bluuebunny/crossref_metadata_2025_split huggingface dataset:
B-098 Analytical Performance Evaluation of Sigma Strong Clinical Chemistry Assays on the Alinity c System
Authors: Berman M , Bhartia V , Wang X , Cheng P , Kulasingam V 
Published: September 2023

Abstract

Background
The aim of this study was to evaluate the analytical performance of 5 Abbott next generation (Sigma Strong) clinical chemistry assays on the Abbott Alinity c system. Method comparison, precision, linearity, accuracy, and sigma metrics were assessed for Albumin BCG2 (Bromocresol green), Albumin BCP2 (Bromocresol purple), Cholesterol2, Total Protein2 and Amylase2.

Methods
Method comparison between new (second generation) and current on market Alinity assays was performed by measuring 126–138 serum/plasma samples in duplicate. Assessment of imprecision was performed by running 2 levels of quality control material (BioRad; Chemistry UA) and 3 pooled patient samples 5x twice per day for 5 days. 10 replicates of ERM-DA470 k IFCC material for albumin, ERM-AD456 k IFCC material for amylase, NIST SRM 927 material for total protein, and NIST 1951cL1 for cholesterol were run to determine the accuracy and calculated sigma value for each analyte. Linearity testing was performed by running 5–6 levels of commercially available linearity materials in replicates of 3. Bias, acceptable imprecision, and total allowable error were based on Clinical Laboratory Improvement Amendments and Accreditation Canada Diagnostics guidelines. Statistical analysis was performed using EP evaluator.

Results
Data for method comparison (Passing Bablok), precision (Range of total %CV across 5 concentrations), accuracy (% Bias from target value), and linearity (Range of % recovery) for 5 Abbott second generation clinical chemistry assays are shown in Table 1. All assays demonstrated ≥6 Sigma performance.

Conclusion
The Abbott second generation (Sigma Strong) clinical chemistry assays on the Alinity c system showed acceptable performance for precision, accuracy, linearity, and agreement with the on-market Alinity c clinical chemistry assays.
B-102 Screening Food Allergies in Our Health Primary Care Area
Authors: De Haro Romero T , Aldana C , González Cejudo T , de Haro Muñoz T 
Published: September 2023

Abstract

Background
Allergy is the immunological disease with the greatest impact in the world. Food allergy typically manifests with cutaneous, digestive and/or respiratory symptoms, of immediate onset, usually immunoglobulin E-mediated. Doctors from primary health-care providers are often challenged with these patients, becoming the first-line for the recognition and management of food allergies. As a laboratory, our duty is to provide the health care system with the most effective diagnostic tools.

Methods
We recollected all the results from Primary care of our health area analyzed in our laboratory for one year. Screening assay included a panel of specific IgE antibodies to the most common food allergens: egg yolk, egg white, milk, cod, wheat, peanut and soybean. They were detected semi-quantitatively by enzyme-labeled chemiluminescent immunoassay using the Immulite Allergy Food Panel FP5 kit (Siemens Diagnostic Products Corporation, Los Angeles, USA), according to the test procedure. If the assay was positive, all specific IgE allergens contained in the mixture were analyzed separately to determine their responsibility for the positive screening test.

Results
Our laboratory processed 24 125 samples from primary care patients. Of these, 1251 were positive (greater than 0.35 Ku/L), which represented 5.19% positive of the total analyzed. Once all the specific IgE allergens contained in the mixture were analyzed, the results were: 608 positive for egg yolk, 753 positive for egg white, 523 positive for milk, 109 positive for cod, 405 positive for wheat, 597 positive for peanut and 480 positive for soybean.

Conclusion
As with most medical disorders, a thorough medical history is the initial step in diagnosing adverse food reactions. The medical history is extremely useful, especially in acute reactions, but it can be unreliable in chronic disorders such as atopic dermatitis and asthma. In vitro assays help in the diagnosis, but they must be considered as a screening and no diagnosis tool, especially when no symptoms are associated with the positive food allergen result. That’s why in vitro results must be confirmed by prick test, which is considered gold standard for allergy diagnosis. In our study, egg white is the most prevalent allergen detected (60.19%), followed in order by egg yolk (48.60%), peanut (47.72%), milk (41.81%), soybean (38.37%), wheat (32.37%) and being cod the least allergen detected (8.71%).
B-108 T-cell-mediated Immunity against SARS-CoV-2 in Health Care Workers: Head-to-head Comparison of Two Interferon-Gamma Release Assays and Associations between Cellular and Humoral Immunity
Authors: Sabalza M , Martinek J , Tomášková H , Lochmanová A , Zelená H , Motlochová J , Dieckmann K , Grage-Griebenow E , Saschenbrecker S , Zapf D , Herbst V , Ježo E , Janošek J 
Published: September 2023

Abstract

Background
T-cell responses are a crucial constituent in the adaptive immunity to SARS-CoV-2 and can be quantified using interferon-gamma (IFN-γ) release assays (IGRAs). This study aimed at comparing the results of two commercial IGRA systems, the EUROIMMUN Quan-T-Cell SARS-CoV-2 and the Oxford Immunotec T-SPOT.COVID, presenting the first head-to-head comparison of these two assays for the evaluation of SARS-CoV-2-specific T-cell activity.

Methods
Blood samples were collected at the Public Health Institute Ostrava from 90 health care professionals with a history of COVID-19 infection or vaccination. All samples were tested for T-cell-mediated immunity using the two IGRAs as well as for humoral immunity using the EUROIMMUN Anti-SARS-CoV-2 QuantiVac ELISA IgG and an in-house virus neutralization test.

Results
Similar results were obtained by both IGRAs, yet the sensitivity of the Quan-T-Cell appeared to be insignificantly higher than that of the T-SPOT.COVID.

Conclusion
Both assays demonstrated excellent overall agreement with virus neutralization activity and anti-S IgG positivity, with the only exception that 4/6 subjects in the subgroup of unvaccinated Omicron convalescents were devoid of IgG. In these cases, however, T-cell responses were at least borderline positive, indicating that IGRAs provide higher sensitivity in detecting immune responses to SARS-CoV-2 than do IgG-specific assays. This applies particularly to unvaccinated persons who contracted only SARS-CoV-2 Omicron variant infection but is also likely to be relevant to other patient groups.
B-113 Diagnostic Value of Autoantibodies against D-3-phosphoglycerate Dehydrogenase (PGDH) among Patients with Liver Diseases
Authors: Venkataraman I , Feng X , Liu Y , Karl I , Ott A , Scheper T , Meyer W , Yan H 
Published: September 2023

Abstract

Background
We determined serum autoantibodies against D-3-phosphoglycerate dehydrogenase (anti-PGDH) in patients with liver diseases using a well-validated line immunoblot assay, and analysed their diagnostic significance.

Methods
The studied panel comprised serum samples from 383 patients with the following liver diseases: 87 autoimmune hepatitis (AIH), 88 primary biliary cholangitis (PBC), 76 chronic hepatitis B, 79 hepatitis C, 53 drug-induced liver injury as well as sera from 69 patients with autoimmune diseases (systemic lupus erythematosus or rheumatoid arthritis) and 30 healthy blood donors. The line immunoblot EUROLINE Autoimmune Liver Diseases 14 Ag (EUROIMMUN) was used to test for anti-PGDH. The intensities of the bands were automatically evaluated using the EUROLineScan software (EUROIMMUN). Indirect immunofluorescence was used to detect other autoantibodies, including anti-nuclear autoantibodies (ANA) and anti-smooth muscle antibodies (ASMA).

Results
The prevalence of anti-PGDH was 18.3% across all patients with liver diseases (36.8% in AIH; 10.2% in PBC), 1.5% in patients with autoimmune diseases, and 3.3% in blood donors. ANA but not ASMA were detectable in all anti-PGDH positive patients with liver diseases. Patients with anti-PGDH displayed no significant differences in age, liver function, IgG serum level and ANA patterns compared to those without anti-PGDH. Anti-PGDH positivity was observed at various stages of liver disease, including acute and chronic liver injury, liver cirrhosis, and liver cancer.

Conclusion
The anti-PGDH prevalence in AIH patients was highest among patients with liver or autoimmune diseases. Presence of anti-PGDH seems to be a specific marker for AIH and may support the diagnosis of AIH.
B-120 Atellica® Ci 1900 Assay Sigma Metrics Evaluation
Authors: Kolewe K W , Leipold H , Lewisch S A , Snyder J T 
Published: September 2023

Abstract

Background
The Atellica® CI 1900 Analyzer is a stand-alone, integrated clinical chemistry and immunoassay analyzer. Offering the same assay portfolio as the Atellica® Solution, the Atellica® CI 1900 analyzer is designed to complement the Atellica® Solution in hub-and-spoke settings, enabling labs of every size to offer state-of-the-art patient testing. Six Sigma is synonymous with process performance, and Sigma metrics have become the analytical quality benchmark for the medical device industry. In this study, Sigma metrics were calculated for a total of 71 Atellica® assays to provide a simple, translatable value to evaluate a given assay’s performance on the Atellica® CI 1900 Analyzer.

Methods
Allowable total error (ATE) for each assay was defined from the Clinical Laboratory Improvement Amendment (CLIA) table. When an analyte was not present in the CLIA table, alternative sources were consulted, including the RiliBÄK table, Royal College of Pathologists of Australasia (RCPA) table, and Ricos Biological Variability. Precision studies were conducted in accordance with Clinical and Laboratory Standards Institute (CLSI) document EP05-A3 over 20 days (n = 80 replicates) using the Atellica® CI 1900 Analyzer. Method comparison studies conducted on the Atellica® CI and Atellica® CH/IM Analyzers, with at least 100 patient samples spanning the assay’s measuring interval in accordance with CLSI document EP09-A3, were used to establish bias at the selected target precision concentration. Sigma metrics were determined for each assay using the equation Sigma metric = (ATE – %bias)/(Within-lab %coefficient of variation [CV]).

Results
Sigma metrics were determined for a total of 71 Atellica® assays, resulting in 93% of assays performing above Five or Six Sigma and 0 assays performing below 4 Sigma. Of these, 44 of 52 clinical chemistry and 15 of 19 immunoassays performed above the 6 Sigma level.

Conclusions
Sigma metrics that provide a benchmark for laboratory quality classify over 90% of assays on the Atellica® CI 1900 Analyzer with scores of 5 or 6, corresponding to the classification of excellent or world-class performance. Therefore, laboratories can expect high quality assay performance with strong comparability between the Atellica® CI 1900 Analyzer and the Atellica® Solution. **Not available for sale in the US. Product availability varies by country.
B-141 Surprisingly Good Agreement of Siemens and Roche ALT Reference Change Values in Ottawa Hospital Outpatients Distilled from 5 years and 3 years of Siemens and Roche ALT, Respectively
Authors: Cembrowski G , Qiu J , McCudden C 
Published: September 2023

Abstract

Background
Sequential patient data can be transformed into the variable component of the reference change value (RCV) calculation: (CVA2 + CVI2)1/2 (PMID 35137000). We have analyzed sequential healthy and abnormal outpatient ALT to derive RCVs of Ottawa Hospital outpatients (OHOP) who had sequential ALT measured by Siemens or Roche assays.

Methods
We used the American College of Gastroenterology definition of normal ALT with supplementation of P5P as &lt;25 U/L and &lt;33 U/L in females and males, respectively. We defined abnormal as between the upper limit of normal (ULN) and 3xULN. 5 years of Siemens ALT measurements and subsequently 3 years of Roche ALT were abstracted from the Ottawa Hospital EMR. For the 8 patient cohorts, we tabulated consecutive pairs of intrapatient ALT by time intervals of separation: 0–1 weeks, 1–2 weeks, 2–3 weeks . . ., up to 51–52 weeks. For each interval, we determined the standard deviation of duplicates (SDD) between the paired intrapatient results. SDD was graphed against the midpoints of the weekly interval. Linear regression was used to determine the y-intercept (yo). The 95% RCVs of the male and female, normal and abnormal populations were calculated for the Siemens (with P5P) and Roche (non P5P) assays.

Results
The Table describes each cohort, yo and RCV. According to the Roche/Siemens cross-over study, Roche ALT values were 10% less than Siemens. This Roche bias is reflected in the normal outpatient ALT means and less so in those with elevated ALT. Also presented are the RCV of low ALT (normal) patients as documented by Ricos and Carobene.

Conclusion
Our RCVs are realistic: normal ALT patients demonstrate lower RCVs, close to Ricos’ but much larger than Carobene’s which are unachievable due to diurnal variation (over 40% of OHOP ALT are drawn at different times of the day). Furthermore, Carobene’s CVA is tiny.
B-147 Evaluation of Laboratory Database: Is there a Causal Relationship between COVID-19 and Type 1 Diabetes
Authors: Castelo M C , Cruz M , Bandeira S P , Lopes A C , Cavalcante L L 
Published: September 2023

Abstract

Background
Type 1 diabetes mellitus (T1DM) constitutes about 5% of all diagnosed cases of diabetes. The global incidence is increasing over the past few years. To date, the pathophysiology of the disease is not fully understood. with descriptions of activation of the immune system by some viral agents. SARS-CoV-2 has been suggested as a potential inducer of new-onset type 1 diabetes mellitus (T1DM). DASA has one of the largestData and Analytics areas in Diagnostic Medicine. The use of laboratory data can represent an important tool in broader knowledge of this relationship. This study aimed to evaluate the frequency of new-onset T1DM in the years 2019, 2020 and 2021.

Methods
This study was done through an observational, retrospective big data laboratory approach with a network that extends over a large part of Brazil to analyze whether there was an increase in T1DM cases. Individuals aged 18 years or younger were evaluated from January 2019 to December 2021. The subjects were characterized with possible new-onset T1DM through the presence of glycated hemoglobin equal to or greater than 6.5% in the presence of at least one disease-related antibody. The antibodies evaluated were: anti-GAD, anti-islet, anti-insulin and anti-zinc transporter type 8. For data evaluation, the means and standard deviations and the chi-square test were used. The results of patients who underwent RT PCR COVID19 were evaluated.

Results
A total of 431 060 subjects (&lt;18 years) were evaluated, with 229 201 female (53.17%). Table 1 shows the distribution of data over the years evaluated, the number of patients with glycated levels greater than 6.5% and the number of probable new cases of DM1 from the positivity of at least 1 antibody. In the years evaluated, there was no statistical difference in the incidence of the disease between the sexes (2019 - 51.2%; P:0.92, 2020 - 50.3%; P:0.99 and 2021 - 48.9%; P: 0.67). The mean age with standard deviation in the years 2019, 2020 and 2021, respectively, was: 12.4% ± 4.4; 12.6 ± 4.3 and 12.5% ± 4.3. The mean values of glycated hemoglobin of patients with a value ≥6.5% with standard deviation in the years 2019, 2020 and 2021, respectively, were: 9.3% ± 2.1; 9.2 ± 2.5 and 9.3% ± 3.4. When comparing the incidence of the disease between the years, there was a significant increase in cases when comparing the years 2021 with 2020 and 2019 (P: 0.01 and P &lt; 0.01, respectively). Of the total number of patients in 2020, only 5 underwent RT PCR COVID 19, with no positive result, and in 2021 a total of 32, with 7 positive, corresponding to 21.8% of cases.

Conclusion
The present study, using a large database, seems to demonstrate an increase in the incidence of DM1 among children diagnosed with diabetes. Prospective studies that evaluate the possible relationship of the disease with the SARS-CoV-2 virus may show this agent as a trigger of disease-related automunity.
B-183 The Impact of 3-EPI-25-Hydroxyvitamin D on 25-Hydroxyvitamin D Measurement by Liquid Chromatography/Mass Spectrometry
Authors: Turner K A , Radecki T W , Boughner E L , Bolhuis K D 
Published: September 2023

Abstract

Background
25-hydroxyvitamin D is the recommended target to evaluate vitamin D status. The accurate measurement of 25-hydroxyvitamin D by liquid chromatography/mass spectrometry (LC/MS/MS) is impacted by the presence of the biologically inactive epimer of 25-hydroxyvitamin D2 and D3, 3-EPI-25-hydroxyvitamin D2 and D3. The epimers are isomers and share the same mass and fragment transitions as 25-hydroxyvitamin D2 and D3. For an accurate measurement the epimer should be chromatographically separated from 25-hydroxyvitamin D. Herein we assess the significance of 3-EPI-25-hydroxyvitamin D in our patient population.

Methods
A LC/MS/MS method was developed to chromatographically separate 25-hydroxyvitamin D2 and D3 from 3-EPI-25-hydroxyvitamin D2 and D3 on a Waters Xevo TQ-S Micro with an Acquity UPLC System using a 2.6 μm Pentafluorophenyl (PFP) column (Phenomenex). There were 231 residual serum samples analyzed.

Results
The cohort tested consisted of 16 infant samples (&lt;1 years), 62 pediatric samples (1–17 years), adult samples (≥18 years), and 20 pregnant samples. 3-EPI-25-hydroxyvitamin D2 was not detected in any sample analyzed (&lt;1 ng/mL). The prevalence and concentration of 3-EPI-25-hydroxyvitamin D3 was variable (Fig. 1).

Conclusion
The specificity of 25-hydroxyvitamin D measurement by LC/MS/MS is not affected by 3-EPI-25-hydroxyvitamin D2 as it is not present in our patient population. However, 3-EPI-25-hydroxyvitamin D3 is a significant interference. The presence of 3-EPI-25-hydroxyvitamin D3 is variable with the highest prevalence and concentration in infants. The prevalence and concentration decrease with age and is minimal in pregnancy. For infant and pediatric samples, an assay that chromatographically separates 3-EPI-25-hydroxyvitamin D3 from 25-hydroxyvitamin D3 is needed. For adult samples, it may be appropriate not to separate 25-hydroxyvitamin D3 from the epimer. For this patient population a balance between accuracy and throughput must be established.
B-204 Determination of Lyso-GB3 in Dried Blood Spots: A Useful Biomarker for Fabry Disease
Authors: Paulo B F , Novo E M , Zauli D A , Serra A P 
Published: September 2023

Abstract

Background
Fabry disease, an X-linked inborn error of metabolism, results from pathogenic mutations in the α-galactosidase A gene (GLA). These mutations reduce or abolish the α-galactosidase A activity, which result in accumulation of glycosphingolipids in the lysosomes, including globotriaosyl-sphingosinein (lyso-GB3), throughout the body, in particular the kidney, heart, and brain. Lyso-GB3 may be elevated in symptomatic patients and supports a diagnosis of Fabry disease. It may also be helpful as a tool for monitoring disease progression, as well as determining treatment response in known patients. Moreover, measurement of Lyso-GB3, may provide additional diagnostic information in the evaluation of uncertain cases, such as in asymptomatic heterozygous female patients, individuals with novel GLA variants of unclear clinical significance, as well as asymptomatic patients identified by family screening. This study aimed to determine Lyso-GB3 in dried blood spot (DBS) samples with a simple, rapid and sensitive LC-MS/MS method, and identify its reference interval in the Brazilian population.

Methods
All experiments were performed on the Waters TQ-S Micro LC-MS/MS system. The gradient chromatographic separation was carried out using a Waters BEH C18 column in 3.5 min. One DBS punch of 3.1 mm diameter was used for analysis in a microtiter plate and then, a solvent extraction containing stable isotope analogue of Lyso-GB3 was added. After incubation time, the supernatant was directly injected into LC-MS/MS system. The method was validated for linearity, carryover, intra and inter-day precision and the limit of quantification was determined. A reference interval was obtained by analyzing 94 healthy volunteers (49 women and 45 men). The difference of Lyso-GB3 concentration between men and women was investigated (Wilcoxon paired test). The reference interval was determined by the superior limit of the confidence interval (90% CI) of a normal distribution of the results.

Results
The method was linear between 0.2–100.0 ng.mL−1. The recovery was between 81.0 and 139.7%, which was acceptable considering CLSI guidelines for DBS validation (CLSI NBS04-A). The intra and inter-day precision were below 12.1%, and the limit of quantification was 0.2 ng.mL−1. The reference interval determined was below 0.8 ng/mL.

Conclusion
In conclusion, the LC-MS/MS method for Lyso-GB3 determination in DBS samples was successfully validated. The sample preparation is simple and the chromatographic method is rapid for routine laboratory. The cutoff determined is comparable with what is available in the literature and adequate for analysis in clinical routine.