Chemiluminescent Immunoassay Research Articles

Biochemical markers of renal functions in hypothyroidism – A study in Indian population

The global burden of hypothyroidism is significant among the disorders of thyroid gland. In the developed world, hypothyroidism prevalence is approximately 4-5% and that of subclinical hypothyroidism is approximately 4-15%.The present study was done to evaluate the association between thyroid function and renal parameters among euthyroid, subclinical and overt hypothyroid individuals. To evaluate the renal functions in hypothyroid patients. To estimate & compare, freeT3, freeT4, TSH, serum creatinine, urea and uric acid, eGFR, urinary microalbumin, urinary creatinine levels in euthyroid (control group) & hypothyroid patients (study group).To calculate & compare urinary albumin to creatinine ratio (UACR) in both groups (control group and study group). This is a Cross sectional analytical study carried out at Clinical Chemistry Laboratory, at Sir Sayajirao General Hospital (S.S.G.H) and Medical College Baroda, Vadodara. Study subjects were divided into three groups depending upon the levels of the TSH and free T4.The Chemiluminescent Immunoassay (CLIA) was used to measure: S.TSH, fT4 and fT3 levels by micro particle enzyme immunoassays.The Fully automatic Erba XL 640 was used to measure-Serum Creatinine, Serum Urea, Serum Uric acid were measured on Erba XL 640. The semiautomatic Microlab RX-50V was used to measure-Urinary Microalbumin.All statistical analysis was done by using MedCalc statistical software. ANOVA comparison analysis, we found significant differences in mean results of several parameters in three thyroid groups. In overt hypothyroid subjects, free T4 levels showed significantly moderate strong negative correlations (p=0.002, r= -0.412 & p<0.001, -0.539) with UACR & urinary microalbumin. In overt hypothyroid group, Serum TSH: levels showed weak positive correlations (p=0.04, r=0.28) with urinary creatinine, moderately strong positive correlations with UACR and urinary microalbumin (p=<0.001, r=0.57 & p=<0.001, r=0.72). Serum TSH: In subclinical hypothyroid groups, TSH levels showed positive correlations with serum uric acid urinary creatinine, UACR, and urinary microalbumin (p=0.01, r= 0.32, p=0.00, r= 0.46, & p=<0.001, 0.43). Present study were found increased levels of serum creatinine, uric acid, urine albumin creatinine ratio, urinary microalbumin and decreased eGFR levels in hypothyroid group as compared to euthyroid group. The prevalence of microalbuminuria and urine albumin creatinine ratio is high in overt hypothyroidism.

Establishing Decisional Cutoff Values of Neurofilament Light Chains in Cerebrospinal Fluid Measured by Fully Automated Chemiluminescent Enzyme Immunoassay.

Neurofilament light chain (NfL) is one of the most important biomarkers in the field of clinical neurochemistry. Several analytical methods have been developed in the last decade. Recently, Fujirebio introduced a ready-to-use assay kit for measuring NfL levels in the cerebrospinal fluid (CSF) on the fully automated LUMIPULSE G System. In this study, we established the decisional cutoffs for CSF NfL. We performed a retrospective observational study including patients with cognitive decline. CSF NfL levels were measured by two analytical methods: the NF-light ELISA kit (UmanDiagnostics) and the Lumipulse G1200 fully automated system (Fujirebio). We calculated the cutoffs for the Lumipulse, starting from the consolidated cutoffs of the ELISA method for each age and using the equation obtained by the regression analysis. The study population consisted of 100 patients with cognitive decline. The median levels of CSF NfL measured by Lumipulse and ELISA were 776.5 ± 772.6 pg/mL and 473.5 ± 443.5 pg/mL, respectively, significantly different (p < 0.001). The Spearman's rank correlation coefficient was 0.962, indicating a robust positive correlation between the two measurement methods. The equation derived from the Passing-Bablok regression analysis was CSF CLEIA = -61.16 + 1.83 × CSF ELISA. Based on this equation, we defined the decisional cutoff values. Decisional cutoffs are fundamental tools for guiding clinicians to use biomarkers' results and interpretation appropriately. This is the first study establishing the decisional cutoff value of NfL measured by Lumipulse, a fully automated platform widely used in clinical laboratories.

The Evaluation of Biochemical Parameters in Positive COVID-19 RealTime PCR Patients: A Retrospective Study

Coronavirus, a member of the beta coronavirus family, encompasses a range of illnesses from common colds to severe disorders. SARS-CoV-2, transmitted mainly through respiratory droplets that are generated by a patient who is sneezing, coughing and talking, caused the global pandemic COVID-19 in 2020. The virus primarily targets the respiratory system especially in the lung cell, leading to diverse symptoms and severe consequences. This study was carried out in the COVID-19 Isolation Centre in Mukalla City, Yemen, to evaluate biochemical tests in COVID-19 patients. In the retrospective single-centre study on 116 COVID-19 patients, some of biochemical Analysed Parameters were glucose, Liver function tests, renal function tests, lipid profile, and proinflammatory markers; convenience sampling based on existing records for socio-demographics, medical history, and biochemistry were analysed by using a spectrophotometry and Chemiluminescent immunoassay analyser. used SPSS version 25 to analyse data. Most COVID-19 patients in Mukalla City (91.4 % of those over 46 years old) have common symptoms such as fever, cough, and respiratory problems. The study found links between chronic health disorders (hypertension 96.6 %, diabetes mellitus 94.8 %) and greater vulnerability to COVID-19. Blood glucose levels substantially impact COVID-19 occurrences (p 0.0001). Some liver function tests are associated with COVID-19 (total protein, albumin, LDH, and GGT) (p = 0.044, 0.010, 0.0001, and 0.0001, respectively). Urea and creatinine levels imply renal function and their significant association (p=0.001 for both), whereas uric acid had no significant association with COVID-19 (p = 0.134). However, lipid profile tests lack statistical significance; they do identify trends. Proinflammatory markers CRP and ferritin strongly correlate with positive COVID-19 patients (p=0.0001 for both). In conclusion, COVID-19 significantly affects glucose metabolism, liver function, renal dynamics, and inflammatory markers, necessitating vigilant monitoring for clinical care and informing future research.

Serum levels of thyroxine, thyroid-stimulating hormone, and anti-thyroid peroxidase antibodies and their association with anxiety in environmentally exposed populations in Kazakhstan.

Little is known about the impact of environmental pollution on thyroid function in the non-occupationally exposed population of Kazakhstan. This study aimed to investigate serum levels of thyroxine (T4), thyroid-stimulating hormone (TSH), and anti-thyroid peroxidase (TPO) antibodies in the environmentally exposed population of Kazakhstan in relation to symptoms of anxiety. A total of 1,388 nominally healthy individuals residing in areas exposed to three major types of environmental pollution prevalent in Kazakhstan-non-ferrous metallurgy, condensate gas extraction, and activities of the Semipalatinsk Nuclear Test Site (SNTS)-were enrolled. All comparisons were made with 493 individuals residing in settlements without industrial or military pollution. Serum-free T4, TSH, and anti-TPO levels were tested using a solid-phase chemiluminescent immunoassay. The Generalized Anxiety Disorder 7-item (GAD-7) inventory was utilized to screen for anxiety symptoms. The prevalence of subclinical hypothyroidism was significantly higher in residents of settlements near the condensate gas field than in control sites (20.3 vs. 15.0%). In comparison, the prevalence of overt hypothyroidism was insignificantly higher (0.7 vs. 0.6%). The prevalence of subclinical hyperthyroidism was insignificantly higher in residents of settlements around the SNTS. The prevalence of overt hyperthyroidism was insignificantly higher in residents of areas proximal to the condensate gas field compared to the controls. The prevalence of both normal and elevated serum levels of anti-TPO antibodies did not differ significantly between different sites. Moderate and severe anxiety symptoms were the least common in residents of the two control sites (5.9%). This study carries potential implications for tailored public health interventions and policies.

Evolution of autoimmune diagnostics over the past 10 years: lessons learned from the UK NEQAS external quality assessment EQA programs.

External quality assessment (EQA) programs play a pivotal role in harmonizing laboratory practices, offering users a benchmark system to evaluate their own performance and identify areas requiring improvement. The objective of this study was to go through and analyze the UK NEQAS "Immunology, Immunochemistry and Allergy" EQA reports between 2012 and 2021 to assess the overall level of harmonization in autoimmune diagnostics and identify areas requiring improvement for future actions. The EQA programs reviewed included anti-nuclear (ANA), anti-dsDNA, anti-centromere, anti-extractable nuclear antigen (ENA), anti-phospholipids, anti-neutrophil cytoplasm (ANCA), anti-proteinase 3 (PR3), anti-myeloperoxidase (MPO), anti-glomerular basement membrane (GBM), rheumatoid factor (RF), anti-citrullinated protein antibodies (ACPA), mitochondrial (AMA), liver-kidney-microsomal (LKM), smooth muscle (ASMA), APCA, and celiac disease antibodies. In the analyzed period, the number in participating laboratories showed an increase for almost all programs. Among solid phase methods, the use of ELISA techniques showed a progressive reduction, while new technologies, such as the fluoroenzymatic immunoassay, chemiluminescence immunoassay, Luminex and immunoblot showed an increased number of users. The number of results complying with the expected negative or positive target slightly increased for almost all antibodies in the last decade. A description of the most frequent causes of mistakes or misinterpretation for each specific test and method is also provided in this study. Although numerous challenges need to be addressed in the area of autoantibody detection to enhance testing quality and attain higher harmonization, the period analyzed revealed that the ever-expanding range of autoantibodies, coupled with the introduction of new tests and methodologies and the advent of automated platforms, has brought about significant changes in autoimmune diagnostics.

Multicenter study of ovarian cancer score for diagnosing ovarian cancer.

Early detection is crucial for improving survival of patients with ovarian cancer (OC), yet current diagnostic tools lack adequate sensitivity and specificity, especially for early stage disease. The study aimed to validate the serum small extracellular vesicles (sEV) protein based Ovarian Cancer Score (OCS) in detecting OC. This multicenter study included 1183 adult females with adnexal masses from four hospitals in China (October 2019-April 2023). Of these, 1024 samples were prospectively collected, and 159 were from biobanks. All serum samples were collected before surgery. The concentrations of sEV carbohydrate antigen 125 (CA125), human epididymis protein 4 (HE4), and complement component 5a protein (C5a) were quantified using chemiluminescence immunoassay and then used for calculating OCS. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were calculated. The OCS demonstrated high sensitivity (95.4%) and specificity (90.4%) in diagnosis of OC in the prospective cohort (n=1024) and in total cases (n=1183, 95.5% and 90.2%), with stable performance across menopausal status and FIGO stages. The OCS maintained a high specificity in premenopausal patients (89.6%) and postmenopausal patients (92.1%). The OCS showed high sensitivity in early stage epithelial OC (FIGO I: 89.7%, I+II: 91.4%), in patients aged ≤45years (92.7%), and in patients with normal CA125 levels (72.7%), although these results were obtained from subgroups with small sample sizes. This multicenter study demonstrated that the OCS is a promising non-invasive diagnostic tool for the detection of OC. This study was registered at ClinicalTrials.gov: NCT06366997.

Development and Evaluation of an Immunochromatographic Strip and a Magnetic Chemiluminescence Immunoassay for Detection of Porcine Circovirus Type 2 Antigen

Porcine circovirus type 2 (PCV2) is the main and primary causative agent of Postweaning Multisystemic Wasting Syndrome (PMWS). To date, immunoperoxidase monolayer assay (IPMA), indirect immunofluorescent assay (IFA), and enzyme linked immunosorbent assay (ELISA) are the most commonly diagnostic methods for detecting PCV2 antigens. However, these methods require specialized equipment and technical expertise and are suitable for laboratory use only. This study aims to develop an immunochromatographic strip and a magnetic chemiluminescence immunoassay for the detection of PCV2 antigens. The recombinant protein was constructed using a prokaryotic expression system, and the polyclonal antibody was obtained by animal experiments. Polystyrene microspheres are used as solid phase carriers to covalently bind to the amino groups of proteins to form immunoprobes. Monodisperse beads are covalently bound to antigens or antibodies as solid phases to bind antibodies or antigens in the liquid phase in a superior manner, thereby capturing and separating antigens and antibodies in the liquid phase. The immunochromatographic strip is qualitative detection method, this method can detect PCV2a strain, PCV2b strain, and PCV2d strain. The immunochromatographic strip had minimum detection limits of 102.89TCID50/0.1 mL, 103.19TCID50/0.1 mL, and 103.49TCID50/0.1 mL for PCV2a/LG, PCV2b/SH, and PCV2d/JH. The results of testing PEDV (CV777 strain), PRV (HB2000 strain), CSFV (WH-09 strain), PRRS (JXA1-R strain), PPV (WH-1 strain), and ASFV (SD strain) were negative. The agreement between the immunochromatographic strip and the ELISA kit was 93.33% (140/150) and the Kappa was 0.866 (Kappa &gt; 0.81). On the premise of ensuring sensitivity, the most important feature of the immunochromatographic strip is that this method can save time when testing; results can be obtained within 5 to 10 min. Magnetic chemiluminescence immunoassay is quantitative detection method; this method can detect PCV2 Cap proteins in swine serum, the linear range of this method was 0.25 ng/mL to 32 ng/mL and R2 of the standard curve was 0.9993. The limit of detection (LOD) is 0.051 ng/mL and the limit of quantitation (LOQ) is 0.068 ng/mL. The agreement between the magnetic chemiluminescence immunoassay and the ELISA kit (test PCV2 Cap proteins) was 97.14% (68/70). This method took less than 30 min to achieve results, which is less than the ELISA kit. The results of this study show that immunochromatographic strip and magnetic chemiluminescence immunoassay for PCV2 antigens had great sensitivity and specificity, which lays the foundation for PCV2 clinical detection.

Epstein-Barr virus infection in patients with MOGAD

Background: Epstein-Barr virus (EBV) infection increases the risk of having multiple sclerosis (MS). Data on adults with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) are lacking. Objective: To compare EBV serological status in MOGAD versus MS. Methods: We measured antibodies to Epstein-Barr nuclear antigen (EBNA-1) and viral capsid antigen (VCA) antigens in 129 patients (MS = 74, MOGAD = 55) by chemiluminescence immunoassays. Results: VCA-IgG were detected in 97.3% of MS and 96.4% of MOGAD cases, while EBNA-1-IgG in 97.3% of MS and 80% of MOGAD (p = 0.001). EBNA-1 (p < 0.001) and VCA (p = 0.03) antibodies levels were higher in MS patients. Conclusion: EBV antibodies are higher in MS versus MOGAD, suggesting a possible different role of EBV in the pathogenesis of the two conditions.

Relationship of Serum 25-Hydroxyvitamin D Concentrations, Diabetes, Vitamin D Receptor Gene Polymorphisms and Incident Venous Thromboembolism.

The association between vitamin D and the risk of venous thromboembolism (VTE) remains inconclusive. We aimed to explore the association of serum 25-hydroxyvitamin D (25OHD) with incident VTE among participants with and without diabetes, and examine the modifying effect of genetic susceptibility of VTE and vitamin D receptor (VDR) gene polymorphisms on this association. A total of 378,082 participants free of VTE at baseline from the UK Biobank were included. Serum 25OHD concentrations were measured by the chemiluminescent immunoassay method. The primary outcome was incident VTE, including deep vein thrombosis (DVT) and pulmonary embolism (PE). The genetic risks of VTE were estimated using 297 single nucleotide polymorphisms (SNPs) associated with VTE. The VDR gene polymorphisms included SNPs of rs7975232, rs1544410, rs2228570 and rs731236. During a median follow-up duration of 12.5years, 10,645 VTE cases were recorded. Serum 25OHD had a significantly stronger inverse association with incident VTE in participants with diabetes (per SD increment, adjusted HR: 0.87; 95% CI: 0.81-0.93) than in those without diabetes (per SD increment, adjusted HR: 0.97; 95% CI: 0.95-0.99; p-interaction=0.003). Similar trends were found for incident DVT and PE. Among participants with diabetes, the genetic risk of VTE did not significantly modify the association between serum 25OHD and incident VTE (p-interaction=0.607). However, a stronger inverse association of serum 25OHD with incident VTE was found in the VDR rs2228570 AA genotype (vs. GG/AG; p-interaction=0.031). Serum 25OHD was inversely associated with the risk of VTE, especially among participants with diabetes, regardless of genetic risks of VTE.

Comparison of a chemiluminescence immunoassay with LC-MS/MS in the determination of the plasma aldosterone concentration in patients with impaired renal function.

Compared with chemiluminescence immunoassay (CLIA), the quantification of the plasma aldosterone concentration (PAC) via liquid chromatography-tandem mass spectrometry (LC-MS/MS) yields lower values. The extent to which this difference is exacerbated by a reduced glomerular filtration rate (eGFR) is unclear. Therefore, this study aims to assess the impact of renal insufficiency on PAC as measured by CLIA using LC-MS/MS as the reference method. In subjects with a normal or reduced estimated eGFR, the PAC was measured using both LC-MS/MS and two different CLIA kits (Mindray and Liaison). In total, 383 patients were included in our study. Among them, 71 subjects had eGFRs>90 (Group one), 79 had eGFRs range from 60 to 89 (Group two), 108 had eGFR range from 30 to 59 (Group three), 51 had eGFRs range from 15 to 29 (Group four), and 74 had eGFRs<15 (Group five) ml/min per 1.73m2. In all the subjects, PAC as measured by CLIA [68.2 (37.1-122.1) pg/ml for Mindray, 109.0 (68.1-170.0) pg/ml for Liaison] were significantly higher than those measured by LC-MS/MS [47.2 (22.9-88.7) pg/ml]. PAC as measured by CLIA was positively correlated with PAC as measured by LC-MS/MS, but the correlation coefficient gradually decreased as eGFR decreased. Between the LC-MS/MS and Liaison CLIA kits, the difference in PAC values increased with reduced eGFR in groups one through five (76.8%, 69.2%, 113.2%, 152.2%, and 476.2% for groups one through five, respectively). However, this difference increased only in Group five with the Mindray CLIA kit (46.4%, 48.1%, 45.7%, 45.0%, and 74.9% for groups one through five, respectively). CLIA progressively overestimated PAC as eGFR decreased, particularly with the Liaison method, indicating the need for caution when interpreting these measurements in patients with impaired renal function. In patients with impaired renal function, LC‒MS/MS measurements for PAC are preferable.

Analysis of the Clinical Value of hsa_circ_0001955 in Papillary Thyroid Cancer Treated with 131 Iodine.

The prevalent histological variant within differentiated thyroid carcinoma is papillary thyroid carcinoma, also known as PTC. The study investigated the clinical performance of serum hsa_circ_0001955 in predicting the prognosis of PTC treated with radical thyroidectomy and iodine 131 nail clearance. The relative expression of serum circ_0001955 of PTC patients was detected before and after accepting radical thyroidectomy combined with 131I thyroid remnant ablation by RT-qPCR. Serum thyroglobulin (Tg) and thyroglobulin antibody (TgAb) levels were quantified by an automatic chemiluminescence immunoassay analyzer. Multivariate logistic regression analysis was employed to investigate the risk factors associated with the prognosis of PTC patients with postoperative 131I therapy. The serum circ_0001955 levels in 127 PTC patients were higher than that in 96 multinodular goiter patients and 110 healthy controls before treatment and had diagnostic values for PTC patients. After 131I treatment, serum circ_0001955 levels and Tg value have a correlation with potential recurrence (WBS positive). Serum circ_0001955, Tg, and TgAb value, and their combination may have diagnostic value in predicting recurrence. Serum circ_0001955 levels in patients with PTC after radical thyroidectomy and iodine 131 thyroidectomy may help predict recurrence.

Vitamin D, intact parathyroid hormone, and bone mineral density in postmenopausal women

Background: Osteoporosis and vitamin D deficiency (VDD) are growing concerns for the elderly population, especially postmenopausal women worldwide. The association between osteoporosis and VDD among Bangladeshi postmenopausal women was not adequately evaluated. Objective: To assess the association between VDD, intact parathyroid hormone (iPTH) status, and bone mineral density (BMD) status among postmenopausal Bangladeshi women. Methods: This single-center, cross-sectional study included 60 postmenopausal women. A pre-designed case record form was used to record baseline demographic variables. BMD was assessed using dual-energy X-ray absorptiometry on eligible patients who met the inclusion and exclusion criteria, where T-scores indicating normal (&gt; -1), osteopenia (-1 to -2.5), or osteoporosis (&lt; -2.5) based on lumbar spine (LS) and femoral neck (FN) measurements. Vitamin D was categorized as deficient (&lt;20 ng/mL), insufficient (VDI: 20–29 ng/mL), or sufficient (≥30 ng/mL) based on serum 25(OH)D levels. Vitamin D and iPTH were measured by chemiluminescence immunoassay. Results: Among 60 postmenopausal women, 43.3% had osteoporosis and 56.7% had no osteoporosis. VDD, insufficiency, and sufficiency were present in 50%, 35%, and 15% respectively in the study participants. Serum iPTH was higher in 20.0% of the study participants. Vitamin D levels were lower in women with osteoporosis than those without [15.6±5.5 vs. 20.6±8.9, p &lt;0.001]. Serum iPTH negatively and moderately correlated with 25(OH)D and LS-BMD [both: r=-0.4, p=0.001] but not with FN-BMD. In multivariate regression analysis, only serum iPTH [B=0.4, p=0.001] and vitamin D insufficiency [B= 0.5, p=0.015] had a predictive association with LS-BMD. Conclusion: Both VDD and osteoporosis, are common in postmenopausal Bangladeshi women. Low vitamin D levels can play a role in developing osteoporosis by increasing bone remodeling as an effect of raised iPTH. J Assoc Clin Endocrinol Diabetol Bangladesh, July 2024;3(2): 47-52

Prevalence of Thyroid Disorders in the Patient Visiting Tertiary Care Hospital in Jhapa District, Nepal

Background Thyroid dysfunction is a leading global endocrine disorder, affecting 30-40% of endocrine patients. Thyroid hormones regulate metabolism, growth, and cardiovascular health. Both hyper- and hypothyroidism are linked to serious health issues. Undiagnosed cases are common, with 42 million affected in India. Screening programs, especially for women, are vital for early detection and treatment. Methods This is a prospective hospital based study was conducted in the central laboratory at B&amp;CMedical College Teaching Hospital and Research Centre Birtamode, Jhapa from March 2022 to January 2023.Venous Blood samples was collected and fT3,fT4 and TSH was estimated by Chemiluminescence Immunoassay (CLIA) method using Backman Coulter Access 2 analyser. Thyroid statuses were categorized as euthyroid, hypothyroid, subclinical hypothyroid, hyperthyroid, and subclinical hyperthyroid based on test results. Results The most common thyroid disorder in female was sub-clinical hypothyroidism (14.7%) and the least common was hypothyroidism (0.8%). The most common thyroid disorders was sub-clinical hypothyroidism (11.8%) and the least common was hypothyroidism (1.2%) in male. Among the thyroid disorders, subclinical hypothyroidism was most prevalent in all the age groups. Hyperthyroidism and its subclinical type (0.6%) were the least prevalent in the age group less than 15 years. Conclusions The prevalence of subclinical hypothyroidism was more significant and it increased with the age. Cross-sectional study comparing with different etiological factors like stress levels, geographic, environment, auto immunity, drugs, iodine status etc. may be required.

A Study of Vitamin B12 Deficiency in Type-II Diabetic Patients on Metformin Therapy in Eastern Reason of Nepal

Background Diabetes mellitus, a metabolic disorder marked by elevated blood glucose level, requires effective management to prevent complications. Metformin, a common frontline treatment for type -II diabetes, is linked to Vitamin B12 deficiency, which may trigger severe health disorders like anemia and neurological problems if remain undiagnosed for a longer duration. This study aims to assess the prevalence of Vitamin B12 deficiency among type 2 diabetic patients on metformin therapy. The objective is to assess the distribution of patients affected by this deficiency and understand how metformin therapy influences B12 levels among these patients. The Study was conducted at B&amp;C Medical College Teaching Hospital and Research Center, Birtamod, Jhapa, Nepal. Methods A total of 200 diabetes patients on metformin were included in the study. Patients were included if they were diagnosed with type -II diabetes, were currently undergoing metformin therapy, and had been on the medication for at least 6 months. Data collected comprised patient age, gender, duration of metformin use, and serum vitamin B12 levels measured using chemiluminescence immunoassay (CLIA). Vitamin B12 deficiency was defined as serum levels &lt;200 pg/mL, insufficiency as 200-300 pg/mL, and sufficiency as &gt;300 pg/mL. Statistical analysis involved descriptive statistics and Chi-square tests. Results Out of the 200 diabetic patients taking metformin, 45% exhibited Vitamin B12 deficiency based on serum levels (&lt;200 pg/mL), 30% had insufficient Vitamin B12 levels (200–300 pg/mL), and 25% had sufficient levels (&gt;300 pg/mL) Deficiency rates were similar across genders but higher in patients over 47 years. A significant correlation was observed between longer metformin use and lower Vitamin B12 levels. Conclusion The results highlight a prominent rate of Vitamin B12 deficiency among diabetes patients prescribed metformin, especially in older patients and those on long-term therapy. Routine monitoring of vitamin B12 levels is recommended for these patients to prevent serious complications and improve health outcomes

Evaluation of the hematological parameters, inflammatory biomarkers, and thyroid hormones in hypothyroidism patients

AimHypothyroidism is created by disruption of thyroid hormone production, which can destroy the emotional, relational, social, and working life of patients if left untreated. Hypothyroidism has multiple etiologies. We evaluated the relationship of hematological parameters and inflammatory biomarkers with thyroid hormones to find the potential use of these items in patients screening and prognosis.MethodsThis is a cross-sectional study, which was done on 88 individuals of both genders (32 male and 56 female), over 18 years old with a mean age of 45 years old. These patients were referred by physicians after examination to our laboratories of Qaem Medical Laboratory of Kuhchenar and Jahrom University of Medical Sciences, Fars, Iran. The patients had recent symptoms and signs of hypothyroidism with increased TSH above the normal range, and negative serum anti-TPO antibody. To determine ABO, Rh, and Lewis (Le) blood groups was used anti-A, anti-B, anti-D, anti-Lea, and anti-Leb monoclonal antibodies. Serum T3, T4, and TSH was measured by direct chemiluminescent immunoassay. Anti-TPO antibody was measured by ELISA. CRP was determined using an immunoturbidimetric assay. CBC count assessment was done via an automated cell counter.Exclusion criteria were patients with acute or chronic inflammatory diseases. Herein, we evaluated the correlation of hematological parameters consisting ABO, Rh, and Le blood groups, RBC and WBC parameters, and platelet count as well as inflammatory biomarkers including ESR, CRP, IL-8, and NLR with T3, T4, and TSH in hypothyroid patients.ResultsOur study showed a significant correlation between Lea blood group (non-secretor) in comparison with Leb blood group (secretor) with TSH (P = 0.01). There was no correlation between Leb and Lea blood groups with T3 and T4. We did not observe the correlation between Rh and ABO blood groups with T3, T4, and TSH. We observed significant correlations between Hb, Hct, and MCH with T3 (PHb = 0.012, PHct = 0.021, and PMCH = 0.032) and also, with T4 in hypothyroidism (PHb = 0.023 and PHct = 0.026). We revealed significant correlations between Hb, Hct, and MCH with TSH in hypothyroidism (PHb = 0.017, PHct = 0.019, and PMCH = 0.007). The significant correlations between CRP and IL-8 with T3, T4, and TSH was not explored. The significant correlations between ESR with T3 and TSH was not detected. ESR showed a significant correlation with T4 (PESR = 0.020). There were also no significant correlations between the counts of neutrophils, lymphocytes, monocytes, and eosinophils, as well as NLR with T4. There was only significant correlation between monocyte count with T3 (PMono = 0.029) and also lymphocyte count with TSH (PLymph = 0.041).ConclusionIn this investigation, we observed a significant relationship between Lea blood group in comparison with Leb blood group with TSH. We demonstrated significant correlations between Hb and Hct with T3, T4, and TSH, and also correlations between MCH with T3 and TSH. In conclusion, the assessment of Hb, Hct, MCH, and Le blood groups as hematological parameters can help physicians in the management of hypothyroidism.

Pattern of Thyroid Disorders in a Tertiary Care Centre of a High-Altitude Region of Nepal: A hospital-based retrospective study

Background: Millions of people globally suffer from thyroid disorders, with over half of them are unaware of their conditions. Untreated, these disorders can lead to severe health complications such as heart problems, pregnancy complications, goiter, bone health issues, etc. Jumla, a high-altitude Himalayan region in Nepal, includes iodine-deficient areas, making it prone to thyroid disorders. This study aimed to identify the prevalence and pattern of thyroid disorders in this region. Methods: A retrospective hospital-based cross-sectional study was conducted using data from the Karnali Academy of Health Sciences, Jumla, spanning from 1st January–31st December 2023. Participants of all ages with complete thyroid function test results (fT3, fT4, and TSH assessed via chemiluminescence immunoassay) were included. Data were extracted from Bahmni EMR, cleaned in MS-Excel, and analyzed in R software, with a significance threshold of p &lt; 0.05. Results: Among 816 participants (mean age: 35.66 ± 14.60 years), 660 (80.8%) were female, and 156 (19.1%) were male. The most represented age group was 25–34 years. Subclinical hypothyroidism was the most prevalent disorder, affecting 33 males (21.15%) and 143 females (21.66%). Primary hyperthyroidism was the least common, found in 1 male (0.64%) and 7 females (1.06%). Other disorders included secondary hypothyroidism, secondary hyperthyroidism, primary hypothyroidism, and subclinical hyperthyroidism. Conclusion: Subclinical hypothyroidism was the most common thyroid disorder, with females disproportionately affected. Wider population screening for early detection and management is essential to mitigate health risks.

To Assess the Relationship Between Reticulocyte Hemoglobin Content and Iron Status in Hemodialysis-Dependent Patients

Objectives: This study aims to evaluate the diagnostic utility of reticulocyte hemoglobin content (RET-He) and its correlation with transferrin saturation (TSAT) and other iron markers for identifying iron deficiency anemia in hemodialysis patients. Methods: The study was conducted at Hematology Department of Shaikh Zayed Hospital in Lahore, from March 2022- April 2023. Total 120 patients with chronic kidney disease on hemodialysis were enrolled in this study. Ferritin was determined by chemiluminescence immunoassay. Flow cytometry and spectrophotometry was performed to determine RET-He and iron status including serum iron and Total iron binding capacity (TIBC). Patients of both genders, aged 18-80 and those on hemodialysis for 3 months or more were selected. Patients excluded were those with bleeding from any site in last three months, received oral or parenteral iron supplementation in one month. Results: In this study, 120 hemodialysis dependent chronic kidney disease patients were enrolled. Among them, 65 (54.2%) were males, while 55 (45.8%) were females; 18 years to 80 years was the age range, with 53.48 ± 13.782 years being mean age. Mean RET-He was 29.439 ± 3.51 pg/cell, while mean serum iron was 68.96 ± 38.63 µg/dl, mean TIBC was 224.41 ± 55.109 µg/dl, serum ferritin mean value being 386.91 ± 357.51 ng/ml and mean TSAT was 31.93 ± 18.52%. Sensitivity (Se) was 56.0%, specificity (Sp) was 74.6%, positive predictive value (PPV) 36.8%, negative predictive value (NPV) 86.6% and accuracy of RET-He in diagnosing Iron deficiency anemia was 70.8% respectively. Conclusion: Reticulocyte hemoglobin content is highly effective in diagnosing iron deficiency anemia in chronic kidney disease patients. Its lower cost compared to traditional markers makes it a valuable tool for clinical practice.

RUSS-AGE study: Markers of carbohydrate metabolism and their time course in different age groups of a healthy population of the Russian Federation

Background. One of the important tasks of modern science is to search for key biomarkers of aging of various body systems. Parameters of carbohydrate metabolism play an essential role in maintaining vital activity. The prevalence of carbohydrate metabolism disorders increases with age, but the time course of changes in individual markers remains poorly understood. Therefore, it is important to investigate the patterns of changes in carbohydrate metabolism markers in different age groups among healthy participants, which is the objective of the RUSS-AGE study. Aim. To evaluate changes in carbohydrate status markers (adiponectin, leptin, glucose, glycated hemoglobin, insulin, and carboxymethyllysine – CML) in different age groups of a healthy Russian population. Materials and methods. The study was conducted at the Pirogov Russian National Research Medical University in collaboration with the Moscow City Outpatient Clinic No. 220. The study group included subjects 18 years of age and older who signed an informed consent form; the exclusion criteria were current acute disease, exacerbation of a chronic disease, surgical intervention within the last month, and moderate to severe chronic age-associated diseases. Blood samples were taken to measure aging markers: glucose (enzymatic ultraviolet method), insulin (chemiluminescent enzyme immunoassay), glycated hemoglobin (calorimetric method), CML, adiponectin, and leptin (enzyme immunoassay). The study was approved by the local ethics committee (Minutes No. 59 dated 13.09.2022). Statistical analysis was carried out using the R programming language version 4.4.0. The significance threshold for the p-value values given in the article is 0.05. Results. The study included 711 participants, which were divided into eight age groups. According to the intergroup comparison, a statistically significant direct relationship of age with adiponectin (p0.001), glucose (p0.001), and glycated hemoglobin (p0.001) was found. No significant correlation with age was found for leptin (p=0.116), insulin (p=0.078), and CML (p=0.506). After conducting a statistical analysis using linear regression to assess the dependence of variables on age, it was found that only adiponectin, glucose, and glycated hemoglobin significantly increase with age (p0.001). Conclusion. The study showed a significant increase in adiponectin, glucose, and glycated hemoglobin, while leptin, insulin and CML had no significant correlation with age.

Development of a thrombin-antithrombin complex detection kit and study in venous thromboembolism complicated by cervical cancer

ObjectiveOur study successfully developed an assay kit for thrombin-antithrombin complex (TAT) and demonstrated the predictive value of plasma TAT concentration in the development of venous thromboembolism (VTE) in patients with cervical cancer.MethodA retrospective analysis was conducted on 177 patients with cervical cancer who received treatment at the Affiliated Hospital of Jiangnan University in Wuxi City from July 1, 2023 to October 1, 2023. This study provides a comprehensive analysis of cervical cancer patients and their VTE risk factors. The patients were divided into two groups: 27 cases with VTE (Thrombosis group) and 150 cases without VTE (Non-thrombotic group). Additionally, the patients were classified into four stages based on tumor stage: 42 cases of stage I, 45 cases of stage II, 62 cases of stage III, and 28 cases of stage IV. The control group consisted of 80 healthy patients undergoing medical check-ups. Thrombin-antithrombin complex (TAT), fibrinolytic enzyme-α2-fibrinolytic inhibitor complex (PIC), thrombomodulin (TM), and tissue-type plasminogen activator inhibitor 1 complex (t-PAIC) were detected using quantitative chemiluminescence immunoassay. The study assessed the variations in thrombotic marker levels among cervical cancer patients of different stages through a receiver operating characteristic (ROC) curve.ResultThe TAT reagent demonstrated a detection limit of 0.048 ng/mL, with a linear R value of 0.9997, indicating high accuracy and precision. The reagent's accelerated stability was also excellent, with deviations of less than 10%. Furthermore, the correlation coefficient of this method with Hyson Mecon was R2 = 0.9683. Notably, in patients with cervical cancer, TAT and PIC levels were found to be elevated compared to those of the healthy population. Cervical cancer patients who developed thrombosis had significantly elevated levels of TAT and fibrinogen degradation products (FDP) compared to those who did not. Furthermore, patients with stage III-IV cervical cancer exhibited higher levels of the six markers than those with stage I-II during staging. Notably, the combination of four or six markers significantly improved the sensitivity and specificity of the diagnosis, as demonstrated by the ROC curves.ConclusionOur developed TAT test kit has excellent performance and low cost, making it a clinically valuable tool for widespread use. Elevated TAT levels have significant predictive value for thrombosis occurrence in cervical cancer patients. The combination of t-PAIC, TM, TAT, PIC, D-dimer(D-D), and FDP markers is superior to using a single marker for diagnosing VTE in patients with malignant tumors. Screening cervical cancer patients for the six markers is essential to aid in active prophylaxis, determine optimal treatment timing, and implement nursing interventions to improve prognosis, reduce venous thrombosis incidence and mortality, and prolong survival time.

The effects of age and sex on reference intervals for cobalamin, homocysteine, and serum and urinary methylmalonic acid in healthy adult dogs.

In dogs, data on reference intervals (RIs) for cobalamin, markers of metabolism (markersB12met), age and sex effects are limited. Establish RI for serum cobalamin, homocysteine, and methylmalonic acid (sMMA) concentrations, urinary methylmalonic acid-to-creatinine ratio (uMMA:crea), and determine effects of sex and age. Prospective study using healthy dogs (1-10 years). Cobalamin and markersB12met were determined using chemiluminescence immunoassay (cobalamin) and liquid chromatography/tandem mass spectrometry (homocysteine, sMMA, uMMA:crea). In dogs with outlying data, changes in health, markersB12met, and onset of gastrointestinal signs were reevaluated after 9-15 months. Twelve of 120 healthy dogs had abnormal uMMA:crea ratios. No other cobalamin analyte outliers were found. Outlying data re-examination (odRE) was performed in 10/12 dogs. Chronic gastrointestinal signs occurred in 64% of odRE-dogs, whereas 36% remained healthy. In total, 112 dogs (67 females, 45 males; median ages, 3.5 and 3.75 years, respectively) were included in RI analyses. Reference intervals were 178.5-851 pmol/L (cobalamin), 5.8-29.0 μmol/L (homocysteine), 45.3-159.5 μg/L (sMMA), and ≤22.4 mg/g (uMMA:crea). Only age affected cobalamin concentrations (significant decrease). Compared by sex and neuter status, intact male dogs had significantly higher uMMA:crea ratios (median, 13.5; range, 1.9-83.6 mg/g) than the other groups (median, 2.5; range, 0.7-9.7 mg/g; P < .0001). Sex-specific RI were ≤58.9 mg/g (intact male) vs ≤5.2 mg/g (females and neutered males). Intact male dogs had significantly higher uMMA:crea ratios than the other groups. Thus, sex-specific RI are recommended for uMMA:crea. Because of the wide distribution of uMMA:crea ratios, careful interpretation in intact male dogs is advised.