Background Measurements Research Articles

Testing [formula omitted]-attractor quintessential inflation against CMB and low-redshift data

Due to universality and attractor properties, α-attractor quintessential inflation establishes direct relations between inflationary observables such as the scalar tilt ns and the tensor-to-scalar ratio r, and late-time dark energy equation of state parameters w0 and wa. In this work, we examine three different physically motivated regimes, considering complete freedom in the parameter α, models inspired by supergravity where α takes on values up to α=7/3, and Starobinsky inflation (α=1). We investigate the consistency and constraints imposed by Cosmic Microwave Background measurements from the Planck satellite, B-mode polarization data from the BICEP/Keck collaboration, and low-redshift observations. Additionally, we consider small-scale CMB measurements released by the Atacama Cosmology Telescope, which give results approaching the Harrison-Zel’dovich spectrum (ns≈1). Here α-attractors lead to an improved fit over ΛCDM. For the large-scale CMB measurements, α≳2 models can provide equally good fits as ΛCDM.

Finite Bubble Statistics Constrain Late Cosmological Phase Transitions.

We consider first order cosmological phase transitions (PTs) happening at late times below standard model temperatures T_{PT}≲GeV. The inherently stochastic nature of bubble nucleation and the finite number of bubbles associated with a late-time PT lead to superhorizon fluctuations in the PT completion time. We compute how such fluctuations eventually source curvature fluctuations with universal properties, independent of the microphysics of the PT dynamics. Using cosmic microwave background (CMB) and large scale structure measurements, we constrain the energy released in a dark-sector PT. For 0.1 eV≲T_{PT}≲keV this constraint is stronger than both the current bound from additional neutrino species ΔN_{eff}, and in some cases, even CMB-S4 projections. Future measurements of CMB spectral distortions and pulsar timing arrays will also provide competitive sensitivity for keV≲T_{PT}≲GeV.

Ultra-long-period Cepheids as Standard Candles from Gaia to Rubin-LSST

An analysis of the properties of ultra-long-period Cepheids (ULPs) could significantly contribute to understanding the Hubble constant tension, e.g., the current discrepancy between determinations based on local distance indicators and those relying on cosmic microwave background measurements. These highly luminous variables are observable beyond 100 Mpc, so if they were confirmed to behave as standard candles, they would allow us a direct measurement of cosmological distances without any secondary distance indicator, thus reducing potential systematic errors in the calibration of the cosmic distance scale. This paper presents an analysis of the largest known sample of 73 ULPs, including 15 objects in nearby galaxies, with new accurate and homogeneous photometry obtained by Gaia DR3, and a new object, in our Galaxy, identified as a long-period variable in Gaia DR3, but recently reclassified as a ULP. The obtained results suggest that, by improving photometric accuracy, the ULP period–Wesenheit relation shows a smaller dispersion than that obtained in literature and is in better agreement with the classical Cepheid (CC) one, supporting the hypothesis that ULPs are the extension of the CCs at higher period, mass, and luminosity. However, to reach this aim, it is necessary to enrich the sample with high-quality data. The Rubin Observatory Legacy Survey of Space and Time (Rubin-LSST) survey offers the possibility to achieve this thanks to its photometric characteristics and time extension. In particular, we will explore the capabilities of the Rubin-LSST survey to recover ULP theoretical light curves by using a new tool called PulsationStarRecovery, built by our group for this type of analysis.

Radiological Health Risk of Exposure to Gamma Radiation in Private Diagnostic Center in Khana Local Government Area Rivers State, Nigeria

The <i>In-situ</i> measurement of background ionizing radiation of Centre of Life hospital Bori in Khana Local Government Area of Rivers state of Nigeria has been carried out. Digilert-200 Radiation meters was utilized in measurement of background ionizing radiation and Global Positioning System (Garmin 765) was used in measuring coordinates of the sampling points. Fifteen (15) sampling points were arbitrarily selected within the diagnostics centre. The results of the BIR outdoor and indoor varies from 0.010 - 0.015 with mean of 0.013 mRhr-1. Absorbed Dose rate varies from 87.0 -130.5 nGy/yr with mean of 114.3 nGy/yr and 116.0 nGy/yr for outdoor and indoor. AEDE varies from 0.107 – 0.160 with mean of 0.140 mSv/yr and 0.142 mSv/yr and Excess life cancer risk varies from 0.37×10-3 – 0.56×10-3 with mean of 0.50×10-3 and 0.50×10-3 for outdoor and indoor respectively. The obtained values for BIR of Centre of Life Hospital Ltd was within recommended standard limit of 0.013mR/h. The obtained result for AEDE was within the recommended safe limit. The obtained results of ELCR and the ADR are all higher than the recommended standard of 0.29 x 10-3 and 84.0 nGy/h respectively. The result of radiation dose to different body organ shows that the testes have the highest radiation percentage for outdoor and indoor respectively.

Tomography of flavoured leptogenesis with primordial blue gravitational waves

We explore a scenario where an early epoch of matter domination is driven by the mass scale MN of the right-handed neutrinos, which also characterizes the different flavour regimes of leptogenesis. Such a matter-domination epoch gives rise to peculiar spectral imprints on primordial Gravitational Waves (GWs) produced during inflation. We point out that the characteristic spectral features are detectable in multiple frequency bands with current and future GW experiments in case of Blue GWs (BGWs) described by a power-law with a positive spectral index (nT > 0) and an amplitude compatible with Cosmic Microwave Background (CMB) measurements at the CMB scale. We find that the three-flavour leptogenesis regime with MN ≲ 109 GeV imprints BGWs more prominently than the two-flavour and one-flavour regimes characterized by a higher right-handed neutrino mass. In particular, a two-flavour (three-flavour) leptogenesis regime is expected to leave distinct imprints in the mHz–Hz (μHz–mHz) band. Moreover, we translate the current Big Bang Nucleosynthesis (BBN) and LIGO limits on the GW energy density into constraints on the flavour leptogenesis parameter space for different GW spectral indices nT . We provide a rigorous statistical analysis of how the future GW detectors would be conjointly able to distinguish the flavour regimes. Interestingly, the scenario also offers unique GW signals testable in the next LIGO run with a correlated signature in the PTA frequency band with an amplitude comparable to the one expected from supermassive black holes.

Socioeconomic background and childhood cancer survival in Germany – A nationwide register study

Abstract Introduction Evidence is accumulating that not all children with cancer have benefitted equally from diagnostic and therapeutic improvements and that socioeconomic conditions are also associated with prognosis - even in high-income countries where equal access to healthcare is presumed. We investigated the association between area-based socioeconomic background and childhood cancer survival in Germany with the ultimate aim to identify groups of children that may benefit from supportive interventions. Methods We identified all children with a first cancer diagnosis before the age of 15 years in 1997-2016 from the German Childhood Cancer Registry (N = 35,443). Based on individual residential address information (at diagnosis) we applied the German Index of Socioeconomic Deprivation as measure of area-based socioeconomic background. Using Cox proportional hazards models, we assessed the association between absolute area-based socioeconomic deprivation (AASD) and ten-year overall survival (OS) to estimate hazard ratios (HR) and corresponding 95% confidence intervals (CI). Results The Cox analysis (adjusted for diagnostic year, birth year and place of residence) revealed a null association for AASD and OS from all cancers combined (HR = 1.00, 95% CI 0.97; 1.03). Among children diagnosed with acute myeloid leukemia and germ cell tumors, a higher AASD (implying more severe levels of deprivation) was associated with worse survival, particularly pronounced in boys (HR = 1.18, 95% CI 1.01; 1.37; HR = 1.67, 95% CI 1.13; 2.45, respectively). The opposite was observed for childhood CNS tumours, yielding worse survival by decreasing AASD (HR = 0.93, 95% CI 0.88; 0.98) for both malignant and non-malignant CNS tumours. Conclusions Contrary to reports from other European countries, we found little evidence for pronounced social inequalities in childhood cancer survival in Germany based on a composite score, with inconsistent patterns across cancer types and age at diagnosis. Key messages • We found little evidence for pronounced social inequalities in childhood cancer survival in Germany on the area-based level. • Our findings indicated inconsistent patterns of social inequalities across cancer types and age at diagnosis.and age at diagnosis.

The Dark Energy Survey Supernova Program: Cosmological Analysis and Systematic Uncertainties

We present the full Hubble diagram of photometrically classified Type Ia supernovae (SNe Ia) from the Dark Energy Survey supernova program (DES-SN). DES-SN discovered more than 20,000 SN candidates and obtained spectroscopic redshifts of 7000 host galaxies. Based on the light-curve quality, we select 1635 photometrically identified SNe Ia with spectroscopic redshift 0.10 < z < 1.13, which is the largest sample of supernovae from any single survey and increases the number of known z > 0.5 supernovae by a factor of 5. In a companion paper, we present cosmological results of the DES-SN sample combined with 194 spectroscopically classified SNe Ia at low redshift as an anchor for cosmological fits. Here we present extensive modeling of this combined sample and validate the entire analysis pipeline used to derive distances. We show that the statistical and systematic uncertainties on cosmological parameters are σΩM,stat+sysΛCDM= 0.017 in a flat ΛCDM model, and (σΩM,σw)stat+syswCDM = (0.082, 0.152) in a flat wCDM model. Combining the DES SN data with the highly complementary cosmic microwave background measurements by Planck Collaboration reduces by a factor of 4 uncertainties on cosmological parameters. In all cases, statistical uncertainties dominate over systematics. We show that uncertainties due to photometric classification make up less than 10% of the total systematic uncertainty budget. This result sets the stage for the next generation of SN cosmology surveys such as the Vera C. Rubin Observatory's Legacy Survey of Space and Time.

Detection prospects of gravitational waves from SU(2) axion inflation

We study detection prospects of a gravitational-wave background (GWB) sourced by SU(2) gauge fields considering all possible observational constraints. More precisely, we consider bounds set by cosmic microwave background measurements, primordial black hole overproduction, as well as backreaction of the gauge fields on the background evolution. Gravitational-waves data from the first three observing runs of the LIGO-Virgo-KAGRA Collaboration show no evidence for a GWB contribution from axion inflation. However, we are able to place conservative constraints on the parameters of the SU(2) inflation with current data. We investigate conditions on the inflationary potential that would lead to a detectable signal that evades astrophysical and cosmological constraints and discuss detection prospects for third generation networks. Published by the American Physical Society 2024

Memory for health information: Influences of age, hearing aids, and multisensory presentation.

We investigated how presenting online health information in different modalities can influence memory, as this may be particularly important for older adults who may need to make regular decisions about health and could also face additional challenges such as memory deficits and sensory impairment (hearing loss). We tested whether, as predicted by some literature, older adults would disproportionately benefit from audio-visual (AV) information compared with visual-only (VO) or auditory-only (AO) information, relative to young adults. Participants were 78 young adults (aged 18-30 years old, M = 25.50 years), 78 older adults with normal hearing (aged 65-80 years old, M = 68.34 years), and 78 older adults who wear hearing aids (aged 65-79 years old, M = 70.89 years). There were no significant differences in the amount of information remembered across modalities (AV, VO, AO), no differences across participant groups, and we did not find the predicted interaction between participant group and modality. The older-adult groups performed worse than young adults on background measures of cognition, with the exception of a vocabulary test, suggesting that they may have been using strategies based on prior knowledge and experience to compensate for cognitive and/or sensory deficits. The findings indicate that cost-effective, text-based websites may be just as useful as those with edited videos for conveying health information to all age groups and hearing aid users.

A Systematic Review of Public Relations Research in the Context of Artificial Intelligence

In the context of the rapid development of artificial intelligence technology, this article provides a systematic review of public relations research in the context of artificial intelligence to provide valuable references for future public relations research and practice. Collect literature data from CNKI, use systematic review methods to select literature that meets the standards, and sort and summarize it from four dimensions: application background, application scenarios, challenges faced, and response measures. Research has found that currently, applying artificial intelligence technology to public relations practice has become a basic consensus in academia; The paradigm of public relations research in the era of artificial intelligence has changed; In the short term, artificial intelligence technology will not completely replace public relations personnel; The measures for responding to public relations in the era of artificial intelligence can be summarized and divided into two levels: theoretical and practical. In the future, it is necessary to further explore and improve public relations theories related to artificial intelligence, construct new analytical frameworks and research methods to adapt to the changes brought about by technology.

Gemini dark matter

The S8/σ8 tension in the large-scale structure can be explained by decaying dark matter with an almost degenerate spectrum and small enough decay width. Here we propose the Gemini dark matter model, which contains a heavy mother particle χ3 and two twins χ1/2, which are almost degenerate in mass and are produced at the same time. The dark sector is charged under the same Froggatt-Nielsen symmetry that can explain the hierarchy of the Standard Model Yukawa couplings. The slightly heavier χ2 decays into χ1 and the axionic component of the flavon, which washes out the small-scale structure and resolves S8/σ8 tension. We present the production mechanism of Gemini dark matter and viable parameter regions. We find that, despite the preferred dark matter mass being O(1)–O(100) keV, they constitute cold dark matter. The Gemini dark matter model predicts an abundance of dark radiation that will be probed in future measurements of the cosmic microwave background. Published by the American Physical Society 2024

Multispectral pattern camouflage materials based on PU/Al-flake composite: A CNN-based evaluation

With the continuous progress in optical sensor technologies, the emergence of imagery detection systems operating in the infrared (IR) band has become a reality. In response, we present a novel approach designed to deceive imagery IR detectors targeting fighter jets. To implement this method, we developed a specialized coating technique using a Polyurethane (PU)/Aluminum (Al)-flake composite. This composite coating enables the precise application of IR camouflage patterns while preserving the existing visible camouflages on aircraft surfaces. We customized fighter jet IR image datasets by integrating flow and heat transfer numerical analysis results with real-world background measurements. We then employed the YOLOv3 algorithm, based on a convolutional neural network (CNN), which is known for its high performance in object detection. Through this approach, we analyzed the effects of various pattern shapes on camouflage performance. The proposed PU/Al-flake composite coating offers a versatile and effective solution for overlapping IR camouflage patterns onto existing visible camouflages, providing enhanced protection against advanced IR imagery detection systems. This study highlights the potential of a comprehensive approach to developing and evaluating multispectral camouflage materials and effective camouflage strategies, emphasizing practical applications and real-world performance against IR image detectors.

Encyclopædia Inflationaris: Opiparous Edition

The current flow of high-accuracy astrophysical data, among which are the Cosmic Microwave Background (CMB) measurements by the Planck satellite, offers an unprecedented opportunity to constrain the inflationary theory. This is however a challenging project given the size of the inflationary landscape which contains hundreds of different scenarios. Given that there is currently no observational evidence for primordial non-Gaussianities, isocurvature perturbations or any other non-minimal extension of the inflationary paradigm, a reasonable approach is to consider the simplest models first, namely the slow-roll single-field models with minimal kinetic terms. This still leaves us with a very populated landscape, the exploration of which requires new and efficient strategies. It has been customary to tackle this problem by means of approximate model-independent methods while a more ambitious alternative is to study the inflationary scenarios one by one. We have developed the publicly available runtime library ASPIC11https://github.com/cosmicinflation/aspic. to implement this last approach. The ASPIC code provides all routines needed to quickly derive reheating-consistent observable predictions within this class of scenarios. ASPIC has been designed as an evolutive code which presently supports 118 different models. In this paper, for each of the ASPIC models, we present and collect new results in a systematic manner, thereby constituting the first Encyclopædia Inflationaris.

B-346 Diagnostic Performance of the Atellica IM Free PSA Assay in Men Undergoing Prostate Cancer Screening

Abstract Background Measurement of free prostate specific antigen (fPSA) in serum is used to aid in distinguishing prostate cancer (PC) from benign prostate conditions in men 50 years or older with hsPSA of 4.0-10.0 ng/mL (µg/L) and digital rectal exam (DRE) nonsuspicious for PC. Studies were performed to evaluate clinical performance for the Atellica® IM fPSAII assay* [fPSAII/hsPSAx100 ratio]. Methods Serum samples were prospectively collected from 1250 patients referred to an urologist for PC evaluation at 26 sites throughout the United States. At diagnostic cutoffs for %fPSAII spanning the spectrum of %fPSAII values, the percentage of PCs detected (sensitivity) and the corresponding percentage of biopsies avoided in men without PC (specificity) were tabulated. At a pre-specified sensitivity near 90%, %fPSAII specificity (relative to biopsy result) was compared to hsPSA specificity. The mean PC probabilities on biopsy and nonparametric 95% CI (2.5th and 97.5th percentiles) were calculated. The difference between these proportions was evaluated to estimate the improvement in specificity of %fPSAII relative to hsPSA alone. Difference in specificity was significant if the zero value was not bounded by 2.5th and 97.5th percentile values of the improvement estimate with a minimum of 5% improvement in specificity. Results Sensitivity and specificity results are presented in the table. The cutoffs provided a range of sensitivity estimates from 86%-100%. At 22% cutoff, sensitivity (90.3%) plus specificity (21.4%) is greater than 110.0%. Significant improvement in %fPSAII specificity over hsPSA alone was 8.9% with 95% CI of 6.8%-11.5%. Conclusions The clinical performance of the Atellica IM Analyzer fPSAII assay was acceptable and demonstrated an improvement in detection of PC than using hsPSA alone in this study. *CAUTION: Investigational Device. Not available for sale. Future availability cannot be guaranteed. The results are preliminary and were achieved in unique setting with no expected timeline for completion.

A-095 A New CO2 Assay with Concentrated Reagent Having Superior Onboard Stability on Mindray BS-2800M Analyzer

Abstract Background Measurement of total content of CO2 in serum or plasma can be used to assist in the diagnosis of various acid-base disorders. There are small amounts (about 0.04%) CO2 in the earth’s atmosphere, or more in an enclosed clinical laboratory space. The environmental CO2 could be dissolved into the CO2 reagent continuously, in particular at lowered temperature when it is opened and stored on the system, which leads an impact on CO2 assay performance. Presently, competitors mainly use additional inserts or with small opening of the reagent container to reduce the contact with air from reagent, to improve its onboard stability. Here, we designed a new CO2 assay by optimizing the reagent formulation with a new protection mechanism to reduce the amount of CO2 absorption to the reagent and improved its onboard stability. This study evaluated performances of the new CO2 assay on Mindray BS-2800M analyzer. Methods Mindray CO2 assay with concentrated reagent is based on PEPC (Phosphoenolpyruvate Carboxylase) enzymatic method. It is designed with an innovative mechanism of reagent formulations with a protective layer of chemical(s) on top of the reagent that prevents CO2 from entering the reagent and reduced its impact to its on-board stability. The onboard stability was conducted with a constant reagent consumption mode to simulate as it in clinical lab use. The onboard study used two levels of Quality Control materials and serum pools. According to CLSI protocols, the following assay performances were evaluated: onboard stability, precision, method comparison, linearity, and interference. Results On Mindray BS-2800M analyzer, Mindray CO2 assay demonstrated an excellent onboard stability. With uncapped reagent on the system, the stability is for 21 days without recalibration, with less than ± 5% deviation from day zero. In parallel onboard stability studies, with Roche CO2 reagent on Cobas c701 system, the relative deviation from day zero was found to be within ±10%; and other three manufacturers` results with deviation exceeded ±10% vs. day zero in 7 days. The linearity of Mindray CO2 assay was determined as from 2.0 to 50.0 mmol/L. Our CO2 assay correlated well with Roche CO2 on Cobas c701 (Mindray = 1.0032 * Roche - 0.0186, r≥0.99). The repeatability and with-lab CVs were ranged from 0.64% to 3.41%, respectively. There was no significant interference (&amp;lt;±10%), at CO2 concentration of 15 mmol/L with bilirubin up to 60 mg/dL,hemolysate up to 800 mg/dL, Intralipid up to 1000 mg/dL, triglycerides up to 1000 mg/dL. Conclusions On Mindray BS-2800M analyzer, the new CO2 assay demonstrated a good ability against environmental CO2 inference in 21 days of onboard time. The new CO2 assay also shown good performances in precision, correlation (accuracy) and anti-interference from endogenous substances. Therefore, we conclude that the new Mindray CO2 assay is suitable for routine clinical laboratory use.

A-061 Analytical Performance and R55G Mutant Detection Ability of an Improved Thyroid-Stimulating Hormone Assay, TSH3-Ultra II, on the ADVIA Centaur Immunoassay System and the Atellica IM Analyzer

Abstract Background Measurement of thyroid stimulating hormone (TSH) is a critical tool for the investigation of thyroid disorders. Previous studies have demonstrated that some immunoassays are unable to detect TSH from patients with the R55G mutation in the TSHβ subunit. This study evaluated the analytical performance of the ADVIA Centaur® and Atellica® IM TSH3-Ultra II (TSH3ULII) assay and its ability to detect the R55G TSH mutant. Methods Limit of quantitation (LoQ) and linearity were determined as described in CLSI EP17-A2 and EP06, respectively. Precision and method comparison (MC) studies were performed with three reagent lots according to CLSI EP05-A3 and CLSI EP09c using native and contrived human serum and plasma samples. For precision, one aliquot of each sample was tested in duplicate in two runs per day &amp;gt;2 hours apart on each analyzer for ≥20 days. MC studies were performed by testing native human serum samples using ADVIA Centaur TSH3-UL assay (current TSH assay) and the newer ADVIA Centaur TSH3ULII assay. An additional MC was performed by testing native human serum samples with the TSH3ULII assay on both the ADVIA Centaur XP and the Atellica IM Analyzer. Samples from 61 patients with TSH results below the LoQ when using TSH3-UL were sequenced and confirmed to have the R55G mutant. Each of these samples was tested in duplicate using the ADVIA Centaur TSH3ULII assay. Results LoQ on both the ADVIA Centaur XP and the Atellica IM Analyzer was estimated to be 0.010 μIU/mL (mIU/L). Linearity was verified from 0.010 to 150.000 μIU/mL (mIU/L). ADVIA Centaur TSH3ULII repeatability %CVs ranged from 1.4 to 3.6% at 0.099 and 91.993 μIU/mL (mIU/L), and within-lab %CVs ranged from 2.3 to 6.2% at 4.908 and 91.993 μIU/mL, respectively. Atellica IM TSH3ULII repeatability %CVs ranged from 1.1 to 3.4% at 4.800 and 93.097 μIU/mL, and within-lab %CVs ranged from 2.2 to 4.6% at 0.103 and 93.097 μIU/mL, respectively. For the MC studies, slopes determined by the Passing-Bablock regression model were approximately 1 (0.96-0.97 range) across the sample interval tested. All TSH3ULII results from the 61 mutant patient samples were greater than LoQ, ranging from 0.864 to 23.443 μIU/mL (mIU/L). Conclusions Evaluation of the TSH3ULII assay using the ADVIA Centaur system demonstrated performance comparable to the commercially available TSH3-UL assay for LoQ, linearity, and precision, when using normal patient samples. TSH3ULII results on the Atellica IM Analyzer were comparable to the results obtained on the ADVIA Centaur XP. All 61 TSH mutant samples used in this study that had TSH values below the LoQ with the TSH3-UL assay, were detectable with the TSH3ULII assay. The data presented here demonstrate the ability of the TSH3ULII assay to detect the TSH in samples from patients with the R55G mutation.

A-306 High Sensitivity Capability of an Anti-müllerian Hormone Assay on the Beckman Coulter DxI 9000 Immunoassay Analyzer*, a Next Step Toward Enabling Ovarian Failure Staging?

Abstract Background Measurement of anti-müllerian hormone (AMH) has proven value in the evaluation of ovarian reserve using assays such as the Beckman Coulter Access AMH assay. If improved sensitivity of AMH measurement can be achieved, enhanced clinical utility during the assessment of reproductive aging and ovarian response to enable staging of ovarian failure is possible (Practice Committee of the American Society of Reproductive Medicine 2020, Cappola et al. 2023). The Beckman Coulter DxI 9000 Immunoassay Analyzer* has been designed with new technology that can be leveraged to improve assay sensitivity. Such technological advancements include the new Lumi-Phos PRO chemiluminescent substrate which yields markedly increased signal-to-noise, a new luminometer with increased dynamic range, and improved low-volume pipetting capabilities. Data herein summarize results from analytical verification studies of the Access AMH assay on the DxI 9000 Immunoassay Analyzer. Results demonstrate an example of DxI 9000 technologies enabling sensitivity claims that are up to 20-fold improved. * The official name is DxI 9000 Access Immunoassay Analyzer. Methods A method comparison study was performed based on CLSI guideline EP09c, 3rd ed. to compare results for the Access AMH assay on DxI 9000 to the predicate device, the Access AMH assay on the Access 2 Immunoassay System. Within-laboratory precision was also evaluated following CLSI EP05-A3. Finally, performance at low analyte levels was evaluated following CLSI EP17-A2, and linearity was evaluated following CLSI EP06-Ed2. Results Method comparison of the Access AMH assay on DxI 9000 compared to the Access AMH assay on the Access 2 yielded excellent agreement with a Passing-Bablok slope of 1.02 for N=126 samples. Further, bias estimates for a number of key medical decision points suggest minimal bias (≤ 2%) across the assay range, and minimal non-linearity was observed. 20-day imprecision studies yielded CV’s between 2 and 5% across a broad range of concentrations evaluated. Sensitivity studies yielded estimates of limit of quantitation (LoQ) between 0.001 and 0.003 ng/mL. This represents an approximately 10- to 20-fold improvement in sensitivity claims compared to the AMH assay on the Access 2 and other commercially available automated immunoassay analyzers. Conclusions The data herein present performance data for the Access AMH assay on the DxI 9000 Immunoassay Analyzer. The assay demonstrates excellent accuracy relative to the predicate device, while showing good linearity and imprecision. Of note, the Access AMH assay exhibits exceptional low-end performance on the DxI 9000 analyzer as demonstrated by the ability to enable sensitivity claims that are up to 20-fold improved in comparison to existing immunoassays for the measurement of AMH. The sensitivity capabilities of the Access AMH assay on DxI 9000 suggest an opportunity for the addition of further intended uses for scenarios where extremely low AMH measurements can provide additional value of clinical significance. Further studies are needed to fully understand additional clinical utilities of the Access AMH assay with high sensitivity capability on DxI 9000, including the assessment of reproductive aging for menopause diagnosis or ovarian response for fertility treatment.

B-347 Analytical Performance Evaluation of the High Sensitivity PSA Assay and the Free PSAII Assay on the Atellica IM Analyzer

Abstract Background Measurement of serum prostate specific antigen (PSA) levels may be used in prostate cancer (PC) screening, but elevated PSA levels also are observed in patients with other etiologies such as benign prostatic hypertrophy. Studies suggest that measuring PSA with or before digital rectal examination (DRE) provides a better method of detecting PC than DRE alone. The free prostate specific antigen (fPSA) assay is an aid for distinguishing PC from benign prostate conditions in men 50 years or older with PSA values 4.0-10.0 ng/mL (µg/L) and DRE findings nonsuspicious for PC. The goal of this study was to evaluate the analytical performance of the high sensitivity PSA (hsPSA)* and free PSA (fPSAII)* assays on the Atellica® IM Analyzer. Methods Detection capability studies were performed per CLSI EP17-A2. Precision testing was performed per CLSI EP05-A3 with native human serum and QC samples, 3 reagent lots, 1 analyzer, 2 runs/day, 2 replicates/run for 20 days. For Atellica® hsPSA and fPSAII assays a multi-site reproducibility study was conducted per CLSI EP-05 A3 using native and contrived serum samples, 3 reagent lots, and 3 different sites and analyzers; samples were assayed in triplicate for five days, two runs/day ∼2 hours apart. Linearity testing was performed per CLSI EP06-A on a dilution series made from a high PSA sample (native human male serum pool) and a low sample (native human female serum), 4 replicates, 3 reagent lots, and 1 analyzer. Specimen equivalency was determined by Weighted Deming regression model per CLSI EP09c-ed3. Results Results are presented in the table. Conclusions The Atellica IM hsPSA assay and fPSAII assays detection capability, precision, linearity, and specimen equivalency were acceptable. *CAUTION: Investigational Device. Not available for sale. Future availability cannot be guaranteed. The results are preliminary and were achieved in unique setting with no expected timeline for completion.

Ultrasound Measurement of Optic Nerve Sheath Diameter as Non-Invasive Detector of Raised Intracranial Pressure in Adult Traumatic and Non-Traumatic Neurocritical Patients in ICU

Abstract Background Measurement of intracranial pressure (ICP) is crucial in the management of many neurological conditions. However, due to the invasiveness, high cost, and required expertise of available ICP monitoring techniques, many patients who could benefit from ICP monitoring do not receive it. As a result, there has been a substantial effort to explore and develop novel non-invasive ICP monitoring techniques to improve the overall clinical care of patients who may be suffering from ICP disorders. Objective Assessment of the role of ultrasound as a non-invasive method (bedside) to measure the raising of intracranial pressure by measuring the optic nerve sheath diameter in traumatic and nontraumatic neurocritical patients. Patients and Methods: A total of 100 patients of both sexes above 18 years old diagnosed with traumatic &amp; non-traumatic brain injury with high intracranial pressure (ICP) which suspected by the initial CT brain and Marshall Classification were enrolled. Patients were divided into control group that included 50 patients with no evidence of any intracranial abnormality or severe head injury. Mean ONSD in the control group was considered to be normal. Study group subjects included 50 patients aged above 18 years old who sustained a severe traumatic or non-traumatic brain injury (GCS &amp;lt;8) All patients had a non-contrast CT head b efore any surgical or non-surgical i ntervention. The CT head was used to determine the Marshall score. Results Optic nerve sheath diameter was statistically significant higher in all periods 0-24 hours among cases with high intracranial tension compared with control ones with statistically significant positive correlations between it and age at 6hrs. and 24hrs and Marshal score at Ohr. and 24hrs and negative correlation between it and GCS score at Ohr. and 24hrs. The best cut off value for detector of raised intracranial pressure was 4.9 with sensitivity 94.7%, specificity 83.3%, positive predictive value 94.7% and negative predictive value 83.3%. Conclusion The evaluation of the optic nerve sheath diameter is a simple non-invasive procedure, which is a potentially useful tool in the assessment and monitoring of traumatic and nontraumatic neurocritical patients suspected of having raised intracranial pressure.

What Are the Pillars of Reionization? Revising the AGN Luminosity Function at z ∼ 5

In the past, high-z active galactic nuclei (AGNs) were given a minor role as possible drivers of reionization, despite initial evidence in favor of their large space densities at low luminosities by Chandra and the Hubble Space Telescope. Recent observations from JWST are finding relatively large numbers of faint AGNs at z > 4, convincingly confirming these early results. We present a sample of z ∼ 5 AGNs, both from wide, shallow ground-based surveys and from deep, pencil-beam observations from JWST, allowing us to estimate their space densities with unprecedented accuracy. The bright end (M 1450 < −26) of the z ∼ 5 AGN luminosity function is well constrained, with a rather steep slope. The faint end (M 1450 ≥ −22) indicates a high space density, the scatter is significant, and the knee (M 1450 ∼ −24) is mostly undetermined. Comparisons with state-of-the-art models find reasonable agreement with the observed AGN luminosity function at z = 5, while the predicted space density evolution at higher redshifts appears to be too fast with respect to observational constraints. Given the large variance at the faint end, we consider different options in fitting the luminosity functions and deriving the ionizing emissivity. Even in the most conservative scenario, the photoionization rate produced by z ∼ 5 AGNs is consistent with the ultraviolet background measurements. A slow evolution of the space density of faint AGNs is observed, indicating that active SMBHs are probably producing large amounts of ionizing photons at z > 6, well into the Epoch of Reionization. This is an important indication that high-z AGNs could be major contributors to the reionization of the Universe.