Practical Laboratory Medicine最新文献

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

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

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

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

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

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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引用次数: 0

The interference and elimination of nitrite on determination of total urinary protein by Pyrogallol Red–Molybdate method 焦红-钼酸盐法测定尿总蛋白时亚硝酸盐的干扰与消除

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-10-15 DOI: 10.1016/j.plabm.2024.e00436

Background

Some urine samples showed negative values of total urinary protein by Pyrogallol red–molybdate (PRM) method. Interestingly, these samples showed notably high levels of nitrite in the urine dipstick test.

Methods

A total of 120 urine samples were collected and categorized into four groups (0 - < 100, 100-<500, 500-<1000, ≥1000 mg/L) based on total urinary protein concentration. Various concentrations of nitrite (2, 10, 50, 100, and 200 mg/L) were added to urine samples to investigate potential interference of nitrite in total urinary protein measurement by the PRM method. Additionally, different concentrations of L-ascorbic acid (100, 500, 1000, and 2000 mg/L) were added to urine-nitrite mixtures to explore the possibility of reversing the interference effects.

Results

2 mg/L nitrite had no impact on the test results.10 mg/L nitrite only showed significant effects on the detection results among the groups with 0 - < 100 and 100-<500 mg/L (P < 0.05). 200 mg/L nitrite caused a noticeable decrease in the urinary protein detection results of the four groups (0 - < 100, 100-<500, 500-<1000, ≥1000 mg/L), and the concentrations were reduced to 2.7 %, 26.85 %, 75.22 %, and 89.33 % of their original levels, respectively. 500 mg/L L-ascorbic acid effectively eliminated the interference from 200 mg/L nitrite and almost had no effect on detection.

Conclusions

Nitrite had negative effect on the detection of total urinary protein by PRM method and L-ascorbic acid was effective in counteracting the interference caused by nitrite.

背景部分尿样经焦聚醇红钼酸盐（PRM）法检测显示尿总蛋白呈阴性。方法共收集了 120 份尿液样本，并根据尿液总蛋白浓度分为四组（0 - 100、100-500、500-1000、≥1000 mg/L）。在尿样中加入不同浓度的亚硝酸盐（2、10、50、100 和 200 mg/L），以研究亚硝酸盐对 PRM 方法测定尿蛋白总量的潜在干扰。结果2 毫克/升亚硝酸盐对检测结果没有影响。10 毫克/升亚硝酸盐只对 0 - < 100 和 100 - < 500 毫克/升组的检测结果有显著影响（P < 0.05）。200 mg/L 亚硝酸盐使四组（0 - <100、100-<500、500-<1000、≥1000 mg/L）的尿蛋白检测结果明显下降，浓度分别降至原来的 2.7 %、26.85 %、75.22 % 和 89.33 %。结论亚硝酸盐对 PRM 法检测尿总蛋白有负面影响，L-抗坏血酸能有效抵消亚硝酸盐的干扰。

{"title":"The interference and elimination of nitrite on determination of total urinary protein by Pyrogallol Red–Molybdate method","authors":"","doi":"10.1016/j.plabm.2024.e00436","DOIUrl":"10.1016/j.plabm.2024.e00436","url":null,"abstract":"<div><h3>Background</h3><div>Some urine samples showed negative values of total urinary protein by Pyrogallol red–molybdate (PRM) method. Interestingly, these samples showed notably high levels of nitrite in the urine dipstick test.</div></div><div><h3>Methods</h3><div>A total of 120 urine samples were collected and categorized into four groups (0 - < 100, 100-<500, 500-<1000, ≥1000 mg/L) based on total urinary protein concentration. Various concentrations of nitrite (2, 10, 50, 100, and 200 mg/L) were added to urine samples to investigate potential interference of nitrite in total urinary protein measurement by the PRM method. Additionally, different concentrations of L-ascorbic acid (100, 500, 1000, and 2000 mg/L) were added to urine-nitrite mixtures to explore the possibility of reversing the interference effects.</div></div><div><h3>Results</h3><div>2 mg/L nitrite had no impact on the test results.10 mg/L nitrite only showed significant effects on the detection results among the groups with 0 - < 100 and 100-<500 mg/L (P < 0.05). 200 mg/L nitrite caused a noticeable decrease in the urinary protein detection results of the four groups (0 - < 100, 100-<500, 500-<1000, ≥1000 mg/L), and the concentrations were reduced to 2.7 %, 26.85 %, 75.22 %, and 89.33 % of their original levels, respectively. 500 mg/L L-ascorbic acid effectively eliminated the interference from 200 mg/L nitrite and almost had no effect on detection.</div></div><div><h3>Conclusions</h3><div>Nitrite had negative effect on the detection of total urinary protein by PRM method and L-ascorbic acid was effective in counteracting the interference caused by nitrite.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-10-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142442029","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

Validation of a LC-MS/MS assay for citric acid, cysteine and oxalic acid determination and its application to explore pre-analytical sample storage 验证测定柠檬酸、半胱氨酸和草酸的 LC-MS/MS 分析法及其在探索分析前样品储存中的应用

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-30 DOI: 10.1016/j.plabm.2024.e00433

Objectives

Citrate, oxalate and cystine in 24-h urine are considered to be associated with the incidence and recurrence risk of urinary stone disease (USD). An evaluation of the LC-MS/MS kit for simultaneous quantification of the three analytes was undertaken.

Design

& Methods: The analytical performance of the kit was investigated based on FDA, EMA and CLSI guidelines. To promote the standardization of sample storage, this kit has been applied to perform systematic pre-analytical stability study of these analytes in urine.

Results

This method was validated with good linearity with accuracy of 93.1%–104 %. Intra-day and inter-day imprecision were ≤5.55 % and 5.34 %, respectively. Recoveries of citrate, oxalate and cystine added to clinical samples were in the range of 92.0–103 %, 94.8–100 % and 99.0–107 % with CV ≤ 5.52 %. It was recommended that urine preserved with hydrochloric acid could be preferable in consideration of both reliable test results and neglected sample heterogeneity.

Conclusions

This kit is suitable for measurement of citrate, oxalate and cystine for understanding the etiology of urinary stones, and the proper storage of urine samples is crucial for the correctness of the test results.

目的 24 小时尿液中的柠檬酸盐、草酸盐和胱氨酸被认为与尿石症（USD）的发病率和复发风险有关。我们对 LC-MS/MS 试剂盒进行了评估，以同时定量分析这三种分析物：根据 FDA、EMA 和 CLSI 指南对试剂盒的分析性能进行了调查。结果：该方法线性关系良好，准确度为 93.1%-104%。日内和日间误差分别小于5.55%和5.34%。临床样本中柠檬酸盐、草酸盐和胱氨酸的回收率分别为 92.0%-103%、94.8%-100% 和 99.0%-107%，CV ≤ 5.52%。结论：该试剂盒适用于测定枸橼酸盐、草酸盐和胱氨酸，可用于了解尿路结石的病因，尿样的妥善保存对检测结果的正确性至关重要。

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引用次数: 0

Performance evaluation of Eu3+-based CRP/SAA and PCT/IL-6 lateral flow immunoassay kits and their diagnostic value in respiratory tract infections 基于 Eu3+ 的 CRP/SAA 和 PCT/IL-6 侧流免疫测定试剂盒的性能评估及其在呼吸道感染中的诊断价值

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-27 DOI: 10.1016/j.plabm.2024.e00432

Objectives

Respiratory infections are among the most common infectious diseases, resulting in significant morbidity and mortality. C-reactive protein (CRP), serum amyloid A (SAA), procalcitonin (PCT), and interleukin-6 (IL-6) are advantageous for diagnosing respiratory tract infections. This study assessed the analytical performance and accuracy of new kits for Eu3⁺-based CRP/SAA and PCT/IL-6 lateral flow immunoassay and its diagnostic value in respiratory tract infections.

Methods

This study evaluated the detection performance of a test kit using guidelines from the Center for Medical Device Evaluation (CMDE) and the Clinical and Laboratory Standards Institute (CLSI). The test results were compared to those of the commercial kits (CRP: Mindray; SAA: Norman; PCT: Shanghai Upper; IL-6: Wantai BioPharm). A total of 156 patients with respiratory tract infections (53 with bacterial infections (Bac group); 50 with viral infections (Vir group); and 53 with co-infections (Bac + Vir group)) were enrolled, along with 50 healthy controls (HC group). Venous blood samples were collected to measure levels of SAA, PCT, CRP, and IL-6 using both the test and commercial kits. The diagnostic value of these biomarkers was assessed using receiver operating characteristic (ROC) curves.

Results

Correlation analysis demonstrated a strong concordance between the test kits and commercial kits (CRP: r = 0.9396, P < 0.0001; SAA: r = 0.8986, P < 0.0001; PCT: r = 0.9594, P < 0.0001; IL-6: r = 0.9009, P < 0.0001). The diagnostic performance of the test kits in identifying bacterial, viral, and co-infections was highly consistent with that of the commercial kit.

Conclusions

The Eu3⁺-based CRP/SAA and PCT/IL-6 lateral flow immunoassay test kits demonstrated high levels of consistency with commercial kits in terms of quantitative outcomes and diagnostic performance for respiratory tract infections.

目的呼吸道感染是最常见的传染病之一，会导致严重的发病率和死亡率。C反应蛋白（CRP）、血清淀粉样蛋白A（SAA）、降钙素原（PCT）和白细胞介素-6（IL-6）是诊断呼吸道感染的有利指标。本研究评估了基于 Eu3+ 的 CRP/SAA 和 PCT/IL-6 侧流免疫测定新试剂盒的分析性能和准确性及其在呼吸道感染中的诊断价值。检测结果与商用试剂盒（CRP：Mindray；SAA：Norman；PCT：Shanghai Upper；IL-6：Wantai BioPharm）的检测结果进行了比较。共招募了 156 名呼吸道感染患者（53 名细菌感染患者（Bac 组）；50 名病毒感染患者（Vir 组）；53 名合并感染患者（Bac + Vir 组））和 50 名健康对照组（HC 组）。采集静脉血样本，使用检测试剂盒和商业试剂盒测量 SAA、PCT、CRP 和 IL-6 的水平。结果相关性分析表明，检测试剂盒与商用试剂盒之间具有很强的一致性（CRP：r = 0.9396，P <；0.0001；SAA：r = 0.8986，P <；0.0001；PCT：r = 0.9594，P <；0.0001；IL-6：r = 0.9009，P <；0.0001）。结论基于 Eu3+ 的 CRP/SAA 和 PCT/IL-6 侧流免疫测定试剂盒在呼吸道感染的定量结果和诊断性能方面与商业试剂盒具有高度的一致性。

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引用次数: 0

The potential relationship between EasyNAT system Tt values and Cobas z480 Ct values in the detection of SARS-Cov-2 EasyNAT 系统 Tt 值与 Cobas z480 Ct 值在检测 SARS-Cov-2 中的潜在关系

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-26 DOI: 10.1016/j.plabm.2024.e00431

Objectives

This study aimed to evaluate the potential relationship between the time threshold (Tt) values of a commercial EasyNAT system, which is based on cross priming amplification (CPA) technology, and the cycle threshold (Ct) values of the Cobas z480 analyzer, which is based on a real-time fluorescence polymerase chain reaction (PCR) method, in the detection of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) from oropharyngeal swabs. Design and Methods: Data were retrospectively collected from a clinical laboratory between December 4, 2022 and July 1, 2024.

Results

A total of 277 EasyNAT-positive samples (Tt values from 3.83 to 29.5) were simultaneously investigated using the Cobas z480 analyzer (Ct values from 10.74 to 38.78). The concordance rate between the two systems was 100 %. Among the positive samples, the mean and maximum PCR Ct values of O and N genes increased in line with increasing Tt values of the left and right amplification areas of the EasyNAT system. The maximum Ct values of the O or N gene determined by the Cobas z480 analyzer were no more than 29.52 when the Tt values of the left or right amplification areas of the UC0116 analyzer were no more than 6.

Conclusions

The safe, simple, fast, accurate, and automatic EasyNAT system used in conjunction with a PCR system might be a better choice for the detection of SARS-CoV-2 in hospitals, especially in settings without sophisticated PCR facilities. The Tt value (≤6) of the EasyNAT system can be a reference index for estimating the maximum Ct value (29.52) in SARS-CoV-2-positive samples.

目的本研究旨在评估基于交叉引物扩增（CPA）技术的商用 EasyNAT 系统的时间阈值（Tt）与基于实时荧光聚合酶链反应（PCR）方法的 Cobas z480 分析仪的周期阈值（Ct）之间在检测口咽拭子中的严重急性呼吸系统综合征冠状病毒-2（SARS-CoV-2）方面的潜在关系。设计与方法：结果使用 Cobas z480 分析仪同时检测了 277 份 EasyNAT 阳性样本（Tt 值从 3.83 到 29.5 不等）（Ct 值从 10.74 到 38.78 不等）。两个系统的吻合率为 100%。在阳性样本中，O 和 N 基因的平均 PCR Ct 值和最大 PCR Ct 值随着 EasyNAT 系统左右扩增区 Tt 值的增加而增加。当 UC0116 分析仪左右扩增区的 Tt 值不超过 6 时，Cobas z480 分析仪测定的 O 或 N 基因的最大 Ct 值不超过 29.52。EasyNAT 系统的 Tt 值（≤6）可以作为估计 SARS-CoV-2 阳性样本中最大 Ct 值（29.52）的参考指标。

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引用次数: 0

Laboratory considerations in the assessment of 25-hydroxyvitamin D in pregnant women by automated immunoassays 使用自动免疫测定法评估孕妇体内 25- 羟维生素 D 的实验室注意事项

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-25 DOI: 10.1016/j.plabm.2024.e00430

Background

Because of the pathophysiological role of vitamin D in health, there is an increased interest to check the clinical status of this vitamin. Immunochemical assays are commonly employed to determine 25-hydroxyvitamin D (25 (OH) D) in clinical laboratories and its testing could be influenced by pre-analytic and analytic issues. The aim of this study was to compare the 25(OH)D results obtained from three commonly used immunoassays in pregnant women to check a possible discrepancy between tests.

Material and methods

A group of 50 pregnant women who were in their third trimester were included in this study. The quantification of serum vitamin D was performed utilizing three immunochemistry-based assays including Elecsys, VIDAS and Alegria. We also involved 21 non-pregnant volunteers to clinically assess the vitamin D status in this group of people.

Results

Our findings revealed a significant inconsistency between the obtained results from three assays for serum 25(OH)D. The 25(OH)D showed higher values when measured by the Elecsys assay while the VIDAS assay had lower values compared to the other immunoassays. More notably, the 25(OH)D testing in non-pregnant subjects showed consistent results in all three immunoassays.

Conclusions

The results of the 25(OH)D measurements in pregnant women should be interpreted carefully due to a great inaccuracy in immunoassay testing. There is no such disagreement in non-pregnant people. Standardization of vitamin D testing in various settings is a crucial matter for clinical laboratories.

背景由于维生素 D 在健康中的病理生理作用，人们对检查这种维生素的临床状态越来越感兴趣。临床实验室通常采用免疫化学方法来测定 25- 羟基维生素 D（25 (OH) D），其检测结果可能会受到分析前和分析过程中问题的影响。本研究的目的是比较三种常用免疫测定法测定孕妇 25（OH）D 的结果，以检查不同检测方法之间可能存在的差异。使用三种基于免疫化学的检测方法（包括 Elecsys、VIDAS 和 Alegria）对血清维生素 D 进行定量。我们还邀请了 21 名非孕妇志愿者对这部分人群的维生素 D 状态进行临床评估。与其他免疫测定法相比，Elecsys 法测定的 25（OH）D 值较高，而 VIDAS 法测定的 25（OH）D 值较低。更值得注意的是，在对非孕妇进行 25（OH）D 检测时，所有三种免疫测定法的结果都是一致的。在非孕妇中则没有这种分歧。对临床实验室来说，在不同环境中进行维生素 D 检测的标准化至关重要。

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引用次数: 0

Biochemical indices of patients with enteric fever and pancreatitis: A comparative cross-sectional study 肠炎和胰腺炎患者的生化指标：横断面比较研究

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine

Pub Date : 2024-09-18 DOI: 10.1016/j.plabm.2024.e00429

Objective

Enteric fever (EF), a potentially fatal febrile illness, is prevalent in developing countries. Elevated levels of lipase and amylase in serum, typically associated with acute pancreatitis (AP), have been observed in patients with EF. The elevated enzymes in both conditions may lead to diagnostic confusion and care delays. This study aimed to determine biochemical indices that are peculiar to EF and AP.

Methods

A cross-sectional comparative study was conducted at the Korle-Bu Teaching Hospital, Ghana. Volunteers were categorized into three groups: EF (n = 32), AP (n = 30) and healthy controls (n = 31). A standard questionnaire was used to collect socio-demographic and clinical information from the participants. Blood and stool samples were obtained, followed by biochemical analysis: total amylase, lipase, pancreatic amylase, serum elastase 1, hepatic enzymes, calcium, magnesium, phosphate, stool colour, stool pH, and stool fat presence.

Results

The AP group displayed higher total amylase, lipase, elastase-1, alkaline phosphatase, aspartate aminotransferase, and gamma-glutamyl transferase levels compared to the EF and control groups (p < 0.05 respectively). Elastase 1 levels were found to be high in all AP participants, whereas no elevations were observed in the EF group. Positive associations were observed in the AP and EF groups for lipase vs total amylase (ρ = .543, p = 0.001; ρ = .543, p = 0.001 for both).

Conclusions

Elevated levels of total/pancreatic amylase and lipase were found to be indicative of a patient with AP and EF. Further, elastase-1 was found to be a good biomarker to distinguish between AP and EF.

目的肠胃热（EF）是一种可能致命的发热性疾病，在发展中国家很普遍。在肠炎患者中观察到血清中脂肪酶和淀粉酶水平升高，这通常与急性胰腺炎（AP）有关。这两种情况下的酶升高都可能导致诊断混乱和护理延误。本研究旨在确定 EF 和 AP 所特有的生化指标。志愿者被分为三组：EF 组（32 人）、AP 组（30 人）和健康对照组（31 人）。采用标准问卷收集参与者的社会人口学和临床信息。采集血液和粪便样本，然后进行生化分析：总淀粉酶、脂肪酶、胰淀粉酶、血清弹性蛋白酶 1、肝酶、钙、镁、磷酸盐、粪便颜色、粪便 pH 值和粪便脂肪含量。所有 AP 参与者的弹性蛋白酶 1 水平都很高，而 EF 组则没有发现任何升高。在 AP 组和 EF 组中，脂肪酶与总淀粉酶呈正相关（ρ = .543，p = 0.001；两者均为ρ = .543，p = 0.001）。此外，还发现弹性蛋白酶-1是区分 AP 和 EF 的良好生物标志物。

{"title":"Biochemical indices of patients with enteric fever and pancreatitis: A comparative cross-sectional study","authors":"","doi":"10.1016/j.plabm.2024.e00429","DOIUrl":"10.1016/j.plabm.2024.e00429","url":null,"abstract":"<div><h3>Objective</h3><div>Enteric fever (EF), a potentially fatal febrile illness, is prevalent in developing countries. Elevated levels of lipase and amylase in serum, typically associated with acute pancreatitis (AP), have been observed in patients with EF. The elevated enzymes in both conditions may lead to diagnostic confusion and care delays. This study aimed to determine biochemical indices that are peculiar to EF and AP.</div></div><div><h3>Methods</h3><div>A cross-sectional comparative study was conducted at the Korle-Bu Teaching Hospital, Ghana. Volunteers were categorized into three groups: EF (n = 32), AP (n = 30) and healthy controls (n = 31). A standard questionnaire was used to collect socio-demographic and clinical information from the participants. Blood and stool samples were obtained, followed by biochemical analysis: total amylase, lipase, pancreatic amylase, serum elastase 1, hepatic enzymes, calcium, magnesium, phosphate, stool colour, stool pH, and stool fat presence.</div></div><div><h3>Results</h3><div>The AP group displayed higher total amylase, lipase, elastase-1, alkaline phosphatase, aspartate aminotransferase, and gamma-glutamyl transferase levels compared to the EF and control groups (<em>p</em> < 0.05 respectively). Elastase 1 levels were found to be high in all AP participants, whereas no elevations were observed in the EF group. Positive associations were observed in the AP and EF groups for lipase vs total amylase (ρ = .543, <em>p</em> = 0.001; ρ = .543, <em>p</em> = 0.001 for both).</div></div><div><h3>Conclusions</h3><div>Elevated levels of total/pancreatic amylase and lipase were found to be indicative of a patient with AP and EF. Further, elastase-1 was found to be a good biomarker to distinguish between AP and EF.</div></div>","PeriodicalId":20421,"journal":{"name":"Practical Laboratory Medicine","volume":null,"pages":null},"PeriodicalIF":1.7,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142320182","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}

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