Background Nanoparticles have been used as a tool for delivering therapeutics since few decades. Researchers has been focusing on advances and modifications to improve the properties of these nanoparticles such as sustained drug delivery and bioavailability. This study focuses on modifying the conventional solid lipid nanoparticles (SLN) with Arginine-Glycine-Aspartic acid tripeptide (RGD). The peptidyl

Background Cancer stem cells (CSCs) represent only a small fraction of the tumor population, yet they present a profound challenge to cancer treatment. CSCs contribute to tumor complexity via their unique ability to self-renew, develop into multiple lineages, and maintain an unchecked proliferation potential. To identify CSCs, the cytoprotective enzyme aldehyde dehydrogenase 1A1 (ALDH1A1) is a well-annotated

Background C-peptide is a useful biomarker for distinguishing among different types of diabetes and is a proxy measure of endogenous insulin production, useful in diabetes management. Additionally, C-peptide tests can be used to diagnose non-diabetic hypoglycemia and insulinoma. However, differences among clinical assays can limit the application of C-peptide testing. To address this issue, efforts

Background Retrospective analysis of clinical laboratory data is employed to monitor the performance of instruments, evaluate test utilization and support operational changes. Urine drug testing in the context of opioid use disorder is used to assist in the management of patients. This testing is typically performed by an immunoassay screen followed by mass spectrometry confirmation. Immunoassay screens

Background HbA1c testing using EDTA whole blood as specimens is essential for monitoring glycemic control in diabetic patients. In the laboratory that using total laboratory automation system, the transportation process might be impact the quality of HbA1c result according to red blood cell sedimentation. This study, we aimed to evaluate the impact of HbA1c result from red blood cell sediment which

Introduction The effects of aging on human thyroid function are well studied in relationship to thyroid stimulating hormone (TSH) and free tiroxine (FT4); TSH increases, while FT4 decreases with age. Although animal studies show that total triiodotironine (TT3) is lower in aged male rats, these changes are still not clear enough in humans. The National Academy of Clinical Biochemistry (NACB) suggests

Background An accurate and reliable measurement of glomerular filtration rate (GFR) is essential to monitor for rejection and disease progression post-kidney transplantation. Measured GFR (mGFR) is the current gold standard. However, it has scarce availability at many centers and is labor intensive. Newer estimated GFR (eGFR) methods containing cystatin-C and/or other biomarkers have not been clinically

Background Free cholesterol accumulation in the liver has been suggested to be one of risk factors for the progression of non-alcoholic fatty liver to non-alcoholic steatohepatitis. Therefore, a non-invasive approach to assess hepatic cholesterol accumulation in the early stage without elevation of liver enzymes (AST and ALT) may be useful in clinical setting. In this study, we show that serum apoE-rich

Background With entering into the era of SARS-CoV-2 vaccine boosters and shifting from pandemic to endemic, understanding how boosters change antibody levels and durability is important for vaccination strategies. This study investigated antibodies against different antigens and neutralizing antibody levels in immunocompetent healthcare workers who have received the primary 2 doses and booster mRNA

Background Urinary Tract Infection (UTI) is one of the second common infections among the geriatric population. It is more common in women than men and the incidence increases with age. UTI can cause serious complications and it is a significant cause of morbidity and death. The high mortality rate is largely due to delayed presentation and the development of bacteremia/sepsis. Physicians rely heavily

Background The complement system membrane attack complex is comprised of the C5b fragment along with C6, C7, C8 and C9 polymers that form a pore to disrupt a membrane during complement activation. Inactive complexes that are not membrane-bound combine with Protein S to form soluble C5b-9 (sC5b-9). Elevated concentrations of sC5b-9 are associated with risk of development of hematopoietic stem cell

Background Myasthenia gravis (MG) is a neuromuscular disease characterized by skeletal muscle weakness and fatigue. These symptoms are due to a reduction in synaptic signal transduction caused by autoantibodies against post-synaptic proteins in the neuromuscular junction. Approximately 85% of patients with MG have autoantibodies against acetylcholine receptors (AChR); however, autoantibodies against

Introduction Pancreatic insufficiency (PI) is common in people with Cystic Fibrosis (PwCF), contributing to malabsorption of fat and fat-soluble vitamins. Thus, PI PwCF are prescribed pancreatic enzyme replacement therapy (PERT) and supplementation with fat-soluble vitamins. The circulating vitamin levels are monitored to guide dietary therapy. Currently, there are multiple cystic fibrosis transmembrane

Background Glycated albumin (glycoalbumin, GA) is a biomarker that represents the glycemic status of a short period. While the Norudia GA assay kit (Sekisui Medical Co., Ltd., Tokyo, Japan) demonstrated a performance comparative to that of the Lucica GA-L (Asahi Kasei Pharma Corporation, Tokyo, Japan), we have experienced a few cases with extremely low GA levels measured with Norudia GA, inconsistent

Background Biotin’s role in the immune response have emergently revealed that biotin is related to inflammation and that its deficiency leads to an increase in the level of proinflammatory cytokines. A biotin-deficient diet was recently shown to induce a colitis-like phenotype in mice, alleviated by biotin substitution. Mice with dextran sulphate sodium (DSS)-induced colitis showed biotin deficiency

Background Voluntary blood donation exercise remains one the safest means of sourcing for blood product made available for patients. However, there are several eligibility criteria put in place before a prospective donor can be accepted for donation exercise. One of the eligibility criteria not commonly considered is the glycemic control of a donor. This is because pooly controlled diabetes being treated

Background A major challenge of clinical diagnostic applications in the field of emergency department is the not only fast but also accurate measurement of multiple protein biomarkers with broad dynamic range spectrum. Here, we describe the development of a versatile immunoassay platform, the VEUS (Versatile, Easy, and User-friendly System), with compact size which occupies minimal space. Methods The

Background Autoantibodies against the glomerular basement membrane (GBM) are important markers in the diagnosis and monitoring of autoimmune glomerulonephritides. Fast and reliable detection of these autoantibodies is crucial as anti-GBM disease can progress rapidly with fatal outcome. Here, we investigated the diagnostic performance of a newly developed, standardized anti-GBM chemiluminescence immunoassay

Background Thrombotic thrombocytopenic purpura (TTP) is a rare thrombotic microangiopathy (TMA) caused by congenital or acquired severe deficiency of disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS-13), an enzyme cleaving von Willebrand factor (VWF). ADAMTS-13 deficiency leads to the accumulation of ultra-large VWF multimers, and subsequent platelet aggregation

Background Serum-neutralizing antibodies (NAbs) against SARS-CoV-2 may be produced as a result of either viral infection or vaccination. NAbs can disrupt the connection between the RBD (Receptor-Binding Domain) of the Spike protein and the ACE2 receptor, hindering the virus's entry into cells. However, only a portion of these antibodies are able to neutralize the virus and prevent it from infecting

Background Distinguishing between different causes of microcytic anemia is essential for management of anemic patients. More than 20 different RBC indices have been used to screen thalassemia trait with inconsistent results. Differentiation between iron deficiency anemia (IDA) and alpha-thalassemia is challenging based on RBC indices alone. Moreover, thalassemia and IDA may coexist. A highly sensitive

Background Early detection of cancer has significant potential to impact human health and society by decreasing cancer-related morbidity and mortality. While previous approaches to identify cancer-informative biomarkers are predominantly statistical, Harbinger Health has utilized foundational discoveries from developmental biology to design a targeted methylation assay for early cancer detection from

Background Hememics™ Biosensor System (HBS) is a platform technology enabling antigen and molecular testing in the field. The system consists of a reader, HemBox™, and a biosensing chip, HemChip™. The HemBox™ is a battery-operated, cell phone size with Bluetooth and WIFI module that can be integrated into the Health Management System. The biosensing chips can be programed with bio-receptors to detect

Background Lipoprotein(a) [Lp(a)] is now thought of as an independent risk factor for coronary heart disease, stroke, and calcific aortic valve stenosis, and drugs specifically targeting Lp(a) are showing promise in clinical trials. Our laboratory recently validated two commercially available methods and used them to characterize a randomly selected group of samples from an outpatient clinic in the

Background Lipid panel assays are used to calculate LDL-C as a proxy for cardiovascular disease risk. Further investigations are required to classify the patient’s dyslipidemia into a phenotype to assist with management. We explored the information contained within the lipid panel with two aims: First, to estimate cardiovascular risk directly, bypassing LDL-C calculation. Second, to provide a novel

Background Since the global pandemic of coronavirus disease (COVID-19), some studies have reported on the emergence of opportunistic nosocomial pathogens associated with co-infection on the outcome of COVID-19 patients. The aim of this study was to describe the increase of six unusual species of Non-fermentative Gram-negative bacilli (NF-GNB) clinical isolates recovered from inpatients in several Brazilian

Background Vitamin K1 (phylloquinone) is a fat-soluble cofactor; its deficiency depresses synthesis of plasma prothrombin (factor II) and other factors, causes excessive bleeding, and increases the risk of bone fractures and osteoporosis. Biochemical and metabolic studies on vitamin K1 require both highly sensitive and specific techniques. Analytical challenges to quantitation include the presence

Background Phosphorus containing biomolecules perform an essential biochemical function in maintaining extra and intracellular acid-base status. Maintaining normal concentration (2.5–4.5 mg/dl) of phosphorus is indispensable for optimal cellular function and homeostasis. Serum concentration of phosphorus (mainly inorganic orthophosphates) is an indicator of H2PO4−/HPO42− acid-base buffer condition

Background Currently, standard test kits based on the immunochromatography principle use 40 nm gold colloids as the labeling material. However, some kits use enzymes such as horseradish peroxidase and alkaline phosphatase (ALP) to improve sensitivity. Among the various labeling substances, 150 nm gold colloidal nanoparticles are thought to enable higher sensitivity in immunochromatography than the

Background There is no doubt that the whole world has been shaken by the SARS-CoV-2 pandemic, which has affected both global health and the global economy. At the same time the importance of molecular methods for the accurate diagnosis of respiratory infections has been reinforced together with the need of testing methodologies that minimize the risk of misleading results. During the last three years

Background The Alinity ci system Sample Interference Indices (HIL) provides a more accurate and consistent method for interpretation of interferents than time consuming visual interpretation. The Alinity c system uses specific wavelength pairs and an algorithm to provide a Sample Interference Index that can correlate with sample interference due to hemolysis, bilirubin and turbidity present in serum/plasma

Background There has been an increase on the demand for Protein Electrophoresis and Hemoglobin Electrophoresis exams over the past few years. This growth drew attention and motivated the laboratory’s Production Planning and Control (PPC) team to carry out a process flow analysis of the electrophoresis samples coming from the external units, which are responsible for approximately 60% of the total samples

Background Cystic fibrosis (CF) is a genetic disease that affects the respiratory, digestive, and reproductive systems. One of the issues associated with CF is oxidative stress, which is an imbalance between the production of reactive oxygen species (ROS) and the ability of the body to neutralize them. Peroxynitrite, a member of ROS, is a very noxious molecule formed from the reaction of nitric oxide

Background Hemolysis is a pre-analytic issue that challenges clinical laboratories. When a specimen with significant hemolysis is obtained in our laboratory, tests where the hemolysis threshold is exceeded are not reported and blood is recollected. Unfortunately, in a subset of patients, the recollected specimen is also hemolyzed (termed “recurrent hemolysis”). In these cases, the second recollection

Objective Ionized magnesium (iMg) is the physiologically active form of the analyte. Despite this, clinical adoption of iMg is infrequent, and there is only one commercially available analyzer that measures iMg. There are now numerous studies that have examined iMg levels in healthy individuals, and this report will summarize their findings and report a consensus reference range. Relevance Although

Background Most cases of death from Acute Myocardial Infarction (AMI) occur in the first hours after the manifestation of clinical symptoms, constituting 40%–65% in the first hour and approximately 80% in the first 24 h. For the safe, effective, and rapid diagnosis of a patient with suspected AMI, international guidelines recommend that it be done based on clinical symptoms, together with electrocardiogram

Background Trend analysis is a powerful tool in any data analysis due to its preventive characteristics. In proficiency testing (PT) it is also important because it can anticipate errors that could impact on patient’s results. Therefore, it is a key tool to patient safety. Although this is the current and logical premise, efficacy of trend analysis has not been measured by laboratories. This work aims

Background Accurate measurement of CD34-positive hematopoietic stem cells (HSCs) is critical for successful peripheral blood stem cell transplantation (PBSCT). Flow cytometry is by far the gold standard for measuring CD34-positive stem cells. However, its complicated procedure requires time, cost and highly-trained operators, thus the necessity of simpler and cheaper alternative method is emerging

Background Major depressive disorder (MDD), also known as depression, has become the most prevalent mood disorder today. Currently, the diagnosis remains a major challenge given the disease heterogeneity and have been made by associating signs and symptoms with other diagnostic criteria. Several treatment options are available for MDD. However, less than 35% of patients achieve remission while 60%

Background Serum free light chains (SFLC) analysis for detection and initial diagnosis of monoclonal gammopathies (MC) is a critical tool in the comprehensive assessment of risk and in management of established disease. Our reference intervals (RIs) for SFLC were based on the seminal report by Katzmann. Recent literature indicates with current analytic platforms and reagent formulations, significantly

Background Ultracentrifugation for LDL-C (low-density lipoprotein cholesterol) measurement is the gold standard, but it is unsuitable for routine use. Direct LDL-C assays and predictive equations such as the Friedewald equation are thus used as alternatives. The Friedewald equation is known to be error-prone in hypertriglyceridaemic patients, as well as in LDL-C levels < 1.8 mmol/L (70 mg/dL) which

Backrground Laboratory diagnosis of the antiphospholipid antibody syndrome (APS) requires evidence ofpersistently positive lupus anticoagulant (LAC), detected using clot-based assays and/or thepresence of high-titer serum anti-cardiolipin (aCL) and/or anti-beta-2 glycoprotein-1 (aB2GPI)antibodies, measured by semi-quantitative solid-phase immunoassays. Several non-criteria anti-phospholipid antibodies

Introduction Polyclonal antibodies are a mixture of antibodies produced by plasma B-cells and are often obtained by injecting a specific antigen into a host system. They are commonly used for research and diagnostic purposes and are inexpensive and relatively quick to produce. But they lack batch-to-batch reproducibility making them less reliable than recombinant monoclonal antibodies (mAbs). Our team

Background Advances in unbiased metagenomic next generation sequencing (mNGS) technologies have enabled the study of microbial and host genetic material (DNA and RNA) in one test. In this study, we aimed to develop machine learning-based differential diagnostic models (MLBDDMs) using the metagenomic and human transcriptomic data generated by an affordable bronchoalveolar lavage fluid (BLAF) mNGS assay

Background An estimated 5 million people are evaluated in emergency departments (ED) for Traumatic Brain Injury (TBI) in the United States each year. The vast majority (80%) of patients evaluated for TBI in the ED will receive head CT scans, however less than 10% of those will have any findings of acute traumatic abnormalities. This highlights the need for objective, rapid, accurate tools to help clinicians

Background Cardiac troponin (cTn) is the preferred biomarker for the diagnosis of acute myocardial infarction due to its high sensitivity and specificity relative to other available cardiac markers. Accurate measurement is therefore paramount to proper risk stratification of patients. Analytical outliers and false positive results have been previously reported on various platforms though the exact

Background It is estimated that 10% of patients that suffered from severe acute SARS-CoV-2 infection experience symptoms beyond 3 months post-disease onset. Long COVID is a multisystemic condition that comprises more than 200 symptoms. Common new-onset medical conditions include cardiovascular, type-2 diabetes and chronic fatigue syndrome. Whilst progress has been made in characterising the mechanisms

Background Saliva is a good alternative to the nasopharyngeal swab because it is non-invasive and does not require separate collection personnel. SMARTCHEK® SARS-CoV-2 Detection Kit (Genesystem, Daejeon, Korea) and SMARTCHEK® SARS-CoV-2 Fast Detection Kit (Genesystem) are rapid PCR kits for SARS-CoV-2 using a microfluidic chip-based PCR method. These two kits can provide results in 40 min and 20 min

Background Sexually transmitted infections (STI) spread through oral sex potentially cause infections of the mouth, throat, genitals, or rectum. Saliva may be an important source of transmission of STI following oral sex. Multiplexed STI assays are useful diagnostically for patients with risk factors for STI as co-infections occur frequently. Methods Alimetrix STI is a multiplexed laboratory developed

Background Every year, Influenza A (FluA), Influenza B (FluB) and Respiratory Syncytial Virus (RSV) affect our communities and increase the number of patients in our health systems. Molecular techniques, such as real-time PCR have become essential, not only for the diagnostic but also for the epidemiological studies. High amounts of samples or retrospective analysis need the use of samples stored at

Background Prostaglandin D2 (PGD2) is a major prostaglandin produced by the brain and by mast cells, and plays a role in vasodilation (“niacin flush”) and in the development of allergic diseases such as asthma and alopecia. We sought to develop a bioanalytical method for multiple specimen types for PGD2 for clinical use. Methods An analytical method was developed using a TX-4 HPLC system (Thermo-Fisher)

Background Immunochromatographic assay (ICA) is frequently used as a point-of-care testing (POCT) in the field of infectious diseases, but it has a problem of low detection sensitivity. Many interfering substances in ICA test materials have been reported to case a decrease in detection sensitivity. For the purpose of increasing the sensitivity of ICA, bovine serum albumin or a polymer with phosphorylcholine

Background Neuroimmune disorders are a complex group of inflammatory conditions of the nervous system and remarkable discoveries over the last two decades have elucidated the autoimmune basis of several, previously poorly understood, neurological disorders. Autoimmune Encephalitis has been linked to a wide variety of neuronal autoantibodies targeting both intracellular and plasma membrane antigens

Background Infections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) are among the most prevalent and treatable sexually transmitted diseases in the US. Currently, most available testing methods require patient samples to be split between CT/NG and TV assays. Here, we evaluate performance characteristics of the Seegene Novaplex STI Essential Assay, a real-time

Background Homologous recombination deficiency (HRD) has been used as a biomarker of PARP inhibitors (PARPi) sensitivity in ovarian cancer (OC), especially in high-grade serous (HGS) types. Initially, only likely pathogenic (LPV) and pathogenic variants (PV) in BRCA1/2 were screened to define PARPi eligibility. However, LPV and PV are shown in less than 20% of OC, which restricted PARPi therapies to

Background Pre-analytical errors, which account for 50%–75% of all laboratory errors, include various processes handled by various occupations such as prescription, data input, sample collection, sample transport, and sample reception, making it difficult to present standardized quality indicators. Internationally, efforts are being made to present pre-analytical quality indicators and standardize/harmonize

Background Hemoglobin A1c (HbA1c) is the major non-enzymatic glycation product of hemoglobin A (HbA) and usually measured as a percentage of total hemoglobin. It is widely used in the screening, diagnosis, and monitoring of diabetes because HbA1c correlates with the average blood glucose level over the past 8–12 weeks in patients with a normal RBC lifespan. However, many factors can cause inaccurate

Background The National Kidney Foundation (NKF) established a Laboratory Engagement Working Group (WG) that issued strategies for implementing the race-free CKD-EPI 2021 eGFR equation following the recommendation from the National Kidney Foundation/American Society for Nephrology Joint Task Force on Reassessing the Inclusion of Race in Diagnosing Kidney Diseases. These guidelines covered four areas

Background The diagnosis of T lymphoproliferative diseases is usually a challenge due to the difficulty indifferentiating pathological T cells from reaction cells and also due to the limitation of clonalitytests currently available. TCRB1 is a monoclonal antibody specific for region 1 of the TCR T cellreceptor Beta chain constant, detecting clonal populations of TCRab positive T cells in caseswhere

Background Small RNAs are an important class of biomarkers in liquid biopsy for cancer diagnostics. New discoveries in the field of “epitranscriptomics” have uncovered further functional layers of tumor biology that are ignored by standard gene expression measurement methods. Therefore, there is a pressing need for sequence specific methods that can detect methylation stoichiometry on small RNAs purified