Establishment and Validation of an Automated System for the Antifactor IIa Assay: A Case Study of Potency Assessment of a Pharmaceutical Gel Formulation.

Antithrombotic agents and anticoagulant drugs, such as those from the heparin family, are employed in clinical settings for the prevention and treatment of clotting, thromboembolism, and wound healing. The potency assessment of antithrombotic agents is typically conducted using antifactor IIa assay with manual systems which are time-consuming and often lack repeatability. Here, we present a novel automated system that significantly enhances assay repeatability, attaining an outstandingly low relative standard deviation (RSD) % of only 0.6% for repeatability. This system has been applied to a pharmaceutical gel formulation for wound healing developed by Abdi Ibrahim Pharmaceuticals R&D Center as a case study for validation. The automated system demonstrated substantial improvements over manual systems in linearity (R2 = 0.9927), precision, accuracy, specificity, and robustness. The system aligns with the European Pharmacopoeia specifications, promising to enhance quality control across pharmaceutical formulations and conduct absorbance-based end-point assays within the pharmaceutical industry while offering increased throughput and cost-effectiveness.

Accuracy of the Apple Watch in measuring oxygen saturation: comparison with pulse oximetry and ABG.

BACKGROUND: Smartwatches have gained tremendous attention in recent years and have become widely accepted by patients, despite not being intended for medical diagnosis. OBJECTIVE: This study aimed to determine the accuracy of Apple Watch oxygen saturation measurement in patients with acute exacerbation of COPD by comparing it with medical-grade pulse oximetry and ABG. METHOD: This single-center, prospective, cross-sectional study involved 167 patients. Patients presenting with cardiac arrest, life-threatening symptoms, severe hypoxia, or obvious jaundice were excluded. Additionally, patients whose SpO2 measurements with the Apple Watch took more than 2 min or required eight attempts were also excluded. Vital signs were measured simultaneously using the IntelliVue MX500 monitor with the Masimo Rainbow Set pulse oximeter and the Apple Watch. Concurrently, arterial blood gas (ABG) samples were drawn. RESULTS: A strong correlation between the Apple Watch 6 and medical-grade pulse oximetry (r = 0.89, ICC = 0.940) was noted. The Bland-Altman analysis revealed a mean error of 0.458% between the Apple Watch 6 and ABG (SD: 2.78, level of agreement: - 5.912 to 4.996). The mean error between pulse oximetry and ABG (SD: 5.086, level of agreement; - 10.983 to 8.953) was 1.015%. There was a correlation between respiratory rate and the number of attempts to measure SpO2 with the Apple Watch 6 (r = 0.75, p < 0.05). CONCLUSION: Apple Watch 6 is an accurate and reliable method for measuring SpO2 levels in emergency patients who presented with acute exacerbation of COPD. However, tachypneic patients may encounter challenges due to the potential need for multiple attempts to measure their oxygen saturation.

Diagnosis of a Ruptured Pulmonary Hydatid Cyst in a 26-Week Pregnant Female With Bedside Lung Ultrasound in Emergency (BLUE) Protocol: A Case Report.

Pulmonary hydatid cyst during pregnancy is extremely rare and life-threatening for the mother and fetus. Throughout pregnancy, hydatid cysts may enlarge due to the suppression of cellular immunity and steroids secreted from the placenta. In late pregnancy, the cysts can reach a huge volume with an increased risk for subsequent rupture due to the compression of the enlarging uterus and anaphylactic shock. Intrabronchial rupture is a rare and life-threatening complication of pulmonary hydatid cysts. It is vital to diagnose it as early as possible and manage patients with surgical intervention with aggressive medical treatment. Plain radiograph, computed tomography (CT) scan, and magnetic resonance imaging (MRI) can be used to identify pulmonary hydatid cysts. However, the diagnosis of hydatid cyst is quite challenging in pregnant patients due to concerns of radiation. Herein, we present a 26-week pregnant patient with acute respiratory failure. Bedside lung ultrasound was notable for thickened and severely broken pleural line with a large subpleural consolidation, and a giant fluid-filled cyst covered almost the entire left thorax, causing a mediastinal shift. In the present case, we highlighted that the bedside lung ultrasound in emergency (BLUE) protocol is an easy, safe, and fast way to identify pulmonary hydatid cyst. It should be the initial technique of choice for the diagnosis of pulmonary hydatid cysts in pregnant patients.

Resistant Lactic Acidemia Due to Accidental Cheese Starter Culture Ingestion.

Lactic acid is the end-product of anaerobic glycolysis. It is generally believed that elevated blood lactate levels are associated with poor patient outcomes. Literature reports that lactic acidosis can be related to supplementary food intake in the pediatric age group however, in adult patients, it is not common to see lactic acidosis due to oral ingestion unless the patient has a history of short bowel syndrome or jejunoileal bypass surgery. With the current case presentation, we report an accidental cheese starter culture intake that resulted in resistant lactic acidosis with no signs of critical illnesses.

Functional assessment of autologous platelet-rich plasma (PRP) after long-term storage at -20 °C without any preservation agent.

BACKGROUND: Platelet-rich plasma (PRP) is increasingly being used in the treatment of chronic wounds, pathologies of the musculoskeletal system, and in cosmetic medicine; however, the preparation of platelet-rich plasma is both time-consuming and requires invasive intervention. Additional costs are introduced if special equipment is used during preparation. The aim of the present study is to test whether autologous platelet-rich plasma (PRP) preserves the feature of growth factor release when stored at -20 °C after preparation. METHOD: Autologous PRP concentrates were prepared using whole blood samples obtained from 20 healthy subjects and divided into three parts to form three groups. Epidermal growth factor (EGF), vascular endothelial growth factor (VEGF), platelet derived growth factor-AB (PDGF-AB), insulin-like growth factor 1 (IGF-1), transforming growth factor-beta (TGF-ß), and P-Selectin levels were immediately analysed in the control group. The other groups were defined as the experimental groups and were stored at -20 °C and analysed on the 7th and the 14th days. The same growth factors were tested in the experimental groups. RESULTS: The growth factors (EGF, VEGF, PDGF-AB, IGF-1, TGF-ß) and P-selectin levels were significantly decreased in the autologous PRP samples stored at -20 °C compared to the control group. CONCLUSION: The growth factor levels on days 7 and 14 suggest that autologous PRP can be stored at -20 °C without preservative agents, although in vivo studies are required in order to evaluate the clinical efficacy of the detected growth factor levels.

Clinical biochemistry laboratory rejection rates due to various types of preanalytical errors.

INTRODUCTION: Preanalytical errors, along the process from the beginning of test requests to the admissions of the specimens to the laboratory, cause the rejection of samples. The aim of this study was to better explain the reasons of rejected samples, regarding to their rates in certain test groups in our laboratory. MATERIALS AND METHODS: This preliminary study was designed on the rejected samples in one-year period, based on the rates and types of inappropriateness. Test requests and blood samples of clinical chemistry, immunoassay, hematology, glycated hemoglobin, coagulation and erythrocyte sedimentation rate test units were evaluated. Types of inappropriateness were evaluated as follows: improperly labelled samples, hemolysed, clotted specimen, insufficient volume of specimen and total request errors. RESULTS: A total of 5,183,582 test requests from 1,035,743 blood collection tubes were considered. The total rejection rate was 0.65 %. The rejection rate of coagulation group was significantly higher (2.28%) than the other test groups (P < 0.001) including insufficient volume of specimen error rate as 1.38%. Rejection rates of hemolysis, clotted specimen and insufficient volume of sample error were found to be 8%, 24% and 34%, respectively. Total request errors, particularly, for unintelligible requests were 32% of the total for inpatients. CONCLUSIONS: The errors were especially attributable to unintelligible requests of inappropriate test requests, improperly labelled samples for inpatients and blood drawing errors especially due to insufficient volume of specimens in a coagulation test group. Further studies should be performed after corrective and preventive actions to detect a possible decrease in rejecting samples.

Tear osmolarity and tear film parameters in patients with unilateral pterygium.

PURPOSE: The aim of this study was to evaluate the differences in tear osmolarity and tear film parameters between pterygium-affected and healthy fellow eyes. METHODS: The study enrolled 65 patients with unilateral pterygium. Tear osmolarity, tear film break-up time (TBUT), Schirmer I test measurements, fluorescein corneal staining, and conjunctival redness were evaluated. The results were compared between pterygium-affected eyes and healthy fellow eyes of the same patient (controls). The pterygium thickness was measured using optical coherence tomography. We also evaluated the relationship between pterygium thickness and tear osmolarity and between TBUT and Schirmer I test results in eyes with pterygium. RESULTS: The mean tear osmolarity was 307 mOsm/L in pterygium-affected eyes and 294 mOsm/L in control eyes. The mean values of TBUT, Schirmer I test, corneal staining, and conjunctival redness scores were 10.3 ± 3.4 seconds, 14.8 ± 9.2 mm, 1.2 ± 1.1, and 0.9 ± 0.9 in the pterygium group, whereas the mean values were 12.3 ± 4.4 seconds, 16.2 ± 7.2 mm, 0.4 ± 0.8, and 0.4 ± 0.7 in the control group, respectively. Eyes with pterygium had significantly higher tear osmolarity levels, corneal staining, and conjunctival redness scores; and lower tear film TBUT and Schirmer I test values than eyes without pterygium (Wilcoxon signed rank test, P < 0.05). There was no significant correlation between pterygium thickness versus tear osmolarity, TBUT, and Schirmer I test values in eyes with pterygium (r = 0.159, 0.738, 0.321, respectively; P > 0.05). CONCLUSIONS: This study showed that pterygium is associated with tear hyperosmolarity and abnormal tear film function.

The use of polypropylene suture as a frontalis suspension material in all age groups of ptosis patients.

PURPOSE/AIM: To evaluate the use of 2-0 polypropylene suture for frontal suspension in ptosis patients with poor levator function. MATERIALS AND METHODS: This retrospective study included 20 eyelids of 16 patients (5 female, 11 male) with 4 mm or less levator function. The operation was considered successful when the difference between the two upper lids was ≤ 1 mm, and the upper lid covered the upper limbus by <3 mm. RESULTS: Median patient age was 22.94 years (2 to 59). Mean follow-up time was 18.06 months (12-29). A successful result was obtained in 14 patients (87.5%). Ptosis recurrence was observed in two patients (12.5%). Lagophthalmos with punctate epithelial keratitis and subsequent spontaneous recovery occurred during the first postoperative week in six patients (37.5%). Two patients with hypocorrection underwent revision surgery in the first postoperative week. Granuloma and material exposition at the forehead incision site observed in one patient at the postoperative fifth month were repaired by excision of the granuloma and suture reposition. CONCLUSIONS: Polypropylene suture as a frontalis suspension material in ptosis patients with poor levator function maintained satisfactory results at follow-up. This material allows easy and repeatable eyelid height adjustment and does not obviate future eyelid procedures.

Comparison of photorefraction, autorefractometry and retinoscopy in children.

Photorefractive devices have been evaluated for their effectiveness in detecting anisometropia, hyperopia, myopia, and astigmatism. We investigated the reliability of Plusoptix S08, the newest photoscreener, and Topcon autorefractometer by comparing them with cycloplegic retinoscopy. Plusoptix S08, cycloplegic retinoscopy, and cycloplegic autorefractometer measurements for 235 eyes of 118 children (59 female, 59 male) with a mean age of 4.9 ± 2.6 and median age of 5 years (range 1-12) were conducted. The Plusoptix S08 produced the following mean (± SD) results--spherical 0.27 ± 1.64, cylindrical power -0.81 ± 0.71, axis 89.73 ± 61.18, and spherical equivalent -0.05 ± 1.61. The cycloplegic retinoscopy produced the following mean (± SD) results--spherical 0.12 ± 1.35, cylindrical power -0.89 ± 0.71, axis 92.18 ± 68.39, and spherical equivalent -0.15 ± 1.31. The cycloplegic autorefractometer produced the following mean (± SD) results--spherical 0.16 ± 1.44, cylindrical power -0.88 ± 0.72, axis 90.86 ± 68.21, and spherical equivalent -0.12 ± 1.41. This study has shown that cycloplegic autorefractometer and retinoscopy results are similar and Plusoptix S08 is a very safe, easy-to-use and reliable screening method of refraction, especially for ophthalmologists unskilled in retinoscopy. Plusoptix S08 is a useful tool for estimating refraction in patients for whom conventional autorefraction is not an option.

Glycemic control, oxidative stress, and lipid profile in children with type 1 diabetes mellitus.

BACKGROUND: In diabetes mellitus, persistence of hyperglycemia was reported to cause increased production of oxidative parameters including malondialdehyde (MDA). In the present study, the effect of glycemic control on oxidative stress and the lipid profile of pediatric type 1 diabetes mellitus (DM) patients were investigated. METHODS: Serum total cholesterol, HDL cholesterol, VLDL cholesterol, apolipoprotein A, apolipoprotein B, lipoprotein a, HbA(1c), and MDA levels were assessed in 96 children with type 1 DM. Study cases were evaluated in two groups in view of their mean HbA(1c) values, as metabolically well controlled (HbA(1c) < or =8%) and poorly controlled (HbA(1c) >8%) patients with DM. Fifty healthy children were included as normal controls. RESULTS: Total cholesterol, LDL cholesterol, apolipoprotein A, apolipoprotein B, and MDA levels of total diabetic patients were significantly (p<0.05) higher than those of the control group. Serum MDA levels and MDA/LDL cholesterol index were significantly increased in metabolically poorly controlled in relation to metabolically well-controlled DM patients and were similar in metabolically well-controlled DM patients with relation to control group and in metabolically poorly controlled patients with relation to control group. CONCLUSIONS: In the present study, increased levels of MDA, MDA/LDL index, and dyslipoproteinemia showed that especially metabolically poorly controlled DM children are at high risk of atherosclerosis and vascular complications of DM and that there is a significant relationship between the lipid profile and oxidative stress. Thus, it may be appropriate to evaluate MDA in addition to routine laboratory assessments in evaluation of type 1 DM pediatric patients.