Practical Laboratory Medicine最新文献_第8页

Development of a droplet digital PCR method for the detection of Ureaplasma urealyticum 解脲支原体液滴数字PCR检测方法的建立。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2025-01-01 DOI: 10.1016/j.plabm.2024.e00443

Yong-Zhuo Zhou , Yun-Hu Zhao , Yan-Lan Chen , Hua Luo , Yu-lin Zhou , Bing Gu , Wei-Zhen Fang , Chao-Hui Duan , Xu-Guang Guo

Background

Human infection with Ureaplasma urealyticum(UU) is mainly manifested as non-gonococcal urethritis, where it can lead to cervicitis, premature rupture of membranes and abortion in women, as well as infertility in males, which becomes a major problem in clinical diagnosis and treatment. At present, real-time fluorescence quantitative PCR and culture are the two main methods for detecting UU. The real-time fluorescence quantitative PCR method is cumbersome and cannot accomplish absolute quantification on nucleic acids, while the cultivation method has limitations such as low sensitivity and being time-consuming. The aim of this study is to establish a more rapid and accurate droplet digital PCR(ddPCR) method for the detection of UU.

Methods

Primers were designed for the ParC gene of UU. Nucleic acids from a standard strain of UU were extracted. Specificity, sensitivity, and repeatability detection was performed using ddPCR, and the detection performance of ddPCR was evaluated.

Results

The detection process could be completed in 92 min. It has a high sensitivity of up to 3.8 pg/μL. With a high specificity, no positive microdrop were detected in eight negative control pathogens in this experiment. In addition, ddPCR detection of UU has good repeatability, and the calculated CV is 2.1 %.

Conclusion

Our data indicated that ddPCR detection technology has the characteristics of absolute quantification, high stability, high specificity and high sensitivity of UU. It can promote the accurate detection of UU, providing a more scientific basis for clinical diagnosis and treatment.

背景：人类感染解脲支原体（UU）主要表现为非淋球菌性尿道炎，可导致女性宫颈炎、胎膜早破、流产，男性不育，成为临床诊断和治疗的一大难题。目前，实时荧光定量PCR和培养是检测UU的两种主要方法。实时荧光定量PCR方法操作繁琐，无法完成对核酸的绝对定量，而培养法则存在灵敏度低、耗时等局限性。本研究旨在建立一种快速、准确的液滴数字PCR（ddPCR）检测UU的方法。方法：设计UU ParC基因引物。提取UU标准菌株的核酸。采用ddPCR进行特异性、敏感性和重复性检测，并对其检测性能进行评价。结果：该方法可在92 min内完成检测，灵敏度可达3.8 pg/μL。8种阴性对照病原菌均未检出微滴阳性，特异性高。此外，ddPCR检测UU具有良好的重复性，计算CV为2.1%。结论：本实验数据表明，ddPCR检测技术对UU具有绝对定量、高稳定性、高特异性和高灵敏度的特点。可促进UU的准确检测，为临床诊断和治疗提供更科学的依据。

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引用次数: 0

Enhancing laboratory test consistency through linear transformation: A multi-center study 通过线性变换提高实验室检测一致性：一项多中心研究。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-12-24 DOI: 10.1016/j.plabm.2024.e00445

Shitong Cheng , Dongliang Man , Zhiwei Zhou , Hui Kang

Objectives

China is promoting the mutual recognition of clinical laboratory test results to reduce redundant testing, provide more convenient medical services, and lower economic burdens. This study aimed to enhance the consistency of test results across laboratories using a linear transformation method, focusing on five representative biochemical parameters: ALP, CA, TBIL, TC, and TG.

Methods

Five ISO 15189 accredited laboratories participated in this study. We established inter-laboratory and intra-laboratory conversion relationships using patient sample comparisons and daily quality control (QC) data. These relationships were used to develop a web-based tool enabling real-time conversion and mutual recognition of laboratory test results.

Results

The study found that the linear transformation method effectively improved the consistency of test results. After three stages of conversion, most test results showed deviations within ±1/2 TEa when compared to a reference laboratory. However, some parameters in the low-value range exhibited less significant conversion effects, likely due to the sensitivity of percentage deviation measurements in this range.

Conclusions

The developed approach and web-based tool show potential for enhancing result consistency and facilitating mutual recognition across laboratories. Despite its effectiveness, the study's limitations, such as a small sample size and a narrow focus on five biochemical parameters, indicate the need for further research and broader application.

目的：中国正在推动临床实验室检测结果互认，以减少重复检测，提供更便捷的医疗服务，减轻经济负担。本研究以ALP、CA、TBIL、TC、TG这5个具有代表性的生化参数为研究对象，采用线性变换的方法，提高各实验室检测结果的一致性。方法：5家ISO 15189认证实验室参与本研究。我们利用患者样本比较和日常质量控制（QC）数据建立了实验室间和实验室内的转换关系。这些关系被用来开发一个基于网络的工具，实现实验室测试结果的实时转换和相互识别。结果：研究发现，线性变换方法有效地提高了检测结果的一致性。经过三个阶段的转换，与参考实验室相比，大多数测试结果的偏差在±1/2 TEa以内。然而，低值范围内的一些参数表现出不太显著的转换效应，可能是由于该范围内百分比偏差测量的敏感性。结论：开发的方法和基于网络的工具显示出增强结果一致性和促进实验室相互认可的潜力。尽管其有效性，但该研究的局限性，如样本量小，只局限于五个生化参数，表明需要进一步研究和更广泛的应用。

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引用次数: 0

Development of a rapid LFA test based on direct RT-LAMP for diagnosis of SARS-CoV-2 开发基于直接 RT-LAMP 的快速 LFA 检验，用于诊断 SARS-CoV-2

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-11-01 DOI: 10.1016/j.plabm.2024.e00437

Negar Sadeghi , Neda Shirazi , Moein Dehbashi , Bahareh Maleki , William C. Cho , Zohreh Hojati

Introduction

In response to the rapid spread of the SARS-CoV-2 virus, we developed a rapid molecular approach to diagnose COVID-19 without the need for RNA extraction.

Methods

The study utilized two molecular methods, RT-qPCR and colorimetric RT-LAMP, to diagnose the RdRp and ORF8 genes, respectively, in oro-nasopharyngeal swabs. Due to the high sequence diversity of ORF8 in SARS-CoV and SARS-CoV-2, it has been identified as a suitable target for virus detection. The RT-LAMP method was also carried out directly on heat-treated swab samples. The strip tests were made using gold nanoparticles and combined with the RT-LAMP for further analysis.

Results

The results showed that the isothermal amplification method had a sensitivity of 95 % (95 % C.I.: 86.08 %–98.96 %) and a specificity of 75 % (95 % C.I.: 19.41 %–99.37 %). The RT-LAMP-LFA method was able to distinguish positive and negative samples with 100 % sensitivity (95 % C.I.: 91.96–100) and 77.27 % specificity (95 % C.I.: 54.63–92.18). This method only required heating swab samples for 10 min at 65 °C before the RT-LAMP reaction.

Conclusion

By utilizing the RT-LAMP in combination with the LFA, it is possible to diagnose SARS-CoV-2 rapidly without the need for RNA extraction. The entire process from sample collection to test interpretation takes only 75–90 min, and the results can be interpreted by untrained individuals with the naked eye. By employing the ORF8 gene as a diagnostic target and eliminating the need for RNA extraction, the direct RT-LAMP-LFA method achieves a significant breakthrough that was not previously reported.

方法该研究利用 RT-qPCR 和比色 RT-LAMP 两种分子方法分别诊断口鼻咽拭子中的 RdRp 和 ORF8 基因。由于 ORF8 在 SARS-CoV 和 SARS-CoV-2 中具有高度序列多样性，因此被确定为检测病毒的合适目标。RT-LAMP 方法也是直接在经过热处理的咽拭子样本上进行的。结果表明，等温扩增法的灵敏度为 95 %（95 % C.I.：86.08 %-98.96 %），特异性为 75 %（95 % C.I.：19.41 %-99.37 %）。RT-LAMP-LFA 方法能够区分阳性和阴性样本，灵敏度为 100 %（95 % C.I.：91.96-100），特异度为 77.27 %（95 % C.I.：54.63-92.18）。该方法只需在 RT-LAMP 反应前将拭子样本在 65 °C 下加热 10 分钟即可。从样本采集到检验结果判读的整个过程只需 75-90 分钟，未经训练的人也能用肉眼判读结果。直接 RT-LAMP-LFA 方法采用 ORF8 基因作为诊断靶标，无需提取 RNA，实现了前所未有的重大突破。

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引用次数: 0

Assay precision, 99th percentile reference value and proportion of detected healthy european adults for VIDAS® high-sensitive troponin I VIDAS®高敏感肌钙蛋白I的检测精度、99百分位参考值和检测到的健康欧洲成年人比例。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-11-01 DOI: 10.1016/j.plabm.2024.e00441

Nathalie Auberger , Isabelle Coin , Laure Marillet , Frédérique Raymond , Sandrine Michel-Busseret , Pierre-Géraud Claret , Camille Pease

Introduction/objectives

Following the IFCC (The International Federation of Clinical Chemistry and Laboratory Medicine) guidelines concerning high-sensitivity cardiac troponin assays, we performed an assessment of the VIDAS® High-Sensitive Troponin I (TNHS) assay. The test was evaluated on its capacity to detect at least 50 % of healthy individuals and checked that the coefficient of variation was less than 10 % at the 99th percentile.

Methods

High-sensitivity performance was assessed by examining the limits of detection, the determination of the 99th percentile value, the evaluated imprecision at said value and the detectable results above limit of detection (LoD) in a cohort of healthy European individuals. The capacity of detection on a healthy population of VIDAS® TNHS was validated on a total of 808 plasma samples.

Results

One thousand six hundred and nineteen values (888 values for male samples and 731 values for female samples) were included in the analysis. The total imprecision of VIDAS® High-Sensitive Troponin I assay at the 99th percentile was 5.2 %, and 57.4 % of healthy individuals had troponin I values exceeding the LoD. Since the test detected more than 50 % of healthy individuals and had a coefficient of variation less than 10 % at the 99th percentile, it met the criteria of high-sensitivity cardiac troponin assays.

Conclusion

VIDAS® High-Sensitive Troponin I assay is a high-sensitivity cardiac troponin assays meeting the definition provided by IFCC guidelines.

简介/目的：根据IFCC（国际临床化学和检验医学联合会）关于高灵敏度心肌肌钙蛋白检测的指南，我们对VIDAS®高灵敏度肌钙蛋白I （TNHS）检测进行了评估。评估了该测试至少检测50%健康个体的能力，并在第99个百分位数检查变异系数小于10%。方法：通过检查检测限、测定第99百分位值、在该值处的评价不精确度和检测结果高于检测限（LoD）对欧洲健康人群进行高灵敏度评价。在总共808份血浆样本上验证了VIDAS®TNHS在健康人群中的检测能力。结果：共纳入1619个值，其中男性样本888个，女性样本731个。VIDAS®高敏感肌钙蛋白I检测在第99百分位的总不精确性为5.2%，57.4%的健康个体的肌钙蛋白I值超过LoD。由于该测试检测到超过50%的健康个体，并且在第99百分位数的变异系数小于10%，因此它符合高灵敏度心肌肌钙蛋白检测的标准。结论：VIDAS®高灵敏度肌钙蛋白I检测是一种高灵敏度心肌肌钙蛋白检测，符合IFCC指南提供的定义。

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引用次数: 0

The measurement of immunosuppressive drugs by mass spectrometry and immunoassay in a South African transplant setting 在南非移植环境中通过质谱法和免疫测定法测量免疫抑制药物

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-11-01 DOI: 10.1016/j.plabm.2024.e00440

Amy Strydom, Doreen Jacob, Taryn Pillay, Refeletse Malahlela, Sean Currin

Objectives

Liquid chromatography tandem mass spectrometry (LC-MS/MS) is the gold standard for measurement of immunosuppressive drugs (ISDs), but is technically demanding and less accessible in resource-limited countries. Immunoassays can also measure ISD concentrations, but may be limited by cross-reactivity. We evaluated the performance of the Roche electrochemiluminescence immunoassay (ECLIA) for cyclosporine, everolimus and sirolimus against LC-MS/MS in an African population for the first time.

Methods

Bias for ECLIA was estimated by comparing ECLIA-measured ISD concentrations to those obtained by LC-MS/MS in 42, 43 and 47 patient samples for cyclosporine, everolimus and sirolimus, respectively. Precision was assessed by performing replicate measurements of quality control materials.

Results

Deming regression analysis for all ISDs showed strong correlation between ECLIA and LC-MS/MS with a Pearson's r of >0.94. The slopes for cyclosporine, everolimus and sirolimus were 0.94 [95 % CI: 0.87–1.03], 1.35 [95 % CI: 1.23–1.44] and 0.96 [95 % CI: 0.85–1.15] with y-intercepts of 31.60 μg/L [95 % CI: 2.02–57.63], 0.23 μg/L [95 % CI: 0.21 – 0.72] and 2.61 μg/L [95 % CI: 1.30–3.56], respectively. Difference plots showed a median bias of 2.07 % [95 % CI: 1.42 – 6.99 %], 41.2 % [95 % CI: 34.9–51.8 %] and 34.9 % [95 % CI: 28.4–47.3 %] for cyclosporine, everolimus and sirolimus, respectively.

Conclusions

The cyclosporine ECLIA yielded results comparable to LC-MS/MS while poorly comparable results were obtained for everolimus and sirolimus, which may be explained by ISD metabolite cross-reactivity, amongst other factors. The poor comparability, although not unique, is noteworthy and the clinical consequences of these differences require further investigation.

目标液相色谱串联质谱法（LC-MS/MS）是测量免疫抑制剂（ISD）的黄金标准，但技术要求高，在资源有限的国家较难获得。免疫测定也可以测量 ISD 的浓度，但可能会受到交叉反应的限制。我们首次在非洲人群中评估了罗氏电化学发光免疫分析法（ECLIA）与液相色谱-质谱联用法（LC-MS/MS）在环孢素、依维莫司和西罗莫司方面的性能。结果对所有 ISD 进行的回归分析表明，ECLIA 与 LC-MS/MS 之间具有很强的相关性，Pearson's r 为 0.94。环孢素、依维莫司和西罗莫司的斜率分别为 0.94 [95 % CI: 0.87-1.03]、1.35 [95 % CI: 1.23-1.44]和 0.96 [95 % CI: 0.85-1.15]，Y-截距分别为 0.15、0.15 和 0.15。15]，Y-截距分别为 31.60 μg/L [95 % CI：2.02-57.63]、0.23 μg/L [95 % CI：0.21-0.72] 和 2.61 μg/L [95 % CI：1.30-3.56]。差异图显示，环孢素、依维莫司和西罗莫司的中位偏差分别为 2.07 % [95 % CI: 1.42 - 6.99 %]、41.2 % [95 % CI: 34.9 - 51.8 %]和 34.9 % [95 % CI: 28.4 - 47.3 %]。结论环孢素 ECLIA 的检测结果可与 LC-MS/MS 相媲美，而依维莫司和西罗莫司的检测结果可比性较差，这可能与 ISD 代谢物交叉反应等因素有关。可比性差虽然不是独一无二的，但值得注意，这些差异的临床后果需要进一步研究。

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引用次数: 0

Corrigendum to “Unified calibration of D-dimer can improve the uniformity of different detection systems” [Practical Laboratory Medicine 40 (2024) e00413] 对 "统一校准 D-二聚体可提高不同检测系统的一致性 "的更正 [Practical Laboratory Medicine 40 (2024) e00413]。

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-11-01 DOI: 10.1016/j.plabm.2024.e00442

Kun Wang , Xinwei Zang , Wenjie Zhang , Xiangyu Cao , Huiru Zhao , Chunyan Li , Cuiying Liang , Jun Wu

引用次数: 0

Falsely abnormal serum protein electrophoresis after administration of intravenous immunoglobulins (IVIG): A retrospective cohort study 静脉注射免疫球蛋白（IVIG）后血清蛋白电泳异常：回顾性队列研究

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-11-01 DOI: 10.1016/j.plabm.2024.e00434

Andrew Sulaiman, Patrizio Caturegli

Intravenous immunoglobulin (IVIG) therapy, used in several neurologic, hematologic, immunologic and dermatologic conditions, is known to interfere with the results of some serum laboratory tests. We analyzed the potential interference of IVIG on serum protein electrophoresis (SPEP) by reviewing more than a decade of SPEP studies performed by the clinical immunology laboratory of the Johns Hopkins Hospital. Of the total 100,350 SPEP performed between January 1, 2013 and December 31, 2023, 395 contained the keyword IVIG in the pathologist report, contributed by 348 patients confirmed to have received IVIG by chart review. Of the 348 patients, 20 (6 %) had a M-spike on SPEP suggestive of monoclonal gammopathy, while 328 (94 %) did not have it. Of the 20 patients, 14 received IVIG within 30 days from the SPEP collection date, while 6 received beyond 30 days. Serum immunofixation electrophoresis (SIFE) and clinical follow up showed no evidence of monoclonal gammopathy in 5 of the 14 patients. Overall, this 11-year retrospective cohort study showed that 5 of 348 (1.4 %) patients treated with IVIG and tested by SPEP had a false M-spike, that is a spike not confirmed to be caused by a monoclonal gammopathy by subsequent studies. Although small, the false positive rate of 1.4 % suggests that integrating knowledge of recent IVIG administration into the pathologist report would reduce SPEP misdiagnosis.

众所周知，静脉注射免疫球蛋白（IVIG）疗法会干扰某些血清实验室检测的结果，该疗法可用于多种神经、血液、免疫和皮肤病的治疗。我们通过回顾约翰霍普金斯医院临床免疫学实验室十多年来进行的 SPEP 研究，分析了 IVIG 对血清蛋白电泳（SPEP）的潜在干扰。在 2013 年 1 月 1 日至 2023 年 12 月 31 日期间进行的总共 100,350 例 SPEP 中，有 395 例病理学家报告中包含 IVIG 关键字，其中 348 例患者通过病历审查确认接受了 IVIG 治疗。在这 348 名患者中，有 20 人（6%）在 SPEP 中出现了提示单克隆性腺病的 M 峰，而 328 人（94%）没有出现 M 峰。在这 20 名患者中，14 人在 SPEP 采集日期后 30 天内接受了 IVIG 治疗，6 人在 30 天后接受了 IVIG 治疗。血清免疫固定电泳（SIFE）和临床随访显示，14 名患者中有 5 人未发现单克隆抗体病。总体而言，这项为期 11 年的回顾性队列研究显示，在 348 例接受 IVIG 治疗并接受 SPEP 检测的患者中，有 5 例（1.4%）出现了假 M-棘波，即后续研究未证实是由单克隆丙种球蛋白病引起的棘波。1.4% 的假阳性率虽然很小，但表明将近期 IVIG 用药知识纳入病理学家报告可减少 SPEP 误诊。

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引用次数: 0

Glycated albumin in pregnancy correlates negatively with body mass index and contributes to the risk of gestational diabetes mellitus 孕期糖化白蛋白与体重指数呈负相关，并增加妊娠糖尿病的风险

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-10-23 DOI: 10.1016/j.plabm.2024.e00439

Toril Ø. Osestad , Kristin Lilleholt , Øyvind Skadberg , Linda R. Sagedal , Ingvild Vistad , Thomas Hundhausen

Objectives

The aims of our study were to establish a reference interval for glycated albumin (GA) in gestational week 30, to investigate whether GA can replace or reduce the need for oral glucose tolerance test (OGTT) in pregnancy, and to reassess the usefulness of body mass-index (BMI), age and fasting glucose in detection of gestational diabetes (GDM).

Design

and methods: We measured GA in 486 healthy pregnant women. Reference interval was calculated using the central 95 % of the results. ROC curves were created to assess the ability of GA, fasting glucose and BMI separately to detect GDM, and logistic regression analysis was used to estimate risk of developing GDM given the level of the same markers. Finally, multiple logistic regression analysis based on GA, fasting glucose and BMI was used to find a strategy of predicting a patient's risk of GDM.

Results

The reference interval for GA at week 30 of gestation is 6.8–10.3 %. The analysis has a low AUC (0.53) with respect to detecting GDM. It increases slightly to 0.64 when corrected for BMI, as GA is inversely correlated to BMI. Combining GA with fasting glucose and BMI at gestational weeks 16–20 could raise the AUC to 0.80.

Conclusion

GA cannot be recommended to replace OGTT for the diagnosis of GDM. Nor can it be used to identify women at risk of developing GDM. GA combined with fasting glucose and BMI in early pregnancy could be a useful model to estimate risk of GDM.

目的我们的研究旨在确定妊娠 30 周糖化白蛋白（GA）的参考区间，研究 GA 是否可以取代或减少妊娠期口服葡萄糖耐量试验（OGTT），并重新评估体重指数（BMI）、年龄和空腹血糖在检测妊娠糖尿病（GDM）中的作用：我们测量了 486 名健康孕妇的妊娠期糖尿病。以结果的 95% 为中心计算参考区间。绘制了 ROC 曲线，分别评估 GA、空腹血糖和体重指数检测 GDM 的能力，并使用逻辑回归分析估算在相同指标水平下罹患 GDM 的风险。最后，基于 GA、空腹血糖和 BMI 的多重逻辑回归分析被用来寻找预测患者 GDM 风险的策略。该分析在检测 GDM 方面的 AUC 较低（0.53）。由于 GA 与体重指数成反比，因此在对体重指数进行校正后，AUC 略微上升至 0.64。将 GA 与空腹血糖和孕 16-20 周时的 BMI 相结合，可将 AUC 提高到 0.80。GA不能取代OGTT用于诊断GDM，也不能用于识别有患GDM风险的妇女。GA与孕早期空腹血糖和体重指数相结合，可作为估计GDM风险的有用模型。

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引用次数: 0

A novel case of Hb Bart's hydrops fetalis following prenatal diagnosis: Case report from Huizhou, China 产前诊断后出现 Hb Bart 胎儿水肿的新病例：来自中国惠州的病例报告

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-10-23 DOI: 10.1016/j.plabm.2024.e00438

Zeyan Zhong , Dina Chen , Zhiyang Guan , Guoxing Zhong , Zhiyong Wu , Jianmin Chen , Jianhong Chen

Objective

Presentation of a novel case of a patient with Hb Bart's hydrops fetalis, which was accurately identified by SMRT sequencing leading to expand the mutation spectrum of α-thalassemia.

Case report

A 26-year-old pregnant woman and her husband underwent molecular analysis of thalassemia due to abnormal hematological results. The molecular analysis showed that the pregnant woman carried -α^3.7/--^SEA, while her husband exhibited a negative result. Accordingly, the pregnant woman continued the pregnancy until the 19-week gestational age. She was subsequently referred to our department for genetic counseling due to abnormal ultrasound findings in the fetus. A novel deletional α-thal mutation was detected for the husband by MLPA, and the precise location of the mutation was determined through SMRT sequencing, which revealed a 45.2 kb deletion. Later, an interventional umbilical cord blood puncture was offered for the pregnant woman. The cord blood was subjected to capillary electrophoresis, which revealed apparent Hb Bart's and Hb Portland peaks associated with Hb Bart's hydrops fetalis syndrome.

Conclusion

It is imperative that Hb Bart's hydrops fetalis syndrome be diagnosed with the utmost expediency. If results of molecular analysis are not consistent with the clinical hematological findings, the presence of a novel thalassemia could be suspected. To identify the novel genotype, the SMRT sequencing represents an effective method for achieving an accurate diagnosis.

病例报告一位 26 岁的孕妇及其丈夫因血液学结果异常而接受了地中海贫血分子分析。分子分析结果显示，孕妇携带-α3.7/--SEA，而其丈夫的结果为阴性。因此，孕妇继续妊娠至孕 19 周。由于胎儿的超声检查结果异常，她随后被转诊到我科接受遗传咨询。通过 MLPA 检测，发现丈夫有一个新的缺失α-thal 基因突变，并通过 SMRT 测序确定了基因突变的确切位置，发现有一个 45.2 kb 的缺失。随后，为孕妇进行了介入性脐带血穿刺。对脐带血进行了毛细管电泳，发现明显的 Hb Bart's 峰和 Hb Portland 峰与 Hb Bart's 胎儿水肿综合征有关。如果分子分析结果与临床血液学结果不一致，则可能怀疑存在新型地中海贫血。要确定新型基因型，SMRT 测序是实现准确诊断的有效方法。

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引用次数: 0

Comparison of qPCR and chromogenic culture methods for rapid detection of group B streptococcus colonization in Vietnamese pregnant women 比较 qPCR 和色原培养法快速检测越南孕妇 B 群链球菌定植情况

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-10-15 DOI: 10.1016/j.plabm.2024.e00435

Manh-Tuan Ha , Huyen Tran-Thi-Bich , Thao Bui-Thi-Kim , My-Linh Nguyen-Thi , Thanh Vu-Tri , Thuy-Duong Ho-Huynh , Tuan-Anh Nguyen

Introduction

Neonatal infections can rapidly become severe, with delays in treatment often proving fatal. Streptococcus agalactiae (Group B Streptococcus, GBS) is a common cause, typically transmitted from colonized pregnant women to neonates during childbirth. In Vietnam, routine prenatal care lacks standardized GBS screening protocols. This study aims to compare enhanced qPCR methods with the culture method, evaluate the diagnostic accuracy of these qPCR procedures, and assess the frequency of GBS infection in pregnant Vietnamese women during their final trimester.

Materials and methods

Pregnant women aged 35 weeks gestation or more were recruited. Rectovaginal swabs were collected and analyzed for GBS using chromogenic culture, a commercial real-time PCR kit, and in-house real-time PCR assays targeting the cfb and sip genes. Clinical diagnostic values were calculated, and GBS prevalence was determined.

Results

The study included 259 pregnant women with a mean age of 30.2 ± 5.0 years. Of these, 96.6 % had gestational ages of 37 weeks or more at delivery. The sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of the cfb-based and sip-based qPCR assays were 94.1/92.7, 99.0/99.5, 97.1/98.5, 97.8/97.3, and 97.6 %, respectively. The Kappa values were excellent (0.940 and 0.939), with results available in under 2 h. GBS prevalence was 24.7 % and 25.5 % by cfb-based and sip-based qPCR assays, aligning with the culture method (25.5 %).

Conclusions

Both direct real-time PCR assays demonstrated high accuracy and were comparable to chromogenic culture in diagnosing GBS. A significant prevalence of GBS colonization was found among Vietnamese pregnant women in their final trimester.

导言：新生儿感染会迅速恶化，延误治疗往往会导致死亡。无乳链球菌（B 组链球菌，GBS）是一种常见的致病菌，通常在分娩过程中由带有菌落的孕妇传染给新生儿。在越南，常规产前护理缺乏标准化的 GBS 筛查方案。本研究旨在比较增强型 qPCR 方法和培养方法，评估这些 qPCR 程序的诊断准确性，并评估越南孕妇在最后三个月感染 GBS 的频率。收集直肠阴道拭子，并使用色原培养法、商用实时 PCR 试剂盒和针对 cfb 和 sip 基因的内部实时 PCR 检测法进行 GBS 分析。计算了临床诊断值，并确定了 GBS 患病率。其中，96.6%的孕妇分娩时胎龄为 37 周或以上。基于 cfb 和基于 sip 的 qPCR 检测的灵敏度、特异性、阳性预测值、阴性预测值和准确性分别为 94.1/92.7、99.0/99.5、97.1/98.5、97.8/97.3 和 97.6%。基于 cfb 和基于 sip 的 qPCR 检测方法的 GBS 感染率分别为 24.7% 和 25.5%，与培养方法（25.5%）一致。结论两种直接实时 PCR 检测方法在诊断 GBS 方面都具有很高的准确性，与色原培养法不相上下。

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