Clinical chemistry最新文献

{"title":"A-355 Comparison of Arterial and Venous Whole Blood Samples Analyzed on the QuantraSystem With the QPlusand QStatCartridges","authors":"A A Uribe, A Flores, J Fiorda-Diaz, E Vera-Miquilena, J Reeves, B Applegate, A Waldron, G Oldendorp, F Viola, D Winegar","doi":"10.1093/clinchem/hvae106.349","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.349","url":null,"abstract":"Background The Quantra Hemostasis System (HemoSonics, LLC) is a cartridge-based viscoelastic testing system used to monitor the coagulation status of whole blood samples. The clinical performance of the System with the QPlus and QStat Cartridges was demonstrated in patients undergoing surgical procedures using venous blood samples. However, depending on the nature of the surgical procedure, arterial or venous samples may be more accessible for testing. It is currently unknown if differences exist between the two samples for the Quantra System. This study compared QPlus and QStat parameters measurements in venous and arterial blood samples collected in parallel from patients undergoing cardiac or liver transplant surgery. Methods Two studies were conducted according to CLSI EP09. The cardiac study enrolled 50 adult patients undergoing cardiac surgery utilizing cardiopulmonary bypass to evaluate QPlus parameters. Matching arterial and venous samples were obtained at two time points: during bypass and post-protamine. The liver study enrolled 25 adult patients undergoing liver transplantation to evaluate QStat parameters. Matching arterial and venous samples from were obtained at three time points: baseline, anhepatic and reperfusion phases. All arterial samples were drawn from an existing arterial catheter whereas venous samples were drawn from the venous side of the bypass circuit or from the central venous catheter (proximal port to minimize infusion contamination). Linear regression analysis and means comparison (paired t-test) were used to assess whether the two sample types provided equivalent results, Results Table 1 provides the mean values for each parameter determined for venous and arterial samples. None of the parameters showed a significant difference between sample types (P > 0.05). Additionally, the linear regression analysis show strong correlation between the results for each parameter. Conclusions Both studies demonstrated that venous and arterial whole blood samples provide equivalent results on the Quantra System with the QPlus and QStat Cartridges.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"40 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-013 Improving the Workflow of Blood and Coagulation Tests in clinical laboratory through the Utilization of Laboratory Automation Track Systems","authors":"M Yang, H Hsieh, C LEE","doi":"10.1093/clinchem/hvae106.377","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.377","url":null,"abstract":"Background The Laboratory Automation Track System (TLA) is an automated system designed for executing highly repetitive tasks within a laboratory, commonly applied in biochemical and immunological testing systems. It aims to reduce human errors in specimen handling, enhance the overall process quality, and provide better Turnaround Time (TAT) from specimen collection to result reporting. For the first time in our laboratory, we have integrated the blood and coagulation systems with TLA. Consequently, we seek to evaluate the differences in the testing workflow and reporting efficiency of the blood and coagulation systems after being connected to TLA. Methods Abbott GLP systems Track was the TLA system for connecting with blood and coagulation systems. Two Sysmex XN-9100 fully automatic hematology systems and two Sysmex CS-5100 fully automatic coagulation analyzers were developed for blood and coagulation system, respectively. TUNYEN Laboratory Information System was established for Laboratory information system (LIS). Results Through the analysis of quality indicators and integration with intelligent information systems, improvements have been made, including the reduction of blood collection tube usage, efficient manpower utilization management, tracking of specimen progress and achievement of timely reporting rates.(1)Approximately 2,915 blood collection test tubes are saved every month, with a converted cost of 0.15 USD per tube, and a total saving of 437 USD. And reduce the carbon emissions of 32 kgCO2e, comply with the spirit of ESG sustainable development.(2)The TLA no longer requires staff to collect and deliver specimens as in the past,reducing staff and enhancing work efficiency.One of manpower was saved and new inspection items were developed.(3)Tracking of specimen progress:The laboratory has set up a specimen tracking system to monitor the specimen delivery location and provide timely response to the clinical status.The one-hour TAT for blood and coagulation increased from 82.0% and 76.9% before improvement to 91.8% and 93.3% after improvement respectively. Conclusions The implementation of Laboratory Automation Track Systems (TLA) leads to a reduction in medical errors and specimen sample volume, while also enhancing accuracy and precision, thereby improving the safety of laboratory staff. Although the introduction of TLA may require an initial investment, it brings the benefits of automation, offering ease and efficiency to laboratory processes.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"23 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362985","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-017 Benchtop glyco-analyzer: from development of biomarker to potential use in clinical setting","authors":"H Shimazaki, S Fuseya, A Ono, H Ootani, S Mizukado, T Obayashi, N Tanaka, K Kajiyama, M Ashitomi, K Yamauchi, S Yasuda, T Miyabe, K Nakamura, O Segawa, A Kuno, K Sawakami","doi":"10.1093/clinchem/hvae106.381","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.381","url":null,"abstract":"Background Disease-related glycan alteration has attracted much attention as a promising biomarker candidate, especially in cancer or inflammation related diseases. Lectin is a naturally occurring functional protein that recognizes various glycan moieties and has a long history of use in glycan research. In the effort of omics-based biomarker development, lectin microarray (LMA), has accelerated the discovery of glyco-alteration and the candidate verification with high sensitivity in detection and simplicity in sample pretreatment. However, large-scale validation is still challenging because of the manual operation process and chip lot-to-lot variation in LMA. Methods An automated analytical system, GlycoBIST1-3, a milli-sized lectin bead array handled by simple robotics, was used. To overcome the above issue, we improved the simplicity and throughput by shortening all reaction processes to be completed around 30 min and adopting a touch panel interface. For an entry of analysis, a “standard tip” comprising 15 lectins with different binding specificities was designed, which can be produced in a thousand scale of the same lot. The utility was evaluated using 12 polyacrylamide (PAA)-glycan conjugates. The reliability was confirmed by repeatability tests and long-term storage tests. A lectin/antibody hybrid bead array using the antibody against a target biomarker was adopted to detect glyco-alteration more precisely. Results Twelve different PAA-glycan conjugated with mono/di-/trisaccharides clearly highlighted distinct binding specificities of 15 lectins in the standard tip. In a within-run reproducibility test, the measurement results indicated that the maximum CV value was 13.5%, and the average CV for the 15 lectins was 8.2%. A day-to-day reproducibility test showed that most lectins had a CV of less than 10% during 5-days. For the first multilectin/antibody beads array application, serum M2BP, whose glycosylation isomer has been used as a liver fibrosis marker approved by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan 4,5, was verified. M2BP was preliminarily immunoprecipitated from HCC sera and then subjected to the glycan profiling with an automatic 32-min operation for the hybrid beads array. The preliminary data was consistent with that of the lectin microarray, suggesting the possibility of M2BP subtyping. Conclusions A fully automated glyco-analyzer has realized rapid glycan analysis in around 30 minutes with sufficient accuracy and versatility. With the ability to detect glycan qualitative change on a target protein, it would help to detect disease-related glycan alteration more precisely, leading to the development of an effective glyco-biomarker. This rapid and user-friendly system would accelerate glyco-biomarker development, including the validation phase, and could be used in clinical settings in the future. Reference: 1) Shimazaki, H., et al. Anal. Chem. 2019, 91; 11162-11169, 2) Shimazaki, H., et al. Curr. Protoc. ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"48 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362940","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-367 Development of a Multimodal Point-of-Care Diagnostic Platform to Perform Rapid, Accurate, and Cost-Effective Molecular, Immunochemistry, Clinical Chemistry, and Cytometry Tests","authors":"E Charrault, K Chew, A Habibi, T Ramezan, K Currier, C So, A Banaszczyk, S Bai, V Niu, K Lai, W Chang, D Caron, K Pham, O Ghosh, R Khan, B Milbes, H Swadia, J Chien, K Sathyamoorthy, P Naranatt, S Maktabi, A Singh, T Patel, F Izadi Kharazi, R Heltsley","doi":"10.1093/clinchem/hvae106.361","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.361","url":null,"abstract":"Background Access to point-of-care (POC) testing can make a significant impact on the quality of care. However, because POC diagnostic platforms available today are expensive and only perform one type of test, clinicians are unable to implement all the POC tests they wish to perform. Fluxergy is developing a multimodal POC diagnostic platform that consolidates diverse diagnostic modalities into a single, compact platform to minimize the cost of POC testing and standardize testing workflow for the most common clinical chemistry, hematology, immunochemistry and molecular tests. This study describes feasibility studies performed to benchmark these assay modalities on the Fluxergy Analyzer. Methods Fluxergy Analyzer: The Fluxergy Analyzer integrates conventional detection systems—colorimetric, fluorometric, and electrochemical—into a singular POC platform. This unique design expands -omics testing capabilities, including molecular, immunochemistry, clinical chemistry, and hematology within a single instrument. Benchmarking Feasibility Studies: Molecular benchmarking was performed using a multiplex respiratory panel on contrived samples in UTM/VTM. Immunochemistry benchmarking was performed using a procalcitonin assay on spiked sodium citrate plasma samples. Cytometry benchmarking was performed using a white blood cell count (WBC) assay and testing contrived samples whole blood samples. Results For molecular testing, the Fluxergy Analyzer was able to accurately detect flu A, flu B, SARS-CoV-2, and RSV with agreements with the Luminex ARIES® Flu A/B & RSV Assay and Cepheid Xpert® SARS-CoV-2 test results. For immunochemistry testing, the Fluxergy Analyzer accurate quantified PCT levels at 0.3, 0.6, 1.25 and 2.5 ng/mL. For hematology testing, the Fluxergy Analyzer demonstrated a strong correlation across the reportable range against the standard of care HemoCue analyzer. For clinical chemistry testing, the Fluxergy Analyzer demonstrated a strong correlation against the Siemen’s epoc® Blood Analysis System. Conclusions The Fluxergy Analyzer is uniquely suited to offer a comprehensive menu of the most common POC tests on a single, cost-effective platform.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"76 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362971","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-010 Intercomparison Study of Methods between Atellica Solution® and CI® Analyzers for Sodium, Potassium, and Chloride","authors":"S Garcia-Valdecasas, S Lapeña-Garcia, M Ruiz-Alvarez, T Costales-Lucia, A Moreno-Romero, S Molina-Blas, M Barrionuevo-Gonzalez","doi":"10.1093/clinchem/hvae106.374","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.374","url":null,"abstract":"Background Method verification is an essential analysis routinely conducted in accredited Clinical Laboratories whenever a change of method or instrument for a specific analyte is desired. Objectives The aim of the study is to verify that the results measured by the Atellica Solution® analyzer (Siemens) and the new CI® analyzer (Siemens) for Sodium, Potassium, and Chloride are interchangeable. Methods To conduct the intercomparison study of Sodium, Potassium, and Chloride, the techniques were properly calibrated and controlled on both analyzers. For each assay, 40 patient samples were selected, covering the entire measurement range, and analyzed by both instruments. To determine the degree of agreement between the instruments, a Bland Altman analysis of mean differences and a Passing Bablok regression were performed. Statistics are expressed with their 95% confidence intervals (CI). The evaluation of results was carried out using the statistical program Method Validator. Results In both the Bland-Altman and Passing Bablok regression analyses, a slight constant systematic error was detected for all three assays, as the 95% confidence interval of the observed mean difference and the 95% confidence interval of the intercept of the regression line do not include zero. No systematic proportional differences were observed based on the slope, as the 95% confidence interval includes the value one Conclusions The small constant systematic differences found in the analyses should be re-evaluated after performing a new calibration of the methods. In none of the cases are the differences clinically significant, as they do not exceed the total error established in our quality specification. Therefore, it can be concluded that the Atellica Solution® and CI 1900® analyzers are interchangeable for Sodium, Potassium, and Chloride assays","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"48 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362972","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-195 Accelerating Molecular Diagnostics: Development of a novel Rapid, Integrated PCR System for Acute Respiratory Infections Detection","authors":"T Ma, L Dong, H Chen, Z Lv, J Chen, Y Yang","doi":"10.1093/clinchem/hvae106.555","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.555","url":null,"abstract":"Background The COVID-19 pandemic and acute respiratory infections have underscored the necessity for high-throughput and timely molecular diagnostics. Existing molecular diagnostic methods are labor-intensive, a challenge particularly evident in large-scale testing. This study aims to streamline the nucleic acid testing process by integrating extraction and detection in PCR testing, thereby optimizing efficiency. Methods We developed 'EXP-160R', an integrated PCR system capable of rapid thermal cycling. This innovation employs advanced temperature control technology to markedly reduce heating, cooling, and annealing-extension times. The PCR reagent-kit (Zybio Inc.) was optimized to complement the instrument's capabilities, aiming for pathogen nucleic acid detection in acute respiratory infections within 25 minutes. The precision of in-tube temperature during rapid amplification was validated by using temperature-sensitive molecular probes in system development stage. Performance evaluation used the WHO International Standard for SARS-CoV-2 RNA to assess sensitivity and detection limits. We also analyzed 500 clinical samples from multiple Chinese hospitals, including 295 COVID-19 positives and 205 negatives, comparing the EXP-160R system's performance with an NMPA-approved PCR kit. Results The innovative system significantly improved PCR cycle times, enabling detection of 16 samples in 22 minutes and a throughput of 2400 tests per day, without compromising sensitivity or specificity. Validation confirmed a detection limit of 200 copies/mL, and the system achieved a 100% detection rate for medium and high viral load samples, with a coefficient of variation (CV) for Ct values ≤ 5%. Clinical trial comparisons with clinical standard diagnostics revealed a sensitivity of 98.05%, specificity of 100%, accuracy of 99.2%, and a Kappa coefficient of 0.984. When compared to the established PCR kit, our system showed comparable efficacy, with a sensitivity of 98.50%, specificity of 98.67%, accuracy of 98.6%, and a Kappa of 0.971. Conclusions The rapid PCR system represents a significant advancement in molecular diagnostics, offering rapid, high-throughput, and accurate detection of SARS-CoV-2. This system is particularly beneficial in urgent testing scenarios, such as airports and fever clinics. It addresses current pandemic needs and sets a new benchmark for future respiratory and infectious disease diagnostics, enhancing both efficiency and user experience.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"25 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142369003","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-296 Streck Urine Preserve Provides Sample Stability for Cepheid Xpert CT/NG test","authors":"C M Connelly, J Li","doi":"10.1093/clinchem/hvae106.293","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.293","url":null,"abstract":"Background Sexually transmitted infections (STIs) are one of the most common communicable diseases worldwide and are associated with significant morbidity and mortality. Data indicates that the four curable STIs - chlamydia, gonorrhea, trichomoniasis, and syphilis - cause over 375 million infections annually. Further, the infection rate for gonorrhea has increased by 63% in the United States and the emergence of resistant gonorrhea is an urgent global public health concern. To prevent transmission of gonorrhea and other curable STIs and minimize the escalation of untreated infections, early and effective prevention and control strategies are paramount. Rapid diagnostic testing and nucleic acid amplification tests (NAATs) have become the gold standard for STI detection. However, limited global access to these technologies often requires that samples be shipped to central laboratories for analysis. Current protocols recommend that neat urine be analyzed within 24 hours of collection if stored at 2 °C to 8 °C or within four days if frozen, as prolonged storage and exposure to freeze-thaws can induce cell lysis and release of nucleases, leading to degradation of DNA and false negative test results. Without sample stabilization, laboratories are left with a small window for accurate analysis. Here, we demonstrate that Streck Urine Preserve (SUP) maintains target and donor DNA concentrations during prolonged storage and that these stabilized samples are compatible with Cepheid’s automated GeneXpert System and associated Xpert CT/NG test. Methods Fresh human urine, with or without SUP, was tested neat or spiked with Neisseria gonorrhoeae (N. gonorrhoeae). Samples were stored at room temperature for up to 18 days before being analyzed on the Cepheid GeneXpert System using the Xpert CT/NG test per manufacturer’s instructions. Differences in average Ct values were compared for the sample processing control, sample adequacy control, and N. gonorrhoeae targets. DNA stability was assessed by comparing the changes between fresh and SUP-treated samples throughout the study period. Results Following prolonged storage, Ct values for neat, untreated urine increased by 3-7 cycles, correlating to a 10- to 100-fold decrease in detectable copies of N. gonorrhoeae and the sample adequacy control compared to urine samples stabilized with SUP. The average Ct value for samples stabilized with SUP did not change by more than 1.5 cycles throughout the study period. Additionally, Ct values for the sample processing control remained constant throughout the testing period, indicating that SUP did not impact sample processing. Conclusions When limited point-of-care testing options require storage and shipping of samples to central laboratories, urine stabilizers are imperative to obtain results representative of the patient sample at the time of collection. SUP effectively stabilized N. gonorrhoeae DNA and donor DNA prior to analysis with the Cepheid Xpert CT/NG test. This cont","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"92 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142369086","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"B-009 Verification of Result Interchangeability Between Two Analyzers in the Determination of Uric Acid and Urea","authors":"S Garcia-Valdecasas, S Lapeña-Garcia, M Ruiz-Alvarez, T Costales-Lucia, J Sanchez-Fuertes, M Barrionuevo-Gonzalez","doi":"10.1093/clinchem/hvae106.373","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.373","url":null,"abstract":"Background Uric acid and urea are two parameters widely used in the diagnosis and management of renal pathology. In our laboratory, they are determined using Atellica Solution® analyzers (Siemens Healthineers). After validating a new Siemens equipment, Atellica CI®, it is essential to ensure result interchangeability in our laboratory accredited by ISO 15189:2012. Objectives evaluate the interchangeability of results for uric acid and urea measured by Atellica Solution® and CI® analyzers. Methods A total of 40 serum samples from patients with uric acid values between 1.3 and 15.2 mg/dL, and another 40 serum samples from patients with urea values between 7 and 142 mg/dL were processed in parallel. Statistical analysis of the results was performed using Passing-Bablok regression and Bland Altman mean difference analysis with Method Validator Version 1.19. Results are expressed with their 95% confidence interval. Results Uric Acid: After analyzing Bland-Altman differences, a statistically significant slight systematic error was found, as the 95% CI does not include 0, with slightly higher results in CI 1900®. Regarding Passing-Bablok regression analysis, there were no systematic errors of constant type (since the 95% CI of the intercept includes 0) but a discreet significant proportional systematic error was observed (the confidence interval of the slope does not include 1).Urea: In Bland-Altman analysis, a discreet systematic error was observed as the 95% CI of the mean difference does not include the null value. Regarding Passing-Bablok regression analysis, there were no systematic errors of constant type (since the 95% CI of the intercept includes 0) or proportional type (since the 95% CI of the slope includes 1), indicating interchangeability between both analyzers. Conclusions The results obtained by both Atellica Solution® and CI® analyzers for uric acid and urea assays are interchangeable since the statistically significant differences observed can be considered analytically and clinically insignificant.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"3 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362986","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-356 A hand-held microfluidic platform for rapid and sensitive identification of respiratory viruses from nasal swab samples","authors":"W Zhang, Z Goh, Y Zhou, B Ma, C Lu, M Wang, L Zheng, Y Seow, E Boey, J Geng, Y Chen, N Hsieh, D Shim","doi":"10.1093/clinchem/hvae106.350","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.350","url":null,"abstract":"Background Identifying the infected individual with a fast and accurate test is essential to constrain the spread of viruses and provide the proper treatment. Antigen rapid test (ART) provides quick screening of infection for patients; however, it shows less promising in the detection of early infection and patent’s full recovery as its inferior sensitivity to the nucleic acid detection method. On the other hand, bulky and costly instrument, tedious and prolonged procedures in traditional nucleic acid testing is also unfavorable for the screening. Delta is developing a fully automated hand-held POC using molecular technology to simultaneously detect 4 targets in 20 mins. The POC can be stand-alone or linked to mobile or PC app for different application scenarios. The proprietary recipe of the lysis buffer could neutralize the inhibition in the sample with effective pathogen lysis in seconds. The microfluidic cartridge containing lyophilized reagent can be stored at room temperature. The amplification signal is detected via the optical system from the colorimetric LAMP. This study is to evaluate the performance of the POC system in detecting SARS-CoV2 (SC2), FluA and B viruses in nasal swab. In addition, the assay performance was further compared with other commercial products available. Methods The attenuated SC2 virus, FluA and B viruses were diluted with 1xTE into different concentrations. The diluted viruses were spiked into the lysis buffer in 5% v/v ratio. Nasal samples collected from donors were soaked and swirled inside the cartridges containing lysis buffer according to the manufacturers’ instructions. For commercial products without lysis buffer, direct swabs were used. The cartridges were then put into the respective devices for further testing. Results The lyophilized SC2 assay consistently detected the viruses at 1000 copies/ml (20 out of 20) in real nasal samples in the presence of Delta Lysis Buffer (containing lyophilized neutralizer). However, without Lysis buffer, there was no signal detected even in the presence of 240x LoD viruses. The whole workflow sensitivity was tested with SC2 positive samples at 1x, 4x, 10x LoD and negative samples in the nasal sample matrix on Delta hand-held system. The results were processed via embedded algorithm and displayed on device as well as on PC and mobile app respectively. Out of 79 positive samples tested, the detection rate was 100%. There was no false positive detection for 31 negative samples tested. Positive internal control indicated the valid runs. 5 major SC2 subtypes (99.8% in silico analysis of 366,707 strains), 10 FluA and 9 FluB subtypes were successfully detected. Further, Delta hand-held platform outperformed in the LoD of SC2 with 500 copies/swab comparing to the ≥50,000 copies/swab of the benchmarked commercial platforms. Conclusions The performance of the hand-held molecular detection system we developed demonstrated a rapid, sensitive, and competitive analytical performance ","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"27 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362857","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A-347 A Comprehensive Exdia TRF-LFIA for Simultaneous Quantification of GFAP and NT-proBNP in Distinguishing Ischemic and Hemorrhagic Stroke","authors":"D R Sayyed, M Lee, S Hong, H Kim, H Kim, J Sanchez, S Choi, E Han, H Kang, J Kim, M Joan, H Kim, H Chae, J Park","doi":"10.1093/clinchem/hvae106.341","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.341","url":null,"abstract":"Background The goal of this study is to create a highly sensitive time-resolved fluorescence lateral flow immunoassay (TRF-LFIA) capable of concurrently measuring glial fibrillary acidic protein (GFAP) and the N-terminal fragment of B-type natriuretic peptide precursor (NT-proBNP). This assay is designed as a diagnostic tool and aims to provide an algorithm for stroke management, specifically for distinguishing between Ischemic stroke (IS) and Hemorrhagic stroke (HS). However, LFIA to quantify simultaneous serum NT-proBNP and GFAP are not yet available. Methods We have developed and validated a novel TRF-LFIA for the simultaneous quantitative detection of NT-proBNP and GFAP. The sensitivity and reproducibility of the immunoassay were significantly improved by employing specific monoclonal antibodies linked to europium nanoparticles (EuNPs) that specifically target NT-proBNP and GFAP. The detection area on the nitrocellulose membrane featured sandwich-style complexes containing three test lines for NT-proBNP, GFAP, and Control. The fluorescence intensity of these test lines on the nitrocellulose membrane was measured using an in-house developed Exdia TRF-Plus analyzer. As proof-of-concept, we enrolled patients suspected of having a stroke who were admitted within a specific time frame (6 hours). A small amount of clinical specimen (serum) was used with a well-assembled cartridge for the measurement of GFAP and NT-proBNP. Results To optimize the LFIA, an EuNPs conjugated antibodies were investigated to improve the detection sensitivity and decrease the background signal as well shorten the detection time. The Exdia TRF-LFIA cartridge offers a wide linear dynamic detection range, rapid detection, high sensitivity, and specificity. The limit of detection was determined to be 98 pg/mL for NT-proBNP and 68 pg/mL for GFAP, with minimal cross-reactivity. There were 200 clinical human serum samples that were used to evaluate this platform with high correlation. By combining the results of NT-proBNP and GFAP, we formulated an algorithm for the clinical assessment of Ischemic Stroke (IS) and Hemorrhagic Stroke (HS). According to our proposed algorithm, the combination of GFAP and NT-proBNP emerged as the most effective biomarker combination for distinguishing between IS and HS. Conclusions Exdia TRF-LFIA shows great potential as a supplemental method for in vitro diagnostics in the laboratory or in other point-of-care testing (POCT) applications. Its development substantially decreases the diagnosis time for IS and HS. The proposed algorithm not only minimizes treatment delays but also lowers medical costs for patients.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":"220 1","pages":""},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362967","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}