Clinical chemistry最新文献

{"title":"A-257 Revolutionizing Fungal Infection Diagnosis: A Sensitive, Cost-Effective, and Time-Efficient Solution","authors":"K Ramakrishnan, M Maung, V Ezike, P Poudel, R Senthilvelan, C Cui, J Mccabe, S Sackeyfio, A Senejani, E Kirkor, S Sinha","doi":"10.1093/clinchem/hvae106.254","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.254","url":null,"abstract":"Background Fungal infection detection is essential for optimizing therapeutic strategies, preventing complications, enhancing overall health, and alleviating the financial burden, and preventing transmission. According to the CDC, fungal illness resulted in 75,000 hospital admissions and 9 million outpatient visits annually, with 7,199 deaths predicted in the United States in 2021. The rising prevalence of fungal infections, influenced by factors such as population expansion and evolving treatment strategies poses a growing challenge to achieving an early and accurate diagnosis. There is the crucial need for improved detection methods to promptly identify various fungal infections, including Candida species, spanning from skin issues to potentially fatal systemic diseases, ultimately reducing associated morbidity and mortality. Severe and profound infections with life-threatening potential are common in individuals with compromised immune systems and those who are hospitalized. This risk is notably elevated among patients with organ transplants, immunosuppressive treatments, diabetes, recent broad-spectrum antibiotic usage, catheter utilization, and extended hospitalization periods. Our advancement seeks to introduce innovative methods leveraging carbon-based nanomaterials for the detection of fungal infections, offering distinct advantages including cost-effectiveness, ease of operation, and time efficiency compared to conventional techniques. Methods Our technology utilizes carbon-based nano materials, a promising advancement in nanotechnology to detect fungal infections, especially Candida manifestations. The samples are brought into contact with pre-probed carbon-based nano materials sensors maintained at a specific annealing temperature, facilitating nucleic acid hybridization. Subsequently, alterations in the carbon nanotube's electrical signal are observed, indicating a change in conductivity. This change can allow for the measurement of a voltage difference across a continuous flow of electricity, correlating with the concentration of targets present in the sample, thereby enabling the detection of specific microorganisms. No change was noticed in electrical properties of carbon-based nano material when negative experiments were conducted. Results The initial findings showed the presence of specific microorganisms within the sample in less than 15 minutes with carbon-based nano materials sensors. Comparative analysis of the electrical signal magnitude values obtained from carbon nanotube measurements against the corresponding CT values from quantitative PCR (qPCR) provides insights into the correlation between the electrical readouts and molecular quantification, offering a comprehensive evaluation of the nanotube-based detection system's performance in diagnostics procedure. Conclusions Unlike conventional blood culture and qPCR, our technology, delivers outcomes with heightened sensitivity, cost-effectiveness, and time efficiency. Our t","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":null,"pages":null},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142369122","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-184 Purifying High-Quality Genomic DNA From Frozen Blood Samples Stored up to 1.5 Years at -20°C","authors":"A Wood, Y Wang","doi":"10.1093/clinchem/hvae106.544","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.544","url":null,"abstract":"Background Maintaining DNA integrity in blood samples, from transport to storage to processing, is crucial to the success of downstream applications, especially regarding diagnostic applications. Additionally, due to the invasive nature of collecting blood samples, minimizing resampling to avoid excess patient pain and cost of collection and transportation are important to consider. Having the option to store and maintain portions of blood samples in the freezer enables future retesting without recollection. Since -20°C freezers generally are more affordable, require less energy, and have smaller footprints than -80°C freezers, demonstrating frozen blood stability at -20°C temperatures could decrease sampling burdens for labs with facility constraints. Methods Whole blood was collected into 9mL vacuum tubes (HemaSure-OMXP) from healthy donors. Aliquots of whole blood and buffy coat samples were stored at -20°C and thawed for genomic DNA extractions (QIAamp DNA Blood Mini Kit, Qiagen) at a range of different timepoints; frozen whole blood samples were processed at 0, 49, 141, and 148 days and frozen buffy coat samples were processed at 7, 27, 36, 185, 246, 373, 394, 584, and 604 days. Purified gDNA was quantified with Qubit (Broad Range dsDNA Assay, ThermoFisher) and qualified with Nanodrop One Microvolume UV-Vis Spectrophotometer (ThermoFisher) and TapeStation (Genomic DNA ScreenTape, Agilent Technologies). Results No significant decrease was observed for DNA yield and quality between fresh and frozen whole blood samples. Average DNA yields from 200 μL whole blood were 4.5 ± 2.2 μg and 5.3 ± 1.2 μg for fresh and frozen blood respectively. Average DNA integrity (DIN) was 6.9 ± 0.4 and 7.1 ± 0.3 for fresh and frozen blood respectively. Donor differences in blood samples can help explain the variance in DNA yields reported. No significant decrease was observed for DNA yield and quality in buffy coat samples frozen for longer at -20°C. In total, 84 whole blood and 25 buffy coat samples were processed in this study. Conclusions Although buffy coat samples tended to have higher yields than whole blood, due to the higher amount of white blood cells present, both sample types provided sufficient amounts of gDNA for downstream applications. Freezing blood samples for future testing can be effective at reducing the need for resampling without sacrificing the nucleic acid yield or quality of fresh samples. Additionally, as technological advancements are made for equipment and assays, frozen blood samples can be retested and compared to previous results for improved diagnostic decisions, done without requiring recollection from labs and patients.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":null,"pages":null},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142368758","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-205 Performance of a Novel Fluorogenic Assay for Detection of Carbapenemase-producing Enterbacteriaceae","authors":"Z Zhou, S Li, D Jiang, Z Wang, Y Wang, Y Zhang, H Wang, Y Su","doi":"10.1093/clinchem/hvae106.565","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.565","url":null,"abstract":"Background In recent years, under the selective challenge of antibiotics, the variety and number of drugresistant pathogenic microorganisms have increased significantly, which brings great challenges to clinical diagnosis and treatment, especially the infection caused by carbapenem resistant Enterobacteriaceae (CRE). Carbapenemases production is the main mechanism of drug resistance of Enterobacteriaceae to carbapenems. Drug resistance of Carbapenems can be caused by three mechanisms, resulting in the production of five major Carbapenemases. These are Klebsiella pneumoniae enzyme (KPC), New Delhi metal β-lactamase (NDM), carbapenem hydrolyzed oxalase (OXA-48 like), integrin-encoded metal β- lactamase (VIM) and IMP (Imipenemase). The real-time fluorescence quantitative PCR (qPCR) method based on molecular beacons was combined with the melting curve analysis to identify five drug resistance genes simultaneously by a single PCR reaction, with rapid detection, high sensitivity and strong specificity. Based on this principle, we developed the novel fluorogenic assay for rapid detection of Carbapenemases in multidrug-resistant Enterobacteriaceae (Dynamiker Biotechnology (Tianjin) Co., Ltd.). Methods We evaluated the performance of the novel fluorogenic assay for rapid detection of Carbapenemases in multidrug-resistant Enterobacteriaceae, including the limit of detection (LoD) and cross-reactivity, and compared it with the lateral flow immunochromatography assay (LFA). Results The LoD ranged from 75-450 CFU/mL for the five carbapenemase genes. The analytical specificity for target genes was 100%, as assessed with a panel of 15 pathogens, which indicated no cross-reactions. Comparison of qPCR and LFA results from twenty-three CRE clinical isolates with characterized carbapenemase content demonstrated a complete agreement (Table 1). Conclusions The novel fluorogenic assay for rapid detection of Carbapenemases in multidrug-resistant Enterobacteriaceae is an accurate and rapid method to identify KPC, NDM, VIM, IMP and OXA-48-like carbapenemases in the clinical microbiology laboratory, which can guide infection control programs to limit the spread of these organisms.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":null,"pages":null},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142369046","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-210 Ldl-c to non-hdl-c ratio method: a simple way to determine bias for ldl-c methods on hypertriglyceridemic samples","authors":"T A Gcingca, M Sampson, J W Meeusen, L J Donato, A S Jaffe, A T Remaley","doi":"10.1093/clinchem/hvae106.208","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.208","url":null,"abstract":"Background Beta-quantification (BQ) is the reference method for LDL-C but is not widely available. It is difficult, therefore, for clinical laboratories to independently assess the accuracy of their methods for either calculating or directly measuring LDL-C. Our goal was to investigate if an interrelationship between the tests in the standard lipid panel could be used to compare the performance of different LDL-C methods against BQ, specifically in samples with hypertriglyceridemia, a major cause of bias for LDL-C testing. Methods BQ results from Mayo Medical Labs (n=39,667) and the NIH (n=18,338) were used to identify a linear relationship by least-squares regression analysis between lipid panel test results and LDL-C to facilitate a statistical comparison between different LDL-C methods. Results It is well established that the number of VLDL particles increases as TG increases, because VLDL is the main carrier of TG. As a consequence, the ratio of LDL-C to non-HDL-C is inversely related to TG, which can be made linear by taking the square root of TG (Figure). Nearly identical regression equations were found for this relationship, using two different BQ datasets. When LDL-C was calculated by either Sampson equation, the LDL-C/non-HDL-C regression lines nearly overlapped with the one for BQ. In contrast, the Martin equation showed a positive bias with increasing TG, whereas the Friedewald equation showed a negative bias, consistent with past reports on their LDL-C biases with hypertriglyceridemia. In the UKBiobank, the Beckman direct LDL-C showed a positive bias for TG, which was confirmed in CAP proficiency test surveys. By simulation analysis, approximately 80 samples with high (>200 mg/dL) and low (<100 mg/dL) TG is statistically sufficient to assess if the LDL-C/non-HDL-C regressions lines of LDL-C methods differ from BQ. Conclusions The LDL-C/non-HDL-C ratio method is a simple way to examine LDL-C methods for bias on hypertriglyceridemic samples.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":null,"pages":null},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142368786","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-031 A new Ready to use Bio-Rad Quality Control to Streamline Daily Workflow","authors":"A M Yagoot, H Khalil, M Alharbi, G Almalayo, A Borai","doi":"10.1093/clinchem/hvae106.395","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.395","url":null,"abstract":"Background A comprehensive Quality Management System starts with performing a daily Quality Control (Q.C.) process. The daily Q.C. process monitors the Instrument’s optimal performance and detects shifts and trends. However, the existing traditional daily Q.C. process is not only prone to manual errors, but also time consuming, costly and labor intensive. We evaluated a Bio-Rad InteliQTM Load and go Quality Control that comes in a barcoded tube ready to be loaded. We monitored the workflow efficiency gained in comparison to the traditional quality control material that comes in glass vials. Methods We evaluated the new quality control material ready to load on the instrument. This new Q.C. (Bio-Rad InteliQ Assayed Multiqual Control - 3 levels) were processed in parallel with our routine Q.C. (Bio-Rad Assayed Chemistry Lyphocheck vials - 2 levels). We performed the evaluation on Abbott Architect c8000 Chemistry analyzers in our central Laboratory (NGHA-Jeddah). The Q.C. was stored frozen. Before testing it was thawed at room temperature as per the insert instruction. Over a 5 days period, in parallel with our routine quality control, we run the new Q.C. Two times per day for 33 analytes. We monitored the processing time difference between the new and current approaches. We monitored the stability of all the analytes in the tube after Two days and again after Five days. We also monitored the cost effectiveness, labor intensiveness, probability of operator error and the overall improvement in workflow and Turn Around Time. Results Over the evaluation period, we observed the following: - Saving 40 minutes in average per week only for chemistry Q.C (time spent in reconstituting, mixing and aliquoting old Q.C) - 100% reduction in waste of plastic consumables such as pipette and plastic tubes. - Save an average of 1.0 ml dead volume in every 5.0 ml old Q.C. vial (20% of the volume, hence saving 20% of the total Q.C. cost). The dead volume wasted due to aliquoting step using the old Q.C. - 100% Eliminated delays caused by operator error such as wrong reconstitution, inadequate mixing and wrong Q.C. aliquoting. Not needed for the InteliQ. - High score of staff satisfaction. - Stability of the 32 analytes was excellent except that of Co2, which deteriorated by 14% after Two days as indicated in the insert package. Co2 day five result deteriorated by 34%. Conclusions Bio-Rad InteliQ is easy to use. It saves time and cost. When combined with Unity Q.C. data management solution it can streamline Q.C. workflow, eliminate operator errors, reduce T.A.T. and increase the overall laboratory performance. It may also work optimally with Instruments that have on-board fridge for Q.C.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":null,"pages":null},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362969","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-006 Use of Sysmex UN-3000 Research Parameters for Semiquantitative Analysis of Urine Microscopic Elements","authors":"M Nakashima, H Shelestak, M Lauren, M Chappell","doi":"10.1093/clinchem/hvae106.370","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.370","url":null,"abstract":"Background Microscopic examination of urine is an important component of urine analysis. However, it is labor-intensive and requires a skilled microscopist. The Sysmex UN-3000 (Kobe, JP) combines a Siemens CLINITEK Novus (Munich, GER) with a Sysmex UF-5000 flow cytometer and Sysmex UD-10 digital imaging device for fully automated urine analysis. It is FDA-approved for quantitation of red and white blood cells, epithelial cells, casts, and bacteria. It also flags for other particles such as sperm, yeast, pathologic casts, and crystals, which can then be confirmed on the UD-10. We sought to determine if and how the UF-5000 research parameter results could be used for semi-quantitative grading of pathologic casts, squamous epithelial cells, non-squamous epithelial cells, and crystals to match our reporting system. Methods Urine samples were analyzed by the UN-3000 and by manual review of urine sediment per laboratory protocols. Epithelial cells and crystals grades were none seen, few, moderate, many. Cast grades were 0, 1-3, 4-10, and >10. Results of manual microscopy were used to determine numerical cutoffs for the UF-5000 results which would agree within one grade in ≥90% of samples. Sperm and yeast are reported as either present or absent. For these particles, manual microscopy was compared to the results of the UF-5000 flagging and subsequent review of the UD-10 images. Results Rate of agreement between the methods is shown in the table. For sperm the UN-3000 showed 91.7% sensitivity and 100% specificity; for yeast, 93.8% sensitivity and 97.7% specificity. Conclusions We were able to use the research parameters from the UF-5000, in conjunction with the UD-10, to perform semi-quantitative grading. Adoption of this analyzer increases automation, with 70% of samples auto-validating per our protocols, while still conforming to our previous reporting system.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":null,"pages":null},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142362982","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-068 Plasma calprotectin as an index of draining tunnel formation in Hidradenitis suppurativa","authors":"A Havelka, T Kanni, E J Giamarellos-Bourboulis","doi":"10.1093/clinchem/hvae106.430","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.430","url":null,"abstract":"Background Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease which affects areas rich in apocrine glands. The main disease manifestations are inflammatory nodules (IN) and draining tunnels (dT). The course and progression of the disease are difficult to predict. There is currently lack of any broadly accepted biomarker which may inform on the activity of hidradenitis suppurativa (HS). Draining tunnel (dT) formation is the hallmark of HS in the affected skin. The existence of a biomarker which may predict dT formation before dTs appear in skin may become a tool for early biological treatment. Calprotectin, also known as S100 A8/A9 protein has been shown to be involved in various inflammatory conditions, including HS. Aim of this study was to evaluate circulating calprotectin as an index of dTs in the affected skin. Methods The study group consisted of 40 patients with confirmed HS and varying disease activity, assessed by number of dTs and International Hidradenitis Suppurativa Severity Score System (IHS 4 score) . Plasma samples were collected and stored at -80°C until analysis. Calprotectin was measured with GCAL® turbidimetric assay (Gentian AS, Norway). Results Fifteen patients had mild HS and 25 patients had moderate/severe HS. Positive association was found between circulating calprotectin and the absolute dT count (Pearson’s r2 = +0.750; p<0.0001) and the IHS4 (International HS 4 score) (Pearson’s r2 = +0.671; p<0.0001). Circulating calprotectin was significantly increased in patients with more than 2 dTs. Plasma calprotectin greater than 0.5 mg/L was associated with odds ratio 8.00 (1.87 to 34.22; p = 0.005) for 2 or more dTs. Conclusions Calprotectin is presented, for the first time, as a biomarker which indicates the formation of dTs in the skin. Its use as surrogate of early start of biologicals and response to treatment remains to be explored.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":null,"pages":null},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142369090","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-331 Monitoring Operators Proficiency at Point of Care is Crucial for Reliable Patient Values. A Practical Example with Patient Blood Chloride, Potassium and Sodium Measurands Assayed with i-STAT®","authors":"V Genta, C M Aston, F M Alferes, P M Darville, S Shumate","doi":"10.1093/clinchem/hvae106.325","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.325","url":null,"abstract":"Background While i-STAT® cartridges offer the Physician a spectrum of analytical methods at the point of care for prompt diagnosis and interventions, these methods have to be harmonized with the laboratory methods in order to reliably detect shifts and trends. With this practical example we illustrate the importance of a program of routine comparisons between the i-STAT® and laboratory methods to detect analytical differences exceeding the CLIA’s criterion and potentially having adverse clinical implications. Methods Patient blood chloride (Cl), potassium (K) and sodium (Na) values as obtained by nurses with i-STAT Chem 8 ™ cartridges (Abbott Laboratories) at the point of care, where daily compared with the values as obtained with the Laboratory method (two cobas 6000®, Roche Diagnostics) using green top BD® lithium heparin tubes (Becton Dickinson) collected within thirty minutes of the i-STAT assay. The data were electronically stored in RALS™ (RALS Informatics) and transferred to Minitab® (Version 21, Minitab Inc.) statistical software. The two analytical methods were compared using the orthogonal and the polynomial ordinary least squares (POLS) regression models and their graphic representations. The aptness of the methods was evaluated with the standardized residuals diagnostics for normality, independence, outliers (Standardized residual >|3|) and influential observations (Hi>0.5). For acceptance of the differences the CLIA’s total error criterion was employed. (CI: target value ± 5%; K: target value ± 0.5 mmol/L; Na: target value ± 4 mmol/L). Results In the first four months of the study the number of differences exceeding the CLIA’s criterion was not acceptable. [Cl: 10% (165/1564); K: 7% (109/1593); Na: 4% (66/1586)]. These differences were occurring throughout the analytical range (AMR). Consequently, the operator’s technique was suspected and the POCT senior technologists (CA, FA) adopted operator specific interventions. This strategy was effective in the following month and the improvements were maintained for seven consecutive months. Monthly differences exceeding the CLIA’s criterion decreased significantly [Cl:1.9% (52/2777): K:0.9% (25/2868): Na:0.5% (15/2896)]. This was clearly illustrated with the dot plot by date and the parallel box plots by month. Regression analysis showed that the orthogonal and the OLS models were equivalent. Cl: Orthogonal y=1.7+0.99x, OLS y=12+0.88x. K; Orthogonal y=0.2+1.2x, OLS y=0.1+0.96x. Na: orthogonal y=3+0.98x, OLS y=14+0.9x. Additionally, the POLS model showed a linear relationship within the AMR intervals with few outliers (Cl=11; K=7; Na=9), no influential observations (Hi<0.5) and equality of monthly regression lines (P>0.05). Conclusions The implementation of daily comparisons between patient values as obtained with the i-STAT method and those as obtained by the Laboratory method in the interval of thirty minutes, allowed the identification of individual operators r","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":null,"pages":null},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142369089","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-107 Sample Matrix Matters: A Precision Study of BioRad, TechnoPath, and Patient Pooled Samples Across 20 High Volume Chemistries and Immunoassays","authors":"K Sobhani, A K Quizon, R Masukawa, C Hernandez, I Peteros, E Manimtim","doi":"10.1093/clinchem/hvae106.106","DOIUrl":"https://doi.org/10.1093/clinchem/hvae106.106","url":null,"abstract":"Background BioRad is a major provider of QC materials in the US with robust peer data, and Technopath has emerged as a recent competitor, especially on cost. While many factors are considered when selecting QC materials, primary considerations include commutability, matrix effects, decision levels, and acceptability limits. A couple studies comparing BioRad and Technopath QC performance were published in recent years. However, none have compared performance to patient-pooled samples. We undertook a comparison of BioRad/Technopath QC performance, with the addition of patient-pooled samples in order to assess potential matrix effects. Methods We compared precision for 20 high-volume chemistry/immunoassay tests (Table 1) across two levels of BioRad and Technopath QC and a patient pooled sample over 7 days on 2 Abbott Alinity-i and 4 Alinity-C instruments. Each immunoassay control level was run 5 times/day across 10 tests and 7 days per instrument, (i.e., 700 results/level), and the same for chemistry controls (1,400 results/level). Lithium-heparin plasma patient-pool was prepared by obtaining sufficient volume and preparing daily frozen aliquots (i.e., 1400 immunoassay and 2800 chemistry results). Results BioRad and Technopath Chemistry QCs were highly comparable with all levels demonstrating <1% CV difference. Notably, CO2, B12, FT4 pooled-patient CVs were >2% lower than the best performing high control. Additionally, greater differences in performance were observed across immunoassay controls with high BioRad QC performing better for 7 tests. Conclusions Chemistry QC for Technopath and BioRad are largely comparable (i.e., CV differences <1%). Overall, BioRad immunoassay control performance was slightly to somewhat better (i.e., B12, CA125, and CA15-3). B12 and CO2 were particularly unstable (as reflected by patient-pool CVs). That said, differences in performance were not untenable and could be handled based on a tailored approach of extending QC limits if assay/instrument performance allows, and/or changing control material or reagents on a tighter schedule.","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":null,"pages":null},"PeriodicalIF":9.3,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142368785","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":"Clinical Perspective on the Use of Urine as a Tissue Surrogate in the Diagnosis of Genitourinary Diseases.","authors":"Yuan Liang,Ping Wang,Weimin Ci","doi":"10.1093/clinchem/hvae145","DOIUrl":"https://doi.org/10.1093/clinchem/hvae145","url":null,"abstract":"","PeriodicalId":10690,"journal":{"name":"Clinical chemistry","volume":null,"pages":null},"PeriodicalIF":9.3,"publicationDate":"2024-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142328832","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}