iLABMED最新文献

{"title":"Accuracy evaluation of Roche Accu-Chek Performa blood glucose meters at low glucose concentrations: A nine-year retrospective study","authors":"Zhipeng Zhao,&nbsp;Runqing Li,&nbsp;Xiuying Zhao,&nbsp;Lina Zhang,&nbsp;Tengjiao Wang,&nbsp;Song Yang,&nbsp;Ning Han,&nbsp;Dong Zhu","doi":"10.1002/ila2.49","DOIUrl":"https://doi.org/10.1002/ila2.49","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>To evaluate the accuracy of Roche Accu-Chek Performa glucose meters at a low glucose concentration of &lt;5.55 mmol/L (100 mg/dL) over a 9-year period.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The accuracy of the Roche Accu-Chek Performa glucose meters at low glucose concentrations was evaluated using annual comparison data for 9 consecutive years from 2015 to 2023, according to the acceptability criteria specified in International Organization for Standardization (ISO) 15197:2013. Blood samples with low glucose concentrations of &lt;5.55 mmol/L were prepared by incubation and glycolysis. The glucose concentration was detected using Roche Accu-Chek Performa glucose meters and a biochemical analyzer in the central laboratory.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>A total of 2978 pairs of comparison results from 211 glucose meters at a low glucose concentration of &lt;5.55 mmol/L were retrospectively analyzed from 2015 to 2023. The clinical use duration spanned from 1 to 9 years and 40.76% (86 out of 211 glucose meters) had been used for more than 2 years. The correlation coefficient <i>r</i> between glucose meter measurements and laboratory reference values was 0.98 (<i>p</i> &lt; 0.001). The mean according to Roche Accu-Chek Performa glucose meters was 0.05 mmol/L (0.9 mg/dL) higher than that of the biochemical analyzer (<i>Z</i> = −13.82, <i>p</i> &lt; 0.0001). The results showed that 100.00% (211 out of 211) of the Roche Accu-Chek Performa glucose meters met the acceptability criteria specified in ISO 15197:2013. At a low glucose concentration of &lt;5.55 mmol/L, 99.90% (2975 out of 2978) of the comparative data pairs in the error distribution fell within the range of ±0.83 mmol/L (15 mg/dL). Parkes consensus error grid analysis showed that 100.00% (2978 out of 2978) of comparative data pairs fell within region A.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>This study demonstrated that Roche Accu-Chek Performa glucose meters successfully met the accuracy standards of ISO 15197:2013 for measuring blood glucose within the hypoglycemic range. Greater attention should be given to the performance of blood glucose monitoring systems in the low glycemic range, especially for patients with diabetes who are prone to hypoglycemia and require precise measurements.</p>\u0000 </section>\u0000 </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 3","pages":"141-148"},"PeriodicalIF":0.0,"publicationDate":"2024-06-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.49","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142404804","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}

{"title":"A case of central nervous system infection with Scedosporium boydii","authors":"Zhen Cai,&nbsp;Dongchao Pan,&nbsp;Ronghua Geng,&nbsp;Jidi Fu,&nbsp;Fen Qu","doi":"10.1002/ila2.48","DOIUrl":"10.1002/ila2.48","url":null,"abstract":"<p><i>Scedosporium boydii</i> is considered an opportunist fungal pathogen in immunocompromised patients. It also causes serious and fatal central nervous system infections. In this study, a man with brain abscesses infected with <i>S</i>. <i>boydii</i> was diagnosed using multiple methods, including microscopy, culture combined with Matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MOLDI-TOF MS), internal transcribed spacer sequencing and Metagenomic next-generation sequencing (mNGS). This successful diagnosis highlights the importance of using a variety of techniques to identify and treat infections caused by this dangerous fungus.</p>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 3","pages":"221-225"},"PeriodicalIF":0.0,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.48","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141359769","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}

{"title":"Hypermethylation of GSTM5 and its effect on oxidation in myelodysplastic syndrome","authors":"Chi Wang,&nbsp;Yafei Yu,&nbsp;Qing Chang,&nbsp;Tengteng Dong,&nbsp;Liye Wang,&nbsp;Mianyang Li","doi":"10.1002/ila2.47","DOIUrl":"10.1002/ila2.47","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Hypermethylation of glutathione-S-transferase 5 (<i>GSTM5</i>) and its effect on oxidation in the pathogenesis of myelodysplastic syndrome (MDS) were investigated.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p><i>GSTM5</i> methylation was detected in bone marrow (BM) samples from MDS patients, acute myeloid leukemia (AML) patients, and control individuals using methylation-specific PCR and MassARRAY analysis. Bisulfite sequencing PCR was performed to verify methylation levels, while mRNA levels were determined using reverse transcription polymerase chain reaction. Correlations between <i>GSTM5</i> methylation and clinical parameters were analyzed. The MDS cell line, SKM-1, was treated with decitabine, buthionine sulfoximine, or overexpression of <i>GSTM5</i>, and the glutathione level and cell viability were detected.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The MassARRAY analysis revealed significant differences in <i>GSTM5</i> methylation levels between the MDS and control groups. <i>GSTM5</i> methylation levels were significantly increased in the high-risk subgroup and showed a significant association with MDS progression to AML (hazard ratio = 3.6). Levels of <i>GSTM5</i> mRNA were significantly decreased in the MDS group, exhibiting a negative correlation with the <i>GSTM5</i> gene methylation level. Normal BM HS-5 cells exhibited significantly lower levels of <i>GSTM5</i> methylation than SKM-1 cells. Overexpression of <i>GSTM5</i> in SKM-1 cells or treatment with buthionine sulfoximine or decitabine resulted in inhibition of proliferation and significantly decreased glutathione levels.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p><i>GSTM5</i> plays an anti-oxidative role in MDS and the tumor suppressor effect of <i>GSTM5</i> may be mediated by reducing glutathione levels. <i>GSTM5</i> hypermethylation and low levels of <i>GSTM5</i> expression may be prognostic markers for MDS.</p>\u0000 </section>\u0000 </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 2","pages":"108-124"},"PeriodicalIF":0.0,"publicationDate":"2024-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.47","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141357612","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}

{"title":"Bridging the divide: Harmonizing polarized clinical laboratory medicine practices","authors":"Yi-Wei Tang,&nbsp;Joseph D. Yao","doi":"10.1002/ila2.46","DOIUrl":"https://doi.org/10.1002/ila2.46","url":null,"abstract":"<p>In today's healthcare, clinical laboratory medicine stands as a cornerstone of patient care, providing vital diagnostic insights that inform decisions in disease management. Yet, within this crucial field, a dichotomy persists between two predominant models of laboratory testing to support clinical practice: point-of-care testing (PoCT) and central laboratory testing [<span>1</span>]. This schism, while born of practical necessity and evolving technology, presents both opportunities and challenges that warrant closer examination.</p><p>Point-of-care testing, characterized by its immediacy and accessibility, offers rapid results at or near the patient's location, facilitating swift clinical interventions and enhancing patient satisfaction [<span>2</span>]. Devices used for PoCT are often compact and portable, enabling testing in diverse settings, from emergency departments to remote clinics [<span>3</span>]. This model provides healthcare providers with real-time data to make timely care decision, as a result of reducing the time to diagnosis and treatment initiation.</p><p>Conversely, central laboratory testing operates on a larger scale, often in dedicated facilities equipped with advanced instrumentation and automation. Central clinical laboratories boast a wide menu of tests, offering comprehensive diagnostic capabilities that encompass a spectrum of medical specialties. Standardization and quality control measures are rigorously enforced, ensuring the sensitivity, reliability, and accuracy of test results. Furthermore, central laboratories facilitate economies of scale, driving down costs and promoting efficiency in resource utilization.</p><p>However, this division between PoCT and central laboratory testing has fostered challenges in interoperability, data management, and standardization. Integration of PoCT results into electronic health records (EHR) remains a significant hurdle, limiting the seamless exchange of clinical data across different care settings [<span>4</span>]. In addition, differences in testing methods and quality assurance protocols between PoCT devices and central laboratory assays may introduce discrepancies in results and interpretation of results, posing risks to patient safety and clinical decision-making.</p><p>Yet, amidst these challenges, there exists a growing recognition of the need for synergy between PoCT and central laboratory testing. Collaborative efforts are underway to bridge the gap, leveraging technological innovations to enhance connectivity, streamlining data exchange, and harmonizing testing methods across different care settings. Interoperable EHR systems and middleware solutions are facilitating the seamless integration of PoCT results into central laboratory databases and EHR, fostering an integrated approach to patient care.</p><p>Furthermore, advancements in point-of-care technologies, such as lab-on-a-chip devices, hand-held devices, and mobile phone applications, hold promise in expanding t","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 2","pages":"67-69"},"PeriodicalIF":0.0,"publicationDate":"2024-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.46","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141435642","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}

{"title":"The exploration of cell population data in clinical use: Beyond infectious diseases","authors":"Shayuanzi Huang,&nbsp;Yin Liu,&nbsp;Liu Qian,&nbsp;Juan Zhou,&nbsp;Dong Wang","doi":"10.1002/ila2.41","DOIUrl":"10.1002/ila2.41","url":null,"abstract":"<p>Cell population data (CPD) is regarded as the fingerprint of a blood cell at a given moment. CPD parameters harbor information associated with cell morphology and can be automatically generated using modern hematological analyzers. Various studies have revealed many unique clinical applications for CPD, especially for infectious diseases, such as sepsis. For example, one monocyte-related CPD parameter is the monocyte distribution width (MDW), which can be generated using a Beckman Coulter hematological analyzer. MDW has received FDA and CE approval for aiding in sepsis diagnosis in adult patients in the emergency department. Additionally, MDW can serve as a diagnostic biomarker in patients infected with SARS-CoV-2. CPD has also been widely explored for possible clinical applications beyond infectious diseases, such as for predicting myelodysplastic syndromes, screening for hematological malignancies, and detecting sterile inflammation. CPD parameter measurements are easily obtained and quite cost-effective, making them practical for clinical use. However, there are some potential drawbacks of CPD parameters. Some pre-analytical conditions can affect CPD values. Furthermore, CPD are specific to certain hematological analyzers and the result cannot be transferred between different analyzers. The practical usefulness of CPD reference intervals is also still questionable. In this review, wesummarize the current studies related to CPD and its clinical applications. Additional well-designed clinical studies related to CPD are still expected.</p>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 2","pages":"125-140"},"PeriodicalIF":0.0,"publicationDate":"2024-05-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.41","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141123160","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}

{"title":"Candidate reference measurement procedure for serum 17-hydroxyprogesterone quantification via isotope dilution liquid chromatography–tandem mass spectrometry","authors":"Ji Zhang,&nbsp;Yang Jiang,&nbsp;Ting Liu,&nbsp;Xiongwei Liu,&nbsp;Hui Huang,&nbsp;Yanxiang Cheng,&nbsp;Jieyan Li,&nbsp;Bangning Cheng,&nbsp;Chungen Qian,&nbsp;Xufu Xiang,&nbsp;Jun-Fa Xu","doi":"10.1002/ila2.39","DOIUrl":"10.1002/ila2.39","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Accurate quantification of 17-hydroxyprogesterone (17-OHP) in serum is vital for clinical and research applications. However, inter-laboratory variability in test results exists owing to the lack of a standardized reference measurement procedure (RMP). Therefore, in this study, we developed a highly accurate, cost-effective, and user-friendly candidate RMP (cRMP) for analyzing 17-OHP in serum.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>We quantified 17-OHP in serum using a one-step liquid–liquid extraction method with the addition of 17-OHP-¹³C₃, followed by liquid chromatography–tandem mass spectrometry. The ability of these methods to suppress interference was evaluated by chromatographic analysis. We assessed accuracy, specificity, the lower limit of quantitation, linearity, and matrix effects by following the standards specified by the Clinical and Laboratory Standards Institute. The consistency between the developed cRMP and the chemiluminescence method was evaluated through experiments with 120 clinical samples.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The developed cRMP required only 8 min for accurate quantification of serum 17-OHP without bias from matrix effects or interference from 19 metabolites added as potential interferents. The method exhibited favorable measurement performance, with a quantitation limit of 0.086 ng/mL, linear range of 0.1–400 ng/mL, a total imprecision of ≤2.90%, spike recovery of 100.1%–100.6%, and relative deviations from assigned target values (RfB Institution) of −2.91% to 1.10%. The cRMP demonstrated good consistency with the conventional assay (chemiluminescence method), with a correlation coefficient <i>R</i> of 0.96977.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusion</h3>\u0000 \u0000 <p>A cRMP with high accuracy, cost-effectiveness, and convenient operation was developed for quantifying 17-OHP in serum. Its simplicity and robust performance make it an invaluable addition to the arsenal of analytical tools available for laboratories. This method can enhance the accuracy and reliability of 17-OHP measurements across various laboratories.</p>\u0000 </section>\u0000 </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 2","pages":"98-107"},"PeriodicalIF":0.0,"publicationDate":"2024-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.39","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140655961","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}

{"title":"Concomitant and sequential administration of nirmatrelvir-ritonavir and azvudine in patients with COVID-19 caused by the Omicron variant: Safety and efficacy","authors":"Guang-Bin Chen,&nbsp;You-Rou Zheng,&nbsp;Yun-Ni Yu,&nbsp;Li-Mian Liang,&nbsp;Chao Chen,&nbsp;Ying-Xia Liu,&nbsp;Hong-Zhou Lu","doi":"10.1002/ila2.40","DOIUrl":"10.1002/ila2.40","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>This study assessed the safety and efficacy of nirmatrelvir-ritonavir (Paxlovid®) and azvudine when administered sequentially or concomitantly in patients with coronavirus 2019 (COVID-19) caused by the Omicron variant.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>Ninety-three patients confirmed to be infected with the Omicron variant by nucleic acid detection were retrospectively investigated. Information was collected on general health status, medication, and adverse drug reactions (ADRs) according to whether nirmatrelvir-ritonavir and azvudine were administered sequentially or concomitantly. Data on times of onset, clinical manifestations, and outcomes of ADRs and on conversion to a negative nucleic acid test were also recorded.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Possible ADRs were recorded in 41 patients (44.1%). There were 22 gastrointestinal reactions in 18 patients and 18 hematological abnormalities in 16 after sequential or concomitant treatment with nirmatrelvir-ritonavir and azvudine. Liver enzyme levels increased in nine cases and creatinine clearance decreased in two. Cases of atrial fibrillation (<i>n</i> = 1), sleep disorder (<i>n</i> = 2), rash (<i>n</i> = 2), dizziness (<i>n</i> = 1), and weakness (<i>n</i> = 5) were also documented. Only vomiting, poor appetite, diarrhea, xerostomia, bitter taste, and rash were considered probable ADRs; others were thought to be possible ADRs. In all cases, the nucleic acid test did not turn negative after the first antiviral was applied. The nucleic acid test of 28 patients did not turn negative before discharge. The remaining 65 patients (69.9%) returned a negative nucleic acid test after receiving the second antiviral agent.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Treatment with nirmatrelvir-ritonavir and azvudine is safe and effective whether administered sequentially or concomitantly in patients with COVID-19 caused by the Omicron variant.</p>\u0000 </section>\u0000 </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 2","pages":"88-97"},"PeriodicalIF":0.0,"publicationDate":"2024-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.40","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140675770","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}

{"title":"Clinical characteristics and risk factors for mortality in Candida auris infections","authors":"Kang Li,&nbsp;Xin Liu,&nbsp;Danfeng Liu,&nbsp;Yuqi Zhi,&nbsp;Chang Dong,&nbsp;Pengrui Sun,&nbsp;Yueming Dong,&nbsp;Hongfang Pan,&nbsp;Yuxiang Zhang,&nbsp;Hong Lei","doi":"10.1002/ila2.38","DOIUrl":"https://doi.org/10.1002/ila2.38","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p><i>Candida auris</i> infections pose a threat to public health, necessitating increased awareness in China. This study aimed to analyze the strains of <i>C</i>. <i>auris</i>, assess the infection status, and investigate clinical characteristics and risk factors for mortality.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>A retrospective analysis was conducted on 18 patients with <i>Candida auris</i> infection. We focused on evaluating basic characteristics, strain sources, and antibacterial susceptibility test results. Statistical methods were used to determine clinical features and identify risk factors for death.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>The strain type, composition ratio, and specimen source of <i>C</i>. <i>auris</i> were not associated with mortality. Neither the infection index nor the length of hospitalization showed an association with the prognosis. However, significant risk factors for mortality included cerebral infarction, cardiac disease, renal dysfunction, hypoproteinemia, and anemia (all <i>p</i> &lt; 0.05).</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Cerebral infarction, cardiac disease, renal dysfunction, hypoproteinemia, and anemia are significant risk factors for death in <i>C</i>. <i>auris</i> infections. These findings indicate the importance of recognizing and addressing these factors in the clinical management of <i>C</i>. <i>auris infection</i>.</p>\u0000 </section>\u0000 </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 2","pages":"79-87"},"PeriodicalIF":0.0,"publicationDate":"2024-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.38","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141435644","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}

{"title":"Differences in the system accuracy acceptability of four types of blood glucose monitoring systems against five different standards","authors":"Tengjiao Wang,&nbsp;Lina Zhang,&nbsp;Lijun Gong,&nbsp;Yangmei Xin,&nbsp;Liang Han,&nbsp;Na Li,&nbsp;Peng Peng,&nbsp;Xiuying Zhao,&nbsp;Runqing Li","doi":"10.1002/ila2.37","DOIUrl":"10.1002/ila2.37","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Objective</h3>\u0000 \u0000 <p>This study aimed to evaluate the system accuracy of four types of blood glucose monitoring systems (BGMSs) and explore the differences in the system accuracy acceptability of each BGMS against five different standards.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Methods</h3>\u0000 \u0000 <p>The glucose measurement values obtained from four types of BGMSs (Roche Accu-Chek^® Performa, Bayer Contour™ TS, Sinomedisite Glupad^® H1 Plus, and Sinocare^® Gold-Accu) were evaluated against the reference values obtained from the biochemical analyzer of the central laboratory. The system accuracy acceptability of each BGMS was determined using the criteria specified in five standards, namely the International Organization for Standardization (ISO) 15197:2003, Clinical Laboratory Standards Institute (CLSI) POCT12-A3, ISO 15197:2013, Chinese Society of Laboratory Medicine (CSLM) consensus, and US Food and Drug Administration (FDA) guidelines.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>From 2018 to 2022, 10,980 pairs of measurement values were obtained from 366 glucose meters of four types of BGMSs. Significant correlations were observed between the glucose measurement values from the BGMSs and the reference values from the biochemical analyzer of the central laboratory. The correlation coefficient <i>r</i> was 0.995 for Roche Accu-Chek^® Performa, 0.994 for Bayer Contour™ TS, 0.983 for Sinomedisite Glupad^® H1 Plus, and 0.997 for Sinocare^® Gold-Accu. The acceptability criteria specified in ISO 15197:2003 were met by 100.00% (135/135) of the glucose meters of Roche Accu-Chek^® Performa, 100.00% (109/109) of Bayer Contour™ TS, 81.61% (71/87) of Sinomedisite Glupad^® H1 Plus, and 100.00% (35/35) of Sinocare^® Gold-Accu. Whereas, the acceptability criteria specified in ISO 15197:2013 were met by 99.26% (134/135) of the glucose meters of Roche Accu-Chek^® Performa, 88.07% (96/109) of Bayer Contour™ TS, 58.62% (51/87) of Sinomedisite Glupad^® H1 Plus, and 91.43% (32/35) of Sinocare^® Gold-Accu.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Conclusions</h3>\u0000 \u0000 <p>Among the four types of BGMSs evaluated, the glucose meters of Roche Accu-Chek^® Performa exhibited superior system accuracy. The system accuracy acceptability of each BGMS varied significantly against the acceptability criteria specified in the five different standards.</p>\u0000 </section>\u0000 </div>","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 2","pages":"70-78"},"PeriodicalIF":0.0,"publicationDate":"2024-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.37","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140224341","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}

{"title":"A preliminary study of the mechanism of compound hearing loss caused by ototoxic drugs combined with impulse noise","authors":"Xin Qiu,&nbsp;Qing-qing Jiang,&nbsp;Wei-wei Guo,&nbsp;Ning Yu,&nbsp;Shi-ming Yang","doi":"10.1002/ila2.34","DOIUrl":"10.1002/ila2.34","url":null,"abstract":"<div>\u0000 \u0000 \u0000 <section>\u0000 \u0000 <h3> Background</h3>\u0000 \u0000 <p>Hearing loss (HL) is becoming increasingly common and is more commonly caused by noise, ototoxic substances, or a combination of ototoxic factors. However, so far, few studies have examined the mechanism by which compound factors cause HL. The only relevant study is about occupational ototoxic substances combined with environmental noise at 85–110 dB SPL. In this study, to address the shortcomings of existing research, we innovatively focused on HL induced by loud noise (impulse noise, &gt;160 dB SPL) combined with common ototoxic drugs. The aim of this study was to establish and validate a mature animal model, and then to compare the characteristics of audiology, pathomorphology and molecular features, and to preliminarily predict pathogenesis in compound HL.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Materials and Methods</h3>\u0000 \u0000 <p>We selected guinea pigs to construct in vivo HL model groups for different extents of exposure, including a blank control group, a single-drug group, a single-impulse noise group, and a compound group. The animal model of the mature compound HL group was established using gentamicin combined with impulse noise. We then performed audiological and pathological verification. We analyzed the auditory brainstem response (ABR), pathological morphology of the cochlea, and molecules (including important self-radicals, cytokines, and apoptosis signal transduction pathway proteins in the pathogenesis of drug- and noise-induced HL), compared the effect of different extents of exposure on HL, and preliminarily predict the pathogenic mechanism of compound HL.</p>\u0000 </section>\u0000 \u0000 <section>\u0000 \u0000 <h3> Results</h3>\u0000 \u0000 <p>Four groups of animal models were established successfully and verified by audiology and pathology. Regarding audiology, there were no significant differences in the ABR thresholds before exposure (<i>p</i> &gt; 0.05), but differences emerged among the groups after exposure. Notably, after 3, 7, and 14 days of exposure, there were significant differences in the ABR thresholds between the compound group and both the drug and noise groups (<i>p</i> &lt; 0.01), and after 14 days, the HL of the compound group was much more severe (greater than the linear sum of single-factor HL group). Regarding the pathomorphology, compared with the control group, the cochleae were damaged to different degrees in the factor exposure groups. The drug group had the least severe HL, the noise group had serious HL (<i>p</i> &lt; 0.05), and the compound group had the most severe HL (<i>p</i> &lt; 0.01). The compound group's damage was greater than the linear sum of the single-factor group in many ways, such as the loss and damage o","PeriodicalId":100656,"journal":{"name":"iLABMED","volume":"2 1","pages":"38-52"},"PeriodicalIF":0.0,"publicationDate":"2024-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/ila2.34","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140245830","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}