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Diagnosing Myocardial Injury in an Acute Chest Pain Cohort; Long-Term Prognostic Implications of Cardiac Troponin T and I. 诊断急性胸痛队列中的心肌损伤;心肌肌钙蛋白 T 和 I 的长期预后意义。
IF 7.1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-03 DOI: 10.1093/clinchem/hvae110
Nasir Saeed, Ole-Thomas Steiro, Jørund Langørgen, Hilde L Tjora, Rune O Bjørneklett, Øyvind Skadberg, Vernon V S Bonarjee, Øistein R Mjelva, Tone M Norekvål, Trude Steinsvik, Kjell Vikenes, Torbjørn Omland, Kristin M Aakre

Background: There are limited data regarding the utility of follow-up cardiac troponin (cTn) measurements after admission for acute chest pain and how long-term stability of myocardial injury and prognostic value differ when using cardiac troponin T (cTnT) or I (cTnI).

Methods: We measured high-sensitivity (hs)-cTnT (Roche Diagnostics) and hs-cTnI (Siemens Healthineers) during hospitalization for acute chest pain and after 3 months. Acute myocardial injury was defined as concentrations > sex-specific upper reference limit (URL) during hospitalization and ≤URL at 3-months. Chronic myocardial injury (CMI) was defined as concentrations > URL at both time points. Patients were followed from the 3-month sampling point for a median of 1586 (IQR 1161-1786) days for a primary composite endpoint of all-cause mortality, myocardial infarction (MI), revascularization, and heart failure, and a secondary endpoint of all-cause mortality.

Results: Among 754 patients, 33.8% (hs-cTnT) and 19.2% (hs-cTnI) had myocardial injury during hospitalization. The rate of CMI was 5 times higher by hs-cTnT (20%) assay than hs-cTnI (4%), while acute myocardial injury was equally common; 14% (hs-cTnT) and 15% (hs-cTnI), respectively (6% and 5% when excluding index non-ST-elevation MI (NSTEMI). For hs-cTnT, peak index concentration, 3-month concentration and classification of CMI predicted the primary endpoint; hazard ratios (HRs) 1.38 (95% CI 1.20-1.58), 2.34 (1.70-3.20), and 2.31 (1.30-4.12), respectively. For hs-cTnI, peak index concentration predicted the primary endpoint; HR 1.14 (1.03-1.25). This association was nonsignificant after excluding index NSTEMI.

Conclusions: Acute myocardial injury is equally frequent, whereas CMI is more prevalent using hs-cTnT assay than hs-cTnI. Measuring hs-cTnT 3 months after an acute chest pain episode could assist in further long-term risk assessment. ClinicalTrials.gov Registration Number: NCT02620202.

背景:关于急性胸痛入院后随访心肌肌钙蛋白(cTn)测量的效用,以及使用心肌肌钙蛋白 T(cTnT)或 I(cTnI)时心肌损伤的长期稳定性和预后价值有何不同,相关数据十分有限:我们在急性胸痛住院期间和 3 个月后测量了高敏 (hs)-cTnT (罗氏诊断公司)和 hs-cTnI(西门子健康公司)。急性心肌损伤的定义是:住院期间浓度>特定性别参考上限 (URL),且 3 个月后≤URL。慢性心肌损伤(CMI)的定义是两个时间点的浓度均大于 URL。从3个月的取样点开始,对患者进行了中位数为1586天(IQR 1161-1786)的随访,以确定全因死亡率、心肌梗死(MI)、血管重建和心力衰竭的主要复合终点以及全因死亡率的次要终点:在 754 名患者中,33.8%(hs-cTnT)和 19.2%(hs-cTnI)在住院期间出现心肌损伤。hs-cTnT(20%)检测的CMI率是hs-cTnI(4%)的5倍,而急性心肌损伤同样常见;分别为14%(hs-cTnT)和15%(hs-cTnI)(如果不包括指数非ST段抬高型心肌梗死(NSTEMI),则分别为6%和5%)。对于 hs-cTnT,指数峰值浓度、3 个月浓度和 CMI 分类可预测主要终点;危险比 (HR) 分别为 1.38(95% CI 1.20-1.58)、2.34(1.70-3.20)和 2.31(1.30-4.12)。对于 hs-cTnI,峰值指数浓度可预测主要终点;HR 为 1.14(1.03-1.25)。排除指数NSTEMI后,这一关联并不显著:急性心肌损伤的发生率相同,但使用 hs-cTnT 检测的 CMI 比 hs-cTnI 更常见。在急性胸痛发作 3 个月后测量 hs-cTnT,有助于进一步进行长期风险评估。ClinicalTrials.gov 注册号:NCT02620202:NCT02620202。
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引用次数: 0
Commentary on Negative Sweat Chloride Testing in the Setting of a Positive Newborn Screen and CFTR Compound Heterozygosity. 关于新生儿筛查阳性和 CFTR 复合杂合体情况下的阴性汗液氯化物检测的评论。
IF 7.1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-03 DOI: 10.1093/clinchem/hvae121
Adrienne Savant
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引用次数: 0
Critical Results in Laboratory Medicine. 实验室医学的关键成果
IF 7.1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-03 DOI: 10.1093/clinchem/hvae120
Kobe Truijens, Glynis Frans, Pieter Vermeersch

Background: Timely and accurate notification of critical results is crucial in laboratory medicine and mandated by accreditation standards like ISO15189. Alert lists do, however, vary widely and clinical laboratories typically rely on a combination of in-house agreed and/or literature-based critical values. Communication by phone is still the preferred method of notification, but digital communication could help improve communication of critical results.

Content: We review the available evidence concerning critical result thresholds and critical result notification practices. The evidence is ranked using an adaptation of the Stockholm Hierarchy. In addition, we propose an evidence-based list of critical result thresholds for hospitalized patients that laboratories can use as a starter list and further customize based on the clinical needs of their patient population.

Summary: A clear distinction between critical results and significantly abnormal results is essential for effective and timely healthcare interventions. Implementation of a policy using differentiated thresholds taking into account individual patient characteristics and how fast medical attention is needed, and the use alternative communication methods could enhance communication efficiency and reduce notification fatigue.

背景:及时、准确地通报关键结果对实验室医学至关重要,也是 ISO15189 等认可标准所要求的。然而,警报列表的差异很大,临床实验室通常依赖于内部商定和/或基于文献的临界值的组合。电话沟通仍是首选的通知方式,但数字通信有助于改善关键结果的沟通:内容:我们回顾了有关临界结果阈值和临界结果通知方法的现有证据。内容:我们回顾了有关临界结果阈值和临界结果通知做法的现有证据,并采用斯德哥尔摩层次理论对证据进行了排序。此外,我们还提出了一份以证据为基础的住院患者危急结果阈值清单,实验室可将其作为入门清单,并根据患者群体的临床需求进行进一步定制。摘要:明确区分危急结果和严重异常结果对于有效、及时的医疗干预至关重要。考虑到患者的个体特征和需要尽快就医的程度,实施一项使用差异化阈值的政策,并使用其他沟通方法,可以提高沟通效率并减少通知疲劳。
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引用次数: 0
Implications of Age for the Diagnostic and Prognostic Value of Cardiac Troponin T and I. 年龄对心肌肌钙蛋白 T 和 I 诊断和预后价值的影响
IF 7.1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-03 DOI: 10.1093/clinchem/hvae107
Rasmus Bo Hasselbalch, Philip Andreas Schytz, Martin Schultz, Caroline Sindet-Pedersen, Jonas Henrik Kristensen, Nina Strandkjær, Sophie Sander Knudsen, Mia Pries-Heje, Manan Pareek, Kristian H Kragholm, Nicholas Carlson, Morten Schou, Mikkel Porsborg Andersen, Henning Bundgaard, Christian Torp-Pedersen, Kasper Karmark Iversen

Background: The influence of age on cardiac troponin is unclear and may vary between cardiac troponin T (cTnT) and I (cTnI). We aimed to compare the impact of age on the diagnostic and prognostic utility of cTnT and cTnI.

Methods: This Danish nationwide, register-based cohort study included patients with at least one cardiac troponin (cTn) measurement from 2009 through June 2022, stratified into decades of age. We used peak cTn concentration during admission, dichotomized as positive/negative and normalized to the 99th percentile. Receiver operating characteristics for myocardial infarction (MI) and logistic regression were used to estimate the odds ratio (OR) for mortality at 1 year.

Results: We included 541 817 patients; median age 66 years (interquartile range [IQR] 51-77) and 256 545 (47%) female. A total of 40 359 (7.4%) had an MI, and 59 800 (14.1%) patients died within 1 year of admission. The predictive ability of both cTns for MI were highest for patients 30 to 50 years. This was most pronounced for cTnT, the specificity of which fell from 83% among patients 40 to 49 years to 4% for patients ≥90 years. The prognostic ability of both cTns for 1-year mortality declined with age. cTnT had stronger prognostic ability for all age-groups; OR for a positive cTnT 28.4 (95% CI, 20.1-41.0) compared with 9.4 (95% CI, 5.0-16.7) for cTnI among patients <30 years.

Conclusions: The predictive and prognostic ability of cTnT and cTnI declined with age. cTnT had a low specificity for MI in elderly patients. However, cTnT was the strongest prognostic marker among all age groups.

背景:年龄对心肌肌钙蛋白的影响尚不明确,而且心肌肌钙蛋白T(cTnT)和心肌肌钙蛋白I(cTnI)之间可能存在差异。我们旨在比较年龄对 cTnT 和 cTnI 诊断和预后效用的影响:这项以登记为基础的丹麦全国性队列研究纳入了从 2009 年到 2022 年 6 月至少进行过一次心肌肌钙蛋白(cTn)测量的患者,并将其按年龄分为不同组别。我们使用入院时的 cTn 峰值浓度,将其分为阳性/阴性,并归一化为第 99 百分位数。使用心肌梗死(MI)的受体操作特征和逻辑回归估算1年死亡率的几率比(OR):我们共纳入了 541 817 名患者;中位年龄为 66 岁(四分位数间距 [IQR] 51-77),女性患者为 256 545 人(47%)。共有 40 359 名患者(7.4%)发生了心肌梗死,59 800 名患者(14.1%)在入院一年内死亡。两种 cTns 对心肌梗死的预测能力在 30 至 50 岁的患者中最高。这一点在 cTnT 中最为明显,其特异性从 40 至 49 岁患者的 83% 降至≥90 岁患者的 4%。cTnT 对所有年龄组的预后能力都更强;cTnT 阳性的 OR 为 28.4(95% CI,20.1-41.0),而 cTnI 阳性的 OR 为 9.4(95% CI,5.0-16.7):cTnT 和 cTnI 的预测和预后能力随着年龄的增长而下降。然而,在所有年龄组中,cTnT 是最强的预后标志物。
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引用次数: 0
Cardiac Troponin I or T for the Diagnosis of Myocardial Infarction and Prediction of Outcomes-Does It Matter? 用于诊断心肌梗死和预测预后的心肌肌钙蛋白 I 或 T--重要吗?
IF 7.1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-03 DOI: 10.1093/clinchem/hvae123
Ziwen Li, Jasper Boeddinghaus, Nicholas L Mills
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引用次数: 0
DPP3 in Cardiogenic Shock. 心源性休克中的 DPP3。
IF 7.1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-03 DOI: 10.1093/clinchem/hvae058
Allan S Jaffe, Leslie J Donato
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引用次数: 0
Failure of Serum Immunofixation Electrophoresis to Detect Intact Monoclonal IgD Lambda Unraveled by Mass Spectrometry. 质谱法揭示血清免疫固定电泳检测完整单克隆 IgD Lambda 失败的原因
IF 7.1 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-03 DOI: 10.1093/clinchem/hvae116
Louis Nevejan, Mark Perkins, Martine Vercammen, Thibault Vanhove, Michel Delforge, Xavier Bossuyt
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引用次数: 0
A-302 Evaluation of real-time PCR assays for detection of sexually-transmitted infections A-302 评估用于检测性传播感染的实时 PCR 检测方法
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-02 DOI: 10.1093/clinchem/hvae106.299
H Soong
Background Sexually transmitted infections (STIs) have serious negative consequences for reproductive health worldwide. They are associated with infertility, premature birth and neonatal infections. Five STI pathogens, namely Trichomonas vaginalis, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma parvum, and Ureaplasma urealyticum were selected for the evaluation of three potential real-time PCR assays that can be adopted for diagnostic testing. Methods A total of 36 samples were included, consisting of genital swabs, urine, abscesses and samples provided by quality assurance programmes. DNA extraction was performed using an automated nucleic acid extraction system, abGenixTM. Commercial genomic controls and DNA extracts donated by external laboratories were used as well. The extracted nucleic acids were tested using three different assays, namely Seegene Anyplex II STI-5 Detection, Thermo Fisher Scientific customized STI Panel assay, and TIB MOLBIOL STI LightMix Modular kits, according to the manufacturers’ instructions. Results A total of 67% and 11% of the samples showed equivalent positive and negative results, respectively. However, 22% of the samples had non-concordant results. TIB MOLBIOL STI LightMix Modular kit was unable to differentiate between Ureaplasma parvum and Ureaplasma urealyticum in 9 samples. Genomic controls were tested, and Seegene Anyplex II STI-5 Detection was unable to detect lower concentrations of DNA for Trichomonas vaginalis, Mycoplasma genitalium and Mycoplasma hominis. All assays were able to detect lower concentrations of Ureaplasma parvum DNA, but detectable concentrations were higher for Ureaplasma urealyticum. Conclusions In conclusion, the performance of each assay differed according to pathogen. None of the assays offered equal performance for all pathogens. We have adopted Thermo Fisher Scientific customized STI Panel assay in our diagnostic testing due to its advantage of being user friendly and cost effective.
背景性传播感染(STI)对全世界的生殖健康都有严重的负面影响。它们与不孕、早产和新生儿感染有关。研究人员选择了五种性传播感染病原体,即阴道毛滴虫、生殖器支原体、人型支原体、副脲原体和尿解支原体,对可用于诊断检测的三种潜在实时 PCR 检测方法进行评估。方法 共纳入 36 份样本,包括生殖器拭子、尿液、脓肿和质量保证计划提供的样本。DNA 提取使用自动核酸提取系统 abGenixTM 进行。此外,还使用了商业基因组对照和外部实验室捐赠的 DNA 提取物。提取的核酸按照制造商的说明使用三种不同的检测方法进行检测,即Seegene Anyplex II STI-5检测法、Thermo Fisher Scientific定制的STI Panel检测法和TIB MOLBIOL STI LightMix Modular试剂盒。结果 分别有 67% 和 11% 的样本显示出相同的阳性和阴性结果。但有 22% 的样本结果不一致。在 9 份样本中,TIB MOLBIOL STI LightMix Modular 试剂盒无法区分副脲原体和尿解脲原体。对基因组对照进行了检测,Seegene Anyplex II STI-5 检测试剂盒无法检测到较低浓度的阴道毛滴虫、生殖支原体和人型支原体 DNA。所有检测方法都能检测到较低浓度的副脲原体 DNA,但尿解支原体的可检测浓度较高。结论 总之,病原体不同,每种检测方法的性能也不同。没有一种检测方法能对所有病原体提供相同的性能。由于赛默飞世尔科技公司定制的性传播感染检测板具有用户友好和成本效益高的优点,因此我们在诊断检测中采用了该检测板。
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引用次数: 0
B-244 Analytical Performance and Method Comparison Evaluation of a New High Throughput Fully Automated Plasma GFAP Immunoassay B-244 新型高通量全自动血浆 GFAP 免疫测定的分析性能和方法比较评估
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-02 DOI: 10.1093/clinchem/hvae106.601
Z Vucetic, M Szabo, M Salvati, B Schlichtmann, J Patzlaff, D Unruh, K Curtis, L Mediger, M Nichkova-Doseva
Background Glial Fibrillary Acidic Protein (GFAP) levels are shown to be an indicator of neurologic injury in conditions like Traumatic Brain Injury (TBI) and stroke and as a marker of disease progression in neuromuscular disorders such as multiple sclerosis. Plasma GFAP is also implicated in detecting AD pathology, correlating to the clinical stage of the disease. The performance characteristics of the plasma GFAP immunoassay currently being developed on Beckman Coulter Access 2 and DxI 9000 analyzers are described. Methods The prototype GFAP assay is a one-step sandwich assay utilizing an anti-GFAP mouse monoclonal (MAb) antibody/alkaline phosphatase conjugate and paramagnetic particles coated with a complementary anti-GFAP mouse MAb. Sample and reactants are incubated and washed, and then a chemiluminescent substrate is added. The light generated is directly proportional to the GFAP concentration in the sample. The assay time to the first result is ∼30 minutes. Analytical performance evaluation and method comparison across different platforms was performed. 43 EDTA plasma samples, consisting of 19 Alzheimer’s Disease (AD) patient samples and 24 age-matched healthy normal samples, were evaluated. Results The prototype GFAP assay has a targeted analytical measuring range of 1.0 pg/ml to approximately 700.0 pg/ml (up to 10,000 pg/ml). All normal samples were quantified with 90% measuring below 20.0 pg/ml and a low dose coefficient of variation &lt;4.0%. A comparison of the prototype GFAP assay on DxI 9000 and Access 2 analyzers shows a Passing-Bablok slope of 0.94 (R=0.992) and an intercept of 0.37 pg/ml. Concordance analysis shows excellent agreement between the Access 2 and DxI 9000 assays. The dose ratio of the median of AD over the median of normal samples for Access 2 and DxI 9000 is 2.31 and 2.41, respectively, with AD patient median dose values of 14.3 pg/ml and 14.6 pg/mL, respectively, and normal sample median dose values of 6.2 pg/ml and 6.0 pg/mL, respectively. Conclusions The prototype GFAP assay provides fast, highly sensitive, and precise results in an automated immunoassay on the Beckman Coulter Access 2 and DxI 9000 platforms. The prototype plasma GFAP assay holds promise for diagnosing and monitoring various neurodegenerative diseases, including AD.
背景 胶质纤维酸性蛋白(GFAP)水平是创伤性脑损伤(TBI)和中风等情况下神经系统损伤的指标,也是多发性硬化症等神经肌肉疾病进展的标志物。血浆 GFAP 还可用于检测注意力缺失症的病理变化,并与该疾病的临床阶段相关联。本文介绍了目前正在贝克曼库尔特 Access 2 和 DxI 9000 分析仪上开发的血浆 GFAP 免疫测定的性能特点。方法 GFAP 检测原型是一种一步式夹心检测法,利用抗 GFAP 小鼠单克隆 (MAb) 抗体/碱性磷酸酶共轭物和涂有互补抗 GFAP 小鼠 MAb 的顺磁颗粒。样品和反应物经过孵育和洗涤,然后加入化学发光底物。产生的光与样品中的 GFAP 浓度成正比。检测时间为 30 分钟。对不同平台进行了分析性能评估和方法比较。对 43 份乙二胺四乙酸(EDTA)血浆样本进行了评估,其中包括 19 份阿尔茨海默病(AD)患者样本和 24 份年龄匹配的健康正常样本。结果 GFAP 检测原型的目标分析测量范围为 1.0 pg/ml 至约 700.0 pg/ml(高达 10,000 pg/ml)。所有正常样本均可定量,其中 90% 的测量值低于 20.0 pg/ml,低剂量变异系数&lt;4.0%。对 DxI 9000 和 Access 2 分析仪上的原型 GFAP 分析进行比较后发现,Passing-Bablok 斜率为 0.94(R=0.992),截距为 0.37 pg/ml。一致性分析表明 Access 2 和 DxI 9000 分析仪之间的一致性非常好。Access 2 和 DxI 9000 的 AD 中位数与正常样本中位数的剂量比分别为 2.31 和 2.41,AD 患者的中位数剂量值分别为 14.3 pg/ml 和 14.6 pg/ml,正常样本的中位数剂量值分别为 6.2 pg/ml 和 6.0 pg/ml。结论 GFAP 检测原型可在 Beckman Coulter Access 2 和 DxI 9000 平台上进行自动免疫测定,结果快速、灵敏度高且精确。血浆 GFAP 检测原型有望用于诊断和监测包括 AD 在内的各种神经退行性疾病。
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引用次数: 0
B-333 Optimizing AFP Cutoffs for Hepatocellular Carcinoma Screening: Insights from the National Cancer Screening Program in Korea B-333 优化肝细胞癌筛查的 AFP 临界值:韩国国家癌症筛查计划的启示
IF 9.3 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2024-10-02 DOI: 10.1093/clinchem/hvae106.690
Y Choi, S Kim, H Kim, H Jeong, H Lee, W Lee, S Chun
Background The incidence rate and mortality rate of liver cancer were 11.6 (ranked 8th among cancers) and 10.7 (4th) per 100,000 individuals respectively globally in 2020, whereas in Korea, they were higher at 29.5 (7th) and 20.6 (2nd) per 100,000 individuals. The National Cancer Screening Program (NCSP) in Korea conducts biannual concurrent liver ultrasound and serum alpha-fetoprotein (AFP) measurement for hepatocellular carcinoma (HCC) surveillance in high-risk groups, including those with chronic hepatitis B and C, and liver cirrhosis. The effectiveness of surveillance is impacted by varying AFP cutoffs; however, within the NCSP, different cutoffs are being used, and it is not clear which cutoffs are being employed. Harmonization of AFP test results by major reagent manufacturers have been achieved, enabling the adoption of a uniform threshold. This study aims to assess the variation of AFP cutoffs among institutions within the NCSP and suggest a unified and optimal AFP threshold. Methods This study examined HCC screening results from the NCSP between 2018 and 2020, investigating unit and cutoff usage for AFP test across institutions each year (number of institutions were 4452 for 2018, 4754 for 2019, and 4847 for 2020). To determine the optimal AFP cutoff for HCC screening, datasets comprised unique patient results from 2018 to 2020 (number of patients = 819,644). Receiver operating characteristic (ROC) curve analyses were conducted for determine best AFP cutoffs. Cancer diagnosis was defined by billing records indicating HCC within one year post-screening. Results More than 96% of institutions used ng/mL as a unit of AFP test. Among institutions using ng/mL, the most frequently used AFP cutoff was 7 ng/mL, with frequency percentages of 75.7%, 72.2%, and 62.2% in 2018, 2019, 2020, respectively. The percentiles (1st, 10th, 90th, 99th) of AFP cutoff usage for the years 2018, 2019, and 2020 were (7, 7, 8.8, 15), (7, 7, 8.9, 15), and (7, 7, 9, 15) respectively. The AUC of ROC was 0.824 and some cut-off points with their sensitivity and specificity values were as follows: 5 ng/mL (0.648, 0.874); 10 (0.457, 0.976); 20 (0.327, 0.993); 40 (0.246, 0.997); 100 (0.169, 0.998); 200 (0.123, 0.999); 400 (0.084, 1). Conclusions Different cutoffs observed across institutions in NCSP. Our study cautiously suggests that the optimal AFP value for screening HCC in NCSP may range from 10 to 20 ng/mL, considering sensitivity and specificity when AFP is combined with ultrasound in regions with a high prevalence of HCC. For a more suitable AFP cutoff recommendation, additional analyses based on ultrasound findings and underlying diseases should be considered.
背景 2020年,全球肝癌的发病率和死亡率分别为每10万人11.6例(在癌症中排名第8位)和10.7例(排名第4位),而韩国的发病率和死亡率较高,分别为每10万人29.5例(排名第7位)和20.6例(排名第2位)。韩国国家癌症筛查计划(NCSP)每半年同时进行一次肝脏超声波和血清甲胎蛋白(AFP)测定,以监测高危人群中的肝细胞癌(HCC),包括慢性乙型肝炎和丙型肝炎患者以及肝硬化患者。不同的 AFP 临界值会影响监测的有效性;然而,在 NCSP 中使用了不同的临界值,目前尚不清楚采用的是哪种临界值。主要试剂制造商已经实现了 AFP 检测结果的统一,从而可以采用统一的临界值。本研究旨在评估 NCSP 内各机构 AFP 临界值的差异,并提出统一的最佳 AFP 临界值。方法 本研究检查了 2018 年至 2020 年 NCSP 的 HCC 筛查结果,调查了每年各机构 AFP 检测的单位和阈值使用情况(2018 年机构数为 4452 家,2019 年为 4754 家,2020 年为 4847 家)。为确定 HCC 筛查的最佳 AFP 临界值,数据集包括 2018 年至 2020 年的唯一患者结果(患者人数 = 819644 人)。为确定最佳 AFP 临界值,进行了接收者操作特征 (ROC) 曲线分析。癌症诊断由筛查后一年内显示 HCC 的账单记录定义。结果 96%以上的机构使用纳克/毫升作为 AFP 检测单位。在使用纳克/毫升的机构中,最常使用的 AFP 临界值是 7 纳克/毫升,2018 年、2019 年和 2020 年的频率百分比分别为 75.7%、72.2% 和 62.2%。2018 年、2019 年和 2020 年 AFP 临界值使用率的百分位数(第 1、10、90、99 位)分别为(7、7、8.8、15)、(7、7、8.9、15)和(7、7、9、15)。ROC 的 AUC 为 0.824,一些临界点及其敏感性和特异性值如下:5毫微克/毫升(0.648,0.874);10毫微克/毫升(0.457,0.976);20毫微克/毫升(0.327,0.993);40毫微克/毫升(0.246,0.997);100毫微克/毫升(0.169,0.998);200毫微克/毫升(0.123,0.999);400毫微克/毫升(0.084,1)。结论 在 NCSP 的不同机构中观察到不同的截断值。我们的研究谨慎地建议,在 HCC 高发地区,考虑到 AFP 与超声波相结合的灵敏度和特异性,NCSP 筛查 HCC 的最佳 AFP 值可能在 10 至 20 纳克/毫升之间。为了推荐更合适的 AFP 临界值,应考虑根据超声检查结果和潜在疾病进行更多分析。
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引用次数: 0
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Clinical chemistry
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