Evolving Paradigm of Prothrombin Time Diagnostics with Its Growing Clinical Relevance towards Cardio-Compromised and COVID-19 Affected Population

Saha, Anubhuti; Bajpai, Ashutosh; Krishna, Vinay; Bhattacharya, Shantanu

doi:10.3390/s21082636

Cited by 7 publications

(6 citation statements)

References 66 publications

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“…In comparison, the 500 mg/kg BW/day dose significantly increased WBCs, which are regarded as an effective marker of inflammation ( Karino et al, 2015 ), indicating that the 500 mg/kg dose may cause hematological toxicity in male rats. PT is a significant coagulation biomarker due to its direct correlation to the physiological clotting time, and prolonged PT represents impairment of coagulation function ( Saha et al, 2021 ). In this study, since the PT did not change in the 500 mg/kg BW/day dose group in females, this was considered to be due to individual differences.…”

Section: Resultsmentioning

confidence: 99%

Subchronic Oral Toxicity of Sodium p-Hydroxybenzoate in Sprague-Dawley Rats

Fan

Song

et al. 2022

Front. Pharmacol.

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p-Hydroxybenzoic acid (p-HBA), which exists extensively in plants, is well known for its anti-inflammatory effects, but various adverse side effects have also been reported. Previous research has found that acid translated to its sodium salt improves the safety profile of compounds. Therefore, we hypothesized that p-HBA translated to sodium p-hydroxybenzoate would improve its safety profile. In the present study, we evaluated the toxicity of sodium p-hydroxybenzoate after 90 days of repeated oral toxicity experiments according to OECD guidelines in male and female Sprague–Dawley rats. Sodium p-hydroxybenzoate was administered orally to SD rats at doses of 0, 125, 250, and 500 mg/kg body weight (BW)/day for 90 days. All animals survived to the end of the study, and no sodium p-hydroxybenzoate treatment-associated mortality or clinical changes were observed during the study period. Sodium p-hydroxybenzoate did not promote any clinical signs of toxicologically relevant effects, including changes in body weight, food intake and urinalysis parameters, in male or female SD rats. Dose-related alterations in hematological parameters, organ weights and histopathological findings in hepatic tissue were examined in animals of both sexes in the 500 mg/kg BW/day group. Based on the study, the no-observed-adverse-effect level (NOAEL) for sodium p-hydroxybenzoate was determined to be 250 mg/kg BW/day in both male and female rats.

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Section: Resultsmentioning

confidence: 99%

Subchronic Oral Toxicity of Sodium p-Hydroxybenzoate in Sprague-Dawley Rats

Fan

Song

et al. 2022

Front. Pharmacol.

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“…Interestingly, upregulated HB-EGF levels negatively correlated with the age of patients (r = −0.44, p = 0.028) and PT (r = −0.410, p = 0.041), both well-known severity predictors in COVID-19. PT, also known as the time of prothrombin, is a coagulation marker that refers to the blood clotting time [34]. Several reports highlighted the clinical relevance of PT in COVID-19 infection, along with other clotting-related parameters such as platelet count, D-Dimers, and fibrinogen [35][36][37][38].…”

Section: Discussionmentioning

confidence: 99%

HB-EGF Plasmatic Level Contributes to the Development of Early Risk Prediction Nomogram for Severe COVID-19 Cases

Moatar,

Chis,

Nitusca

et al. 2024

Biomedicines

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(1) Background: Heparin-Binding Epidermal Growth Factor-like Growth Factor (HB-EGF) is involved in wound healing, cardiac hypertrophy, and heart development processes. Recently, circulant HB-EGF was reported upregulated in severely hospitalized COVID-19 patients. However, the clinical correlations of HB-EGF plasma levels with COVID-19 patients’ characteristics have not been defined yet. In this study, we assessed the plasma HB-EGF correlations with the clinical and paraclinical patients’ data, evaluated its predictive clinical value, and built a risk prediction model for severe COVID-19 cases based on the resulting significant prognostic markers. (2) Methods: Our retrospective study enrolled 75 COVID-19 patients and 17 control cases from May 2020 to September 2020. We quantified plasma HB-EGF levels using the sandwich ELISA technique. Correlations between HB-EGF plasma levels with clinical and paraclinical patients’ data were calculated using two-tailed Spearman and Point-Biserial tests. Significantly upregulated parameters for severe COVID-19 cases were identified and selected to build a multivariate logistic regression prediction model. The clinical significance of the prediction model was assessed by risk prediction nomogram and decision curve analyses. (3) Results: HB-EGF plasma levels were significantly higher in the severe COVID-19 subgroup compared to the controls (p = 0.004) and moderate cases (p = 0.037). In the severe COVID-19 group, HB-EGF correlated with age (p = 0.028), pulse (p = 0.016), dyspnea (p = 0.014) and prothrombin time (PT) (p = 0.04). The multivariate risk prediction model built on seven identified risk parameters (age p = 0.043, HB-EGF p = 0.0374, Fibrinogen p = 0.009, PT p = 0.008, Creatinine p = 0.026, D-Dimers p = 0.024 and delta miR-195 p < 0.0001) identifies severe COVID-19 with AUC = 0.9556 (p < 0.0001). The decision curve analysis revealed that the nomogram model is clinically relevant throughout a wide threshold probability range. (4) Conclusions: Upregulated HB-EGF plasma levels might serve as a prognostic factor for severe COVID-19 and help build a reliable risk prediction nomogram that improves the identification of high-risk patients at an early stage of COVID-19.

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“…The use of blood as an analyte for diagnostic tests also makes hemocompatibility testing critical. Improper sample handling, large inter-device variability due to variations in design and coagulation reagents, and variations in device response due to variability in blood viscosity and hemolytic conditions result in operation-related and data output failures [ 72 ]. Therefore, defining standardized handling practices and proper tests to assess reproducible device performance are valuable for hematological devices.…”

Section: Discussionmentioning

confidence: 99%

A Systematic Analysis of Recent Technology Trends of Microfluidic Medical Devices in the United States

Natu,

Herbertson,

Sena

et al. 2023

Micromachines

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In recent years, the U.S. Food and Drug Administration (FDA) has seen an increase in microfluidic medical device submissions, likely stemming from recent advancements in microfluidic technologies. This recent trend has only been enhanced during the COVID-19 pandemic, as microfluidic-based test kits have been used for diagnosis. To better understand the implications of this emerging technology, device submissions to the FDA from 2015 to 2021 containing microfluidic technologies have been systematically reviewed to identify trends in microfluidic medical applications, performance tests, standards used, fabrication techniques, materials, and flow systems. More than 80% of devices with microfluidic platforms were found to be diagnostic in nature, with lateral flow systems accounting for about 35% of all identified microfluidic devices. A targeted analysis of over 40,000 adverse event reports linked to microfluidic technologies revealed that flow, operation, and data output related failures are the most common failure modes for these device types. Lastly, this paper highlights key considerations for developing new protocols for various microfluidic applications that use certain analytes (e.g., blood, urine, nasal-pharyngeal swab), materials, flow, and detection mechanisms. We anticipate that these considerations would help facilitate innovation in microfluidic-based medical devices.

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Evolving Paradigm of Prothrombin Time Diagnostics with Its Growing Clinical Relevance towards Cardio-Compromised and COVID-19 Affected Population

Cited by 7 publications

References 66 publications

Subchronic Oral Toxicity of Sodium p-Hydroxybenzoate in Sprague-Dawley Rats

Subchronic Oral Toxicity of Sodium p-Hydroxybenzoate in Sprague-Dawley Rats

HB-EGF Plasmatic Level Contributes to the Development of Early Risk Prediction Nomogram for Severe COVID-19 Cases

A Systematic Analysis of Recent Technology Trends of Microfluidic Medical Devices in the United States

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