bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-351 Versatile and Sensitive Microfluidic Immunoassay for Improved Point-of-Care Diagnostics
Authors: Bennett S J , Link J S , Dolence A , Call Z D , Martinez B , Henry C S 
Published: October 2024

Abstract

Background
Healthcare professionals must choose between sensitivity and ease-of-use in diagnostics, particularly for diseases like COVID-19 and strep throat. Traditional enzyme-linked immunosorbent assays (ELISAs) are sensitive but are manually intensive and lengthy. Lateral flow assays (LFAs) are an alternative with low cost, ease-of-use, and rapid results; but LFAs suffer from low sensitivity. Burst Diagnostics presents a groundbreaking solution with the capillary-driven immunoassay (CaDI), a novel microfluidic device delivering sensitivity comparable to ELISA with the ease of LFAs.

Methods
The CaDI is made of flow channels defined by layered transparency and adhesive sheets containing reagent pads with HRP-conjugated antibody and luminol. The system requires only a sample addition step by the user. Sample flow initiates sequential steps of a sandwich ELISA, fully automated by the device, to provide a chemiluminescent signal in 10 minutes or less, depending on sample matrix.

Results
We have demonstrated success with preliminary studies for the detection of SARS-CoV-2 nucleocapsid protein (NP) and group A streptococcus (GAS). Detection of NP was achieved by assembling and optimizing COVID-19 CaDI’s using anti-NP antibodies. Then, spiked nasal swab samples were tested ranging from 10 to 1000 PFU/mL with positive detection as low as 10 PFU/mL, much less than the same samples in a traditional LFA (see figure). Additionally, we have demonstrated successful detection of GAS in optimized buffer conditions up to 100-fold less than commonly used LFAs. Finally, multiplexed CaDI’s increase throughput and cost-effectiveness in the point-of-care setting.

Conclusions
The CaDI platform bridges the ease of LFAs and sensitivity/specificity of laboratory tests. Currently, the CaDI can detect SARS-CoV-2 NP and GAS with higher sensitivity than existing LFAs. Development is underway for a reader to accompany the CaDI and further simplify the test. Importantly, the potential targets for detection are immense due to the sensitivity, simplicity, and adaptability of the platform.
A-355 Comparison of Arterial and Venous Whole Blood Samples Analyzed on the QuantraSystem With the QPlusand QStatCartridges
Authors: Uribe A A , Flores A , Fiorda-Diaz J , Vera-Miquilena E , Reeves J , Applegate B , Waldron A , Oldendorp G , Viola F , Winegar D 
Published: October 2024

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 &gt; 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.
A-358 Extended linearity studies for pO2, pCO2, K+ Cl- on GEM 5000 blood gas analyzers using a combination of verification materials
Authors: Samara Simha Subhash Chandra V , Khatoon H , Yeo K J 
Published: October 2024

Abstract

Background
Blood gas analyzers (BGA) measure blood gases pO2,pCO2,O2Hb,COHb,MetHb, and several analytes in the workup and management of acid-base disorders. GEM 5000 BGA (Instrumentation Laboratory, a Werfen Company) have very broad reportable ranges for the measured analytes. However, manufacturer’s current linearity materials do not cover the entire reportable ranges claims. This poses challenge to clinical laboratories, especially for pO2 and pCO2 to comply with College of American Pathologists (CAP) requirements to verify instruments performance every six months through the entire reportable range. We evaluated secondary materials in combination with manufacturer’s primary linearity materials for pO2, pCO2, K+ and Cl- for an extended linearity verification.

Methods
Routine linearity studies was performed with PVP (5-levels), a primary material provided by the GEM 5000 analyzer manufacturer. Hypoxic (pO2: 5-25mmHg) and hyperbaric (pO2: 600-670mmHg) materials obtained from Eurotrol Inc. and VK-R5 linearity material (Radiometer America Inc.) for pCO2, K+ and Cl- were processed on GEM 5000. All materials at all levels were assayed in duplicate. Results from PVP, Eurotrol and VK-R5 were combined from low to high levels to assess linearity verification.

Results
Linearity range of 15-630mmHg with r2=0.99 was verified for pO2. Using a combination of VK-R5 with PVP, a linearity range of 14-127 mmHg (r2=0.99) for pCO2, 1.1-14.1 mmol/L (r2=1.00) for K+, and 51-153 mmol/L (r2=1.00) for Cl-were verified. See table for details.

Conclusions
A combination of BGA manufacturer’s primary linearity material with secondary vendors material was useful in addressing linearity verification for blood gases pO2, pCO2, and electrolytes K+Cl- over an extended range close to the manufacturer’s claims. We recommend other laboratories that experience similar BGA linearity verification challenges to consider this approach for verification of the manufacturer’s claims. It would have been very helpful if manufacturer can provide materials that cover both the lower and upper limits of their claims.
A-359 Clinical Performance Evaluation of the Polymerase Chain Reaction (PCR)-Based cobas CT/NG/MG Test for Use on the cobas liat System in a Clinical Laboratory Setting and Point-of-Care (POC) Location
Authors: Van Der Pol B , Arcenas R , Boraas C , Chavoustie S , Crane L L , d'Empaire N , Ermel A C , Harnett G , Hinestrosa F , House S , Lillis R , Miller J , Mills A , Poblete R , Young S A 
Published: October 2024

Abstract

Background
Screening for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Mycoplasma genitalium (MG) can be achieved rapidly (in approximately 20 minutes) with the cobas® CT/NG/MG test (assay not cleared by US FDA. Submission currently under review and subject to change per health authority feedback). This automated, qualitative, real-time PCR-based nucleic acid amplification test (NAAT) is for use on the cobas® liat® system. This study evaluated the test’s clinical performance using urogenital samples from symptomatic and asymptomatic patients.

Methods
This non-interventional, non-observational study used prospective clinician-collected and self-collected specimens (urine, and vaginal swabs, all in cobas® PCR Media) from symptomatic/asymptomatic patients ≥14 years old from 13 POC sites across the US. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of cobas liat CT/NG/MG were calculated with respect to patient infected status (PIS), as determined using results from three FDA-approved NAATs and one laboratory-developed test. Due to insufficient positive NG samples during the trial period, further testing used archived samples.

Results
The median (range) age of the study population (N=4,800) was 35.0 (15.0-81.0) years; 40.4% (n=1,941) were symptomatic and 51.9% (n=2,489) were assigned female at birth. The cobas CT/NG/MG nucleic acid test demonstrated good clinical performance (Table 1). Across all specimen types, specificity was &gt;97% for each analyte. Sensitivity was ≥95%, except in female urine (CT 87.0%, NG 93.1%, MG 78.9%). Regardless of specimen type, PPV and NPV were ≥95% for CT and NG; PPV for MG was highest in male urine (92.7%) and NPV was &gt;97.5% across analytes.

Conclusions
In a clinical setting, the cobas CT/NG/MG nucleic acid test showed good clinical performance for the detection of CT, NG, and MG in urogenital samples, in addition to providing a short turn-around time and centralized testing lab quality at the POC for both self- and clinician-collected samples.
A-362 Hemolysis Detection and Flagging of Potassium Results on GEM Premier 7000 with iQM3
Authors: Butler M , Adib L , McNary N , Balasubramanian S , Pamidi P 
Published: October 2024

Abstract

Background
Blood gas analyzers that report whole blood potassium (K+) are vulnerable to inaccurate results due to in vitro hemolysis. GEM Premier 7000 with iQM3 (GEM 7000) automatically detects hemolysis (plasma free hemoglobin) and flags impacted K+ results. Here, we report the hemolysis impact on K+ measurements and the flagging approach used in the GEM 7000 system.

Methods
Hemolysis interference was assessed according to CLSI EP07c at low (3.8 mmol/L) and high (5.3 mmol/L) K+ levels. Ultrasonically-lysed whole blood was used to generate a high test pool (100% = 1000 mg/dL hemoglobin). This was mixed volumetrically with a low pool (0% = native blood) to create additional test pools (25%, 50%, and 75%) and analyzed on three (3) GEM 7000 systems. K+ bias at each test pool was calculated from the low pool to generate hemolysis interferograms. Linear regression was performed to determine the hemolysis level that exceeds the interference limit of 7%.

Results
Hemolysis exceeding the interference limit was ≥ 116 mg/dL for the low K+ and ≥ 147 mg/dL for the high K+ level. These correspond to an elevation of 0.27 mmol/L and 0.37 mmol/L of K+, respectively. Based on this study, the GEM 7000 triggers a hemolysis flag when the detected hemolysis exceeds 115 mg/dL. By default, GEM 7000 hemolysis flags are categorized into mild (116 -300 mg/dL), moderate (301 - 400 mg/dL), and gross (≥401 mg/dL) hemolysis.

Conclusions
The magnitude of the observed increase in K+ (0.277 - 0.295 mmol/L for every 100 mg/dL of hemoglobin) on the GEM 7000 due to in vitro hemolysis is consistent with previously published reports in the literature. Automated hemolysis detection and flagging of K+ results in GEM 7000 overcome the limitation of the inability to detect hemolysis in blood gas samples.
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: Charrault E , Chew K , Habibi A , Ramezan T , Currier K , So C , Banaszczyk A , Bai S , Niu V , Lai K , Chang W , Caron D , Pham K , Ghosh O , Khan R , Milbes B , Swadia H , Chien J , Sathyamoorthy K , Naranatt P , Maktabi S , Singh A , Patel T , Izadi Kharazi F , Heltsley R 
Published: October 2024

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.
B-005 Improved Sensitivity on the Beckman Coulter DxI 9000 Immunoassay Analyzer* Enables Reduction of Required Sample and Reagent Volumes for Immunoassays
Authors: Kuklok S , Lareau R , Thomforde J , Her T , Young A , Thompson T , Tornquist M , Bagley A , Kubista H , Johnson J , Bolstad B , Walt K , Lovett D , Holland M , Mah J , Nelson W , Lengfeld J , Quin M , Bilyeu B , Knutson C , Posnansky M , Malikowski-Hoffarth N , Soller K , Szabo M , Carlson C 
Published: October 2024

Abstract

Background
The Beckman Coulter DxI 9000 Immunoassay Analyzer* includes new technology that improves assay sensitivity capabilities. Such technological advancements include the Lumi-Phos PRO chemiluminescent substrate, a new luminometer, and improved low-volume pipetting capabilities. These enhancements afford opportunities to develop immunoassays using reduced sample and reagent volumes, conserving precious patient samples, minimizing the carbon footprint of plastic packaging, and increasing the number of tests per reagent pack. Studies are presented herein for the Access TSH (3rd IS), Access βhCG (5th IS), and Access Hybritech Total PSA assays to evaluate analytical performance when using decreased sample/reagent volumes on the DxI 9000 analyzer. *The official name is DxI 9000 Access Immunoassay Analyzer.

Methods
To assess performance when using proportionally reduced sample/reagent volumes on the DxI 9000 analyzer compared to standard sample/reagent volumes on the Access 2 Immunoassay System, within-laboratory precision was evaluated following CLSI EP05-A3, limit of quantitation (LoQ) was estimated following CLSI EP17-A2, and accuracy was assessed following CLSI EP09c, 3rd ed.

Results
Results of sensitivity studies are summarized in the table below for assays using reduced sample/reagent volumes on the DxI 9000 analyzer compared to standard volumes on the Access 2 system. Maximum observed LoQ improved 1.4- to 3-fold on the DxI 9000 analyzer, despite employing ∼50% reduction of sample/reagents. Precision and accuracy studies also showed acceptable performance.

Conclusions
The data herein provide evidence for maintained analytical performance goals when using reduced sample and reagent volumes for assays on the DxI 9000 analyzer. The additional sensitivity capability of the DxI 9000 analyzer can be used to reduce the volume of sample and reagents, conserving patient samples and reducing packaging per test. The pipetting accuracy and detection capabilities of the DxI 9000 analyzer provide opportunities for immunoassay developers to drive both improved low-end performance and conservation of resources.
B-006 Use of Sysmex UN-3000 Research Parameters for Semiquantitative Analysis of Urine Microscopic Elements
Authors: Nakashima M , Shelestak H , Lauren M , Chappell M 
Published: October 2024

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 &gt;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.
B-010 Intercomparison Study of Methods between Atellica Solution® and CI® Analyzers for Sodium, Potassium, and Chloride
Authors: Garcia-Valdecasas S , Lapeña-Garcia S , Ruiz-Alvarez M , Costales-Lucia T , Moreno-Romero A , Molina-Blas S , Barrionuevo-Gonzalez M 
Published: October 2024

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
B-022 A New DNA Size-Selection Technology:Methods for Isolating, Capturing, and Recovery of Target Macromolecules by Gel Electrophoresis
Authors: Nix P T 
Published: October 2024

Abstract

Background
The ability to recover DNA fragments in high quantity and purity from agarose gel is an important need for researchers in molecular biology laboratories for downstream applications such as testing and sequencing. There are multiple established methods and corresponding commercial products available at researchers’ disposal. Despite the availability of many methods, researchers often face a trade-off decision between fast and simple methods with low yield and poor DNA quality, and time-consuming and expensive methods with higher yields and better purity.

Methods
Gene Stix (ElectroSep) is a new system for recovery of DNA/RNA from an electrophoresis gel. Using the power of electrophoresis to separate nucleic acids based on size (a well-known technique), the Gene Stix, for the first time, allows one to recover nucleic acids directly from the gel. Gene Stix consisted of a cationic membrane which is inserted (in front of the nucleic acid of interest) into the electrophoresis gel after the nucleic acids are resolved from other contaminants in a separate step. After the Gene Stix is inserted in front of the DNA, the gel is re-run for a short period of time, binding the DNA to the Gene Stix. The Gene Stix is removed from the gel (carrying the DNA) and the DNA is recovered by elution using a special buffer.

Results
Electro-Sep technology allows DNA recovery around 85% and may lead up to 35% process efficiency for purification. It maximizes the process efficiency by not requiring damaging UV sensitive dyes in samples or cutting gel bands and allowing multiple Gene Stix used with one sample. Unique serial numbering system provides unambiguous sample identification.

Conclusions
The yield from different methods varies, however, it is typically at around 60-70%. Many of the commercially available DNA purification kits require around 25-30 minutes for purification. Moreover, the process with available methods could be laborious requiring cutting the gel bands, using UV dyes in sample, or simply requiring specialized gel electrophoresis equipment. Electro-Sep technology (and Gene Stix product using the technology), designed to recover size-selected DNA from agarose gel, provides a viable option that is rapid, easy-to-use yet resulting in high DNA recovery.