bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-140 Evaluating the Performance of Various Lupus Anticoagulants Tests Among Different Coagulation Platforms
Authors: Wang F , Lee H , Chen Y , Ho H 
Published: September 2023

Abstract

Background
Lupus Anticoagulants (LAs), one of the antiphospholipid antibodies, are risk factors for arterial or venous thrombosis with complications such as stroke, acquired thrombophilia, and pregnancy loss. Detection of LAs is challenging for laboratories as the heterogeneity of antibodies and epitopes on protein in the phospholipids. Thus, no single test is sensitive for all LAs, and the International Society on Thrombosis and Haemostasis Scientific and Standardization Committee (ISTH) recommended laboratory should provide two test systems based on different principles, which dilute Russell's viper venom time (dRVVT) should be as the major test, and partnered with LA-sensitive activated partial thromboplastin time (aPTT). There are many different mechanisms of tests proposed by various manufacturers, however, the comparison of different platforms by different manufacturers on LAs remains unknown. In this study, we aimed to evaluate the performance of various LA tests among different platforms.

Methods
A total of 76 specimens from September to December 2022 were collected. dRVVT (dRVVTIL) and silica clotting time (SCTIL) were performed by ACL TOP 500 analyzer (Instrumentation Laboratory, US). In addition, ellagic acid-based aPTT (Siemens Dade Actin FSL reagent, aPTTAFSL), silica-based aPTT (Siemens Pathromtin SL reagent, aPTTPSL), and dRVVT (dRVVTsysmex) were performed by Sysmex CN-6000 analyzer (Sysmex Corporation, Japan). Analytical performances, agreements, and McNemar's test were calculated.

Results
All 76 specimens were originally tested by dRVVTIL and SCTIL, and showed that 30 specimens were positive for both assays, 6 were only positive for dRVVT, 5 were only positive for SCT, and 35 specimens were negative for both assays. In addition, all samples were further tested by dRVVTsysmex. Compared with the integrated use of dRVVTIL and SCTIL, dRVVTsysmex showed 100.0% (41/41) positive agreement and 91.4% (32/35) negative agreement. 3 specimens could only be tested positive on the dRVVTsysmex platform, of which one patient was diagnosed with systemic lupus erythematosus (SLE), another patient was diagnosed with infertility, and the other patient was diagnosed with antiphospholipid syndrome (APS). To further evaluate the performance of aPTT on LA screening, 44 specimens with either dRVVTIL, SCTIL and dRVVTsysmex positive were considered LA-positive and further tested by different aPTT assays. The positive agreement was 65.9% (29/44; 95% CI: 50.1–79.5%) and 77.3% (34/44; 95% CI: 62.2–88.5%) on aPTTAFSL and aPTTPSL, respectively, however, there was no significant difference between the positive agreement of two assays (P = 0.13).

Conclusion
Compared with the integrated use of dRVVTIL and SCTIL, dRVVTsysmex could achieve the same detection rate on LA. Furthermore, aPTTAFSL and aPTTPSL showed no significant difference between the positive agreements for LA-positive specimens.
A-148 Thromboelastography Utilization in a Community Hospital Setting
Authors: Allen J L , Christian M , Zuretti A , Bluth M H 
Published: September 2023

Abstract

Background
Thromboelastography (TEG) applications have been gaining momentum in various clinical settings and service lines. However, the utilization of the technology varies among clinical establishments and requires additional assessment for TEG optimization among its user groups.

Methods
TEG (Haemonetics TEG6s) was applied in a community hospital based setting in SICU, OR and ED service lines to identify instrument prompted blood product support over a two month time period.

Results
Forty one measurement were obtained from twenty patients. SICU represented the majority of TEG use (78%) followed by OR (15%). Global TEG run assessments were completed on 27%, platelet mapping on 46%, and heparin assessment on 56% of samples. Global TEG recommendations included factor deficiency with suggested FFC or PCC use (12%) or no recommendations (10%). Platelet assessments recommended no product (19.5%), or ADP inhibition with platelet consideration if bleeding (14.6%). Heparin assessment indicated no treatment (44%) and above normal CK/R time with FFP or PCC if bleeding (10%).

Conclusion
TEG applications in various services suggested no need for blood product or factor application in the majority of platelet mapping and heparin assessments. Other assessments yielded about a half dozen suggestions from the instrument’s 150 suggestion options. TEG application appears to be easily implementable and suggests no treatment or a few repetitive treatment options for the majority of patients assessed thereby reducing onboarding educational and improving management requirements for select user groups.
A-158 Evaluation of Nucleated Red Blood Cells NRBC) Count on Mindray BC 6800Plus
Authors: Correa Wengerkievicz Lopes A , Siqueira Castanhel A , Muniz Ribeiro Franzon C , Valim Franzen J 
Published: September 2023

Abstract

Background
The detection of NRBCs in the peripheral blood is a marker of many pathological conditions andhas significant prognostic value. Microscopy is the traditional method for NRBC count, but it’s time consuming and has low precision and efficacy and requires experienced technicians. TheMindray BC-6800 Plus is a hematological analyzer that brings SF Cube technology, whichquantifies NRBCs in the WNB channel. This channel differentiates basophils and NRBCs, andcounts white blood cells. The present study aims to evaluate if the automated method is preciseand comparable to the manual microscopy.

Methods
Blood samples from 40 patients with NRBC flag from the laboratory routine were evaluated bymicroscopy. Blood films were prepared automatically with a Mindray SC-120 slidemaker/stainer.NRBC were manually counted and reported as number of NRBC per 100 white cells, which wasconsidered the reference method. The results of microscopic counts were compared with thoseof the automated method and statistically analyzed using the F-test, T-test and Pearson’ scorrelation coefficient.

Results
The results show good correlation between the methods: F-test of 1.36 (below 1.69); t test (0,2791) below the critical T(2,0210) and Pearson’s correlation coefficient was 0.9, which isconsidered an adequate result. Samples used in this evaluation comprised mainly low results andfew samples with higher counts. The maximum observed value was 41%, which was confirmedby microscopy. It is important that samples with larger counts be evaluated to be sure of thelinearity value of the test.

Conclusion
The results demonstrated that the NRBC counts obtained by Mindray BC-6800 analyzer are inagreement with data from manual counts. However, it is necessary that the accuracy of sampleswith very high counts be investigated and compared with the reference method. Thisimplementation of the automatic release of NRBC can allow the laboratory to reduce the time forreleasing tests and optimize the productivity of microscopists.
A-195 The Application of Six Sigma Metrics to Assess Quality Control of Syphilis Tests in a Clinical Laboratory
Authors: Utiyama A H , Pereira R T , Rodrigues T , Bandeira A C , Ramadan D R , Tufik S 
Published: September 2023

Abstract

Background
Clinical laboratories use quality control processes to monitor and evaluate analytical performance in terms of precision and bias. The periodic measurement of those parameters plays an important role in patient safety and it is a requirement in most accreditation organizations. In recent years, Six Sigma metrics has become one of the most efficient tools to monitor the analytical performance of clinical laboratory systems, since it unifies Total Allowable Error (TEa), random and systematic errors in a single index. However, for many analytes, TEa is not available in the literature based on effect of analytic performance on clinical outcomes or in biological variation. In this case, the TEa must be derived from the “state of art”. In this work, it will be described how Six Sigma was established in our laboratory for Syphilis, with TEa derived from external quality assessment program.

Methods
A year worth of data was gathered from internal quality control and external quality assessment evaluation to assess the imprecision (in terms of coefficient of variation—CV%) and bias for Syphilis tests processes in four modules of Alinity I (Abbott). Data was split into two groups: “Non-reactive” and “Reactive”. TEa was calculated from the external quality assessment for both groups, based on the median CV% of the peer group evaluated in the last 2 years. Six Sigma metrics were calculated from TEa, CV% and bias for each equipment, using the formula Sigma = (TEa-bias)/CV%.

Results
TEa for “Non-Reactive” and “Reactive” levels were estimated at 44,25% and 17,7%, respectively. Six Sigma values calculated for “non-Reactive” level were between 4,6 to 5,38 in every equipment. For “Reactive” level, calculated Six Sigma ranged from 4,24 to 5,82. All values found were classified as Good and Excellent according to the Normalized method decision chart.

Conclusion
Six Sigma is a powerful tool to monitor the analytical performance of the exam. For Syphilis, it is important to monitor “Non-Reactive” and “Reactive” levels separately for a better control over the analytical system. Abbott’s Syphilis test has also a satisfying performance in our laboratory. Also, estimating the TEa from external quality assessment programs is a good alternative for analytes with no quality specifications available in the literature.
A-202 Establishing of Lipid-Apolipoprotein Connectivity Map in Hyperglycemia
Authors: Ivanova A A , Parks B A , Rees J , Kuklenyik Z , Barr J R 
Published: September 2023

Abstract

Background
Hyperglycemia, a condition characterized by a significantly increased glucose level in the blood, can lead to insulin deficiency and pre-diabetes. Lack of insulin production also interferes with lipid metabolism and increases the risk for cardiovascular disease. Thus, diagnosis and treatment of hyperglycemic patients can benefit from advanced proteomics and lipidomics testing approaches.

Methods
Disease-focused serum samples from 50 specimens were collected and evaluated, including 29 specimens with a glucose level&gt;180 mg/dL and 21 normal lipidemic specimens. The sample proteomics analysis was conducted with a Perfinity IDP workstation (Shimadzu Scientific, Columbia, MD, USA) using on-line protein digestion with an immobilized enzyme reactor (IMER) directly coupled to a HALO-C18 column (Advanced Materials Technology, Wilmington, DE, USA). Lipidomics data were collected with the Lipidyzer platform (AB SCIEX, Framingham, MA, USA). Statistical analysis was conducted using JMP software (SAS Institute, USA) and custom scripts.

Results
Using targeted lipidomics and proteomics platforms we identified 20 proteins and 575 lipid species across 10 lipid subclasses. We identified specific lipids and lipoproteins dysregulated in hyperglycemic specimens as compared to the normolipidemic samples and linked them to major metabolic pathways. Lipoprotein particles related-proteins apos A1/B/C2/C3/E and lecithin–cholesterol acyltransferase (LCAT) were significantly dysregulated and associated with changes in HDL-mediated lipid transport, very-low-density lipoprotein particle remodeling, acylglycerol homeostasis, and triglyceride homeostasis.

Conclusion
The conducted integrated analysis of lipid and protein concentrations in hyperglycemia specimens to provide new insights into molecular changes associated with hyperglycemia that may inform new diagnostic and therapeutic strategies. The network analysis can allow improved categorization of patients that can lead to more effective and individualized therapeutic intervention approaches. This study provides new experimental and informatics approaches to better assess underlying metabolic conditions and related diseases, including cardiovascular disease, diabetes, and metabolic syndrome.

Disclaimer
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Use of trade names is for identification only and does not imply endorsement by the CDC.
A-204 Associations between Apolipoprotein B/A1 Ratio, Lipoprotein(a) and the Risk of Metabolic-associated Fatty liver Diseases in a Korean Population
Authors: Park K , Park Y , Park H , You E , Kim Y 
Published: September 2023

Abstract

Background
Metabolic-associated fatty liver disease (MAFLD) is a new nomenclature of the fatty liver condition associated with metabolic dysfunction. Little study regarding the association between apolipoprotein and lipoprotein(a) and MAFLD has been performed. This study aimed to investigate the association between apolipoprotein B/A1 ratio (apo B/A1), lipoprotein(a), and MAFLD based on new diagnostic criteria in a Korean population.

Methods
This cross-sectional study consisted of 14 420 consecutive adults underwent abdominal ultrasonography among the general Korean population visiting at comprehensive health promotion center in Samsung Changwon Hospital from January 2021 to December 2021. Clinical data, anthropometric and biochemical parameters were reviewed. According to the Asian Pacific Association for the Study of Liver guideline, the MAFLD was diagnosed based on hepatic steatosis by abdominal ultrasonography and the presence of overweight/obesity, type 2 diabetes, or the evidence of metabolic dysregulation. Multivariate logistic regression was conducted to analyze the independent association between apo B/A1 ratio and MAFLD.

Results
The prevalence of MAFLD in the general Korean population was 34.5% (4978/14 420). Multivariate logistic regression analysis revealed that Apo B/A1 ratio (odds ratio: 3.913, P = 0.019) was independently associated with the MAFLD. Lipoprotein(a) levels are inversely associated with the MAFLD, especially in subjects with hepatic fibrosis (P &lt; 0.0001).

Conclusion
Apo B/A1 ratio and lipoprotein(a) have opposite association with the MAFLD in a Korean population. This study suggests that apo B/A1 ratio could be useful biomarkers for MALFD, while lipoprotein(a) should be used with caution as a predictive biomarker for MAFLD.
A-205 Optimized Time Interval for the Measurement of Plasma Lipids for Assessing Cardiovascular Disease Risk
Authors: Sampson M , Cole J , Remaley A T 
Published: September 2023

Abstract

Background
The measurement of plasma lipids are used to predict atherosclerotic cardiovascular disease (ASCVD) risk and for the management of lipid-lowering therapy. The general recommendation is that plasma lipids should be measured at least every 5 years, but the ideal time may vary depending on the baseline risk, which we examined in this study.

Methods
Using lipid values and other risk factors from the National Health and Nutrition Examination Survey (NHANES) (no diabetes, no lipid medications, n = 9704), which is designed to be representative of the US-general population, we calculated a baseline 10-year ASCVD risk with the pooled cohort risk equations (PCE). Future 10-year risk scores were estimated by chronologically increasing age of the subjects and projecting future systolic blood pressure (SBP) and lipid changes, using the mean-percentile age group change in the NHANES population for SBP (no hypertension medications, n = 17 329) and the Lifelines Cohort study for lipids (no CVD or lipid medications, n = 133 540). Crossing high-risk (&gt;20%/10-years; 25% decison limit) and intermediate risk (&gt;7.5%/10-years; 50% decision limit) PCE thresholds were calculated by baseline age to determine the best time intervals for testing lipids.

Results
As shown in the figure, the likelihood of crossing the intermediate or high-risk threshold depends on the baseline risk. Individuals that are close to one of the risk thresholds are more likely to cross it in the subsequent years. Based on this analysis, we recommend the following time intervals for lipid testing: Baseline risk &lt; 5%/10-year: 5-years, baseline risk 5–15%/10-year: 3-years, baseline risk 16–20%/10-year: 1–2 years.

Conclusions
More frequent lipid testing than once every 5 years is desirable, because it would identify at risk patients sooner and allow for earlier therapeutic intervention, which has been shown to increase the effectiveness of statin therapy for reducing ASCVD events.
A-227 First Brazilian External Quality Assessment Program for Monkeypox Molecular Tests: Results from Two Surveys
Authors: Lima S , Barra G , Poloni J A , Barroso J , Lopes R , Mendes M , Montenegro R , Jerônimo D , Brazão F , Biasoli I , Biasoli V 
Published: September 2023

Abstract

Background
The WHO declared the current Monkeypox (Mpox) outbreak a public health emergency of international concern. PCR test is the preferred diagnostic assay. External Quality Assessment Programs (EQAP) provide an independent assessment of the effectiveness of analytical systems, especially with emerging pathogens. There are a few references about EQAP for Mpox. Here, we report the results of the first Mpox EQAP conducted by a Brazilian EQAP provider, which follows the criteria of ABNT NBR ISO/IEC 17043:2011.

Methods
The quality control samples were inactivated lyophilized suspension of Vero cells (BCRJ 0245/ATCC CCL-81) infected with viable Mpox virus particles and cultured under BSL-3 conditions. The EQAP surveys were conducted in September and October/2022. In the first round, two samples were sent—one negative and one positive [cycle threshold (CT) of 23]. In the second round, 5 samples with different viral loads were sent (CT of 24.9/negative/26.5/34.8/34.6). The percentage of correct results (%CR), sensitivity (SE), specificity (SP), false positive (FP), and false negative (FN) were calculated for each sample, and the performance of laboratory-developed test (LDT) or in vitro diagnosis (IVD) was compared.

Results
A total of 49 laboratories (38 from Brazil) submitted 319 datasets with qualitative results. In the first round, 30 laboratories used LDT methods and 11 IVD methods, and in the second round, it was 32 and 14, respectively. The %CR ranged from 81.4%–100%, SE from 83.3%–100%, SP from 95.45%–97.7%, FP from 2.3%–4.55%, and FN from 2.3%–16.3%. Samples with higher FN have lower viral loads (P = 0.00044).The overall % of CR, SE, SP, FP, and FN for LDT methods were 76.7%–100%, 79.3%–100%, 93.3%–100%, 0%–6.7%, and 0%–20%, and for IVD methods were, 90.9%–100%, 90.9%–100%, 90.9%–100%, 0%–3.1%, and 0%–7.7%, respectively. No statistical difference was found between methods regarding these parameters.

Conclusion
This is the first report of EQAP of Mpox molecular testing from Brazil. The EQAP showed that Mpox PCR had an overall good accuracy and performance. FN rates ranged from 2.3% to 16.3%, suggesting there is room for assay improvement, especially with samples with low viral loads. LDT and IVD tests presented similar performance.
A-235 Results and Interpretation: Serology Testing Platforms and Assays Compatibility Assessment for MASTM SARS-CoV-2 IgG Quality Controls
Authors: Wang H , Krishnaswami N , Crandall D , Hu R 
Published: September 2023

Abstract

Background
Serology testing of antibodies against SARS-CoV-2 viruses serves many purposes: disease diagnosis, on-going and surveillance, epidemiologic and vaccine studies, etc. There was a critical need to provide standardized quality control materials for development and harmonization across different test methods and IVD platforms. The MAS™ SARS-CoV-2 IgG Controls are human plasma-based materials containing IgG antibodies against SARS-CoV-2. The control offers commutability by mimicking patient samples and is intended to be used for monitoring serological assays, providing confidence in routine test results, test methods troubleshooting and system errors identification. We report here the compatibility assessment of MAS™ SARS-CoV-2 Controls testing on different assays and platforms.

Methods
The platforms and assays compatibility was assessed for the MAS™ SARS-CoV-2 IgG Positive and Negative Controls across all 11 assays and platforms listed as below. These serology assays target either total antibodies (IgA, IgM, IgG), IgM/IgG, or IgG against either the SARS-CoV-2 nucleocapsid (N), RBD or spike (S) proteins. Replicated samples were tested on each instrument for statistical confidence.

Results
All results demonstrated conclusively the comparable performance of MAS™ SARS-CoV-2 IgG controls across different clinical diagnostic assays and platforms manufactured by Abbott, Roche, Ortho, DiaSorin, Beckman Coulter and bioMérieux. The positive control showed 100% expected reactive results (IgG Positive) and Negative control at 82% non-reactive results, respectively. Furthermore, both controls were compatible towards assays detecting IgG antibodies targeting specific regions (N, S or RBD).

Conclusion
SARS-CoV-2 serology testing remains unstandardized with numerous assays and platforms receiving FDA EUA. While tested on multiple commonly used assays and platforms, MAS™ SARS-CoV-2 IgG Positive and Negative Controls were found to be platform agnostic. To conclude, MAS Controls will contribute to the harmonization of the SARS-CoV-2 Serology assay offerings, monitor the clinical laboratory analytical performance, streamline the workflow on test method development, validation and verification, and routine assessment.