bluuebunny/crossref_metadata_2025_split huggingface dataset:
A-294 Exocytosis Inhibitor Increases yield of Limulus Amebocyte Lysate (LAL), Used for adjunct diagnosis of Invasive Fungal infection
Authors: Zhang M , Zhang S , Zhang J 
Published: October 2024

Abstract

Background
The limulus amebocyte lysate (LAL) was widely used in endotoxin detection in vitro and the clinical diagnosis of invasive fungal infection. The previous data showed that a caffeine collection solution could prevent degranulation during the blood collection procedure, and caffeine-derived LAL could work in both the chromogenic test and turbidimetric method assays. However, the cell pellets collected by caffeine collection solution aggregates after re-suspension in 5 mM CaCl2. No similar phenomenon was observed with PBS collection buffer. The purpose of this study is to set up a PBS-caffeine bleed solution to improve the yield of LAL

Methods
During the 2023 bleed season, experiments were carried out to test the results of PBS-caffeine solution on the degranulation during bleed process. 6 crabs were bled once a week for a total of 60 crabs by the PBS-caffeine collection solution. The blood of each crab was collected by PBS caffeine collection solution. The cell pellets were finally re-suspended into 5 mM CaCl2 to promote degranulation. The LAL activity was tested by both chromogenic and turbidimetric assay methods.

Results
The data demonstrates that PBS-caffeine collection solution could prevent degranulation for over 4 hours, and the activity yield of PBS-caffeine-derived LAL was higher. There was no discernable impact on the activity yield of the crab’s size during the bleed season. PBS-caffeine-collection solution could reduce amebocyte aggregation/clot formation during processing. Studies described the biochemical characteristics of PBS-caffeine-derived LAL. Moreover, PBS-caffeine-derived LAL could work in both the chromogenic and turbidimetric assays.

Conclusions
First, PBS-caffeine collection solutions prevent amebocyte degranulation during blood collection and processing. Next, a PBS-caffeine collection solution could reduce cell aggregation/clotting during processing, and the activity of PBS-caffeine LAL is higher. Finally, PBS LAL is functional in both the chromogenic test and turbidimetric assays
A-295 New Transport Media to Preserve Viable Parasites, Bacteria and Fungus
Authors: Ordonez-Smith M E 
Published: October 2024

Abstract

Background
Patients with various infections not always show positive results in their cultures. Therefore, the purpose of this study is to show that a transport media is needed to preserve bacteria, parasites and fungi, which can help patients when collecting samples to determine their infections, the most common urine or feces. The microorganisms can be kept immediately in the transport media when they are taken by the patient and the first step is very important to keep them alive. The preanalytical step is essential for a good diagnostic and accurately determines their etiology.

Methods
The transport media that I am referring to, was designed by our laboratory. It is a tube with an enriched broth, it can be kept at room temperature for a year. To show that this transport media can be trusted, different samples were tested such as: Urine, semen, wounds, eye secretions and feces were tested at different temperatures: refrigerator 2°C, environment 18°C and in a “kangaroo” corporal temperature or an incubator at 37°C. Also, times were tested between the collection and transport to the laboratory to be proceeded. To have a good diagnostic the sample should be smeared onto the transport media and kept there at least two or more hours at normal corporal temperature. There is no problem to send the tube at room temperature to the laboratory. All samples were smeared for bacterias in MacConkey agar, EMB (Eosin Methylene Blue) agar, CLED (Cystine-Lactose-Electrolyte Deficient) agar with Andrade Indicator, Blood agar, Chocolate agar, XLD agar. For fungi in Potato or Sabouraud agar. The parasites were studied in saline solution and parasitological lugol.

Results
The samples most studied were 1600 samples of feces, 700 urines and 100 other samples, such as genital, eye secretions, wounds. The percentage of positive etiology with this transport media was 67.9% of fungi versus 73.5% without the transport media. The aerobic bacteria and helminths eggs or adults can be in this transport media for many days, there is no difference and Giardia lamblia trophozoites can be kept as long as seven hours.

Conclusions
Nowadays, there are various commercial transport media for each microorganism. The great advantage of our transport media is used for three etiologies: Bacteria, parasites and fungi, plus can be kept at room temperature for several days. It is very easy to used, the tube of the transport media can be placed in a “kangaroo” style to keep the samples at corporal temperature. It is helpful in case the patient lives far away or takes the sample at night. The transport media can keep the samples at 37°C at all time at corporal temperature. This new transport media is essential to obtain accurate positive cultures and can give a better diagnostic, since the microorganisms are alive. Knowing the etiology, the treatment is accurate and the patient´s health is always necessary.
A-300 Comparative Analysis of Serology Test Performance: Evaluation of Elecsys Platform for Hepatitis Markers
Authors: Metushi I , Kim S , Javier G , Ciobanu D , Nunez G , Jurie R , Drake T A , Garner O 
Published: October 2024

Abstract

Background
Serology tests that target markers such as: anti-hepatitis A IgM virus (anti-HAV IgM), anti-HAV total antibody, anti-hepatitis B core IgM (anti-HBc IgM), anti-HBc total, anti-HB surface (anti-HBs), HBs antigen and anti-hepatitis C virus (anti-HCV) total play a pivotal role in understanding the stage of infection, immunity and vaccination effectiveness. Here, we evaluated these markers on our new total laboratory automation line that uses the Roche Elecsys platform.

Methods
The existing reference method used was the Siemens Centaur. Precision was evaluated by running a negative and a positive sample a minimum of 25 times. Method comparison was performed by using human samples with negative and positive values as outlined in Table 1 below. Analysis was performed by EP Evaluator.

Results
Samples for precision were 100 % concordant. Method comparison for each test yielded the results outlined in Table 1. Tests such as anti-HBs and HBsAg had 100% agreement between the two methods. Anti-HAV total had only one sample classified as positive by Elecsys that was negative by the reference (Centaur), resulting in 99% overall agreement. Anti-HAV IgM had had 4 results positive by Centaur that were negative by Elecsys. Upon further investigation, of the four samples, one was confirmed to be a true negative by chart review, two samples were run on the Abbott platform and were confirmed to be negative matching Elecsys. Anti-HBc IgM had 54% positive agreement and 100% negative agreement with Elecsys giving 6 discordant samples. These results were evaluated by clinical review and ruled to be true negative. Anti-HBc total and anti-HCV total had 99% and 96% overall agreement respectively.

Conclusions
We conclude that the Roche Elecsys platform for infectious serology tests is precise and accurate to be used in the clinical laboratory.
A-302 Evaluation of real-time PCR assays for detection of sexually-transmitted infections
Authors: Soong H 
Published: October 2024

Abstract

Background
Sexually transmitted infections (STIs) have serious negative consequences for reproductive health worldwide. They are associated with infertility, premature birth and neonatal infections. Five STI pathogens, namely Trichomonas vaginalis, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma parvum, and Ureaplasma urealyticum were selected for the evaluation of three potential real-time PCR assays that can be adopted for diagnostic testing.

Methods
A total of 36 samples were included, consisting of genital swabs, urine, abscesses and samples provided by quality assurance programmes. DNA extraction was performed using an automated nucleic acid extraction system, abGenixTM. Commercial genomic controls and DNA extracts donated by external laboratories were used as well. The extracted nucleic acids were tested using three different assays, namely Seegene Anyplex II STI-5 Detection, Thermo Fisher Scientific customized STI Panel assay, and TIB MOLBIOL STI LightMix Modular kits, according to the manufacturers’ instructions.

Results
A total of 67% and 11% of the samples showed equivalent positive and negative results, respectively. However, 22% of the samples had non-concordant results. TIB MOLBIOL STI LightMix Modular kit was unable to differentiate between Ureaplasma parvum and Ureaplasma urealyticum in 9 samples. Genomic controls were tested, and Seegene Anyplex II STI-5 Detection was unable to detect lower concentrations of DNA for Trichomonas vaginalis, Mycoplasma genitalium and Mycoplasma hominis. All assays were able to detect lower concentrations of Ureaplasma parvum DNA, but detectable concentrations were higher for Ureaplasma urealyticum.

Conclusions
In conclusion, the performance of each assay differed according to pathogen. None of the assays offered equal performance for all pathogens. We have adopted Thermo Fisher Scientific customized STI Panel assay in our diagnostic testing due to its advantage of being user friendly and cost effective.
A-308 Placental Growth Factor Kryptor Immunoassay Reveals Quality Control Imprecision and Drift
Authors: Chan C , Chen G , Schaefer R F , Echevarria F J , Yeo K J 
Published: October 2024

Abstract

Background
The utility and value of determining the soluble fms-like tyrosine kinase-1 to placental growth factor (sFlt-1/PlGF) ratio for predicting the likelihood of progression to pre-eclampsia in pregnant women admitted with hypertension are increasingly becoming widely recognized. A key finding of the multi-center PRAECIS trial (NEJM Evid 2022;1(12)) is the observation that sFlt-1/PlGF ratios ≥ 40 correlate with higher risk for adverse maternal outcomes. The sFlt-1 and PlGF immunoassays performed on the ThermoFisher Scientific B·R·A·H·M·S Kryptor autoanalyzer became the first FDA-approved tests in 2023 for determining sFlt-1/PlGF ratio. In this study, an evaluation of the analytical performance of the sFlt-1 and PlGF KRYPTOR immunoassays was performed, which included analyte measuring range (AMR), accuracy, precision, and stability studies.

Methods
Calibration and QC materials (consisting of lyophilized recombinant human proteins), test reagents and solutions, and consumables were purchased and provided by ThermoFisher Scientific. Analytical runs were performed according to vendor’s instructions by trained medical laboratory scientists. Between-day precision of our two instruments for both immunoassays was assessed by assaying all three levels of sFlt-1 and PlGF QC materials, as well as patient serum pools with low PlGF concentration, once to twice daily for multiple consecutive days.

Results
While the analytical performance of the sFlt-1 immunoassay was robust and performed according to expectation (within-day CV &lt;1% and between-day CV &lt;3%), the PlGF immunoassay was surprisingly less reliable. Imprecision and inaccuracy of the PlGF immunoassay at the low end of its analytical measurement range was reflected by both sporadically out-of-control between-day measurements of all three QC levels (with target ranges of 24 - 36 pg/mL, 80 - 120 pg/mL, and 320 - 480 pg/mL), as well as slow downward drifts of particularly the low level QC material. In one instance, a downtrend was observed from 28 pg/mL to 14 pg/mL over 6 days, even with fresh reagents, solutions, and calibration. Such shortened stability of the PlGF assay does not meet the vendor’s claims of calibration stability of 15 days and onboard kit stability of 29 days. Using vendor’s provided material, the AMR of both sFlt-1 and PlGF were adequately verified and showed excellent linearity (r2&gt; 0.99).

Conclusions
Despite low level QC imprecision and drift, the sFlt-1/PlGF ratios determined using the B·R·A·H·M·S Kryptor analyzers are acceptable for clinical use but with the caveat that we will perform batch testing with bracketing QCs and conduct stringent QC monitoring, frequent calibrations, and reduce the onboard kit stability as defined by ThermoFisher Scientific. Our findings serve as a reminder that FDA approval does not preclude thorough verification studies of any assay prior to implementation for clinical use.
A-319 Capillary Blood Collection for Egg-cellent Reproductive Insights
Authors: Brandon W C , Collier B B , Chappell M R , Iacovetti G , Peevler M , Schaff U Y , Sommer G J , Grant R P 
Published: October 2024

Abstract

Background
In the United States, an estimated 13% of women between the ages of 15 and 49 years, experience impaired reproductive potential (fecundity). Assessment of fecundity typically requires an in-person physician visit and venous blood collection to evaluate hormone levels and identify potential reproductive health conditions. Exploring less invasive, at-home sampling options could offer couples insights into their personal reproductive abilities, providing peace of mind and aiding in family planning.

Methods
Capillary blood, obtained using the Tasso®+ capillary blood collection device coupled with a BD Microtainer® serum tube, was utilized for measurements of analytes associated with female fecundity (follicle stimulating hormone, luteinizing hormone, estradiol, progesterone, anti-Müllerian hormone, and prolactin). These are all FDA-approved assays measured on Roche cobas® e801, assay parameters remained unchanged. Professional and self-collected capillary serum samples were acquired in parallel with the standard venous serum samples, to compare clinical equivalency of the capillary sampling option. In addition to isothermal stability studies at room temperature (20-25°C) and refrigerated (2-8°C) conditions, shipping excursion studies based on ISTA 7D recommendations were performed using a novel packaging solution to control sample temperature and thus, specimen integrity. Studies to assess matrix equivalency, linearity, and imprecision of this alternate sample type were also performed to demonstrate analytical performance.

Results
Method comparison of venous and professional collection of capillary samples demonstrated correlations (R) ≥ 0.9720 with slopes ranging from 0.919 to 0.971 and mean biases within ±8.2% for all analytes (n = 19-79). Self-collected capillary serum samples demonstrated correlations (R) ≥ 0.9827 with slopes that ranged from 0.841 to 0.985 and mean biases within ±10.7% (n = 16-26). Isothermal stability was demonstrated for each analyte up to 7 days at room temperature and refrigerated conditions. Simulated shipping excursion results were found to be acceptable for both winter and summer conditions with mean biases for each analyte within ±10.2% and ±19.2%, respectively. Matrix equivalency, linearity, and imprecision results adhered to current CLIA acceptance limits for each respective measurement.

Conclusions
The analytical and stability results affirm the feasibility of collecting capillary serum in a patient-centric manner, providing women with relevant information about their reproductive health.
A-328 Accuracy of the Glucose Test in the i-STAT® G Cartridge Using the i-STAT 1 System for Venous, Arterial and Capillary Whole Blood Specimens in Clinical Settings
Authors: Kornfeld S F , Gonzalez Aguirre M , Zhang H , Hahn S 
Published: October 2024

Abstract

Background
Precise and accurate measurements of whole blood glucose levels are important for the diagnosis, monitoring and treatment of carbohydrate metabolism disorders, such as diabetes and hypoglycemia. This study demonstrates the accuracy of the glucose test in the i-STAT G cartridge with the i-STAT 1 System in arterial, venous, and capillary whole blood specimens in point of care or clinical laboratory settings.

Methods
The accuracy of the glucose test in the i-STAT G cartridge was assessed at external clinical sites in a method comparison study using whole blood specimens across the measurement range of 20 - 700 mg/dL. Specimens used in this study were venous, arterial, and capillary specimens prospectively collected under Institutional Review Board-approved informed consent or were leftover de-identified venous or arterial specimens. The study included venous whole blood samples from 164 adult subjects (≥ 18 years) and arterial whole blood samples from 173 adult subjects at 3 clinical sites, and capillary whole blood samples from 211 adult subject at 3 clinicals sites and 23 neonate subjects (birth to 28 days) at 2 clinical sites.
For venous and arterial whole blood, samples were collected and tested in duplicate on the i-STAT G cartridge and on the i-STAT CHEM8+ cartridge (comparator). For capillary whole blood samples, adult fingerstick samples and neonate heel-stick samples were collected in capillary tubes and tested in singlicate on the i-STAT G cartridge and in singlicate on the epoc® Blood Analysis System (comparator). Passing-Bablok linear regression was performed for venous and arterial whole blood samples using the first replicate from the i-STAT G cartridge versus the mean result of the comparator, and for capillary whole blood samples (adult and neonate combined) using the singlicate result from the i-STAT G cartridge versus the singlicate result of the comparator.

Results
Passing-Bablok regression of i-STAT G cartridge results versus the comparator was used to calculate slope and correlation coefficient (r). Adult venous whole blood results had slope = 1.00 and r = 1.00, and adult arterial whole blood results had slope = 1.00 and r = 1.00. Adult and neonate capillary whole blood results had slope = 1.00 and r = 1.00.

Conclusions
These results demonstrate that the i-STAT 1 System delivers accurate glucose test results within ∼2 minutes using the i-STAT G cartridge for venous, arterial and capillary whole blood samples for adult and neonate subjects across a glucose range of 20-700 mg/dL when tested by end-users in a point of care or clinical laboratory setting.
This study was funded by Abbott Laboratories.
A-337 The Utility of Urinary Human Chorionic Gonadotropin Testing in the Emergency Department
Authors: Kim R , Altura M , Smith K , Hashim I 
Published: October 2024

Abstract

Background
Human chorionic gonadotropin (hCG) levels are measured in both urine and blood as an indication of suspected pregnancy, and assessment of progress of conception. It is also measured in the investigation of patients presenting with acute abdomen and suspected of ectopic or molar pregnancy. This study reviewed the utility of urine pregnancy test in a large university teaching hospital.

Methods
Results of all urinary hCG tests (using hCG Combo Pregnancy kit, MEDLINE, IL) performed as point of care in the emergency department during the year 2023 were obtained. Corresponding plasma hcG levels performed (Total β-HCG Alinity immunoassay, Abbott Diagnostics, IL) were also obtained. Analysis of hCG testing outcomes were assessed.

Results
A total of 2848 urinary hCG tests were performed during the study period. The majority 2113 (74.2%) of samples were negative for hCG whereas 835 samples (29.3) were positive. Among the positive hCG urine samples, 401 patients (48%) had plasma hCG requested and performed. Plasma hCG values ranged from &lt; 2.4 (26.5) to 219,462.5 mIU/mL (median 16,872.35 mIU/mL). One plasma sample with corresponding positive urinary hCG result had plasma hCG level &lt;2.4 mIU/mL which is below the detection limit of the assay suggesting a false positive urinary hCG result. Among the 13 patients with serial plasma hCG values, only one patient exhibited doubling (48 hours) hCG values when less than 13,000 mIU/mL. One patient had a declining serial hCG plasma values suggesting failing conception. The remaining patients with consecutive plasma hCG values cannot be assessed as either the time gap was excessive or hCG values were markedly elevated (&gt; 30,000 mIU/mL).

Conclusions
Although the utility of urinary hCG testing in the emergency department appeared appropriate, unnecessary repeat analysis with appropriate plasma request represented 3.2%. An electronic test request duplicate notification may help resolve this unnecessary repeat.
A-343 Novel In-Line Hemolysis Detection on a Blood Gas Analyzer for Capillary Samples
Authors: Adib L , Butler M , McNary N , Balasubramanian S , Pamidi P 
Published: October 2024

Abstract

Background
Point-of-care (POC) blood gas and electrolyte analyzers utilizing whole blood as the predominant sample type are blinded by the presence of hemolysis until today. Moreover, capillary samples are particularly vulnerable to in-vitro hemolysis due to excessive force applied during sample collection. Here, we introduce the GEM Premier 7000 with iQM3 (GEM 7000) which incorporates automatic, in-line hemolysis detection in capillary blood gas samples without a need for additional sample volume or reagents.

Methods
The hemolysis detection module which is integrated into the disposable GEM cartridge uses acoustophoretic technology and photometric measurements to detect hemolysis in whole blood. In GEM 7000, hemolysis of ≥ 116 mg/dL was found to have significant interference with potassium results. A hemolysis flag is presented as the degree of hemolysis: none (0 - 50 and 51 - 115), mild (116 - 200 and 201 - 300), moderate (301 - 400), and gross (≥401). Due to volume limitations with native capillary samples and challenges in assessing hemolysis levels with a comparator assay, venous blood spiked volumetrically with hemolysate and transferred to capillary devices was used to verify the hemolysis flag performance. An agreement analysis was performed using the Roche cobas hemolysis value. The device's (GEM 7000) ability to flag hemolyzed capillary samples is demonstrated in a simulated clinical setting using native and contrived fingerstick capillary samples.

Results
Hemolysis verification with transferred capillary samples demonstrated that 98.2% (274/279) of samples were correctly flagged based on the cobas hemolysis value of spiked hemoglobin. Hemolysis in the native capillary samples (N = 235) was primarily distributed in the 0-50 mg/dL range. Additionally, native capillary samples altered using vigorous flea mixing (&gt; 1 minute) showed hemolysis distribution over a wide hemolysis degree (none to gross), and their potassium results were flagged accordingly.

Conclusions
By providing integrated hemolysis detection in capillary blood sample measurements, the GEM Premier 7000 with iQM3 system can provide quality and confidence in the clinical interpretation of critical results such as potassium.