Helene Faust, Patricia Duffek, Julia Hentschel, Denny Popp
Background
Long-read technologies such as nanopore sequencing provide new opportunities to detect short tandem repeat expansions. Therefore, a DNA extraction method is necessary that minimizes DNA fragmentation and hence allows the identification of large repeat expansions. In this study, an automated magnetic bead–based DNA extraction method and the required EDTA blood storage conditions as well as DNA and sequencing quality were evaluated for their suitability for repeat expansion detection with nanopore sequencing.
Methods
DNA was extracted from EDTA blood, and subsequently, its concentration, purity, and integrity were assessed. DNA was then subjected to nanopore sequencing, and quality metrics of the obtained sequencing data were evaluated.
Results
DNA extracted from fresh EDTA blood as well as from cooled or frozen EDTA blood revealed high DNA integrity whereas storage at room temperature over 7 days had detrimental effects. After nanopore sequencing, the read length N50 values of approximately 9 kb were obtained, and based on adaptive sampling of samples with a known repeat expansion, repeat expansions up to 10 kb could be detected.
Conclusion
The automated magnetic bead–based DNA extraction was sufficient to detect short tandem repeat expansions, omitting the need for high-molecular-weight DNA extraction methods. Therefore, DNA should be extracted either from fresh blood or from blood stored in cooled or frozen conditions. Consequently, this study may help other laboratories to evaluate their DNA extraction method regarding the suitability for detecting repeat expansions with nanopore sequencing.
背景：纳米孔测序等长读技术为检测短串联重复扩增提供了新的机会。因此，有必要采用一种 DNA 提取方法，以最大限度地减少 DNA 断裂，从而鉴定大重复扩增。本研究评估了一种基于磁珠的自动 DNA 提取方法和所需的 EDTA 血液储存条件以及 DNA 和测序质量，以确定其是否适合用纳米孔测序检测重复扩增：从 EDTA 血液中提取 DNA，然后评估其浓度、纯度和完整性。然后对 DNA 进行纳米孔测序，并评估测序数据的质量指标：结果：从新鲜的乙二胺四乙酸（EDTA）血液以及冷却或冷冻的乙二胺四乙酸（EDTA）血液中提取的 DNA 显示出较高的 DNA 完整性，而在室温下保存 7 天以上则会产生不利影响。纳米孔测序后，读长 N50 值约为 9 kb，根据对已知重复扩增样本的自适应取样，可检测到重复扩增达 10 kb：结论：基于磁珠的自动 DNA 提取足以检测短串联重复扩增，无需使用高分子量 DNA 提取方法。因此，DNA 应从新鲜血液或在冷却或冷冻条件下储存的血液中提取。因此，本研究可帮助其他实验室评估其DNA提取方法是否适合用纳米孔测序法检测重复扩增。
{"title":"Evaluation of Automated Magnetic Bead–Based DNA Extraction for Detection of Short Tandem Repeat Expansions With Nanopore Sequencing","authors":"Helene Faust, Patricia Duffek, Julia Hentschel, Denny Popp","doi":"10.1002/jcla.25029","DOIUrl":"10.1002/jcla.25029","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Long-read technologies such as nanopore sequencing provide new opportunities to detect short tandem repeat expansions. Therefore, a DNA extraction method is necessary that minimizes DNA fragmentation and hence allows the identification of large repeat expansions. In this study, an automated magnetic bead–based DNA extraction method and the required EDTA blood storage conditions as well as DNA and sequencing quality were evaluated for their suitability for repeat expansion detection with nanopore sequencing.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>DNA was extracted from EDTA blood, and subsequently, its concentration, purity, and integrity were assessed. DNA was then subjected to nanopore sequencing, and quality metrics of the obtained sequencing data were evaluated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>DNA extracted from fresh EDTA blood as well as from cooled or frozen EDTA blood revealed high DNA integrity whereas storage at room temperature over 7 days had detrimental effects. After nanopore sequencing, the read length N50 values of approximately 9 kb were obtained, and based on adaptive sampling of samples with a known repeat expansion, repeat expansions up to 10 kb could be detected.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The automated magnetic bead–based DNA extraction was sufficient to detect short tandem repeat expansions, omitting the need for high-molecular-weight DNA extraction methods. Therefore, DNA should be extracted either from fresh blood or from blood stored in cooled or frozen conditions. Consequently, this study may help other laboratories to evaluate their DNA extraction method regarding the suitability for detecting repeat expansions with nanopore sequencing.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.25029","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140174962","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ningning Wang, Qingqing Liu, Feihu Che, Qingyang Sun, Yue Wang, Chunli Yang, Yuzhu Dai, Jun Cheng
Background
To establish a chemiluminescence method for detecting anti-E1 and anti-E2 antibodies in the serum of patients with hepatitis C virus (HCV) infection.
Methods
The microplate was coated with recombinant envelope proteins E1 and E2 by indirect method, respectively, and the kits for detecting anti-E1 and anti-E2 antibodies were prepared. The methodological indexes were evaluated.
Results
The methodological indexes of the kits were as follows: precision test (the variation coefficient of anti-E1 antibody 6.71%–8.95% for within run and 9.91%–12.16% for between run, the variation coefficient of anti-E2 antibody 6.06%–8.44% for within run and 10.77%–13.98% for between run, respectively). The blank limit and detection limit were 1.18 RLIR and 3.16 RLIR for the anti-E1 antibody, and 1.26 RLIR and 3.32 RLIR for the anti-E2 antibody, respectively. The correlation coefficients (r) of anti-E1 and anti-E2 were 0.9963 and 0.9828, the analysis and measurement ranges (AMR) were 1.66–41.28 RLIR and 1.55–19.46 RLIR, and the average recovery was 96.4% and 93.7%, respectively. The rheumatoid factor and other positive serum samples had no interference or cross-reaction to the test, and the kits were stable within 15 months. The positive rates of anti-E1 and anti-E2 antibodies in 45 patients with HCV infection were 35.6% (16/45) and 44.4% (20/45), respectively.
Conclusions
The kits for detecting anti-E1 and anti-E2 meet the requirements of methodology, and can be used in screening diagnosis, disease monitoring, prognosis evaluation, disease mechanism, and epidemiological studies of HCV infection. The HCV envelope proteins E1 and E2 have an immune response in HCV-infected patients.
{"title":"Establishment and methodological evaluation of a chemiluminescence assay for detection of anti-envelope protein (E1, E2) antibodies in the serum of hepatitis C virus-infected patients","authors":"Ningning Wang, Qingqing Liu, Feihu Che, Qingyang Sun, Yue Wang, Chunli Yang, Yuzhu Dai, Jun Cheng","doi":"10.1002/jcla.25011","DOIUrl":"https://doi.org/10.1002/jcla.25011","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>To establish a chemiluminescence method for detecting anti-E1 and anti-E2 antibodies in the serum of patients with hepatitis C virus (HCV) infection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The microplate was coated with recombinant envelope proteins E1 and E2 by indirect method, respectively, and the kits for detecting anti-E1 and anti-E2 antibodies were prepared. The methodological indexes were evaluated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The methodological indexes of the kits were as follows: precision test (the variation coefficient of anti-E1 antibody 6.71%–8.95% for within run and 9.91%–12.16% for between run, the variation coefficient of anti-E2 antibody 6.06%–8.44% for within run and 10.77%–13.98% for between run, respectively). The blank limit and detection limit were 1.18 RLIR and 3.16 RLIR for the anti-E1 antibody, and 1.26 RLIR and 3.32 RLIR for the anti-E2 antibody, respectively. The correlation coefficients (<i>r</i>) of anti-E1 and anti-E2 were 0.9963 and 0.9828, the analysis and measurement ranges (AMR) were 1.66–41.28 RLIR and 1.55–19.46 RLIR, and the average recovery was 96.4% and 93.7%, respectively. The rheumatoid factor and other positive serum samples had no interference or cross-reaction to the test, and the kits were stable within 15 months. The positive rates of anti-E1 and anti-E2 antibodies in 45 patients with HCV infection were 35.6% (16/45) and 44.4% (20/45), respectively.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The kits for detecting anti-E1 and anti-E2 meet the requirements of methodology, and can be used in screening diagnosis, disease monitoring, prognosis evaluation, disease mechanism, and epidemiological studies of HCV infection. The HCV envelope proteins E1 and E2 have an immune response in HCV-infected patients.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.25011","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140139184","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
To explore the clinical effect of predeposit, salvage, and hemodilution autotransfusion on patients with femoral shaft fracture (FSF) surgery.
Methods
Selected patients with FSF were randomly divided into three groups: intraoperative blood salvage autotransfusion, preoperative hemodilution autohemotransfusion, and predeposit autotransfusion. Five days after the operation, the body temperature, heart rate, blood platelet (PLT), and hemoglobin (Hb) of patients were determined. The concentrations of EPO and GM-CSF in the three groups were calculated by ELISA. The content of CD14+ monocytes was calculated by FCM assay. The growth time and condition of the patient's callus were determined at the 30th, 45th, and 60th day after operation. Cox regression analysis was used to analyze the correlation between EPO, GM-CSF, CD14+ mononuclear content, callus growth, and autotransfusion methods.
Results
There were no statistically significant differences in body temperature and heart rate between the three groups (p > 0.05). PLT and Hb in the Predeposit group were markedly increased compared with that in the Salvage and Hemodilution groups. The concentrations of EPO and GM-CSF in the Predeposit group were markedly increased compared with that in the Salvage and Hemodilution groups. The content of CD14+ monocytes in the Predeposit group was significantly higher than that in the Salvage and Hemodilution groups. Predeposit autotransfusion promotes callus growth more quickly.
Conclusion
Predeposit autotransfusion promoted the recovery of patients with FSF after the operation more quickly than salvage autotransfusion and hemodilution autotransfusion.
{"title":"Exploration of the Clinical Effect of Different Autotransfusion Methods on Patients With Femoral Shaft Fracture Surgery","authors":"Yujia Wang, Huan Wang, Jiaming Xu, Jinhuo Wang, Laiwei You, Yu Bai, Jianrong Guo","doi":"10.1002/jcla.25018","DOIUrl":"10.1002/jcla.25018","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To explore the clinical effect of predeposit, salvage, and hemodilution autotransfusion on patients with femoral shaft fracture (FSF) surgery.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Selected patients with FSF were randomly divided into three groups: intraoperative blood salvage autotransfusion, preoperative hemodilution autohemotransfusion, and predeposit autotransfusion. Five days after the operation, the body temperature, heart rate, blood platelet (PLT), and hemoglobin (Hb) of patients were determined. The concentrations of EPO and GM-CSF in the three groups were calculated by ELISA. The content of CD14+ monocytes was calculated by FCM assay. The growth time and condition of the patient's callus were determined at the 30th, 45th, and 60th day after operation. Cox regression analysis was used to analyze the correlation between EPO, GM-CSF, CD14+ mononuclear content, callus growth, and autotransfusion methods.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>There were no statistically significant differences in body temperature and heart rate between the three groups (<i>p</i> > 0.05). PLT and Hb in the Predeposit group were markedly increased compared with that in the Salvage and Hemodilution groups. The concentrations of EPO and GM-CSF in the Predeposit group were markedly increased compared with that in the Salvage and Hemodilution groups. The content of CD14+ monocytes in the Predeposit group was significantly higher than that in the Salvage and Hemodilution groups. Predeposit autotransfusion promotes callus growth more quickly.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Predeposit autotransfusion promoted the recovery of patients with FSF after the operation more quickly than salvage autotransfusion and hemodilution autotransfusion.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.25018","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140101669","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Patient-based real-time quality control (PBRTQC) has gained attention because of its potential to continuously monitor the analytical quality in situations wherein internal quality control (IQC) is less effective. Therefore, we tried to investigate the application of PBRTQC method based on an artificial intelligence monitoring (AI-MA) platform in quality risk monitoring of Down syndrome (DS) serum screening.
Methods
The DS serum screening item determination data and relative IQC data from January 4 to September 7 in 2021 were collected. Then, PBRTQC exponentially weighted moving average (EWMA) and moving average (MA) procedures were built and optimized in the AI-MA platform. The efficiency of the EWMA and MA procedures with intelligent and traditional control rules were compared. Next, the optimal EWMA procedures that contributed to the quality assurance of serum screening were run and generated early warning cases were investigated.
Results
Optimal EWMA and MA procedures on the AI-MA platform were built. Comparison results showed the EWMA procedure with intelligent QC rules but not traditional quality rules contained the best efficiency. Based on the AI-MA platform, two early warning cases were generated by using the optimal EWMA procedure, which finally found were caused by instrument failure. Moreover, the EWMA procedure could truly reflect the detection accuracy and quality in situations wherein traditional IQC products were unstable or concentrations were inappropriate.
Conclusions
The EWMA procedure built by the AI-MA platform could be a good complementary control tool for the DS serum screening by truly and timely reflecting the detection quality risks.
{"title":"Application of Patient-Based Real-Time Quality Control Based on Artificial Intelligence Monitoring Platform in Continuously Quality Risk Monitoring of Down Syndrome Serum Screening","authors":"Xuran Yang, Qianlan Chen, Zhifeng Pan, Jingmao Cheng, Wenting Zheng, Yingliang Liang, Hui Chen, Guanghui Chen, Wandang Wang","doi":"10.1002/jcla.25019","DOIUrl":"10.1002/jcla.25019","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Patient-based real-time quality control (PBRTQC) has gained attention because of its potential to continuously monitor the analytical quality in situations wherein internal quality control (IQC) is less effective. Therefore, we tried to investigate the application of PBRTQC method based on an artificial intelligence monitoring (AI-MA) platform in quality risk monitoring of Down syndrome (DS) serum screening.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The DS serum screening item determination data and relative IQC data from January 4 to September 7 in 2021 were collected. Then, PBRTQC exponentially weighted moving average (EWMA) and moving average (MA) procedures were built and optimized in the AI-MA platform. The efficiency of the EWMA and MA procedures with intelligent and traditional control rules were compared. Next, the optimal EWMA procedures that contributed to the quality assurance of serum screening were run and generated early warning cases were investigated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Optimal EWMA and MA procedures on the AI-MA platform were built. Comparison results showed the EWMA procedure with intelligent QC rules but not traditional quality rules contained the best efficiency. Based on the AI-MA platform, two early warning cases were generated by using the optimal EWMA procedure, which finally found were caused by instrument failure. Moreover, the EWMA procedure could truly reflect the detection accuracy and quality in situations wherein traditional IQC products were unstable or concentrations were inappropriate.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>The EWMA procedure built by the AI-MA platform could be a good complementary control tool for the DS serum screening by truly and timely reflecting the detection quality risks.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.25019","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140101668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Insulin resistance has been correlated with the genetic diversity within the insulin-like binding proteins genes. Moreover, insulin resistance is one of the key characteristics of the widespread reproductive endocrine condition known as polycystic ovarian syndrome (PCOS). Hence, this study is aimed to determine the association between IGFBP3 and IGF2BP2 gene variants and PCOS risk.
Methods
A total of 300 subjects (150 PCOS cases diagnosed based on Rotterdam ESHRE/ASRM consensus criteria and 150 healthy subjects) were recruited in this case–control cross-sectional study. Tetra-primer amplification refractory mutation system polymerase chain reaction (ARMS-PCR) was used for genotyping rs11705701, whereas genotyping of rs1470579 and rs2854744 was done employing PCR-restriction fragment length polymorphism (PCR-RFLP) technique.
Results
The CC and AA+AC genotypes of rs1470579 conferred an increased risk of PCOS in our population. Regarding the rs2854744, an increased risk of PCOS was observed under the codominant homozygous (TT vs. GG) model by 2.54 fold. The C allele of rs1470579 and T allele of rs2854744 enhanced PCOS risk by 1.97 and 1.46 folds, respectively. Haplotype analysis showed that the Ars1470579Ars11705701 haplotype conferred a decreased risk of PCOS (odds ratio = 0.53, 95% confidence interval = 0.34–0.83, p = 0.006). The AC/GG/GT, AA/GA/GT, AC/GA/GG, and AC/GA/GT genotype combinations of rs1470579/rs11705701/rs2854744 were associated with a decreased risk of the disease.
Conclusions
IGF2BP2 rs1470579 and IGFBP3 rs2854744 enhanced PCOS susceptibility in a Southeastern Iranian population. Further investigation involving larger cohorts representing diverse ethnic backgrounds is needed to confirm the current findings.
{"title":"IGF2BP2 and IGFBP3 Genotypes, Haplotypes, and Genetic Models Studies in Polycystic Ovary Syndrome","authors":"Fatemeh Govahi Kakhki, Saman Sargazi, Farzaneh Montazerifar, Mahdi Majidpour, Atena Karajibani, Mansour Karajibani, Marzieh Ghasemi","doi":"10.1002/jcla.25021","DOIUrl":"10.1002/jcla.25021","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Insulin resistance has been correlated with the genetic diversity within the insulin-like binding proteins genes. Moreover, insulin resistance is one of the key characteristics of the widespread reproductive endocrine condition known as polycystic ovarian syndrome (PCOS). Hence, this study is aimed to determine the association between <i>IGFBP3</i> and <i>IGF2BP2</i> gene variants and PCOS risk.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A total of 300 subjects (150 PCOS cases diagnosed based on Rotterdam ESHRE/ASRM consensus criteria and 150 healthy subjects) were recruited in this case–control cross-sectional study. Tetra-primer amplification refractory mutation system polymerase chain reaction (ARMS-PCR) was used for genotyping rs11705701, whereas genotyping of rs1470579 and rs2854744 was done employing PCR-restriction fragment length polymorphism (PCR-RFLP) technique.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The CC and AA+AC genotypes of rs1470579 conferred an increased risk of PCOS in our population. Regarding the rs2854744, an increased risk of PCOS was observed under the codominant homozygous (TT vs. GG) model by 2.54 fold. The C allele of rs1470579 and T allele of rs2854744 enhanced PCOS risk by 1.97 and 1.46 folds, respectively. Haplotype analysis showed that the A<sub>rs1470579</sub>A<sub>rs11705701</sub> haplotype conferred a decreased risk of PCOS (odds ratio = 0.53, 95% confidence interval = 0.34–0.83, <i>p</i> = 0.006). The AC/GG/GT, AA/GA/GT, AC/GA/GG, and AC/GA/GT genotype combinations of rs1470579/rs11705701/rs2854744 were associated with a decreased risk of the disease.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p><i>IGF2BP2</i> rs1470579 and <i>IGFBP3</i> rs2854744 enhanced PCOS susceptibility in a Southeastern Iranian population. Further investigation involving larger cohorts representing diverse ethnic backgrounds is needed to confirm the current findings.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.25021","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140101670","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Koos Korsten, Astrid de Gier, Alexander Leenders, Peter C. Wever, Eva Kolwijck
Background
Urinary tract infections are responsible for a significant worldwide disease burden. Performing urine culture is time consuming and labor intensive. Urine flow cytometry might provide a quick and reliable method to screen for urinary tract infection.
Methods
We analyzed routinely collected urine samples received between 2020 and 2022 from both inpatients and outpatients. The UF-4000 urine flow cytometer was implemented with an optimal threshold for positivity of ≥100 bacteria/μL. We thereafter validated the prognostic value to detect the presence of urinary tract infection (UTI) based on bacterial (BACT), leukocyte (WBC), and yeast-like cell (YLC) counts combined with the bacterial morphology (UF gram-flag).
Results
In the first phase, in 2019, the UF-4000 was implemented using 970 urine samples. In the second phase, between 2020 and 2022, the validation was performed in 42,958 midstream urine samples. The UF-4000 screen resulted in a 37% (n = 15,895) decrease in performed urine cultures. Uropathogens were identified in 18,673 (69%) positively flagged urine samples. BACT > 10.000/μL combined with a gram-negative flag had a >90% positive predictive value for the presence of gram-negative uropathogens. The absence of gram-positive flag or YLC had high negative predictive values (99% and >99%, respectively) and are, therefore, best used to rule out the presence of gram-positive bacteria or yeast. WBC counts did not add to the prediction of uropathogens.
Conclusion
Implementation of the UF-4000 in routine practice decreased the number of cultured urine samples by 37%. Bacterial cell counts were highly predictive for the presence of UTI, especially when combined with the presence of a gram-negative flag.
{"title":"Using the Sysmex UF-4000 urine flow cytometer for rapid diagnosis of urinary tract infection in the clinical microbiological laboratory","authors":"Koos Korsten, Astrid de Gier, Alexander Leenders, Peter C. Wever, Eva Kolwijck","doi":"10.1002/jcla.25004","DOIUrl":"10.1002/jcla.25004","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Urinary tract infections are responsible for a significant worldwide disease burden. Performing urine culture is time consuming and labor intensive. Urine flow cytometry might provide a quick and reliable method to screen for urinary tract infection.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We analyzed routinely collected urine samples received between 2020 and 2022 from both inpatients and outpatients. The UF-4000 urine flow cytometer was implemented with an optimal threshold for positivity of ≥100 bacteria/μL. We thereafter validated the prognostic value to detect the presence of urinary tract infection (UTI) based on bacterial (BACT), leukocyte (WBC), and yeast-like cell (YLC) counts combined with the bacterial morphology (UF gram-flag).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>In the first phase, in 2019, the UF-4000 was implemented using 970 urine samples. In the second phase, between 2020 and 2022, the validation was performed in 42,958 midstream urine samples. The UF-4000 screen resulted in a 37% (<i>n</i> = 15,895) decrease in performed urine cultures. Uropathogens were identified in 18,673 (69%) positively flagged urine samples. BACT > 10.000/μL combined with a gram-negative flag had a >90% positive predictive value for the presence of gram-negative uropathogens. The absence of gram-positive flag or YLC had high negative predictive values (99% and >99%, respectively) and are, therefore, best used to rule out the presence of gram-positive bacteria or yeast. WBC counts did not add to the prediction of uropathogens.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>Implementation of the UF-4000 in routine practice decreased the number of cultured urine samples by 37%. Bacterial cell counts were highly predictive for the presence of UTI, especially when combined with the presence of a gram-negative flag.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-03-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.25004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140059555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giulia Barbieri, Giulia Cassioli, Ada Kura, Rebecca Orsi, Alberto Magi, Martina Berteotti, Giusi Maria Scaturro, Elena Lotti, Anna Maria Gori, Rossella Marcucci, Betti Giusti, Elena Sticchi
Background
Lipoprotein(a) [Lp(a)] level variability, related to atherothrombotic risk increase, is mainly attributed to LPA gene, encoding apolipoprotein(a), with kringle IV type 2 (KIV2) copy number variation (CNV) acting as the primary genetic determinant. Genetic characterization of Lp(a) is in continuous growth; nevertheless, the peculiar structural characteristics of this variant constitute a significant challenge to the development of effective detection methods. The aim of the study was to compare quantitative real-time PCR (qPCR) and digital droplet PCR (ddPCR) in the evaluation of KIV2 repeat polymorphism.
Methods
We analysed 100 subjects tested for cardiovascular risk in which Lp(a) plasma levels were assessed.
Results
Correlation analysis between CNV values obtained with the two methods was slightly significant (R = 0.413, p = 0.00002), because of the wider data dispersion in qPCR compared with ddPCR. Internal controls C1, C2 and C3 measurements throughout different experimental sessions revealed the superior stability of ddPCR, which was supported by a reduced intra/inter-assay coefficient of variation determined in this method compared to qPCR. A significant inverse correlation between Lp(a) levels and CNV values was confirmed for both techniques, but it was higher when evaluated by ddPCR than qPCR (R = −0.393, p = 0.000053 vs R = −0.220, p = 0.028, respectively). When dividing subjects into two groups according to 500 mg/L Lp(a) cut-off value, a significantly lower number of KIV2 repeats emerged among subjects with greater Lp(a) levels, with stronger evidence in ddPCR than in qPCR (p = 0.000013 and p = 0.001, respectively).
Conclusions
Data obtained support a better performance of ddPCR in the evaluation of KIV2 repeat polymorphism.
{"title":"Digital droplet PCR versus quantitative PCR for lipoprotein (a) kringle IV type 2 repeat polymorphism genetic characterization","authors":"Giulia Barbieri, Giulia Cassioli, Ada Kura, Rebecca Orsi, Alberto Magi, Martina Berteotti, Giusi Maria Scaturro, Elena Lotti, Anna Maria Gori, Rossella Marcucci, Betti Giusti, Elena Sticchi","doi":"10.1002/jcla.24998","DOIUrl":"10.1002/jcla.24998","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Lipoprotein(a) [Lp(a)] level variability, related to atherothrombotic risk increase, is mainly attributed to <i>LPA</i> gene, encoding apolipoprotein(a), with kringle IV type 2 (KIV2) copy number variation (CNV) acting as the primary genetic determinant. Genetic characterization of Lp(a) is in continuous growth; nevertheless, the peculiar structural characteristics of this variant constitute a significant challenge to the development of effective detection methods. The aim of the study was to compare quantitative real-time PCR (qPCR) and digital droplet PCR (ddPCR) in the evaluation of KIV2 repeat polymorphism.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We analysed 100 subjects tested for cardiovascular risk in which Lp(a) plasma levels were assessed.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Correlation analysis between CNV values obtained with the two methods was slightly significant (<i>R</i> = 0.413, <i>p</i> = 0.00002), because of the wider data dispersion in qPCR compared with ddPCR. Internal controls C1, C2 and C3 measurements throughout different experimental sessions revealed the superior stability of ddPCR, which was supported by a reduced intra/inter-assay coefficient of variation determined in this method compared to qPCR. A significant inverse correlation between Lp(a) levels and CNV values was confirmed for both techniques, but it was higher when evaluated by ddPCR than qPCR (<i>R</i> = −0.393, <i>p</i> = 0.000053 vs <i>R</i> = −0.220, <i>p</i> = 0.028, respectively). When dividing subjects into two groups according to 500 mg/L Lp(a) cut-off value, a significantly lower number of KIV2 repeats emerged among subjects with greater Lp(a) levels, with stronger evidence in ddPCR than in qPCR (<i>p</i> = 0.000013 and <i>p</i> = 0.001, respectively).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Data obtained support a better performance of ddPCR in the evaluation of KIV2 repeat polymorphism.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.24998","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140039523","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
High-sensitivity C-reactive protein (hsCRP) is a sensitive marker of inflammation. This study aimed to determine whether increased hsCRP levels are associated with all-cause mortality rate.
Methods
We examined data for participants from the 2002 Nomura Cohort Study who attended follow-ups for 20 years (follow-up rate: 93.3%). Of these, 793 were male (aged 61 ± 14 years) and 1040 were female (aged 63 ± 11 years). The Japanese Basic Resident Registry provided data on adjusted relative hazards for all-cause mortality. The data were subjected to a Cox regression analysis using a time variable of age and confounding risk factors.
Results
The median (interquartile range) follow-up period was 6548 days (6094–7452 days). The follow-up confirmed that there were 632 (34.8%) deaths, of which 319 were male (40.2% of all males) and 313 were female (30.6% of all females). Multivariable-adjusted hazard ratio (1.27; 95% confidence interval, 1.01–1.59) in the highest hsCRP category was also significantly higher compared with reference. A higher hsCRP was associated with a greater risk of all-cause mortality in male participants aged ≥65 years, a BMI < 25 kg/m2, and no history of CVD or diabetes, and this association was particularly significant among participants with both of the latter two risk factors (p = 0.004 and 0.022 for interaction, respectively).
Conclusions
Our results indicate a significant association between hsCRP levels and all-cause mortality in a rural Japanese population. Specifically, hsCRP appears to be a crucial biomarker for predicting long-term survival, particularly among older persons.
{"title":"High-sensitivity C-reactive protein is a predictor of all-cause mortality in a rural Japanese population","authors":"Ryuichi Kawamoto, Asuka Kikuchi, Daisuke Niomiya, Teru Kumagi","doi":"10.1002/jcla.25015","DOIUrl":"10.1002/jcla.25015","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>High-sensitivity C-reactive protein (hsCRP) is a sensitive marker of inflammation. This study aimed to determine whether increased hsCRP levels are associated with all-cause mortality rate.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We examined data for participants from the 2002 Nomura Cohort Study who attended follow-ups for 20 years (follow-up rate: 93.3%). Of these, 793 were male (aged 61 ± 14 years) and 1040 were female (aged 63 ± 11 years). The Japanese Basic Resident Registry provided data on adjusted relative hazards for all-cause mortality. The data were subjected to a Cox regression analysis using a time variable of age and confounding risk factors.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The median (interquartile range) follow-up period was 6548 days (6094–7452 days). The follow-up confirmed that there were 632 (34.8%) deaths, of which 319 were male (40.2% of all males) and 313 were female (30.6% of all females). Multivariable-adjusted hazard ratio (1.27; 95% confidence interval, 1.01–1.59) in the highest hsCRP category was also significantly higher compared with reference. A higher hsCRP was associated with a greater risk of all-cause mortality in male participants aged ≥65 years, a BMI < 25 kg/m<sup>2</sup>, and no history of CVD or diabetes, and this association was particularly significant among participants with both of the latter two risk factors (<i>p</i> = 0.004 and 0.022 for interaction, respectively).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Our results indicate a significant association between hsCRP levels and all-cause mortality in a rural Japanese population. Specifically, hsCRP appears to be a crucial biomarker for predicting long-term survival, particularly among older persons.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.25015","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139990192","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Three-part differential (3PD) haematology analysers offer a quick, easy-to-use and economical way to acquire important information about a patient's physiology. In this study, we evaluated a new 3PD analyser, the Sysmex XQ-320, investigated its comparability with its predecessor (Sysmex XP-300) and the five-part differential analyser Sysmex XN-9000, and explored its flagging potential.
Methods
Analytical performance studies were conducted for repeatability, within-laboratory precision, between-day precision, carry-over and linearity with fresh blood and QC material. Method comparison was performed in 493 samples comparing XQ-320 with XP-300, using the XN-9000 as the gold standard.
Results
The XQ-320 excelled manufacturer's specifications in the analytical performance studies, except for MXD in within-laboratory and between-day precisions using the QC material level 1. The XQ-320 showed correlation values greater than 0.94 with XN-9000 for the majority of the 20 reportable parameters (MXD# 0.891, MXD% 0.898 and MCHC 0.849). Improvements over the XP-300 were observed in WBC in the leucocytopenic range (bias −0.038 vs. −0.097) and PLT (bias 2.568 vs. −7.877, intercept 3.880 vs. −8.845). Concordance between XQ-320 and XP-300 was 91.9% for the WBC histogram abnormal distribution flag and 95.3% for the PLT flag. Patterns of increased neutrophils and decreased mixed cells on the XQ-320 were observed in samples that raised a flag on XN-9000.
Conclusion
The XQ-320 showed excellent analytical performance, and very good to excellent correlation with XN-9000 with improvements over XP-300. Flagging combined with parameter patterns identified additional suspected abnormal samples, thus making the XQ-320 an excellent solution for laboratories utilising 3PD analysers.
{"title":"Evaluation of the Sysmex XQ-320 three-part differential haematology analyser and its flagging capabilities","authors":"Christine Coutaz, Adrien Mamin, Konstantinos Mintzas","doi":"10.1002/jcla.25017","DOIUrl":"10.1002/jcla.25017","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Three-part differential (3PD) haematology analysers offer a quick, easy-to-use and economical way to acquire important information about a patient's physiology. In this study, we evaluated a new 3PD analyser, the Sysmex XQ-320, investigated its comparability with its predecessor (Sysmex XP-300) and the five-part differential analyser Sysmex XN-9000, and explored its flagging potential.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Analytical performance studies were conducted for repeatability, within-laboratory precision, between-day precision, carry-over and linearity with fresh blood and QC material. Method comparison was performed in 493 samples comparing XQ-320 with XP-300, using the XN-9000 as the gold standard.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The XQ-320 excelled manufacturer's specifications in the analytical performance studies, except for MXD in within-laboratory and between-day precisions using the QC material level 1. The XQ-320 showed correlation values greater than 0.94 with XN-9000 for the majority of the 20 reportable parameters (MXD# 0.891, MXD% 0.898 and MCHC 0.849). Improvements over the XP-300 were observed in WBC in the leucocytopenic range (bias −0.038 vs. −0.097) and PLT (bias 2.568 vs. −7.877, intercept 3.880 vs. −8.845). Concordance between XQ-320 and XP-300 was 91.9% for the WBC histogram abnormal distribution flag and 95.3% for the PLT flag. Patterns of increased neutrophils and decreased mixed cells on the XQ-320 were observed in samples that raised a flag on XN-9000.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>The XQ-320 showed excellent analytical performance, and very good to excellent correlation with XN-9000 with improvements over XP-300. Flagging combined with parameter patterns identified additional suspected abnormal samples, thus making the XQ-320 an excellent solution for laboratories utilising 3PD analysers.</p>\u0000 </section>\u0000 </div>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.25017","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139939977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
We read with great interest the paper by Tian et al.1 titled “Clinical value of serum AFP and PIVKA-II for diagnosis, treatment and prognosis of hepatocellular carcinoma.” We congratulate Tian et al. for the excellent research, but some issues of the research warrant discussion.
In figure 2a, b in Ref. [1], serum AFP and PIVKA-II levels were compared pairwise among the five groups by rank sum test according to the introduction of statistical methods. Multiple testing in the five groups increased the chance of making type I errors; however, Tian et al. did not pay attention to this matter in their paper. There are many different methods to control type I errors in multiple testing, such as Bonferroni correction by controlling the family-wise error rate and the Benjamini–Hochberg procedure by controlling the false discovery rate.2, 3
The area under the receiver operating characteristic curve (AUROC) was calculated to assess diagnostic performance. Tian et al. found that the diagnostic value of the combined detection of AFP and PIVKA-II was greater than that of AFP and PIVKA-II alone, because the AUROC of the combination of AFP and PIVKA-II (0.975, 95% CI 0.956–0.994) was greater than that of AFP (0.903, 95% CI 0.862–0.944) and PIVKA-II (0.945, 95% CI 0.915–0.975) in comparison with HCC and benign liver disease. This conclusion appears to be arbitrary. It seems to be more rigorous that the statistical significance of difference between two AUROCs was evaluated by the Delong test.4
Despite the above-mentioned potential limitations, Tian et al. have made several contributions in assessing the role of serum AFP and PIVKA-II in the diagnosis, treatment, and prognosis of HCC.
The authors have no conflicts of interest to declare.
亲爱的编辑，我们饶有兴趣地阅读了Tian等人1的论文《血清甲胎蛋白和PIVKA-II对肝细胞癌诊断、治疗和预后的临床价值》。我们对 Tian 等人的出色研究表示祝贺，但研究中的一些问题值得讨论。在参考文献[1]的图 2a、b 中，根据统计学方法的介绍，采用秩和检验对 5 组血清 AFP 和 PIVKA-II 水平进行了配对比较。五组的多重检验增加了发生 I 型错误的几率，但 Tian 等人在他们的论文中没有注意到这一问题。控制多重检验中 I 型误差的方法有很多种，如通过控制族内误差率的 Bonferroni 校正法和通过控制误发现率的 Benjamini-Hochberg 程序。Tian等人发现，AFP和PIVKA-II联合检测的诊断价值大于AFP和PIVKA-II单独检测的诊断价值，因为与HCC和良性肝病相比，AFP和PIVKA-II联合检测的AUROC（0.975，95% CI 0.956-0.994）大于AFP（0.903，95% CI 0.862-0.944）和PIVKA-II（0.945，95% CI 0.915-0.975）。这一结论似乎有些武断。尽管存在上述潜在的局限性，Tian 等人在评估血清 AFP 和 PIVKA-II 在 HCC 诊断、治疗和预后中的作用方面做出了一些贡献。
{"title":"Clinical value of serum AFP and PIVKA-II for diagnosis, treatment and prognosis of hepatocellular carcinoma","authors":"Yujiao Jin, Aifang Xu","doi":"10.1002/jcla.25016","DOIUrl":"10.1002/jcla.25016","url":null,"abstract":"<p>Dear Editor,</p><p>We read with great interest the paper by Tian et al.<span><sup>1</sup></span> titled “Clinical value of serum AFP and PIVKA-II for diagnosis, treatment and prognosis of hepatocellular carcinoma.” We congratulate Tian et al. for the excellent research, but some issues of the research warrant discussion.</p><p>In figure 2a, b in Ref. [<span>1</span>], serum AFP and PIVKA-II levels were compared pairwise among the five groups by rank sum test according to the introduction of statistical methods. Multiple testing in the five groups increased the chance of making type I errors; however, Tian et al. did not pay attention to this matter in their paper. There are many different methods to control type I errors in multiple testing, such as Bonferroni correction by controlling the family-wise error rate and the Benjamini–Hochberg procedure by controlling the false discovery rate.<span><sup>2, 3</sup></span></p><p>The area under the receiver operating characteristic curve (AUROC) was calculated to assess diagnostic performance. Tian et al. found that the diagnostic value of the combined detection of AFP and PIVKA-II was greater than that of AFP and PIVKA-II alone, because the AUROC of the combination of AFP and PIVKA-II (0.975, 95% CI 0.956–0.994) was greater than that of AFP (0.903, 95% CI 0.862–0.944) and PIVKA-II (0.945, 95% CI 0.915–0.975) in comparison with HCC and benign liver disease. This conclusion appears to be arbitrary. It seems to be more rigorous that the statistical significance of difference between two AUROCs was evaluated by the Delong test.<span><sup>4</sup></span></p><p>Despite the above-mentioned potential limitations, Tian et al. have made several contributions in assessing the role of serum AFP and PIVKA-II in the diagnosis, treatment, and prognosis of HCC.</p><p>The authors have no conflicts of interest to declare.</p>","PeriodicalId":15509,"journal":{"name":"Journal of Clinical Laboratory Analysis","volume":null,"pages":null},"PeriodicalIF":2.7,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcla.25016","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139939976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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