bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-047 Comparison of Two Immunoassays for Measuring Anti-Mullerian Hormone
Authors: Tamimi W , Alsughyyir A , Altwaijry A , Al Saedi R , Alhamad A , Alotabi A M , Mohamed M M , Althubiti F M , Al-Zaidi M M , Alkhidhr A , Alhuwayshil S , Almutairi M O 
Published: October 2024

Abstract

Background
Anti-Mullerian hormone (AMH) is produced by follicles in women, and its measurement in blood may be a reliable indicator of ovarian reserve and ovarian function. It can also be of clinical value in the treatment of infertility. Many immunoassays gave been devolved to measure AMH in the blood. Recently a new AMH assay was developed by Snibe company with different immunoassay technique and detecting labeled. The aim of this study was to compare this new AMH immunoassay with the current under use immunoassays.

Methods
A total of 40 blood samples were collected from 40 Saudi women with age between 15 to 49 years. The samples were performed by both immunoassay Cobas e411 (Roche) and Maglumi 4000 plus (Snibe). The Cobas e411 uses Electrochemiluminescence immunoassay (ECLIA) with ruthenium(II) complex labeled, while Maglumi 4000 plus use Chemiluminescence immunoassay (CLIA) with different labeled ABEI. The measuring range was 0.071 to 164 pmol/L and 0.143 to 178 pmol/L for each assay respectively. The Microsoft Excel sheet was used and T Test was used to evaluate the comparison statistics with p value at (0.05).

Results
The correlation of coefficient was found to be 0.9418 between the two assays. The mean and standard deviation were calculated to be 11.8±13 pmol/L and 8.3±8.5 pmol/L for Cobas e411 and Maglumi 4000 plus respectively (p&lt;0.0001). Based on the reference interval for each assay, there was 100% agreement between the two assays.

Conclusions
The Anti-Mullerian Hormone assay by Maglumi 4000 plus (Snibe) had a very good correlation with current assay used in our laboratory and thus can be reliably used to measure AMH in the blood but as with current assay, interpretation of the result must be matched with other clinical findings.
A-049 Effect of Supplementation With Prebiotics on Levels of 25-Hydroxy Vitamin D and on Biomarkers of Bone Remodelling-Results From the OSTEOME Clinical Trial
Authors: Makris K , Trifonidi I , Haliassos A , Lambropoulou-Adamidou K 
Published: October 2024

Abstract

Background
It is proven that intestinal microbes regulate bone metabolism and can affect the quality of the bone. Prebiotics contain no microorganisms, only substances stimulating their growth. Moreover, flavonoids and catechines are transformed by the microbes into bioactive compounds and polyphenols can modify the microflora composition. OSTEOME is a randomized double-blinded clinical trial to evaluate the efficacy of dietary supplements enriched with prebiotics, in advancing the role of gut microbiota in bone remodelling. We present the effect of supplementation with prebiotics on the serum levels of 25-hydroxy vitamin D (25OHD) and on levels bone markers Osteocalcin (OCN), and C-Terminal Telopeptide of Type-I Collagen (CTX).

Methods
We enrolled 120 postmenopausal women with osteopenia. Participants were randomized into three groups of 40-participants. Group-A received a supplement containing 600mg calcium citrate and 2400IUof vitamin D3 only, group-B received a supplement additionally containing flavonoids (120mg Naringin and 120mg Hesperidine) and group-C received additionally prebiotic oligosaccharides (2000mg fructooligosaccharides and acacia gum). Blood collections were performed at baseline and at 3, 6 and 9 months for the measurement of bone remodelling biomarkers. Levels of serum Calcium (sCa), 25OHD, as well as levels bone markers OCN, and CTX were measured at all timepoints of follow-up.

Results
The mean age of group-A, group-B and group-C participants was 60.72(+8.08), 62.37(+7.70) and 62.09(+7.09) (p=NS), and the mean BMIs were 25.35(+3.96), 25.89(+3.80) and 26.25(+4.56) (p=NS). All women were osteopenic as mean total hip T-score was -1.282(+0.617), -1.193(+0.659) and -1.273(+0.573) at baseline for all three groups respectively. The results of OCN, CTX and 25OHD are shown in the table.

Conclusions
Only patients in group-C showed significant changes in CTX and 25OHD at 9-months, and OCN at 6- and 9-months. Addition of prebiotics to supplements might improve the vitamin D absorption from the gut and give positive balance to biomarkers of bone metabolism.
A-058 Biomarkers of Nephropathy and the Angiotensin Converting Enzyme Insertion and Deletion Gene Polymorphisms Among Type 2 Diabetes Mellitus Patients at a Tertiary Hospital in Uganda
Authors: Kiconco R , Kalyesubula R , Kiwanuka G 
Published: October 2024

Abstract

Background
In this cross-sectional study, we aimed at determining the association between the biomarkers of nephropathy and the ACE insertion/deletion gene polymorphisms among type 2 diabetic patients.

Methods
Data were collected from 237 adult type 2 diabetes mellitus patients receiving healthcare at the diabetic clinic of Mbarara Regional Referral Hospital. Peripheral blood genomic DNA was amplified using a conventional PCR technique and analyzed for the ACE homozygous forms of the insertion (II), deletion (DD) and heterozygous insertion deletion (ID) genotypes as well as their respective allele counts. Biomarkers of nephropathy were analyzed on a Beckman coulter AU480 chemistry analyzer using system compatible reagents.

Results
Majority of the participants were older persons (Median = 57, IQR = 49-64) and female 171 (72.2%). Most of them had the Deletion allele 198 (83.5%) and DD genotype 116 (48.9%). At multivariate logistic regression, Insertion allele was associated with increasing glycated hemoglobin (OR =1.082, p = 0.019) and decreasing serum glucose levels (OR = 0.891, p = 0.001). Deletion allele was associated with decreasing glycated hemoglobin (OR = 0.924, p = 0.047) and increasing serum glucose levels (OR= 1.208, p = 0.001). ACE II genotype was associated with decreasing serum glucose levels (OR = 0.873, p = 0.029). ACE DD genotype was associated with decreasing glycated hemoglobin (OR = 0.917, p = 0.010) and increasing serum glucose levels (OR = 1.132, p = 0.001). ACE ID genotype was associated with increasing glycated hemoglobin (OR =1.077, p = 0.022), triglycerides levels (OR = 1.316, p = 0.031) and decreasing serum glucose levels (OR = 0.933, p = 0.038). See Table 1. There was no association between the ACE I/D alleles or genotypes with microalbuminuria and eGFR.

Conclusions
ACE polymorphisms affect the ultimate increase or decrease in the serum glucose, glycated hemoglobin and triglycerides levels.
A-091 Evaluation of the Analytical Performance of the New Prealbumin Assay on the Atellica CH Analyzer
Authors: Lewisch S , Thomas J , Maxwell T , Shalhoub V , Cheek J , Snyder J 
Published: October 2024

Abstract

Background
Analytical performance studies for the new Atellica® CH Prealbumin (PALB) Assay were performed to evaluate precision, detection capability, linearity, and method comparison with the Atellica® CH Prealbumin (PreAlb) Assay.

Methods
Precision was conducted with 3 reagent lots per CLSI EP05-A3. Daily, two runs were performed, separated by &gt;2 hours with 2 replicates/run, for 20 days, using normal human serum, QC material (Bio-Rad Liquid Assayed Multiqual® Level 3), and normal human serum spiked with prealbumin (Cliniqa Prealbumin spike). Reproducibility was determined per CLSI EP05 A3 and internal protocols. Samples were assayed n=5 in 1 run for 5 days using 3 instruments and 3 reagent lots. Method comparison (MC) studies were conducted with 3 reagent lots per CLSI EP09C-ED3. Individual native serum samples were tested in singlicate on two Atellica® CH analyzers. Passing & Bablok regression used PALB assay as test assay and PreAlb assay as predicate assay. Where needed, MC samples were spiked with concentrated prealbumin (Clinqa Prealbumin spike) to cover the assay measuring interval. LoB and LoD testing were conducted with 3 reagent lots per CLSI EP17-A2. For LoB, four blank samples were run (n=6) per day for three days, total 72 per reagent lot. For LoD, and additional four low samples were run (n=6) per day for three days on 3 lots, on one instrument, total 72 per lot. Linearity studies followed CLSI EP06 A; low and high pools were diluted and spiked (9 levels; n=5 per level).

Results
The linear range was 3.0-70.0 (30-700) mg/dL (mg/L). Results are presented in the table below for detection capability, repeatability, and method comparison. Reproducibility was 2.7-6.5% at 15.0-58.4 mg/dL (150-584 mg/L).

Conclusions
The PALB assay detection capability, precision, linearity, and method comparison with the PreAlb assay results were acceptable. This assay is fit for use in a clinical laboratory.
A-106 Determination of Urinary NGAL Reference Intervals from Specimens of Healthy Adult and Pediatric Individuals
Authors: Klause U , Broyles D , Baker T , Bird C 
Published: October 2024

Abstract

Background
Neutrophil gelatinase-associated lipocalin (NGAL) is a 25kDa protein implicated in multiple biological processes, including attenuation of apoptosis and differentiation of renal tubule epithelial cells and nephrons. NGAL is also produced and secreted by injured kidney tubule epithelial cells. As such, NGAL can serve as an early urinary biomarker for acute kidney injury (AKI). This multi-site, cross-sectional study aimed to establish reference intervals for urinary NGAL (uNGAL) in healthy pediatric and adult populations using a particle-enhanced turbidimetric assay.

Methods
Apparently healthy individuals, aged ≥ 3 months, were eligible for this study. Subjects with an active urinary tract infection (UTI) on the day of sample collection, acute kidney injury (AKI) or a history of AKI, stage 4 or 5 chronic kidney disease (CKD), known congenital anomalies of the kidney and urinary tract, known urothelial, urological, or kidney malignancies were excluded from the study. Subjects with uncorrected congenital heart disease, having undergone solid organ or bone marrow transplantation, receiving renal replacement therapy, and having undergone surgery (urologic, nephrectomy, or correction of congenital heart disease) were also excluded. A total of 688 subjects were screened, 677 were eligible, and 629 (91.4%) were considered evaluable per the protocol. The 59 excluded subjects were ineligible due to missing/incorrect information in the informed consent form, or not evaluable due to meeting exclusion criteria, mostly a positive UTI test. Urine samples were tested for NGAL on a Roche cobas® c501 analyzer in single determinations.

Results
Tables 1 and 2 describe the NGAL summary statistics and central 95% reference intervals by age and gender.

Conclusions
These data demonstrate the normal urine NGAL values in an apparently healthy pediatric and adult populations.
A-107 Sample Matrix Matters: A Precision Study of BioRad, TechnoPath, and Patient Pooled Samples Across 20 High Volume Chemistries and Immunoassays
Authors: Sobhani K , Quizon A K , Masukawa R , Hernandez C , Peteros I , Manimtim E 
Published: October 2024

Abstract

Background
BioRad is a major provider of QC materials in the US with robust peer data, and Technopath has emerged as a recent competitor, especially on cost. While many factors are considered when selecting QC materials, primary considerations include commutability, matrix effects, decision levels, and acceptability limits. A couple studies comparing BioRad and Technopath QC performance were published in recent years. However, none have compared performance to patient-pooled samples. We undertook a comparison of BioRad/Technopath QC performance, with the addition of patient-pooled samples in order to assess potential matrix effects.

Methods
We compared precision for 20 high-volume chemistry/immunoassay tests (Table 1) across two levels of BioRad and Technopath QC and a patient pooled sample over 7 days on 2 Abbott Alinity-i and 4 Alinity-C instruments. Each immunoassay control level was run 5 times/day across 10 tests and 7 days per instrument, (i.e., 700 results/level), and the same for chemistry controls (1,400 results/level). Lithium-heparin plasma patient-pool was prepared by obtaining sufficient volume and preparing daily frozen aliquots (i.e., 1400 immunoassay and 2800 chemistry results).

Results
BioRad and Technopath Chemistry QCs were highly comparable with all levels demonstrating &lt;1% CV difference. Notably, CO2, B12, FT4 pooled-patient CVs were &gt;2% lower than the best performing high control. Additionally, greater differences in performance were observed across immunoassay controls with high BioRad QC performing better for 7 tests.

Conclusions
Chemistry QC for Technopath and BioRad are largely comparable (i.e., CV differences &lt;1%). Overall, BioRad immunoassay control performance was slightly to somewhat better (i.e., B12, CA125, and CA15-3). B12 and CO2 were particularly unstable (as reflected by patient-pool CVs). That said, differences in performance were not untenable and could be handled based on a tailored approach of extending QC limits if assay/instrument performance allows, and/or changing control material or reagents on a tighter schedule.
A-142 Usefulness of Targeted RNAseq to Diagnosis of Patients with Suspected hypereosinophilic syndrome: Retrospective Analysis in a single hospital
Authors: Park J , Kang J , Jeon S , Kee S , Na E , Shin M 
Published: October 2024

Abstract

Background
Hypereosinophilia is defined as either a continuous concentration of 1.5×109 /L eosinophils in the blood for at least 1 month apart periods or at least 20% eosinophils on bone marrow biopsy. Hypereosinophilic syndrome (HES) is a group of blood disorders that occur when an individual has high numbers of eosinophils, and the excess eosinophils enter various tissues, eventually damaging body organs. HES is classified into primary HES, caused by myeloid neoplasms (MNs), and secondary HES, in which polyclonal expansion of eosinophils is induced by factors other than MNs. To diagnose HES, genetic tests, such as fluorescence in situ hybridization (FISH) and reverse transcription-polymerase chain reaction, which can detect targeted fusion genes, should be accompanied by chromosomal karyotyping in bone marrow aspirates. Here, we aimed to analyze the results of several genetic tests performed for diagnosing hypereosinophilia, including targeted RNA-sequencing (RNAseq).

Methods
We retrospectively analyzed the information of 68 patients with suspected HES who underwent bone marrow examination from 2018 to 2022. FISH panels for eosinophilia (FIP1L1/PDGFRA, PDGFRB, and FGFR1 rearrangement probes(Abbott)) and chromosomal karyotyping after bone marrow aspiration and biopsy were included. RNAseq was performed to identify fusion genes or genetic variants. Targeted RNAseq was obtained for 85 genes using the panel (KblueBio), and the data was analyzed using NGeneAnalysis (NGeneBio).

Results
Among the 68 patients analyzed, 30 patients (44%) were diagnosed with reactive hypereosinophilia as the final diagnosis. Secondary HES was diagnosed in 33 patients (50%), followed by 4 patients diagnosed with primary HES including myeloid neoplasms with gene rearrangement, and one AML patient. Chromosome karyotyping was performed in 66 patients (97%), and 61 (92%) had normal karyotypes. FISH analysis was performed in 46 patients (68%), and 41 (89%) had negative results. The remaining five patients had the following results; numerical abnormality of FIP1L1/PDGFRA, numerical abnormality of PDGFRB, numerical abnormality of 11q23, positive for FGFR1 rearrangement, and positive for FIP1L1/PDGFRA rearrangement. Targeted RNAseq was performed in 33 patients (49%), and significant gene rearrangements were observed in 4 patients (12%). TCF3::JAK2 fusion was found in the patient diagnosed with HES. FGFR1::CNTRL, FGFR1::SSBP2, and FIP1L1::PDGFRA fusions were found in each patient diagnosed with myeloid/lymphoid neoplasms with eosinophilia and tyrosine kinase fusion genes. FGFR1::SSBP2 fusion was not observed in FISH but only in RNAseq.

Conclusions
To work-up for hypereosinophilia, RNAseq is considered a complementary useful test to find a clonal abnormality that can be missed in existing tests such as chromosomal karyotyping and FISH.
A-285 Adoption of 2023 CLSI Revised Aminoglycoside Clinical Breakpoints on Carbapenem Resistant Enterobacterales Isolates Identified at a Commercial Reference Laboratory in Korea, Republic of
Authors: Bae H , Kwak B , Chang E , Lee M 
Published: October 2024

Abstract

Background
The incidence of carbapenem resistant Enterobacterales (CRE) has been rapidly increasing as a nationally notifiable communicable disease since 2017 in Korea. The therapeutic options available for these pathogens are extremely limited. Several new drugs developed to treat CRE infections was recently introduced in Korea, but was not widely used. Instead, aminoglycoside is used as one of current available antimicrobials in CRE infections. The Clinical and Laboratory Standards Institute (CLSI) publishes revised aminoglycoside breakpoints in Enterobacterales in 2023. The purpose of this study was to evaluate the adoption of changing the aminoglycoside breakpoint in a commercial reference laboratory.

Methods
We retrospectively evaluated aminoglycosides (amikacin, gentamicin, tobramycin) for 1,393 CRE isolates not including surveillance culture identified by MALDI-TOF MS (Bruker Daltonik, Bremen, Germany) from January to December in 2023 at a commercial reference laboratory in Korea. Antimicrobial susceptibility testing was performed using a N415 card on the VITEK2 XL (bioMerieux, France). Susceptibilities of aminoglycoside were assessed based on previous breakpoints in CLSI M100-S32 in 2022 as well as the current breakpoints from the most recent CLSI MIC breakpoints in 2023.

Results
We evaluated 1,393 CRE isolates. Most isolates were Klebsiella pneumoniae [n=876 (62.9%)] and Escherichia coli [n=322 (23.1%)] followed by Citrobacter koseri [n=76 (5.5%)] The new aminoglycoside breakpoints reduced the percentage of strains that were previously judged to be susceptible by CLSI M100-S32 from 87.5% (1,219/1,393) to 71.2% (992/1,393) in amikacin, from 45.5 (634/1,393) to 44.8% (624/1,393) in gentamicin and from 23.3% (323/1,385) to 21.4% (297/1,385) in tobramycin, respectively. In meropenem resistant 56 isolates with MIC≤8 mg/L available of meropenem in combination with a second agent, frequently polymyxins or aminoglycosides, the new aminoglycoside breakpoints reduced the percentage of strains that were previously judged to be susceptible from 92.9% (52/56) to 64.3% (36/56) in amikacin and from 64.3% (36/56) to 60.7% (34/56) in gentamicin, respectively. There was no difference in tobramycin.

Conclusions
Our results show decreased susceptibility of aminoglycoside especially for amikacin in CRE isolates tested. Amikacin is commonly used to treat CRE infections, either alone or as part of combination therapy. Although our study has no correlation with clinical outcomes, we found microbiology laboratories should adopt the updated breakpoints.
A-332 Identifying At-Risk Patients Pre-IV Contrast Administration via POCT Creatinine Measurement
Authors: Hawkins R 
Published: October 2024

Abstract

Background
The use of intravenous iodinated contrast in computerized tomography studies is associated with a small risk of acute kidney injury. Pre-existing chronic kidney disease is a recognized factor and assessment of renal function prior to contrast administration is essential. This study assessed the ability of the Abbott iSTAT creatinine assay to correctly identify IV-contrast patient risk using lab-based eGFR as the gold standard.

Methods
This was a retrospective study comparing POCT creatinine (whole blood, Abbott iSTAT enzymatic) and lab creatinine (plasma, Beckman Coulter AU5800 Jaffe) results on simultaneous samples collected in the emergency department. Anonymised data records were extracted from the laboratory database for 2020-2023. IV contrast risk was calculated using eGFR (CKD-EPI 2021) and classified as high risk (HR: eGFR &lt; 30 mL/min/1.73 m2), moderate risk (MR: eGFR 30-59) and low risk (LR: eGFR &gt;=60) as per the Royal Australian and New Zealand College of Radiologists 2018 guidelines, using the Beckman-based eGFR as the gold standard.

Results
132 paired samples patients were available for analysis (61% male, average age 69 y (23-98), 70% Chinese, eGFR (iStat) 3-143, eGFR (Beckman) 3-121 mL/min/1.73 m2). The proportions of Beckman-based eGFR HR:MR:LR cases were 53:39:40. The prevalence of HR/MR cases was 70%. The diagnostic performance of the iSTAT-based eGFR to accurately identify HR/MR patients was: sensitivity 93.5%, specificity 95%, PPV 97.7%, NPV 86.4%, accuracy 93.9%. For different Beckman-derived eGFR categories, the mean difference in eGFR (iSTAT - Beckman), 95% lower limit of agreement (LOA) and upper LOA was: &lt;30 mL/min/1.73 m2: -1.0, -3.2, -1.1; 30-60 mL/min/1.73 m2: 0.9, -13.3, 15.1; &gt;60 mL/min/1.73 m2: 1.6, -16.8, 20.1. Linear regression fit (Passing-Bablok): CKD-EPI Beckman = 1.193 + 0.9773 CKD-EPI iSTAT. Correlation coefficient was 0.981. Kappa for the 3 categories of risk classification was 0.814.

Conclusions
The iSTAT creatinine assay could reliably identify patients at medium/high risk of acute kidney injury following intravenous contrast administration. Performance was best for low and high risk patients with 100% of high risk patients being correctly identified. It is a useful screening test but differences in eGFR of up to 20 mL/min/1.73 m2 may be seen between the Beckman and iSTAT eGFR values at higher levels, meaning numeric eGFR results are not interchangeable.