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IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01
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引用次数: 0
A case report of an unconventional chronic lead poisoning resulting from daily eyelid application of kohl 每日眼睑涂眼影膏致慢性铅中毒1例报告
IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.plabm.2025.e00517
Charlène Aïn , Antoine Baudriller , Olivier Mathieu , Yoann Cazaubon

Introduction

Lead can be found everywhere in the environment and continues to be a public health concern. Lead exposure through kohl is a well-identified problem. In adults, the few reported cases show that this exposure is underestimated. The health consequences of chronic exposure are not well known.

Case report

a 63-year-old woman contacted the Department of Medical Pharmacology and Toxicology to report suffering from numerous neurological disorders. She mentioned having previously undergone toxicological assessments showing abnormally high levels of lead and mercury about three years ago. Several lead tests revealed active lead exposure but at levels considered subtoxic, 170–198 μg/L. Subsequently, several interviews with an internist and a toxicologist allowed the identification of the contamination source: kohl. After discontinuing the use of kohl, it took a year for lead concentrations to drop below 50 μg/L. Apart from neurological symptoms, neither renal function nor hematopoiesis was affected.

Discussion

This is the first case report describing the effects of chronic lead poisoning in adults over a period of more than 40 years. It is crucial to raise awareness among populations about daily using traditional kohls and to avoid these products due to their manufacturing process using galena.
铅在环境中随处可见,并一直是一个公共卫生问题。通过kohl接触铅是一个很明显的问题。在成人中,少数报告的病例表明这种暴露被低估了。长期接触对健康的影响尚不清楚。病例报告一名63岁妇女联系医学药理学和毒理学部门报告患有多种神经系统疾病。她提到,大约三年前曾接受过毒理学评估,结果显示铅和汞含量异常高。几项铅测试显示了活跃性铅暴露,但被认为是亚毒性水平,为170-198 μg/L。随后,与内科医生和毒理学家进行了几次访谈,确定了污染源:科尔。停止使用眼影粉后,用了一年时间铅浓度才降到50 μg/L以下。除神经系统症状外,肾功能和造血功能均未受影响。这是第一个描述成人慢性铅中毒影响超过40年的病例报告。提高人们对日常使用传统眼影的认识,避免使用这些产品至关重要,因为它们的制造过程中使用了方铅矿。
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引用次数: 0
IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01
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引用次数: 0
IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01
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引用次数: 0
Evaluating extraction-free PCR for rapid detection of beta-lactam antibiotic resistance in urinary tract infection 评价无提取PCR快速检测尿路感染β -内酰胺类抗生素耐药性的方法
IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.plabm.2025.e00516
Sadia Almas , Rob E. Carpenter , Vaibhav K. Tamrakar , Aditya Sharma , Kamalpreet Suri , Salima Karki , Katelyn Kyser , Randy Sronce , Rahul Sharma
The rapid detection of beta-lactam antibiotic resistance is crucial for guiding effective antimicrobial therapy and controlling the spread of resistant bacterial strains. CTX-M Group 1 extended-spectrum beta-lactamases (ESBLs) are among the most prevalent resistance determinants in Gram-negative bacteria, particularly Escherichia coli and Klebsiella pneumoniae, which are major causes of urinary tract infections (UTIs). Conventional molecular diagnostic methods for detecting CTX-M genes rely on nucleic acid extraction before polymerase chain reaction (PCR) amplification. However, these processes are time-consuming, labor-intensive, and resource-intensive, limiting their accessibility in low-resource and high-throughput laboratory settings. This study evaluates Direct-to-PCR (D2P) extraction-free technology as an alternative to traditional extraction-based methods for detecting CTX-M Group 1 genes. A comparative analysis was conducted using reference microbial isolates and clinical urine samples, testing D2P alongside silica column- and magnetic bead-based extraction methods. Quantitative PCR results demonstrated that D2P achieved comparable sensitivity and specificity to traditional extraction methods while significantly reducing sample processing time and cost. Statistical analysis revealed no significant differences (p > 0.05) in cycle threshold (Ct) values between D2P and conventional extraction-based methods, supporting its feasibility as a rapid, cost-effective alternative. The findings suggest that D2P technology may enhance antibiotic resistance surveillance, clinical diagnostics, and infection control programs by enabling faster, extraction-free molecular detection of ESBL-producing pathogens. Further studies should assess its performance in diverse sample matrices and clinical settings.
快速检测β -内酰胺类抗生素耐药性对于指导有效的抗菌药物治疗和控制耐药菌株的传播至关重要。CTX-M 1组广谱β -内酰胺酶(ESBLs)是革兰氏阴性细菌中最普遍的耐药决定因素之一,特别是大肠杆菌和肺炎克雷伯菌,它们是尿路感染(uti)的主要原因。传统的分子诊断方法检测CTX-M基因依赖于核酸提取,然后进行聚合酶链反应(PCR)扩增。然而,这些过程耗时、劳动密集和资源密集,限制了它们在低资源和高通量实验室环境中的可及性。本研究评估了Direct-to-PCR (D2P)无提取技术作为传统基于提取方法检测CTX-M 1组基因的替代方法。采用参考微生物分离物和临床尿液样本进行对比分析,在硅胶柱和磁珠提取方法的基础上检测D2P。定量PCR结果表明,D2P具有与传统提取方法相当的敏感性和特异性,同时显著减少了样品处理时间和成本。统计分析显示,D2P与传统提取方法的循环阈值(Ct)值无显著差异(p > 0.05),支持其作为快速、经济的替代方案的可行性。研究结果表明,D2P技术可以通过更快、无提取的分子检测产生esbl的病原体,从而增强抗生素耐药性监测、临床诊断和感染控制计划。进一步的研究应评估其在不同样品基质和临床环境中的性能。
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引用次数: 0
Multicenter application and evaluation of automated quality control systems on fully automated assembly lines 自动化质量控制系统在全自动化装配线上的多中心应用与评价
IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2026-01-01 DOI: 10.1016/j.plabm.2025.e00518
Li'an Hou , Rui Li , Liangyu Xia , Lu Bai , Shuyi Yang , Peng Li , Ye Zhao , Guoqiang Chen , Shiqing Cheng , Yang Luo , Xiaofei Zhang , Qian Li , Yingqi Liang , Wenyan Niu , Limei Luo , Jianhua Han , Xufu Ye , Bin Yi , Luyan Zhang , Jicai Zhang , Yingchun Xu

Objective

To conduct a multi-center evaluation of the applicability of automated quality control (QC) on fully automated laboratory lines.

Methods

This study assessed the stability and out-of-control rates of both automated and manual QC for 12 biochemical parameters and 11 immunological parameters across 13 hospitals from different regions of China, between January 2021 and July 2021.

Results

Compared to manual QC, which typically requires around 30 min, automated QC significantly reduced processing time to approximately 10 min. Performance comparisons across 23 test items covering 57 testing levels showed no statistically significant difference in sigma (σ) values between automated and manual QC, with both methods achieving σ ≥ 6 in two testing levels of the HCG assay. Additionally, automated QC demonstrated lower out-of-control rates than manual QC: 2.95 % vs. 3.77 % for biochemical tests and 1.54 % vs. 3.10 % for immunoassay tests. Homogeneity analysis revealed that the absolute Bias% between automated and manual QC results within regional peer groups was consistently less than one-quarter of the total allowable error (TEa), indicating good consistency. However, the BIO-RAD peer group showed slightly higher average Bias% values (4.97 %–5.11 %) for both QC methods compared to regional peer groups.

Conclusion

Automated QC demonstrated good consistency with manual QC and met laboratory quality requirements, optimizing internal QC processes. The standardization of automated QC procedures reduced out-of-control rates. Furthermore, automated QC had significant value in promoting the homogeneity of medical test results.
目的对全自动化验线自动化质量控制(QC)的适用性进行多中心评价。方法本研究于2021年1月至2021年7月对中国不同地区13家医院的12项生化参数和11项免疫学参数的自动化和人工QC的稳定性和失控率进行了评估。结果与通常需要30分钟左右的手动QC相比,自动化QC显着将处理时间减少到大约10分钟。在23个测试项目57个测试水平的性能比较中,自动化和人工QC的sigma (σ)值无统计学差异,两种方法在HCG检测的两个测试水平上都达到σ≥6。此外,自动化QC比人工QC显示出更低的失控率:生物化学测试2.95%对3.77%,免疫测定测试1.54%对3.10%。同质性分析显示,在区域对等组中,自动和手动QC结果之间的绝对偏差%始终小于总允许误差(TEa)的四分之一,表明良好的一致性。然而,BIO-RAD同行组与区域同行组相比,两种QC方法的平均Bias%值略高(4.97% - 5.11%)。结论自动化质量控制与人工质量控制一致性好,满足实验室质量要求,优化了内部质量控制流程。自动化QC程序的标准化降低了失控率。此外,自动化质量控制在促进医学检测结果的同质性方面具有重要价值。
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引用次数: 0
Comparative evaluation of two different blood collection tubes for hematological and biochemical testing 两种不同采血管用于血液学和生化检测的比较评价
IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-12-16 DOI: 10.1016/j.plabm.2025.e00515
Michela Salvatici , Francesca Carreras , Monica Gaimarri , Francesca Delia Sansico , Paolo Marinoni , Chiara Masserini , Barbara Bianchi , Carmen Sommese , Lorenzo Drago

Background

Blood collection tubes can influence sample stability and analytical accuracy. We compared two different commercially available tube systems, Vacutainer® (BD) and Vacusera® (Disera), assessing stability of hematological and biochemical parameters under various preanalytical conditions.

Methods

Residual blood samples from routine laboratory testing were aliquoted into both different tubes. Parameters measured included Red blood cells (RBC), White blood cells (WBC), Hemoglobin (Hb), Potassium (K), Chloride (Cl), Sodium (Na), Aspartate aminotransferase (AST), Alanine aminotransferase (ALT) and Lactate dehydrogenase (LDH), along with hemolysis index. Preanalytical variables included storage temperature (ambient vs 4 °C), storage time (T0, 1h, 3h, 24h), and transport conditions (local vs remote collection sites, with/without pre-centrifugation).

Results

From January 27 to July 31, 2025, 95 samples were analyzed: 49 from the Castellanza Hospital site, located approximately 50 km from the main laboratory (26 stored at room temperature, 23 at 4 °C), and 46 from the Fantoli MultiLab Laboratory (25 samples at room temperature, 21 at 4 °C), yielding 6621 determinations. Comparative analysis demonstrated no clinically significant differences between the two tube types under all tested conditions. Minor variations in K, Na and LDH (Castellanza Hospital site), Hb and ALT (Fantoli MultiLab Laboratory) were within acceptable analytical variation. Hemolysis index remained comparable between tubes in all scenarios, including transport and delayed processing.

Conclusion

Vacutainer® (BD) and Vacusera® (Disera) tube systems showed analytical equivalence across hematology and biochemistry parameters under multiple preanalytical conditions. We conclude that the tubes are suitable for common clinical hematological use and show acceptable performance for common clinical chemistry parameters.
血液采集管会影响样品的稳定性和分析的准确性。我们比较了两种不同的市售试管系统,Vacutainer®(BD)和Vacusera®(Disera),在各种分析前条件下评估血液学和生化参数的稳定性。方法将实验室常规检测的残血标本分别放入两种不同的试管中。测定红细胞(RBC)、白细胞(WBC)、血红蛋白(Hb)、钾(K)、氯(Cl)、钠(Na)、天冬氨酸转氨酶(AST)、丙氨酸转氨酶(ALT)、乳酸脱氢酶(LDH)及溶血指数。分析前变量包括储存温度(环境温度vs 4℃)、储存时间(0、1小时、3小时、24小时)和运输条件(本地收集点vs远程收集点,有/没有预离心)。结果从2025年1月27日至7月31日,共分析了95份样品:49份来自Castellanza医院,距离主实验室约50公里(26份保存在室温,23份保存在4°C), 46份来自Fantoli MultiLab实验室(25份保存在室温,21份保存在4°C),共测定了6621份。对比分析表明,在所有测试条件下,两种管型之间无临床显著差异。K, Na和LDH (Castellanza医院现场),Hb和ALT (Fantoli MultiLab实验室)的微小变化在可接受的分析变化范围内。溶血指数在所有情况下仍保持可比性,包括运输和延迟处理。结论在多种分析前条件下,vacutainer®(BD)和Vacusera®(Disera)试管系统在血液学和生物化学参数上具有等效性。我们得出的结论是,该管适用于常见的临床血液学使用,并显示出可接受的性能,常见的临床化学参数。
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引用次数: 0
Assessment of the stability of 20 biochemical analytes in serum and whole blood samples after storage at nonstandard temperatures 血清和全血样品中20种生化分析物在非标准温度下储存后的稳定性评估
IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-12-15 DOI: 10.1016/j.plabm.2025.e00514
Gabriella Iacovetti , Bradley B. Collier , Jill M. Rafalko , Mitchell Peevler , Nicolas Tokunaga , Jason Ragar , Whitney C. Brandon , Matthew R. Chappell , Russell P. Grant , Greg J. Sommer , Ulrich Y. Schaff

Background

Blood specimen transport conditions can have critical impacts on analyte stability and test result accuracy. This study evaluated the impact of multiday storage of specimens at 30 °C and 0 °C, approximating shipment under summer conditions and shipment in contact with melting ice, respectively.

Methods

Blood samples from 16 healthy subjects were processed as serum samples and as clotted whole blood (uncentrifuged) stored at 30 °C on separator gel, and as serum stored in microtainers at 0 °C, each for 24- and 72-h periods prior to analysis. Each sample was analyzed for 20 common analytes and compared to the values from a paired baseline control sample. Mean absolute and/or relative biases were calculated and compared to CLIA acceptance limits.

Results

Serum samples stored at 30 °C for 24- or 72-h met acceptance criteria for all assessed analytes, except for 72-h ALT, Total Bilirubin, Carbon Dioxide, Creatinine, and Sodium. Numerous analytes were unstable at 30 °C in uncentrifuged whole blood, with only Albumin, ALP, Total Bilirubin, Cholesterol, HDL, Total Protein, Triglycerides, Uric Acid, and hsCRP remaining stable up to 72 h. For serum samples stored at 0 °C, all 24- hour and 72-h analytes showed biases within limits.

Conclusion

Storage of serum samples at 0 °C for up to 72 h yielded valid results for all analytes studied. Storage at 30 °C for up to 72-h yielded valid results for most analytes when combined with centrifugation prior to storage. Compared to room temperature storage, ALT and Sodium in serum and whole blood showed signs of accelerated degradation at 30 °C.
血液样本运输条件对分析物的稳定性和测试结果的准确性有重要影响。本研究评估了样品在30°C和0°C条件下多日储存的影响,分别近似于夏季条件下的运输和接触融化冰的运输。方法将16例健康受试者的血液分别作为血清、凝血全血(未离心)在分离凝胶上30°C保存,血清在微容器中0°C保存,分别保存24 h和72 h后进行分析。对每个样本进行20种常见分析,并与配对基线对照样本的值进行比较。计算平均绝对偏差和/或相对偏差,并与CLIA接受限进行比较。结果血清样品在30°C保存24或72小时,除72小时ALT、总胆红素、二氧化碳、肌酐和钠外,所有评估分析物均符合接受标准。在未离心的全血中,许多分析物在30°C时不稳定,只有白蛋白、ALP、总胆红素、胆固醇、高密度脂蛋白、总蛋白、甘油三酯、尿酸和hsCRP在72小时内保持稳定。对于在0°C保存的血清样品,所有24小时和72小时的分析物都在一定范围内显示偏差。结论血清样品在0°C下保存72 h,所有分析结果均有效。储存在30°C下长达72小时,当与储存前的离心结合时,对大多数分析物产生有效的结果。与室温贮藏相比,血清和全血中ALT和钠在30℃下有加速降解的迹象。
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引用次数: 0
Cyclical fluctuations of iron biomarkers in women: Diagnostic implications for iron deficiency 女性铁生物标志物的周期性波动:铁缺乏的诊断意义
IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-12-01 DOI: 10.1016/j.plabm.2025.e00512
Sixtus Aguree , Arthur Owora , Patricia Silveyra

Background

Iron deficiency (ID) and iron deficiency anemia (IDA) are common in women of reproductive age, but the influence of menstrual cycle phase on iron biomarkers is not well defined and is often overlooked in clinical and public health assessments.

Aim

To assess phase-specific variation in iron biomarkers and the prevalence of ID and IDA in non-pregnant women aged 18–44 years using 2003–2006 NHANES data.

Methods

We analyzed 1484 women with complete reproductive and iron status data. Menstrual cycle phase was categorized as menstruation (day 1–5), follicular phase (6−15), early/mid luteal phase (16–23), and late luteal phase (24–35). Eight biomarkers were analyzed: serum iron (SI), transferrin saturation (%TS), soluble transferrin receptor (sTfR), ferritin, erythrocyte protoporphyrin (EPP), hemoglobin (Hb), mean corpuscular volume (MCV) and body iron index (BII). ID and IDA were defined using ferritin-, MCV- and BII-based diagnostic models. All statistical models accounted for the complex design of the NHANES survey.

Results

SI and %TS were lowest during menstruation and increased across the cycle, peaking in the early/mid-luteal phase (SI: p = 0.001; %TS: p = 0.003). sTfR was highest during menstruation (p < 0.05) compared to other phases, consistent with increased iron requirements. Ferritin, EPP, Hb and MCV remained stable across phases. The prevalence of ID varied by model (10.5 %–22.0 %) but showed no consistent phase differences. In contrast, the prevalence of IDA decreased after menstruation, with composite IDA estimates dropping from 7.5 % during menstruation to 3.7 % in the late luteal phase (p = 0.033).

Conclusions

Iron biomarkers and IDA prevalence vary systematically across the menstrual cycle, with iron status being lowest during menstruation and recovering in the luteal phase. Consideration of menstrual phase may improve diagnostic accuracy and interpretation of iron biomarkers in women of reproductive age.
背景:铁缺乏症(ID)和缺铁性贫血(IDA)在育龄妇女中很常见,但月经周期对铁生物标志物的影响尚未明确,在临床和公共卫生评估中经常被忽视。目的利用2003-2006年NHANES数据,评估18-44岁非妊娠女性铁生物标志物的阶段性变化以及ID和IDA的患病率。方法对1484例女性进行完整的生殖和铁元素状况分析。月经周期阶段分为月经期(1-5天)、卵泡期(6 - 15天)、早/中黄体期(16-23天)和晚黄体期(24-35天)。分析8项生物指标:血清铁(SI)、转铁蛋白饱和度(%TS)、可溶性转铁蛋白受体(sTfR)、铁蛋白、红细胞原卟啉(EPP)、血红蛋白(Hb)、平均红细胞体积(MCV)和体铁指数(BII)。使用基于铁蛋白、MCV和bii的诊断模型来定义ID和IDA。所有统计模型都解释了NHANES调查的复杂设计。结果SI和%TS在月经期间最低,在月经周期中升高,在黄体前期/中期达到峰值(SI: p = 0.001; %TS: p = 0.003)。与其他时期相比,月经期间sTfR最高(p < 0.05),与铁需求量增加一致。铁蛋白、EPP、Hb和MCV各期均保持稳定。不同模型的ID患病率不同(10.5% - 22.0%),但没有一致的相位差异。相比之下,月经后IDA的患病率下降,综合IDA估计值从月经期间的7.5%下降到黄体晚期的3.7% (p = 0.033)。结论铁生物标志物和IDA患病率在月经周期中存在系统性变化,月经期铁水平最低,在黄体期恢复。考虑月经期可以提高诊断的准确性和对育龄妇女铁生物标志物的解释。
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引用次数: 0
Fragmentation patterns of pathogen-derived cell-free DNA as a promising non-invasive biomarker for bloodstream infection diagnosis 病原体来源的无细胞DNA碎片模式作为血流感染诊断的一种有前途的非侵入性生物标志物
IF 1.3 Q3 MEDICAL LABORATORY TECHNOLOGY Pub Date : 2025-12-01 DOI: 10.1016/j.plabm.2025.e00513
Qichuan Fu , Jie Wang , Liya Yue , Tianyu Lu , Wenyu Shi , Cuidan Li , Xiaoyuan Jiang , Peihan Wang , Fei Chen

Background

Bloodstream infections (BSIs) caused by bacteria, viruses, and parasites pose a global health challenge, with high mortality rates. Traditional blood cultures are considered the gold standard but are limited by long turnaround times, low sensitivity, and reliance on culturable pathogens. Cell-free DNA (cfDNA) has emerged as a promising non-invasive biomarker for rapid pathogen detection.

Materials and methods

In this study, we analyzed plasma cfDNA from 102 BSI patients (42 bacterial, 34 viral, and 23 parasitic infections) using next-generation sequencing to examine the differences in cfDNA fragmentation patterns across pathogen types.

Results

Pathogen-derived cfDNA fragments were shorter than human-derived cfDNA (median: 166 bp), with bacterial cfDNA averaging 126 bp and viral cfDNA 140 bp. Bacterial cfDNA fragments were typically shorter than viral ones, revealing distinctive patterns that could differentiate bacterial from viral infections. Fragment lengths varied among bacterial and viral species, suggesting the potential for pathogen-specific detection. EBV-derived cfDNA, at 163 bp, resembled human cfDNA possibly due to its nucleosome-bound form, while parasite-derived cfDNA had a broader distribution (median: 165 bp), indicating limitations in using cfDNA length for detecting parasitic infections.

Conclusions

Our findings demonstrate that pathogen-derived cfDNA exhibits distinct fragmentation patterns, providing a potential non-invasive tool to complement traditional diagnostic methods, particularly for hard-to-culture pathogens. However, further studies with larger sample sizes are needed to refine pathogen-specific fragment length ranges and validate its clinical applicability.
由细菌、病毒和寄生虫引起的血液感染(bsi)是一个全球性的健康挑战,具有很高的死亡率。传统的血液培养被认为是金标准,但由于周转时间长、灵敏度低和对可培养病原体的依赖而受到限制。无细胞DNA (cfDNA)已成为一种有前途的非侵入性生物标志物,用于快速检测病原体。在这项研究中,我们使用新一代测序技术分析了102例BSI患者(42例细菌感染,34例病毒感染和23例寄生虫感染)的血浆cfDNA,以检测不同病原体类型的cfDNA片段模式的差异。结果病原菌来源的cfDNA片段比人来源的cfDNA片段短(中位数为166 bp),细菌来源的cfDNA片段平均为126 bp,病毒来源的cfDNA片段平均为140 bp。细菌的cfDNA片段通常比病毒短,这揭示了区分细菌感染和病毒感染的独特模式。片段长度在细菌和病毒种类之间有所不同,这表明有可能用于病原体特异性检测。ebv衍生cfDNA的长度为163 bp,与人类cfDNA相似,这可能是由于其核小体结合形式,而寄生虫衍生cfDNA的分布范围更广(中位数:165 bp),表明使用cfDNA长度检测寄生虫感染存在局限性。结论:我们的研究结果表明,病原体来源的cfDNA具有不同的片段模式,为传统的诊断方法提供了一种潜在的非侵入性工具,特别是对于难以培养的病原体。然而,需要进一步的更大样本量的研究来完善病原体特异性片段长度范围并验证其临床适用性。
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引用次数: 0
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Practical Laboratory Medicine
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