bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-117 Discordance of CKD stage assignment by different Western and Asian estimated GFR formulae in patients of Eastern India
Authors: Hazra A , Goswami K , Dhar A , Chatterjee N 
Published: October 2024

Abstract

Background
Chronic Kidney Disease (CKD) Stage based on estimated GFR governs the decision between treatment choices eg dialysis, transplant etc. There is no customized eGFR formula for Indians, and hardly any data is available regarding concordance between CKD staging by various formulae on Indian population.
The CKD-EPI-Pakistan formula, developed through a collaboration involving original authors of MDRD/CKD-EPI, is the Asian formula ethno-geographically closest to India. However it has not been tested on Indians.

Methods
We compared 4 eGFR formulae: MDRD(4-factor), CKD-EPI-2009, and CKD-EPI-2021-Creatinine and CKD-EPI-Pakistan for 126 patients undergoing kidney function testing in a tertiary care center in Eastern India. Input for race was non-black in all.

Results
Thirty six of 126 (29%) were discordant by 1 stage between 1 or more formula-pairs, and Kendall's W was 0.034366339 suggesting weak concordance.
Among the MDRD CKD3b and CKD4 cases, CKD-EPI Pakistan re-classified 12% by one stage higher. In the same cases, CKD-EPI-2009 and 2021 both assigned 1 stage lower than MDRD in about 18% and 35% respectively. For MDRD-CKD3a cases too CKD-Epi-Pakistan predicted one stage higher in 50%, whereas both CKD-EPI-2009 and 2021 gave one stage lower in 25%. CKD5 staging were mutually concordant, except Pak formula giving 66% more CKD5.

Conclusions
There is a significant under-staging of CKD stages of Indian patients using western CKD-EPI equations compared to MDRD, whereas CKD-EPI-Pakistan over-stages them especially in the severe stages. If Asian CKD-EPI-Pakistan is considered biologically appropriate for Indians, about 20-30% of treatment-needing patients might currently be under-classified and denied life-saving treatment modalities e.g. Dialysis/CRRT/Transplant, and it might become worse if CKD-EPI 2009 or 2021 is adapted instead of MDRD, especially for higher CKD Grades.
The mutual discordance highlights urgent need of having formulae customized for Indian population validated over a large number of patients locally using measured GFR.
A-127 Stability of Ionized Calcium in Blood Gas Specimens
Authors: Reust J , Poventud-Fuentes I , Patel K 
Published: October 2024

Abstract

Background
Ionized calcium monitoring is crucial for monitoring critically ill patients as well as patients undergoing apheresis. According to CLSI C31-A2:2001, the acceptable stability time for all tests to be run on blood gas analyzers in heparinized syringes is thirty minutes from collection. We sought to determine whether the stability of ionized calcium in blood gas samples can be extended to accommodate prolonged transport times.

Methods
Sixty whole blood samples were collected into 1CC syringes containing 23 IU of heparin (Vital Signs, Inc.) and sent to the laboratory for ionized calcium and pH analysis on the Siemens RAPIDLab 1265. If the remaining sample was sufficient, it was set aside for additional testing 40, 60 and 90 minutes after receipt in the laboratory. All samples were kept at room temperature during all timepoints. The three timepoints were compared to the initial reported baseline result and the average percent bias and standard deviation was determined.

Results
When compared to the baseline result, samples analyzed at the 40-, 60-, and 90-minute timepoints showed negligible bias for both pH and ionized calcium. The absolute bias was within +/- 0.6 and +/-0.4 for ionized calcium and pH, respectively.

Conclusions
This study showed that accurate measurements of both ionized calcium and pH can be obtained from blood gas samples collected in heparinized syringes at least till 90 minutes after collection.
A-128 Evaluation of the Analytical Performance of Three Inflammation Related Assays on the Atellica CI Analyzer
Authors: Carter R H , Tyler C , Coward T , Micklitsch C , Arrode-Bruses G , Snyder J 
Published: October 2024

Abstract

Background
The Atellica® CI Analyzer is an automated, high-throughput integrated chemistry and immunoassay analyzer utilizing both Atellica® CH and Atellica® IM Assays. This study evaluated the analytical performance of the the Atellica CH Complement C3 (C3), Complement C4 (C4), and Alpha-1-acid Glycoprotein (AAG) Assays on the Atellica CI Analyzer.

Methods
Precision studies were performed according to CLSI EP05-A3 using native and contrived human serum samples. One aliquot of each sample was tested in duplicate in two runs per day ≥2 hours apart on each analyzer for ≥20 days. Precision was evaluated using three reagent lots on one system. Method comparison (MC) studies were performed using three reagent lots according to CLSI EP09c. Individual native and contrived human serum samples were analyzed using the Atellica CH C3, C4, and AAG Assays on the Atellica CH Analyzer and the Atellica CI Analyzer. LoB and LoD were determined as described in CLSI EP17-A2.

Results
Representative precision and MC results for each assay are listed in the table. For the three assays tested, repeatability and within-lab %CVs were &lt;1.4% and &lt;3.3%, respectively. Slopes determined by the Deming linear regression model were approximately equal to 1. Detection capability for the Atellica CH C3 Assay on the Atellica CI Analyzer was estimated at 0.2 mg/dL (0.00 g/L) and 0.4 mg/dL (0.00 g/L) for LoB, and LoD. For the Atellica CH C4 Assay, LoB and LoD were determined at 0.1 mg/dL (0.00 g/L) and 0.2 mg/dL (0.00 g/L). For the Atellica CH AAG Assay, LoB and LoD were determined at 0.9 mg/dL (0.01 g/L) and 2.0 mg/dL (0.02 g/L).

Conclusions
Evaluation of the Atellica CH C3, C4, and AAG Assays using the Atellica CI Analyzer demonstrated good precision and equivalent performance compared to the same assays on the Atellica CH Analyzer.
A-132 Next generation ammonia reagent with improved reagent composition and assay performance
Authors: Nair S , Chandler S , White L , Acorn R 
Published: October 2024

Abstract

Background
Ammonia is produced by catabolism of protein and other compounds which contain nitrogen. Elevated ammonia levels are toxic for the central nervous system. High plasma ammonia is a prognostic factor for hepatic and kidney disease or inherited metabolic disorders in urea cycle metabolism. The reliable and accurate quantification of ammonia is influenced by assay, reagent, and sample management. Current commercially available GLDH enzyme-based ammonia assay reagents experience high bias between matched Lithium Heparin and K2-EDTA samples, poor accuracy, imprecision at the low end, large HIL (hemolysis, icterus and lipemia) interferences and shorter shelf life. To improve upon the listed deficiencies, we developed an improved GLDH based ammonia assay in a two-part format with improved reagent composition.

Methods
Ammonia reagent in 2-part format R1 and R2 were assessed for accuracy, precision, interference by HIL reportable range, sensitivity (LoB, LoD, LoQ), shelf life, matched matrix comparison (Lithium Heparin vs K2-EDTA) and method comparison. All testing were performed using Li Heparin plasma samples in Beckman DxC700AU analyzer. Accuracy was tested using Verichem ammonia standards which are ACS ammonia standard material. Twenty-day precision studies were performed using three levels of ammonia concentrations using Bio-Rad Liquichek Ammonia controls and plasma samples. Interference was tested in two ammonia concentrations (40-50 µmol/L) and (200-250 µmol/L) using commercially available spiking material for clinical chemistry assays such as conjugated and unconjugated bilirubin, Intralipid and in-house prepared hemolysate. Infinity Ammonia Reagent on Beckman Coulter AU Chemistry Analyzers was used for method comparison studies

Results
Next generation ammonia showed good accuracy with Verichem ammonia standards and acceptable within-run and total precision. Studies showed significant improvement in sensitivity and longer shelf life (&gt;18 months). Next generation ammonia is less affected by interferences from icterus (100 mg/dL), lipemia (1000 mg/dL intralipid) and hemolysis (100 mg/dL). Comparison studies show no significant bias between match Lithium Heparin and K2-EDTA matched samples.

Conclusions
Next Generation Ammonia reagent showed very good overall performance required for reliable and accurate quantification of ammonia in human plasma sample.
A-147 Comparative Precision of Platelet Counting by Optical, Fluorescent, and Impedance Techniques in Thrombocytopenia and Microcytosis Patients
Authors: J H , V G , Pandey S , Sehgal T 
Published: October 2024

Abstract

Background
In today's era of automation driven by Artificial Intelligence, even the most efficient automated hematology analyzer may struggle to accurately determine platelet count in patients with low platelet count and microcytosis. The Sysmex XN-series analyzer (Sysmex, Kobe, Japan) uses optical density, fluorescence, and electronic impedance methods for platelet counting. This study aimed to evaluate the accuracy of optical, fluorescence, and electrical impedance methods in estimating precise platelet counts in thrombocytopenic and microcytic patient samples.

Methods
A cross-sectional study was conducted in the Department of Laboratory Medicine at AIIMS, New Delhi, for 30 days consecutively. A total of 200 blood samples collected, of which 100 samples were of thrombocytopenia (&lt;100x10^9/L) and 100 samples were of microcytosis (Mean corpuscular volume &lt;76 femtoliters). MCV&lt;76 fl was further categorized into 2 groups- MCV 60-70 fl and MCV 71-76 fl accordingly. Males and females were categorized and analyzed distinctly for thrombocytopenia and microcytosis. Statistical analysis was performed using SPSS 16.0 for Windows (SPSS Inc., Chicago, IL, USA) and the Bland Altman plot was analyzed.

Results
Of the 100 patients with thrombocytopenia (platelet&lt;1 lakh/L) females were predominantly 54% while males were 46% and the median age was 29 years (0.02-70). Of the 100 patients with low MCV (&lt;76 fl) females were 53%, while males were 47% and the median age was 29 years (0.3-69). The findings were compared against the standard manual platelet count method in peripheral smears verified by two expert pathologists. The Bland Altman plot for Platelet &lt;1 lakh/L and MCV &lt;76 fl were compared with standard manual platelet count method and the following findings were obtained i) In female with PLT- &lt;1 lakh/L, PLT-O showed least bias (9.8) followed by PLT-F (10.4) and PLT-I (12.1) ii) In males with PLT-&lt;1 lakh/L, PLT-O showed least bias(14.1) followed by PLT-F(16.5) and PLT-I(17.0) iii) For MCV 61-70fl, PLT-O showed the least bias (4.4) followed by PLT-F (6.7) and PLT-I (28.5) iv)For MCV 71-76fl, PLT-F showed least bias (-0.2) followed by PLT-O (1.5) and PLT-I(31.2).

Conclusions
Platelet count by optical method (PLT-O) detects platelet count more accurately with minimum bias when compared with PLT-F and PLT-I in patients with thrombocytopenia. In patients with microcytosis, PLT-I is less reliable in comparison to PLT-O and PLT-F. A limitation of the automated hematology analyzer is the inability to detect platelet clumps which is appreciated in peripheral smears.
A-163 Stability of apixaban in Li-heparin plasma stored refrigerated over mint green-top tube separator gel
Authors: Stickle D , Eberle-Singh J , Kolowrat S A , Korn W R , Kraft W K 
Published: October 2024

Abstract

Background
Apixaban is a factor Xa inhibitor used as a direct oral anticoagulant (DOAC). The laboratory was asked to provide measurements of plasma apixaban in the context of studies regarding interaction of apixaban with other therapeutic drugs. One study involved isolation of plasma from to-be-discarded specimens, where such specimens were those originally collected in mint green-top tubes (Li-heparin tubes containing plasma separator gel), and that had been centrifuged and stored refrigerated for 5 days. Whereas apixaban concentration is known to be stable in refrigerated plasma specimens for up to two weeks, stability of apixaban concentration in plasma stored refrigerated for prolonged periods over plasma separator gel was unknown. Our objective was to examine stability of apixaban in plasma stored refrigerated for 5 days over plasma separator gel.

Methods
Pharmacy records were reviewed to identify inpatients who were prescribed apixaban, and for whom a mint green-top tube specimen (Becton-Dickinson BD Vacutainer PST Gel and Lithium Heparin, #367961) had been drawn for routine chemistry tests. From such specimens, 500 uL aliquots of plasma were obtained on day 1 (A) and day 5 (B) of storage under refrigeration (4 °C). Apixaban concentrations for A and B were measured by LC-MS/MS and compared. Additionally, short term (1 day) stability of apixaban was examined by comparison of replicate measurements of apixaban in a single spiked pooled purple-top plasma specimen (Becton-Dickinson BD Vacutainer K2 EDTA, #367856), with (C) or without (D) exposure to mint green-top tube separator gel for a 24h refrigeration period. Data analyses were conducted using R (version 4.0.5).

Results
A total of 21 specimen pairs (A, B) were examined. [Apixaban] ranged from 30-1000 ng/mL. The ratio B/A was 1.007 ± 0.034, consistent with no effect on plasma [apixaban] of refrigerated storage over separator gel between day 1 and day 5 (by paired t-test: p&gt;0.8). Experiments for replicates of (C, D) specimens (n = 4, average [apixaban] = 410 ng/mL) gave D/C ratio of 1.009 ± 0.019, consistent with no effect on plasma [apixaban] of short term (1 day) refrigerated storage of plasma over separator gel (by paired t-test: p&gt;0.4).

Conclusions
For plasma specimens collected and centrifuged in mint-green plasma separator tubes, there was no effect on plasma [apixaban] of refrigerated storage over separator gel for periods of 0-5 days.
A-169 Artificial Intelligence based Complete Blood Count
Authors: Tohami T , Bahat S , Isman S , Shbita G , Rashid G 
Published: October 2024

Abstract

Background
The OLO device (Sight diagnostics, Israel) is an artificial intelligence based blood counter. OLO contains a fluorescent microscope and a camera embedded inside it. The pictures are processed by an image processing algorithm based on “machine-vision technology” to identify and quantify cells. The measurement analysis is accompanied by messages (flags) that are used to warn of deviations in the counted parameters, which help the operator refer the sample for microscopic analysis.
In this study, we compared the results of 19 complete blood count (CBC) parameters obtained from OLO to the CBC parameters obtained from the ADVIA 2120 device (Siemens, USA). In addition we examined the reliability of OLO alerts (flags) by comparing it to the microscopic analysis findings.

Methods
99 blood samples from patients aged &gt;3 months were sampled by the ADVIA and OLO devices. Regression analysis was performed in comparing the results of 19 parameters between the devices. Specificity and sensitivity values ​​of the OLO device alerts were calculated.

Results
A good correlation was found for CBC parameters between OLO and ADVIA with Pearson correlation (R) of 0.992 (WBC), 0.985 (RBC), 0.991 (HB) and 0.983 (PLT). A fundamental difference in measurement and classification technologies between OLO and ADVIA lead to low correlation measured for monocytes. By comparing OLO alerts against blood smears findings, a total of 14 samples were alerted by OLO but only slight left shift/single pathological cell were found in the smears which is below threshold defined by the manufacturer. These 14 samples were transferred to the true positive category, therefore OLO device alerts showed sensitivity and specificity of 81.8% and 90% (respectively) in identifying pathological cells.

Conclusions
The comparison findings present a technology based on image processing and artificial intelligence that have a good correlation to the ADVIA reference device. In addition, OLO has the ability to warn of pathological findings even below the threshold defined by the manufacturer. The artificial learning is expected to be improved so that this device can integrate CBC and microscopic differentiation simultaneously, a great advantage to the hematology laboratories workflow.
A-191 Improvement of Outpatient Satisfaction Rate at Specimen Collection Area
Authors: Tamimi W , Alfraj S , AlSaqri F , AlSharari M , Althubiti F M , AlZahrani K , Al-Dhuwaibi E M , Al-Otaibi H M , Al-Khalidi A , Al-Thubaiti T M , Badr El Din R M , AlAjlan A 
Published: October 2024

Abstract

Background
The process of collection of body fluid samples and phlebotomy services require highly professionally staff to deal and ensure the reliability of laboratory services to our outpatients when they visit the lab. Satisfaction of the outpatient is one of the quality indicators to monitor and ensure that the laboratory services are adequate and comfortable to outpatient. The aim in this study was to evaluate if the patients are satisfying with our lab services and to improve the services.

Methods
The standardized survey was distributed among adult and pediatric outpatients at three different hospitals within the king Abdulaziz Medical City (KAMC), Riyadh, SA during the second quarter (Q2) and third quarter (Q3) of 2023. The main five elements in survey were convenience of laboratory service hours, waiting time, comfort level, privacy, professionalism and curtsey. The established internal target was selected at greater than 80%Some of the answers by patients were extended to reflect the whole outpatient services and not limited to only the phlebotomy service although the survey structure has specified the laboratory area. In addition, some of the handwritten of the answers was not easy to read or understand them. Therefore, these answers have been excluded from the survey. Few steps have been taking to improve the services such as extending the services hours, reduction in the waiting time, improving the skills of the staff, improving comfort and environment.

Results
A total of 773 and 842 patients participated in the survey during Q2 and Q3 of 2023 respectively. An overall patient satisfaction rate was found to be 63.3% and 81% for Q2 and Q3 of 2023 respectively (p=0.025). The highest average of overall patient satisfaction rate was found to be at 94% for adult during Q3 compared to 53% at Q2 (p&lt;0.001). The lowest overall patient satisfaction rate was found to be 69% for pediatrics’ patients for Q3 compared to 73% for Q2 (p=0.4252). In addition, 98 % of the surveyed patient have stated that they would highly recommend the out-patient phlebotomy service at KAMC for other patients. The waiting time displayed lower satisfaction rate (63 %) while privacy feature has shown the highest satisfaction rate 80%

Conclusions
Increasing of patient’s satisfaction rate has been achieved at the third quarter of the year and after implanting educational and training procedures.
A-202 Quality control design survey reveals 399 ways to do it wrong
Authors: Brooks Z 
Published: October 2024

Abstract

Background
The effectiveness of statistical quality control processes to detect unacceptable patient risk depends on the choices that laboratory professionals make for the design of quality control charts and acceptable patient risk.
Recommended best practice consists of putting a meaningful recent mean and SD on the QC chart, selecting rules based on the method’s margin for error to unacceptable risk or Sigma value, and basing acceptable risk on clinical need.

Methods
A survey was circulated through LinkedIn and Labvine. Forty respondents who included their credentials were included in the final analysis. Respondents were asked to select the one most correct answer four questions regarding the parameters that govern the effectiveness of quality control processes. 1. The best source of the mean on the QC chart? (Four choices) 2. Best source of the SD on the QC chart? (Five choices) 3. Best way to select QC rules for each QC sample? (Six choices) 4. If an analytical process “fails,” we should stop reporting before [errors are reported.] (Five choices)
A total of 400 potential patterns of QC selections were chosen. (4 * 5 * 5 * 4).

Results

When asked acceptable error rate if an analytical process “fails,” responses were More than 5% errors are reported - 11%. Any errors are reported - 66% It varies with clinical use of the test - 16% It varies with capabilities of our method - 8%
While most respondents chose at least one of the recommended answers for QC chart design and rules, only three chose the best choice for all parameters.

Conclusions
Despite decades of recommendations of best practice for quality control, typical practice throughout the laboratory community in general does not reflect this.
It is time to consider a new approach to teaching, validating and certifying competency in medical laboratory quality control.
A-208 Price Transparency of Laboratory Tests Across all Licensed Hospitals in Tennessee
Authors: Hart S A , Khan A , Booth G S , Wiencek J R 
Published: October 2024

Abstract

Background
The Hospital Price Transparency Final Rule federally mandates hospitals to provide gross price, discounted cash, payer-specific negotiated charges, and de-identified minimum and maximum negotiated rates within a machine-readable file and user-friendly display of shoppable services. Since implementation, compliance has been low and price variability has continued.

Methods
To assess hospital compliance, barriers to pricing information, and price variability in Tennessee, all hospitals websites were queried for gross, cash, and Blue Cross Blue Shield (BCBS) prices for 8 high-frequency laboratory tests in both mandated pricing sources. Barriers including click counts, data availability, and intra-hospital price discrepancies were noted.

Results
Only 2.8% of the 145 hospitals were compliant with federal law. Sub-analyses of the available machine-readable files, price estimators, and shoppable services files, only 50.4%, 4.9%, and 21.4% were found to be compliant, respectively. Barriers to pricing information included requiring protected health information (55.9%), missing at least 1 pricing source (7.6%), having no pricing sources available (6.2%), and involving more than 3 clicks to access cash price in machine-readable files (54.1%) and price estimators (68.6%.) The median total number of clicks from homepage to cash price in the machine-readable file and price estimator was 4 (range: 1-7) and 10.5 (range: 6-15), respectively. Average intra-hospital discrepancy for Basic Metabolic Panel cash prices across pricing sources was $101.30 (range: $0-1012.40). Price variability across Tennessee is shown in Figure 1. Maximum to minimum price multiples ranged from 29 to 114 for gross price, 57 to 243 for cash price, and 25 to 115 for BCBS price indicating price variability. Gross and cash prices were affected by median household income of the hospital’s county.

Conclusions
Our study shows low compliance with price transparency mandates, inequitable pricing affected by median household income, inconsistent and inaccessible pricing, and continued price variability in Tennessee.