的期刊上)报告称,在疾病诊断时或疾病进展期间(与对照组、非患病人群相比),血清中的生物标志物浓度有所下降。有人认为,这些生物标志物在正常人群和患病人群之间的下降可能对诊断有用:方法:我们通过经验数据简要研究了血清癌症生物标志物浓度是否会随着癌症的进展而降低:我们提出了一个简单的模型,如果该模型正确,则表明在大多数情况下,疾病进展过程中生物标志物浓度下降可能是一种伪现象或表象(因此代表了错误发现)。在癌症发展和进展过程中血清生物标志物下降的极少数例子支持了我们的观点:结论:血清生物标志物浓度与肿瘤负荷成反比的观点似乎是一种表象。
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引用次数: 0
Emerging Molecular Technology in Cancer Testing. 癌症检测中的新兴分子技术
Q2 Medicine Pub Date : 2024-10-30 eCollection Date: 2024-10-01
Sivapatham Sundaresan, S K Lavanya, Monika Manickam
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引用次数: 0
Characterizing Monoclonal Gammopathies in an East Moroccan Population: University Hospital Findings. 摩洛哥东部人口的单克隆丙种球蛋白病特征:大学医院的研究结果。
Q2 Medicine Pub Date : 2024-10-30 eCollection Date: 2024-10-01
Oussama Grari, Kaoutar Benaissa, Nisma Douzi, Imad-Eddine Elkhamlichi, Amina Himri, Dounia Elmoujtahide, El-Houcine Sebbar, Mohammed Choukri

Background: Monoclonal gammopathies (MG) are frequent, especially among older people. This study aims to establish the features and etiologies of MG detected over seven years in the Biochemistry department of Mohammed VI University Hospital in Morocco.

Methods: The study was performed from Jan 1, 2016, to Sept 1, 2023, and involved 224 patients residing in east Morocco. The diagnosis of MG was conducted through capillary zone electrophoresis, followed by confirmation through immunofixation.

Results: The study included 224 patients, with an average age at diagnosis of 65.91 years. There were 122 (54.46%) males and 102 (45.54%) females, for a sex ratio of 1.19. In terms of immunoglobulin isotypes, IgG was found to be the most common monoclonal protein (59.82%), followed by IgA (19.64%) and IgM (6.71%). Furthermore, 11.6% of cases had exclusive free light chain (FLC) secretion, and 2.23% had biclonal gammopathy. The distribution of diagnoses in our study included multiple myeloma (MM) (78.57%), lymphoma (5.35%), plasma cell leukemia (4.02%), Waldenström macroglobulinemia (WM) (3.57%), and MGUS (1.79%).

Conclusions: Our study noted the high frequency of MM over MGUS. Several factors could contribute to this prevalence, including variations in healthcare access, demographic characteristics, and potentially other elements that warrant further investigation.

背景:单克隆丙种球蛋白病(MG)很常见,尤其是在老年人中。本研究旨在确定摩洛哥穆罕默德六世大学医院生化科七年来发现的 MG 的特征和病因:研究时间为 2016 年 1 月 1 日至 2023 年 9 月 1 日,涉及居住在摩洛哥东部的 224 名患者。通过毛细管区带电泳对 MG 进行诊断,然后通过免疫固定法进行确诊:研究共纳入 224 名患者,确诊时的平均年龄为 65.91 岁。男性 122 人(54.46%),女性 102 人(45.54%),性别比为 1.19。就免疫球蛋白异型而言,IgG 是最常见的单克隆蛋白(59.82%),其次是 IgA(19.64%)和 IgM(6.71%)。此外,11.6%的病例仅有游离轻链(FLC)分泌,2.23%的病例有双克隆抗体病。我们研究中的诊断分布包括多发性骨髓瘤(MM)(78.57%)、淋巴瘤(5.35%)、浆细胞白血病(4.02%)、瓦尔登斯特伦巨球蛋白血症(WM)(3.57%)和 MGUS(1.79%):我们的研究发现,MM的发病率高于MGUS。结论:我们的研究表明,MM 的发病率高于 MGUS。导致这一发病率的因素可能有多种,包括医疗服务的可及性、人口统计学特征以及其他值得进一步研究的潜在因素。
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引用次数: 0
Unveiling the Role of Magnesium: Insights into Insulin Resistance and Glycemic Control in Type 2 Diabetes. 揭示镁的作用:洞察 2 型糖尿病患者的胰岛素抵抗和血糖控制。
Q2 Medicine Pub Date : 2024-10-30 eCollection Date: 2024-10-01
Vidya Sagar Ram, Ashutosh Vishnoi, Mimoh Sharma, Abel Jaison, Nivedita Singh

Background: Diabetes mellitus (DM) is a significant and escalating global health concern, with Type 2 DM (T2DM) constituting approximately 90% of all DM cases. Magnesium (Mg) plays a crucial role in various physiological processes. Hypomagnesemia is prevalent in T2DM patients. The severity of hypomagnesemia correlates with glycemic control and is linked to the development of complications associated with T2DM.

Aim: The objective of our study was to evaluate the occurrence of hypomagnesemia in patients with T2DM and explore its association with both glycemic control and the development of complications in rural and urban populations.

Methods: The study consisted of 300 diabetic and 100 non-diabetic patients between 31 and 55 years of age. Fasting blood glucose, post-prandial blood glucose, and magnesium levels were estimated using a fully automated analyzer, Selectra Pro-XL. HbA1c was measured using Bio-Rad D10. Insulin levels were calculated using the chemiluminescence method. HOMA-IR was also assessed using a formula: fasting insulin (U/mL) multiplied by fasting plasma glucose (FPG) (mmol/L) divided by 22.5.

Result: Magnesium levels were significantly lower in diabetic patients (1.34±0.29) than in the control (2.17±1.87) with p<0.0001. FBS (267.67±89.78 mg/dL vs. 167.87±76.87 mg/dL, p<0.0001), PPBS (376.87±112.87 mg/dL vs. 287.90±99.98 mg/dL, p<0.0001), HbA1c (9.54±2.6 % vs. 7.23±1.8 %, p<0.0001), Insulin (17.21±8.98 IU/mL vs. 14.87±5.98 IU/ mL, p=0.039) and HOMA-IR (7.32±3.67 vs. 6.13±0.99, p=0.012) were significantly elevated in the hypomagnesemia group than the normal magnesium levels. Magnesium levels were negatively correlated with FBS (r=-0.465; p<0.0001), PPBS (r=-0.596; p<0.0001, HbA1c (r=-0.765; p<0.0001), Insulin (r=-0.454; p<0.0001), and HOMA-IR (r=-0.325; p<0.0001).

Conclusion: Our study suggests that monitoring serum magnesium levels is crucial for individuals with Type 2 diabetes mellitus (T2DM) to manage hypomagnesemia, mitigate associated complications, and optimize overall care.

背景:糖尿病(DM)是一个日益严重的全球健康问题,2 型糖尿病(T2DM)约占所有糖尿病病例的 90%。镁(Mg)在各种生理过程中起着至关重要的作用。T2DM 患者普遍存在低镁血症。低镁血症的严重程度与血糖控制有关,并与 T2DM 相关并发症的发生有关。研究目的:我们的研究旨在评估 T2DM 患者中低镁血症的发生情况,并探讨其与血糖控制以及农村和城市人口中并发症发生的关系:研究对象包括 300 名 31 至 55 岁的糖尿病患者和 100 名非糖尿病患者。使用全自动分析仪 Selectra Pro-XL 估算空腹血糖、餐后血糖和镁水平。HbA1c 使用 Bio-Rad D10 进行测量。使用化学发光法计算胰岛素水平。HOMA-IR 的计算公式为:空腹胰岛素(U/mL)乘以空腹血浆葡萄糖(FPG)(mmol/L)除以 22.5:结果:糖尿病患者的镁水平(1.34±0.29)明显低于对照组(2.17±1.87),P=0.05:我们的研究表明,监测血清镁水平对 2 型糖尿病(T2DM)患者控制低镁血症、减少相关并发症和优化整体护理至关重要。
{"title":"Unveiling the Role of Magnesium: Insights into Insulin Resistance and Glycemic Control in Type 2 Diabetes.","authors":"Vidya Sagar Ram, Ashutosh Vishnoi, Mimoh Sharma, Abel Jaison, Nivedita Singh","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Diabetes mellitus (DM) is a significant and escalating global health concern, with Type 2 DM (T2DM) constituting approximately 90% of all DM cases. Magnesium (Mg) plays a crucial role in various physiological processes. Hypomagnesemia is prevalent in T2DM patients. The severity of hypomagnesemia correlates with glycemic control and is linked to the development of complications associated with T2DM.</p><p><strong>Aim: </strong>The objective of our study was to evaluate the occurrence of hypomagnesemia in patients with T2DM and explore its association with both glycemic control and the development of complications in rural and urban populations.</p><p><strong>Methods: </strong>The study consisted of 300 diabetic and 100 non-diabetic patients between 31 and 55 years of age. Fasting blood glucose, post-prandial blood glucose, and magnesium levels were estimated using a fully automated analyzer, Selectra Pro-XL. HbA1c was measured using Bio-Rad D10. Insulin levels were calculated using the chemiluminescence method. HOMA-IR was also assessed using a formula: fasting insulin (U/mL) multiplied by fasting plasma glucose (FPG) (mmol/L) divided by 22.5.</p><p><strong>Result: </strong>Magnesium levels were significantly lower in diabetic patients (1.34±0.29) than in the control (2.17±1.87) with p<0.0001. FBS (267.67±89.78 mg/dL vs. 167.87±76.87 mg/dL, p<0.0001), PPBS (376.87±112.87 mg/dL vs. 287.90±99.98 mg/dL, p<0.0001), HbA1c (9.54±2.6 % vs. 7.23±1.8 %, p<0.0001), Insulin (17.21±8.98 IU/mL vs. 14.87±5.98 IU/ mL, p=0.039) and HOMA-IR (7.32±3.67 vs. 6.13±0.99, p=0.012) were significantly elevated in the hypomagnesemia group than the normal magnesium levels. Magnesium levels were negatively correlated with FBS (r=-0.465; p<0.0001), PPBS (r=-0.596; p<0.0001, HbA1c (r=-0.765; p<0.0001), Insulin (r=-0.454; p<0.0001), and HOMA-IR (r=-0.325; p<0.0001).</p><p><strong>Conclusion: </strong>Our study suggests that monitoring serum magnesium levels is crucial for individuals with Type 2 diabetes mellitus (T2DM) to manage hypomagnesemia, mitigate associated complications, and optimize overall care.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"35 3","pages":"189-194"},"PeriodicalIF":0.0,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11536276/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142591934","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Pilot Survey on Quality Control and Method Evaluation Practices in Clinical Laboratories in Nepal. 关于尼泊尔临床实验室质量控制和方法评估实践的试点调查。
Q2 Medicine Pub Date : 2024-10-30 eCollection Date: 2024-10-01
Vivek Pant, Tze Ping Loh, Santosh Pradhan, Keyoor Gautam, Devish Pyakurel

Background: There is a lack of systematic collection of information on the quality control practice and method evaluation approach in clinical laboratories in Nepal. Such data is important to formulate educational activities and policy that may address any potential knowledge and practice gap identified.

Method: The pilot survey included twelve questions regarding quality control practice and method evaluation approach and was distributed among the laboratory medicine professionals in Kathmandu, Nepal. Data were collected using a structured self-reported questionnaire on the Google Docs platform. A total of 43 responses were received.

Results: Internal quality control and method evaluation practice varied considerably in terms of the number of levels of material used, frequency of analysis, type and source of material and acceptance criteria among responding laboratories.

Conclusion: The variability in quality control practice and method evaluation approach highlights need for augmentation of knowledge, attitude, and practice behavior among laboratory professionals in Nepal.

背景:缺乏对尼泊尔临床实验室质量控制实践和方法评估方法的系统性信息收集。这些数据对制定教育活动和政策非常重要,可以弥补潜在的知识和实践差距:试点调查包括有关质量控制实践和方法评估方法的 12 个问题,调查对象为尼泊尔加德满都的实验室医学专业人员。数据收集采用了谷歌文档平台上的结构化自我报告问卷。共收到 43 份回复:结果:内部质量控制和方法评估实践在所使用材料的等级数量、分析频率、材料类型和来源以及验收标准等方面存在很大差异:质量控制实践和方法评估方法的差异凸显了尼泊尔实验室专业人员在知识、态度和实践行为方面需要加强。
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引用次数: 0
Point of Care Tests - The Future of Diagnostic Medicine. 医疗点检测--诊断医学的未来。
Q2 Medicine Pub Date : 2024-10-30 eCollection Date: 2024-10-01
Sibtain Ahmed, Raif Jafri
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引用次数: 0
History, Implementation and Current Use of the IFCC-IUPAC's Nomenclature for Properties and Units (NPU) Terminology in Denmark, Norway and Sweden. IFCC-IUPAC 属性和单位命名法 (NPU) 术语在丹麦、挪威和瑞典的历史、实施和当前使用情况。
Q2 Medicine Pub Date : 2024-10-30 eCollection Date: 2024-10-01
Steen Antonsen, Erik Koldberg Amundsen, Rebecca Ceder, Karin Toska, Mette Christophersen Tollånes, Young Bae Hansen, Gunnar Nordin

Electronic exchange of health care data demands code/terminology systems. In the Scandinavian countries, the IFCC-IUPAC's Nomenclature for Properties and Units (NPU) terminology is used for results in biochemistry, pharmacology, and immunology. Implementation, use and administration of NPU has differed between the countries despite similar health care and lab sectors. In Norway and in one Swedish region NPU - with supplementary SNOMED CT codes is also used for reporting results in microbiology. In Denmark and to some extent in Norway and Sweden NPU is also used for ordering tests. In Norway NPU (as part of NLK) has since 2018 been mandatory in requesting governmental reimbursement for laboratory tests. The numbers of national codes vary considerably (DAN: 303, NOR: 1612, SWE: 415). Furthermore, in Denmark >3500 local codes are used for requisition and to communicate more details with the analytical result than the NPU terminology allows. Also, in Norway the NPU codes are by many lab professionals considered insufficient for communicating all relevant information with results. However, the Norwegian reimbursement system has been a strong motivator for implementing international NPU codes. We find it necessary to add information about "how" a measurement is done to the information about "what" is measured in the laboratory report. Until this is settled otherwise, we suggest an increased pragmatism towards producing national codes including method specific information. Furthermore, we recommend that organisations responsible for classifications have heavy professional participation and decision-making competencies in order to lead and guide implementation and optimal use of the classifications.

医疗保健数据的电子交换需要编码/术语系统。在斯堪的纳维亚国家,生物化学、药理学和免疫学结果使用的是 IFCC-IUPAC 的 "属性和单位命名法"(NPU)术语。尽管各国的医疗保健和实验室部门相似,但 NPU 的实施、使用和管理却各不相同。在挪威和瑞典的一个地区,NPU(带有 SNOMED CT 补充代码)也用于报告微生物学结果。在丹麦,以及在一定程度上在挪威和瑞典,NPU 也被用于下检验单。在挪威,自 2018 年起,NPU(作为 NLK 的一部分)已成为申请政府实验室检验报销的必备条件。国家代码的数量差别很大(丹麦:303,挪威:1612,瑞典:415)。此外,在丹麦,超过 3500 个地方代码被用于申请和传达分析结果的更多细节,而非国家化验单位术语所允许的。在挪威,许多实验室专业人员也认为 NPU 代码不足以传达与结果相关的所有信息。然而,挪威的报销制度却有力地推动了国际 NPU 代码的实施。我们认为有必要在实验室报告中有关 "测量内容 "的信息之外,增加有关 "如何 "进行测量的信息。在这一问题得到解决之前,我们建议采取更加务实的态度,制定包含具体方法信息的国家代码。此外,我们还建议负责分类的组织应具有较强的专业参与和决策能力,以便领导和指导分类的实施和优化使用。
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引用次数: 0
Navigating Laboratory Medicine's Transformation: Embracing Doughnut Economics for Sustainable Business Redesign. 引领实验室医学的转型:拥抱 "甜甜圈经济学",实现可持续的业务再设计。
Q2 Medicine Pub Date : 2024-08-08 eCollection Date: 2024-08-01
Damien Gruson, Rana Nabulsi, Chiara Peranio
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引用次数: 0
期刊
Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine
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