bluuebunny/crossref_metadata_2025_split huggingface dataset:
B-066 Evaluation on Effectiveness of Colloidal Gold Immunochromatography Assay for Rapid Detection of Carbapenemase-producing Enterobacteriaceae
Authors: Yang G , Yan J , Zhang Z , Yao W , Wang Y , Wang H , Su Y , Zhou Z 
Published: September 2023

Abstract

Background
The identification, treatment, and control of carbapenem-resistant Enterobacteriaceae (CRE) infections are a major challenge for health care institutions and diagnostic laboratories worldwide. A novel Carbapenemase-producing Bacteria Test Kit (Lateral Flow Assay) from Dynamiker Biotechnology (Tianjin) Co., Ltd. is a qualitative test that was easy to operate and can be widely accepted by clinical and primary medical. Results can be read in just 15 minutes using colloidal gold immunochromatography, which can detect double and multiple carbapenemase types (Fig. 1). We analyzed the effectiveness of Dynamiker carbapenemase-producing bacteria test kit for rapid detection of CRE carbapenemase.

Methods
A total of 120 strains of Enterobacterales in blood culture were collected, including 80 strains of CRE and 40 strains of CSE (carbapenem-susceptibility Enterobacteriaceae). PCR was used to detect KPC, NDM, IMP, VIM and OXA-48 genes as gold standard. Dynamiker carbapenemase-producing bacteria test kit was used to detect the carbapenemase produced by CRE, which was conducted by the performance evaluation combined with PCR results.

Results
The 80 strains of CRE expressing carbapenemase genes were all positive for the detection of carbapenemasstre by Dynamiker carbapenemase-producing bacteria test kit, which includes 39 strains producing KPC, 26 strains producing NDM, 8 strains producing IMP, 5 strains producing VIM and 2 strains producing OXA-48 enzymes; the 40 strains of CSE were negative and no carbapenemase were detected. Compared with the PCR results, the sensitivity and specificity of the four enzymes by Dynamiker carbapenemase-producing bacteria test kit were both 100% (Fig. 2).

Conclusion
Dynamiker carbapenemase-producing bacteria test kit can be applied as a simple, rapid, sensitive and specific diagnostic method for the detection of different CRE carbapenemase types, which is of great value for the accurate use of clinical anti-infective therapy.Fig. 1.Operating procedures of colloidal gold immunochromatography.Fig. 2.Results of Dynamiker carbapenemase-producing bacteria test kit C: Control, K: KPC, N: NMD, I: IMP, V: VIM, O: OXA-48.
B-072 Analysis of Anti-SARS-Cov-2 S1-RBD and N IgG in Saliva and Serum
Authors: Shin K , Lee H , Yu S , Lee S , Lee S , Kim W 
Published: September 2023

Abstract

Background
Mucosal antibody testing may be a significant and more practical tool for measuring humoral immunity since it is non-invasive. The aim of this study was to evaluate the SARS-CoV-2-specific antibody prevalence in saliva compared to serum in 2022.

Methods
From February to December 2022, the paired serum and saliva specimens were collected twice over a period. The saliva specimens were collected using a Salivette Cortisol (Sarstedt AG & Co. KG, Germany) device according to manufacturers’ instructions. Antibody tests were performed using nucleocapsid protein-based Elecsys anti-SARS-CoV-2 (anti-N IgG) and spike protein targeted SARS-CoV-2 IgG II Quant (anti-S1-RBD IgG).

Results
162 (97.6%) of 166 had anti-S1-RBD IgG in their serum. At the 1st visit and 2nd visit, 79 (47.5%) and 97 (58.4%) patients, respectively, had anti-N IgG in their serum. At 1st visit and 2nd visit, respectively, 14 (8.4%) and 13 (7.8%) patients had anti-S1-RBD IgG in their saliva. Four (2.4%) and five (3.0%) patients had anti-N IgG in their saliva during the 1st visit and 2nd visit, respectively. The correlation coefficient of the results of anti-S1-RBD IgG and anti-N IgG quantitative results between at 1st visit and 2nd visit were low (r = 0.1721 to 0.6448). All patients in the anti-S1-RBD IgG seronegative group (N = 4) had anti-N IgG in their serum, but neither anti-S1-RBD IgG nor anti-N IgG were detected in their saliva. All anti-N IgG seronegative patients (N = 68) had anti-S1-RBD IgG in serum, while 3 patients had anti-S1-RBD IgG and 7 patients had anti-N IgG in saliva.

Conclusion
Mucosal antibodies were detected in certain seronegative patients. The assessment of SARS-CoV-2-specific saliva antibodies should be regarded as a supplemental non-invasive diagnostic to serum to evaluate the prevalence and transmission of COVID-19.
B-079 Identifying Heterogeneity of Systemic Connective Tissue Diseases by Applying Joint Dimension Reduction and Cluster Analysis to Immunomarkers
Authors: Yu J , Tseng Y , Lin W , Wang Y , Lin T , Chang C , Wang H 
Published: September 2023

Abstract

Background
Accurate identification of systemic connective tissue diseases (SCTDs) can be challenging due to the heterogeneity of each disease. This study aims to explore the heterogeneity of different SCTDs by applying non-supervised learning to immunomarker data and proposes an alternative classification. Additionally, the study investigates the clinical implications of these different groups.

Methods
We utilized multiple correspondence analysis and k-means clustering to analyze the immunomarker data of patients with systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), and Sjögren’s syndrome (SS) in Taiwan between 2001 and 2016. To investigate the clinical correlations of the classification results, we conducted a comprehensive review of the clinical findings and compared the results across different groups.

Results
A total of 11 923 patients with the three SCTDs were classified into six distinct clusters based on their immunomarker patterns. In this clustering system, RA patients were predominantly grouped in cluster 1, whereas SLE and SS patients had a more dispersed distribution. Among patients with SLE, renal involvement was more frequent in clusters 3 and 6 (52% and 51%, respectively) than in other clusters, and discoid lupus was more frequent in cluster 3. Among SS patients, typical SS findings such as inflammation or infection of eyes and allergic reactions were more common in cluster 2 (54% and 51%, respectively). In contrast, patients in cluster 3 had more unspecified benign neoplasms (58%) and were more likely to experience immune disorders (63%).

Conclusion
The immunomarker-driven clustering yields an alternative classification result with new clinical insights. The data-driven approach would provide a more evidence-based classification and aid in a more accurate diagnosis and management for SCTDs.
B-091 Assessing Postvaccination SARS-CoV-2 Neutralizing Antibodies at Different Timepoints: a Laboratory-Based Study
Authors: Souza G M , Carvalho G C , Nunes R A , Cristaldi F M , Ramadan D R , Tufik S 
Published: September 2023

Abstract

Background
Serum-neutralizing antibodies (NAbs) against SARS-CoV-2 may be produced as a result of either viral infection or vaccination. NAbs can disrupt the connection between the RBD (Receptor-Binding Domain) of the Spike protein and the ACE2 receptor, hindering the virus's entry into cells. However, only a portion of these antibodies are able to neutralize the virus and prevent it from infecting new cells. While the presence of NAbs should not be considered a guarantee of neither immunity nor vaccine effectiveness, it can serve as an indicator for seroprevalence studies in healthcare settings. The purpose of this study was to compare results for NAbs from a group of healthcare individuals that received either CoronaVac/Sinovac (CVC/S) or Oxford-AstraZeneca (O/AZ) in São Paulo, Brazil.

Methods
Study Population and Characteristics: The current study evaluated a total of 33 and 34 healthcare professionals that received, respectively, O/AZ and CVC/S in the year 2021. Blood samples were collected 15 days (15D1) after the first dose of vaccination and at 30 (30D2), 60 (60D2), or 90 (90D2) days after the second dose. The presence of neutralizing antibodies was assessed with the cPassTM SARS-CoV-2 Neutralization Antibody Detection Kit GenScript. Results were classified into three categories based on reference values: not reactive (0–20%), undetermined (20–30%), and reactive (greater than 30%).

Results
Among the 67 health professionals, mostly were women in both vaccination groups: CVC/S (85.3%) and O/AZ (90%). At 15 days after receiving the first dose, the presence of neutralizing antibodies was detected in individuals who received both vaccines. However, a total of 32.3% (11/34) and 15.1% (5/33) individuals for CVC/S or O/AZ respectively do not show reactive antibodies at this first period evaluated. NAbs values obtained at 15D1, 30D2, 60D2, and 90D2 for CVC/S and O/AZ were 53.9%, 79.3%, 74.7%, 66.7% (for CVC/S) and 68.2%, 87.7%, 82.9%, 69.6% (for O/AZ). For both vaccination groups, higher levels for neutralizing antibodies were detected at 30 days after the second dose, and decreased at 60 and 90 days.

Conclusion
Oxford-AstraZeneca induced higher levels of neutralizing antibodies in this group of healthcare individuals. Serum follow-up samples taken at 30D2 elicited increased NAbs compared to other timepoints.
B-107 Serodiagnosis of Anti-glomerular Basement Membrane Disease Using a Newly Developed Chemiluminescence Immunoassay
Authors: Sabalza M , Bestmann Y , Hartwig L , Kühnl A , Dähnrich C , Schlumberger W 
Published: September 2023

Abstract

Background
Autoantibodies against the glomerular basement membrane (GBM) are important markers in the diagnosis and monitoring of autoimmune glomerulonephritides. Fast and reliable detection of these autoantibodies is crucial as anti-GBM disease can progress rapidly with fatal outcome. Here, we investigated the diagnostic performance of a newly developed, standardized anti-GBM chemiluminescence immunoassay (ChLIA).

Methods
The diagnostic performance of the EUROIMMUN Anti-GBM ChLIA (IgG), processed on the EUROIMMUN RA Analyzer 10, was assessed using sera from 67 clinically characterized anti-GBM disease patients and 221 disease controls. Results were compared with those obtained by the EUROIMMUN Anti-GBM ELISA (IgG). Inter-assay concordance, measurement range and interference were determined in a subset of samples.

Results
The ChLIA reached 100% sensitivity at a specificity of 98.6%, while the ELISA was less sensitive (89.6%) and more specific (100%). High qualitative concordance between both assays was evidenced by positive and negative agreement rates of 100% and 95.6%, respectively, and a kappa score of 0.901. The ChLIA showed linearity within a measurement range of 3.8–517.3 CU/mL. Coefficients of variation were calculated as 1.2%–3.3% (intra-lot) and 1.6%–4.2% (inter-lot). No interference was observed for hemolyzed, lipemic or icteric samples.

Conclusion
These validation results demonstrate a high quality of the novel Anti-GBM ChLIA. Given its excellent performance compared to the corresponding ELISA, it represents a promising alternative tool for accurate anti-GBM assessment in routine diagnostic settings with the advantage of rapid turnaround time and fully automated random-access processing. Future studies will address the assay’s suitability for monitoring anti-GBM levels during follow-up.
B-112 Routine Application of PR3- and MPO-ANCA Chemiluminescence Immunoassays Demonstrates Enhanced Detection Rates
Authors: Venkataraman I , van Beers J , Damoiseaux J , Dähnrich C , Kühnl A , Schlumberger W 
Published: September 2023

Abstract

Background
Sensitive and accurate PR3- and MPO-ANCA detection are crucial in the diagnosis and monitoring of patients with ANCA-associated vasculitides (AAV) and the specific diseases categorised thereof, including granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA). Chemiluminescence immunoassays (ChLIA) and bead technology have emerged as promising tools for fast, sensitive and accurate autoantibody detection. Applied to PR3- and MPO-ANCA, they could improve limitations in sensitivity, narrow measuring range and level of quantification seen in other assay formats. Here, we examined the routine performance of ChLIAs using human native MPO as well as human recombinant PR3 antigens.

Methods
The Anti-PR3 ChLIA (IgG) and prototype Anti-Myeloperoxidase ChLIA (IgG) were processed on the RA Analyzer 10 (EUROIMMUN) and the EliA PR3S and EliA MPOS on the Phadia250 (Thermo-Fisher Scientific), both in accordance to the recommendations by the manufacturers. For a comparative analysis of the routine performance, 675 sera from 615 individuals requested for PR3-ANCA, MPO-ANCA or both at the Central Diagnostic Laboratory at Maastricht University Medical Center were measured with the respective assays from both automation systems. The results were compared in respect to the qualitative outcome and numerical correlation.

Results
Of the total 675 samples, 585 and 556 were subjected to PR3-ANCA and MPO-ANCA analysis, respectively. For both ANCA types, all samples found positive with EliAs were also positive in the corresponding ChLIAs. 24 and 26 samples resulted positive for PR3- and MPO-ANCA by ChLIA, respectively, but were below cut-off in the relevant EliA test. Of those, 50.0% (n = 12 for PR3) and 96.2% (n = 25 for MPO) were from individuals in follow-up after AAV diagnosis, in the remaining cases an ANCA involvement was suspected based on symptoms of the patients. The overall concordance between the two assay systems was 96.0% for PR3-ANCA and 95.4% for MPO-ANCA detection.

Conclusion
In a routine scenario, the ChLIAs fully covered the PR3- and MPO-ANCA detection by the compared reference test system. Moreover, further positive results in samples found negative by EliA demonstrated enhanced detection rates by both ChLIAs, predominantly in samples from individuals with a known history of AAV. The clinical relevance will be subject to further studies.
B-136 Indirect Estimation and Verification Tool for Reference Intervals Using Unsupervised Machine Learning
Authors: Vieira L M , Dias A C , Oliveira D d , Dias C M , Almeida T , Campos J R 
Published: September 2023

Abstract

Background
Determining the Reference Intervals (RI) of quantitative laboratory tests is crucial. This aspect is also part of the accreditation process, which can be challenging. The goal of our study was to create and validate a model using the R programming language that can estimate and verify Reference Intervals using an indirect method by mining data from the Laboratory Information System.

Methods
The new model integrates algorithms that carry out preliminary processing, grouping, and statistical reduction of results. The algorithm identifies unusual outcomes by analyzing asymmetry and kurtosis and applying the Expectation-Maximization (EM) algorithm. During the grouping and reduction phases, the EM algorithm computes the mean, standard deviation, and weight of the distribution for each group. Additionally, the model integrates algorithms that determine the global mean/median, modes, antimodes, kurtosis, and skewness, to find values that best represent the reference population’s distribution. The distribution is then truncated to the defined IR partition through the combination of algorithms (Fig. 1). The Bias Ratio was used to evaluate the difference between the RI determined by our model and those obtained from the Kosmic and Refine R models. The model’s validity was tested using simulated and real data from anonymous reference individuals.Fig. 1.

Results
The effectiveness of the model was evaluated using was assessed for each test under varying levels of contamination. The overall performance showed excellent results with an accuracy of 0.996, kappa of 0.882, sensitivity of 0.945, specificity of 0.979, positive predictive value of 0.864, negative predictive value of 0.992, and F1-score of 0.896.

Conclusions
The indirect estimation and verification tool for Reference Intervals is a cost-free and valuable resource for clinical laboratories. It supports the accurate interpretation of patient´s results.
B-165 Establishment of a Labile Bound Copper and Labile Bound Copper Ratio Reference Interval in a Healthy Adult Population
Authors: Bitzer A , Day P , Fox J , Wermers M , Jannetto P , Bornhorst J 
Published: September 2023

Abstract

Background
While clinical tests are available to aid in the diagnosis of Wilson’s Disease (WD), some such as total copper determination lack sensitivity and specificity, while others such as liver tissue copper assessment are costly and invasive. WD affects copper metabolism and is known to cause low serum copper concentrations. In addition, an elevated percentage of total serum copper exists as non-protein bound or labile bound copper (LBC). Previous studies have shown that measuring the ratio of labile bound copper to total serum copper may aid in the diagnosis of WD. To support the utility of a laboratory developed test using serum LBC ratios to aid in the diagnosis of WD, serum samples from healthy donors were used to establish a reference range for LBC and the ratio of LBC to total copper in adults.

Methods
Serum samples were collected in trace metal free tubes from 214 donors (n = 110 male, n = 104 female) between the ages of 19–80 years old, selected against pre-determined exclusion criteria including acute hepatitis, chronic hepatitis, renal failure, biliary cirrhosis, celiac disease, and leukemia. Prior to analysis, samples went through a centrifugation-based preparation process to isolate the LBC fraction using molecular weight size exclusion filters and EDTA chelation. Samples were then analyzed via ICP-MS in kinetic energy discrimination (KED) mode to directly measure the LBC and total copper concentrations. LBC ratio values were determined from the LBC/total copper concentrations.

Results
Preliminary reference ranges were developed for both LBC and the LBC ratio based on the 2.5th and 97.5th percentiles with 95% confidence intervals. Established sex specific reference intervals for total copper were deemed acceptable per CLSI guidelines in document EP28-A3c, with ≤10% of results from this sample set falling outside of the established intervals. No statistically significant relationship was found in the mid-95th percentile between LBC concentration or ratio with age or sex. The reference intervals for LBC concentration were calculated as 13.41–104.66 and 11.69–106.50 ng/mL for females and males respectively. The reference intervals for LBC ratio were calculated as 1.04–8.12 and 1.17–10.48 for females and males respectively.

Conclusions
A reference range of LBC and LBC ratio has now been determined for the healthy adult population. Further testing can now be done on disease state populations to determine the sensitivity and specificity of LBC ratio in the detection, monitoring, or diagnosis of WD.
B-205 A Simple Method for Opioids, Synthetic Opioids and PCP Detection in Hair Samples by LC-MS/MS
Authors: Paulo B F , Junior L F , Zauli D A 
Published: September 2023

Abstract

Background
Hair analysis is useful for monitoring exposure to drugs and is a unique body material for the retrospective detection of drug consumption due to its large detection window, and it is easy to collect, store, and transport. Establishing a LC-MS/MS protocol for opioids determination may be challenging due to similarities among the molecular structures and the MS/MS fragmentation profile. This study aimed to develop and validate a simple, rapid, and sensitive LC-MS/MS method for quantification of 6-acetylcodeine, 6-acetylmorphine, codeine, dihydrocodeine, EDDP, PCP, fentanyl, heroin, hydrocodone, hydromorphone, meperidine, methadone, morphine, oxycodone, oxymorphone and tramadol in hair samples.

Methods
In this method, 15 mg of hair in a 2.0 mL microtube was decontaminated sequentially with dichloromethane and methanol. The sample was dried, and 0.75 mL of extraction solvent and a labeled internal standards solution were added. The hair sample was pulverized in a FastPrep-24™ 5G from MP-Biomedicals and then sonicated at 60°C for 60 min. The sample was centrifuged and filtered with Captiva filtration plates. Then, 100 µL of supernatant was added to 100 uL of ultrapure water and 5.0 uL was injected directly into the LC-MS/MS system. Chromatographic separation was performed on an Agilent 1290 Infinity II equipped with HALO Biphenyl column, and employing a mobile phase constituted by acetonitrile with 0.1% of formic acid and 5 mM of ammonium formate. The detection was performed with a Sciex 6500+ QTrap mass spectrometer.

Results
The current method was successfully validated for carryover, linearity, precision, recovery, limits of detection and quantification, and the measurement of uncertainty was calculated. The results were summarized in the Table 1.

Conclusion
The developed LC-MS/MS method was simple, rapid, and sensitive to detect opioids in hair samples.
B-216 Development of a Point-of-care Multiplexed Room Temperature Stable Environmental Toxin Test
Authors: Aithal S , Gupta S , Duong K , Kumar A , Ho N , Guo S , Ando Y , Liu R , Warden J , Ho D H 
Published: September 2023

Abstract

Background
Hememics™ Biosensor System (HBS) is a platform technology enabling antigen and molecular testing in the field. The system consists of a reader, HemBox™, and a biosensing chip, HemChip™. The HemBox™ is a battery-operated, cell phone size with Bluetooth and WIFI module that can be integrated into the Health Management System. The biosensing chips can be programed with bio-receptors to detect pathogens in less than 5 min. This study presents performance characteristics of HBS as a rapid POC to detect toxins from environmental samples.

Methods
The testing protocol consists of insert a HemChip™ into the HemBox™ and mixing the sample with the buffer and apply a drop of this mixture to the chip. In less than 5 min, results are displayed on the screen of HemBox™ or transmitted to user’s cellphone via Bluetooth. Samples were prepared by spiking solutions of mud, serum, vegetable wash, and milk with Staphylococcal enterotoxin B (SEB) and ricin.

Results
HemChip™ was functionalized to recognize Ricin and SEB targets. For testing, these targets were mixed in various matrix. To achieve statistical significance, each sample tested represented a minimum of 10 data points.

Conclusion
Hememics™ Biosensor System (HBS) is designed to be the ultimate Portable Lab Diagnostics for field use. The ability to test for environmental toxins in the field is significant because it allows for quick and on-site detection of potentially harmful substances. Our biosensor system also eliminates the need for sample processing, collection and transportation, which can take significant time and resources. The results of field testing can be available almost immediately, allowing for prompt action to be taken in the case of high toxin levels.