bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-249 Monocyte distribution width (MDW) as a reliable diagnostic biomarker for sepsis in HIV-infected patients
Authors: Sun J , Shao Y , Qian L , Wang X , Tang Y , Lu H , Chen J 
Published: October 2024

Abstract

Background
Sepsis is the main cause of death in patients with acquired immunodeficiency syndrome (AIDS) and early diagnosis of sepsis in AIDS remains a significant challenge. Monocyte distribution width (MDW), as a new type of sepsis auxiliary diagnostic marker, has attracted widespread attention in the research and exploration of its clinical application. This study aims to evaluate the diagnostic efficacy of MDW in the occurrence of sepsis in HIV-infected patients and to construct a new clinical diagnostic model in combination MDW with other indicators.

Methods
A prospective cohort study was conducted at Shanghai Public Health Center with a total of 602 patients enrolled between December 2022 and August 2023. Sepsis-3 criteria were employed as the diagnostic standard for sepsis. MDW was measured at admission, using the hematology analyzer DxH900 (Beckman Coulter Inc.). Comprehensive clinical data, including complete blood counts and biochemical profiles, were collected. Enrolled participants received a follow-up about their survivals on day 30 and day 90. Five machine learning models were evaluated and compared to select the best performing model.

Results
The diagnostic performance of MDW for sepsis yielded an AUC of 0.818. With a cut-off value of 25.26, the sensitivity and specificity reached 0.822 and 0.754 respectively. The best performing variable among all five ML algorithms was Random Forest model. The top three variables with the highest importance ranking were platelet, albumin, and hemoglobin. Incorporating MDW and the top three laboratory indicators into a random forest model, the AUC value improved to 0.931. With a cut-off value of 0.5, the sensitivity was 1.00 while the specificity was 0.732.

Conclusions
MDW was an auxiliary diagnostic biomarker for sepsis in HIV-infected patients with reliable sensitivity and specificity. In combination MDW with other common laboratory biomarkers, a diagnostic model can be established to further improve the diagnostic efficiency of sepsis.
A-292 Validation of Aztreonam-Avibactam MIC Antimicrobial Susceptibility Test for MicroScan Dried Gram-Negative MIC Panels from a Multicenter Assessment of Enterobacterales, Pseudomonas species, and Stenotrophomonas maltophilia
Authors: Diaz J E , Garner O , Harrington A , DesJarlais S , Riedel S , Chipman A , Guzman B M , Hastey C 
Published: October 2024

Abstract

Background
Aztreonam-avibactam (AZA) is a novel antibiotic combination for treating Gram-negative bacterial infections, including metallo-β-lactamase-producing multidrug-resistant pathogens for which there are limited or no treatment options.1 Given the need for accurate antimicrobial susceptibility testing results, a study was conducted with clinical isolates of Enterobacterales, Pseudomonas species, and Stenotrophomonas maltophilia on an investigational MicroScan Dried Gram-negative MIC (MSDGN) panel with AZA.2

Methods
Three clinical sites evaluated MSDGN MIC values to MICs from CLSI reference panels. The study included 602/671 Enterobacterales, 53/59 Pseudomonas species and 69/70 S. maltophilia isolates using Prompt or turbidity inoculation. MSDGN panels were incubated at 35 ± 1°C and read on the WalkAway, autoSCAN-4, and visually at 16-20 hours. Reference panels were prepared according to CLSI methodology, incubated 16-20 hours for Enterobacterales and Pseudomonas species, and 20-24 hours for S. maltophilia and read visually.

Results
Essential agreement was calculated comparing MSDGN panel MIC results against reference panel MIC results for all isolates (Table 1).

Conclusions
AZA MIC results for Enterobacterales, Pseudomonas species, and S. maltophilia from MSDGN panels correlate well with MICs obtained using reference panels in this study.
1Pending approval by US Food and Drug Administration (FDA); not available for in vitro diagnostic use in the US. Not for Distribution in the US. 2Pending submission and clearance by the US FDA; not yet available for in vitro diagnostic use in the US. For Investigational Use Only. The performance characteristics of this product have not been established. In development, pending achievement of CE compliance; not yet available for in vitro diagnostic use. © 2024 Beckman Coulter. All rights reserved. All other trademarks are the property of their respective owners. BEC, the stylized logo and the BEC product and service marks mentioned herein are trademarks or registered trademarks of BEC, Inc. in the US and other countries. 2023-12350
A-341 Precision Evaluation of the i-STAT® Glucose Test in the i-STAT G Cartridge using thei-STAT 1 System for Venous, Arterial and Capillary Whole Blood Specimens in Clinical Settings
Authors: Thibodeau L , Gonzalez Aguirre M , Hahn S , Zhang H 
Published: October 2024

Abstract

Background
Precise and accurate measurements of whole blood glucose levels are important for the diagnosis and treatment of patients suffering from diabetes and hypoglycemia. This study demonstrates the precision of the i-STAT G cartridge with the i-STAT 1 System in arterial, venous, or capillary whole blood in point of care or clinical laboratory settings.

Methods
The precision of the i-STAT G cartridge was assessed at external clinical sites by intended end users with whole blood specimens across the measurement range of 20 - 700 mg/dL. The study included testing venous whole blood samples from 154 adult (≥ 18 years) patients and arterial whole blood samples from 173 adult patients at three clinical sites. Each whole blood sample was run in duplicate on the i-STAT G cartridge. In addition, 139 capillary whole blood specimens from both adult subjects and neonate subjects (birth - 28 days) were collected and tested for capillary whole blood precision. Duplicate fingerstick draws were collected in capillary tubes from 119 adult subjects at two clinical sites and duplicate heel-stick specimens were collected in capillary tubes from 20 neonate subjects at two clinical sites. Specimens used in this study were prospectively collected venous, arterial, or capillary specimens under an Institutional Review Board approved informed consent or were de-identified leftover venous or arterial specimens. For each specimen type, duplicates from each subject were grouped into subintervals based on their mean values. The subintervals included the glucose medical decision levels of 45 mg/dL, 120 mg/dL and 180 mg/dL. The estimates of the pooled standard deviation (SD) and pooled coefficient of variation (%CV), as well as their respective 95% confidence intervals (CI) were calculated for each subinterval (20-90 mg/dL, &gt;90-150 mg/dL, &gt;150-250 mg/dL, &gt;250-700 mg/dL or &gt;250-400 mg/dL and &gt;400-700 mg/dL, as applicable). The precision estimates for each subinterval were compared against an acceptance criteria of the greater of 3 mg/dL or 5% of the mean (mg/dL) of the subinterval.

Results
The whole blood precision was found to be less than or equal to 5.00 %CV for all subintervals for each specimen type. For venous specimens, the %CV ranged from 0.35% to 0.43%; for arterial specimens the %CV ranged from 0.26% to 0.46% and for capillary specimens (adult and neonate combined), the %CV ranged from 1.38% to 2.71%.

Conclusions
The study demonstrated that the i-STAT Glucose test in the i-STAT G cartridge when tested using the i-STAT 1 System delivers precise results within ∼2 minutes for venous, arterial, and capillary whole blood patient specimens across a glucose range of 20 - 700 mg/dL when tested by end users in a point of care or clinical laboratory setting. The studies were funded by Abbott Laboratories.
B-032 Evaluation of Assay Performance for Atellica CI 1900 analyzer in Routine Chemistry, Division of Laboratory Medicine, UMMC
Authors: Yeoh A C , Ramdzan K , Jamaluddin F A , Chew Y Y 
Published: October 2024

Abstract

Background
The Atellica® CI 1900 (Siemens Healthiness) is a stand-alone, integrated clinical chemistry and immunoassay analyzer. Method verification has been done on this analyzer for 14 parameters based on the guideline of the Clinical and Laboratory Standard Institute (CLSI).

Methods
The method evaluation protocol consisted of determination of imprecision based CLSI EP 15-A3; CLSI EP06-A2 protocol was used for verification of linearity and method comparison was carry out in between Atellica® CI 1900 with our current Atellica® Solution based on CLSI EP09-A2 protocol. Method comparison data was analyzed by using statistical software, MedCalc. The data were used to calculate bias for Sigma metrics determination.

Results
Total of 14 analytes including sodium, potassium, chloride, creatinine, urea, alkaline phosphatase, total bilirubin, triglyceride, uric acid, glucose, thyroid stimulating hormone, free-thyroxine, human chorionic gonadotropin and carcinoembryonic antigen were tested. The results showed the repeatability and total imprecision were within acceptable limit as per manufacturer claims for all analytes. It was demonstrated that the analytical system operates within the claimed linearity ranges as stated in the information for use (IFU). Passing - Bablok analysis show the bias for all analytes were within our laboratory pre-set quality specification. The intercept and slope with 95% CI for Passing-Bablok analysis as shown in table 1. Sigma metrics were determined for each assay using the coefficient variation determined from precision study and bias obtained from the method comparison study. It showed that the Sigma for 14 analytes ranging from 3 to more than 6 with more than 93% assay has sigma scores more than 4.

Conclusions
Atellica® CI 1900 shows acceptable precision and bias for all analytes that evaluated. The analyser is fully comparable with Atellica® Solution. We conclude that Atellica® CI 1900 demonstrates good performance capabilities, making this analyzer suitable for low-to-medium volume laboratory.
B-077 F-actin as a New Marker Antigen on an Established Multiparametric Immunoassay Profile for Liver Diseases
Authors: Weiss J , Deerberg A , Ott A , Kai M , Scheper T , Meyer W 
Published: October 2024

Abstract

Background
Autoimmune hepatitis (AIH) and primary biliary cholangitis (PBC) are severe diseases with heterogenous manifestations, which affect people of all populations and age groups. Diagnosis and differentiation from other liver diseases such as primary sclerosing cholangitis (PSC) remain a substantial challenge for hepatologists. Since AIH and PBC are caused by different sets of autoantibodies, we previously developed a line blot for the parallel detection of all relevant parameters. We now added the AIH-specific antigen filamentous actin (F-actin) to this established liver immunoassay profile.

Methods
Sera from 15 patients with AIH, 15 patients with overlap AIH/PBC or AIH/PSC, 32 patients with PSC, 53 patients with PBC, 4 patients with non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NAFLD/NASH), 30 patients with hepatitis B infection and 79 patients with hepatitis C infection as well as sera from 150 blood donors were examined using the EUROLINE line immunoassay system (EUROIMMUN autoimmune liver diseases 9 Ag plus F-actin (IgG); contains the PBC-relevant antigens AMA-M2, M2-3E (BPO), Sp100, PML and gp210, the AIH-associated antigens LKM-1, LC-1 and SLA/LP and F-actin as well as Ro52). The newly included F-actin antigen was polymerized from human globular actin (G-actin) and assessed by sedimentation analysis and dynamic light scattering. The scan software EUROLineScan (EUROIMMUN) was used to automatically determine presence and intensity of the resulting bands on the blot.

Results
Quality assessment revealed successful polymerization of F-actin. Autoantibodies against this newly developed F-actin antigen were detected in 53.3% of sera from AIH patients and 40% of AIH+PBC/AIH+PSC overlap patients. 93% of these positive sera did not contain other autoantibodies associated with AIH. Only one PSC patient (3.1%), two patients with hepatitis C (2.5%) and two blood donors (1.3%) also showed anti-F-actin positivity. All tested sera of PBC, NAFLD/NASH and hepatitis B patients were evaluated as anti-F-actin negative.

Conclusions
The addition of F-actin to the established multiparametric EUROLINE profile for the simultaneous and monospecific detection of AIH- and PBC-relevant autoantibodies is a great advance for routine diagnostics of patients with symptoms associated with various liver diseases.
B-117 Rapid Classification of Cleanliness Grades of Vaginal Discharge through Computational Analysis of SERS Spectra via Variational Auto-Encoder Model And Long Short-Term Memory Networks
Authors: Wang L , Tang J 
Published: October 2024

Abstract

Background
Classification of cleanliness grades of vaginal discharge plays a pivotal role in clinical laboratories, serving as indicators for the presence of various vaginal infections such as bacterial vaginosis and candidal vulvovaginitis, etc. The conventional method for assessing vaginal discharge cleanliness involves manual microscopy, a technique susceptible to variations based on the examiner's expertise and subjective judgment, hindering the attainment of swift and accurate diagnoses.

Methods
This study introduces a novel approach by integrating Surface-Enhanced Raman Spectroscopy (SERS) with a deep learning algorithm for the rapid classification of vaginal discharge cleanliness grades. The proposed classification method combines the Variational Auto-Encoder (VAE) and Long Short-Term Memory (LSTM) to process SERS spectra. The quality of the training data is assessed using the signal-to-noise ratio (SNR) as a standard indicator.

Results
The application of the VAE-LSTM algorithm significantly enhances classification performance, providing swift and accurate results while reducing the required time. Comparative analyses with various classical machine learning algorithms and evaluation metrics reveal the superior predictive capability and time efficiency of the VAE-LSTM algorithm, demonstrating 100% accuracy and a fitting time of 2 seconds. Blind testing of SERS spectra collected from unknown patients further validates the reliability of the proposed method.

Conclusions
This study presents a promising and practical approach for the rapid classification of vaginal discharge cleanliness grades. The integration of the SERS technique with the VAE-LSTM algorithm not only ensures accuracy and efficiency in clinical diagnosis but also lays the foundation for advancements in non-invasive diagnostic technologies in gynecological healthcare.
B-225 Bridging the Gap Between Clinical Microbiology and Molecular Diagnostics: Correlation of PCR Cycle Threshold Values for Establishing Semi-Quantitative CFU/mL Ranges of Bacterial Targets
Authors: Griffith-Vandi J , Valdez A , Rahimian P , Wagenman B 
Published: October 2024

Abstract

Background
Molecular diagnostics (MolDx) has surpassed culture in the clinical microbiology laboratory. Wong (2023) states PCR is more sensitive than urine culture in detecting polymicrobial infections (para. 8), marking an advantage in MolDX for urinary tract infections. This advancement poses a challenge for clinicians in treatment decision-making. To address requests for numerical MolDx result ranges, a validation accessed semi-quantitative Colony Forming Units per milliliter (CFU/mL) through the assessment of PCR cycle threshold (CT) values.

Methods
Bacterial targets of UTI and STI PCR panels were inoculated in nutrient broth (Hardy diagnostics cat#K43) and incubated overnight in a shaking incubator at 35±2°C. The density of the cultures was measured using the OD600 function of a NanoDrop One/One after 18-24 hour incubation. The density of stock cultures was adjusted to 106 CFU/mL. Serial dilutions of stock were made in 1:10 steps covering the range of 106 to 100 CFU/mL. The stock and dilutions were extracted, and PCR was performed in a minimum of 2 replicates of each sample for the UTI and STI PCR panels. Mean CT values, standard deviations and coefficients of variation were calculated for each sample. The linearity of CT values within each organism’s stock and dilution samples were assessed by evaluating the CT differences between each dilution step. Corresponding CFU/mL concentrations were tabulated against each mean CT value.

Results
The average CT values for reportable CFU/mL ranges were established for each stock and dilution. Mean CT values for each CFU/mL breakdown across all organisms were also calculated, along with standard deviations, to investigate universal CT-CFU/mL correlations. A final interpretation table (Table 1) was constructed according to the universal range calculations.

Conclusions
The study confirmed correlation between CT values and CFU/mL ranges. Further data analysis and comparison with other laboratories’ results will enhance accuracy and precision of reportable CFU/mL ranges.
B-312 Overcoming Challenges in Reporting High ß-hCG Results In Cancer Patients: A Tertiary Cancer Institute Experience
Authors: Chavan P , Pagdhune A , Mohite R , Pillai B G , Gavhane U A , Pal S K , Poladia P , Bhat V 
Published: October 2024

Abstract

Background
Serum ß-hCG is levels are a useful marker for diagnosis of Gestational Trophoblastic Disease as well as germ cell tumours of the ovary and testicle. However, values ranging from 50,000 - 1,00,000 mIU/ml are commonly seen in malignancies which are beyond the linearity of the most methods used in routine practice. This poses a great challenge to laboratory professionals while reporting for this test as serial monitoring of ß-hCG values is essential for ascertaining the effectiveness of treatment and progression of disease in oncology patients. The aim of this study was to develop a protocol for reporting beyond linearity values of serum ß-hCG in our laboratory with comparison of the same on two analysers with different linearity.

Methods
One hundred and fifty serum samples for ß-hCG received from patients with trophoblastic as well as germ cell tumours over a period of three months from October 2023 to December 2023 were processed by Chemiluminescence Immunoassay (CLIA) method on Atellica IM (Siemens Healthineers) and Alinity-i (Abbott Healthcare) immunoassay analysers simultaneously. The linearity for Atellica IM is 0 -1000mIU/ml and same for Alinity-i is 0- 15,000 mIU/ml as reported by the manufacturer. The protocol followed for samples processed on Atellica IM was as follows with 50 samples in each group. For values of ß-hCG less than 500 mIU/ml, we repeat tested samples with 1:10 dilution in case any instrument flags were observed in the report. For values between 500-1000 mIU/ml, samples were repeat tested with 1:50 dilution. For values reported as &gt;1000 mIU/ml, samples were repeat tested with 1:5000 dilutions. For Alinity-i, samples with values higher than 15,000 mIU/ml were processed with a dilution of 1:10. For all results with instrument flags, the dilution protocol was followed. Diluent provided by the manufacturer was used for all sample dilution processes. The values obtained on both analysers were compared statistically for correlation using linear regression analysis and coefficient of correlation (R) was calculated.

Results
The serum ß-hCG values observed ranged from 102 mIU/ml to 187,000 mIU/ml. Linear regression analysis for all groups showed good correlation. For serum ß-hCG values &lt; 500 mIU/ml; between 500-1000 mIU/ml and &gt;1000 mIU/ml coefficient of correlation was observed as R=0.9987, 0.9936 and 0.9713 respectively.

Conclusions
Good correlation was observed between values of serum ß-hCG obtained by dilution protocol on Atellica IM and Alinity-i analysers. The protocol developed by our laboratory to report beyond linearity sample results on Atellica IM can be a very useful tool in oncology patients where high values of beta HCG are expected and serial monitoring of values is essential.
B-338 Real-world data shows the effectiveness of a tetravalent vaccine against Human Papilloma Virus types 16 and 18 in Chilean women
Authors: Osorio Castro M J , Miranda J P , Bolivar A , Gómez L , Silva M , Silva C , Guzman P , Henríquez M 
Published: October 2024

Abstract

Background
Cervical uterine cancer (CUCa) is the fourth most common female neoplasm globally. At least 99% of CUCa cases are caused by persistent infection of high-risk Human Papillomavirus (HR-HPV) types. In 2014, Chile began a mandatory immunization plan for 9-year-old girls with the GARDASIL™ vaccine, which confers immunity against types 16 and 18 that cause about 70% of CUCa. This work aims to estimate this vaccine's effectiveness in women after nine years of inoculation.

Methods
We evaluated the results for HPV detection from 21.676 women between 15 and 77 years old between 2019 and 2023 at Bupa Lab. HPV detection and genotyping was performed with the ROCHE Cobas® HPV Test. Effectiveness was measured as the ratio between the number of cases of HPV types 16+18 versus other HR-HPV.

Results
During the analyzed period, the number of tests performed increased significantly, and the positivity rate decreased from 44% in 2019 to 26,9% in 2023. Global positivity was 32% for some HR-HPV types, reaching a peak of 49,5% in the 20 to 24,9 years group. The average 16+18/other HR ratio was 0,39, which decreased significantly to 0,24 in the vaccinated group of women between 15 and 19,9 years, suggesting an effectiveness of 37,5% against HPV types 16 and 18 concerning the total HR types (Table 1).

Conclusions
In recent years, HPV detection has proven useful in preventive monitoring and early detection of CUCa. This increased awareness has triggered a significant rise in HPV testing and could be driving test positivity downwards.
Although a more appropriate study design is required to estimate the actual effectiveness of the vaccine in Chile, our analyses showed a significant decrease in HPV types 16 and 18 in women after nine years of vaccination, which represents a crucial advance toward the eradication of CUCa.
Differential patterns of antibody response against SARS-CoV-2 nucleocapsid epitopes detected in sera from patients in the acute phase of COVID-19, convalescents, and pre-pandemic individuals
Authors: Razim Agnieszka , Pacyga-Prus Katarzyna , Kazana-Płuszka Wioletta , Zabłocka Agnieszka , Macała Józefa , Ciepłucha Hubert , Gamian Andrzej , Górska Sabina 
Published: October 2024

Abstract
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has already infected more than 0.7 billion people and caused over 7 million deaths worldwide. At the same time, our knowledge about this virus is still incipient. In some cases, there is pre-pandemic immunity; however, its source is unknown. The analysis of patients’ humoral responses might shed light on this puzzle. In this paper, we evaluated the antibody recognition of nucleocapsid protein, one of the structural proteins of SARS-CoV-2. For this purpose, we used pre-pandemic acute COVID-19 and convalescent patients’ sera to identify and map nucleocapsid protein epitopes. We identified a common epitope KKSAAEASKKPRQKRTATKA recognized by sera antibodies from all three groups. Some motifs of this sequence are widespread among various coronaviruses, plants or human proteins indicating that there might be more sources of nucleocapsid-reactive antibodies than previous infections with seasonal coronavirus. The two sequences MSDNGPQNQRNAPRITFGGP and KADETQALPQRQKKQQTVTL were detected as specific for sera from patients in the acute phase of infection and convalescents making them suitable for future development of vaccines against SARS-CoV-2. Knowledge of the humoral response to SARS-CoV-2 infection is essential for the design of appropriate diagnostic tools and vaccine antigens.