Cobas E411 Research Articles

Study of thyroid dysfunction in people living with HIV in Nepalese population undergoing antiretroviral therapy: a cross-sectional study.

Thyroid dysfunction is one of the most common endocrine disorders in people living with HIV (PLHIV). The abnormality in thyroid function has been linked with the adverse effects of prolonged antiretroviral therapy (ART) in PLHIV, but its prevalence remains obscure. The present study aimed to determine the prevalence of impaired thyroid function and its relationship to ART duration in Nepalese people living with HIV. This cross-sectional clinical laboratory based study was conducted at SRL Diagnostics Nepal, Pvt. Ltd. from October 2021 to May 2022. Two hundred and three HIV-seropositive patients enrolled at Tribhuvan University Teaching Hospital (TUTH) in Kathmandu, Nepal were examined for their thyroid function test (TFT) by analyzing the serum T3, T4, and TSH concentrations using a fully automated COBAS e411 analyzer (Roche Diagnostics, USA) based on the electrochemiluminescence assay (ECLIA). Out of 203 PLHIV, 22 (10.83%) had a thyroid disorder, with subclinical hypothyroidism (n = 16, 72.73%) being the most common, followed by subclinical hyperthyroidism (n = 3, 13.63%). Thyroid dysfunction had no significant correlation with HIV/ART duration (p = 0.304) and sex (p = 0.419), whereas, the risk of thyroid dysfunction was induced with the rise in the age of the PLHIV (p = 0.002, ϕ = 0.274). There were no significant differences in the mean serum T3, T4 and TSH values among different sexes and the HIV/ART duration, however a significant difference in the mean values of TSH (F (3, 199) = 3.231, p = 0.023) and T3 (F (3, 199) = 4.587, p = 0.004) among the different age-groups were shown. The mean T3 values also indicated a gradual decrease with increasing age. The study revealed subclinical hypothyroidism as the prevailing thyroid disorder associated with PLHIV. The risk of thyroid dysfunction in PLHIV was neither gender specific nor being attributed by the ART duration in Nepalese population; however, elderly PLHIV were highly susceptible to the risk of thyroid disorder.

Estimation of Reference Intervals from Routine Data Using the refineR Algorithm-A Practical Guide.

Accurate reference intervals are essential for the interpretation of laboratory test results. Typically, they are determined by the central 95% range of test results from a predefined reference population. As these direct studies can face practical and ethical challenges, indirect methods using routine measurements offer an alternative approach. We provide step-by-step guidance on how to apply an indirect method in practice using refineR, the most recently published indirect method, and showcase the application by evaluating real-world data of 12 prespecified analytes. Measurements were retrieved from ARUP Laboratories' data warehouse, and were obtained from routine patient testing on cobas c502 or e602 analyzers. Test results were prefiltered and cleaned and, if necessary, physiologically partitioned prior to estimating reference intervals using refineR. Estimated reference intervals were then compared to established intervals provided by the manufacturer. For most analytes, the reference intervals estimated by refineR were comparable to those provided by the manufacturer, shown by overlapping confidence intervals at both reference limits, or only the upper or lower limit. For thyroid-stimulating hormone, refineR estimated higher reference limits, while estimates for prealbumin were lower compared to the established reference interval. We applied the refineR algorithm to a variety of real-world data sets resulting in reference intervals similar to intervals previously established by direct methods. We further provide practical guidance and a code example on how to apply an indirect method in a real-world scenario facilitating their access and thus their use in laboratory settings.

Evaluation of Serum Creatinine and Serum Uric Acid In Hypothyroid Patients: A Cross-sectional Study

Introduction: Hypothyroidism, a prevalent endocrine disorder, leads to a generalised metabolic slowdown due to insufficient thyroid hormone production, potentially resulting in elevated levels of serum uric acid and creatinine, thus affecting renal function and purine metabolism. Aim: To assess serum creatinine and serum uric acid levels in hypothyroid patients while establishing correlations with their thyroid-stimulating hormone (TSH), free triiodothyronine (FT3), and free thyroxine (FT4) levels. Materials and Methods: A comparative cross-sectional study was conducted in the Department of Biochemistry, Government Medical College, Kozhikkode, Kerala, India. The study involved 140 participants, including 70 recently diagnosed hypothyroid patients and 70 age- and sex-matched euthyroid individuals. Thyroid hormone levels (FT3, FT4) and TSH were quantified using the Cobas e411 electro-chemiluminescence technique. Serum creatinine levels were measured using the Modified Jaffe’s method, and serum uric acid levels were assessed through the Uricase method (Enzokit). Data analysis was performed using Statistical Package for the Social Sciences (SPSS) version 21.0, and tables and graphs were generated using Microsoft Word and Excel. Results: The mean age of study participants of control group was 39.02 years and of the hypothyroid group was 36.80 years. The comparative cross-sectional analysis revealed significantly higher levels of serum uric acid and serum creatinine in hypothyroid patients compared to euthyroid controls. Specifically, hypothyroid patients exhibited a mean serum uric acid level of 10.77±2.34 mg/dL, while euthyroid controls had a mean of 4.37±0.94 mg/dL. Mean serum creatinine levels for hypothyroid patients and euthyroid controls were 2.16±0.80 mg/dL and 0.75±0.14 mg/dL, respectively. Notably, a significant positive correlation was observed between serum uric acid and serum creatinine levels with TSH (r=0.42, p-value<0.001 and r=0.45, p=0.00, respectively). Conclusion: The study identified significantly higher levels of serum uric acid and creatinine in hypothyroid patients compared to euthyroid individuals, potentially attributed to haemodynamic changes and disruptions in purine metabolism. Regular monitoring of these parameters is crucial for individuals with hypothyroidism.

HLA-B*0702 class-I allele, anti-FSH, anti-LH, and vitamin D3: Potential links with polycystic ovary syndrome in women of Erbil city, Iraq

Polycystic Ovary Syndrome (PCOS) is a widespread endocrine-reproductive-metabolic condition with severe implications for females’ health. The role of four essential parameters on PCOS, including Human Leukocyte Antigens (HLA) represented by the HLA-B*0702 allele, anti-Follicle Stimulating Hormone (anti-FSH) antibodies, anti-Luteinizing Hormone (anti-LH) antibodies, and vitamin D3 was investigated. A total of 100 samples were collected from Kurdish women attended the Maternity Teaching Hospital and some private hospitals/laboratories in Erbil City from October, 2021 to January, 2022. The samples were genotyped using a PCR-based technique with specific sequence primers. The levels of anti-FSH and anti-LH antibodies were determined using an Enzyme-Linked Immunosorbent Assay (ELISA), while vitamin D3 levels were measured by an Electrochemiluminescence (ECL) test on Cobas e411 immunoassay system. The Odds Ratio (OR) of 2.167 at a 95% Confidence Interval (CI) of 0.8167 to 6.330, indicated an essential link between the HLA-B*0702 allele and a risk of PCOS. Anti-FSH and anti-LH antibodies were significantly greater in PCOS patients, notably infertile women, than in healthy controls. A significant positive linear correlation was observed between antibodies against FSH and LH in patients. Most patients and controls had hypovitaminosis D3, with a significant difference (P-value  0.01). The results indicated that the HLA-B*0702 allele is associated with PCOS susceptibility and could be used as an immunogenetic marker. It also supported the idea that anti-FSH and anti-LH antibodies are naturally presence antibodies in PCOS patients instead of signs for autoimmunity. Women suffer from PCOS are also more prone to develop vitamin D3 deficiency.

Analytical Evaluation and Reference Interval Investigation for Chinese Han Population in Wuhan of CA72-4 Performed on an Architect i2000sr System.

Carbohydrate antigen 72-4 (CA72-4) is a mucin-like, tumor-associated glycoprotein. Its elevation in serum has been found to be associated with various carcinomas. The purpose of this study was to evaluate the analytical performance of the Architect chemiluminescent immunoassay CA72-4 on the Architect i2000sr platform and to determine the reference interval (RI) of CA72-4 for the Chinese Han population in the city of Wuhan. We evaluated the precision, analytical sensitivity, linearity and interference according to the guidelines of the Clinical Laboratory Standardization Institute. Additionally, the Abbott Architect i2000sr CA72-4 assay was compared to the Roche Cobas E602 CA72-4 assay. A total of 448 healthy individuals were selected to determine the RIs of CA72-4. The assay had an imprecision of 1.38% - 2.63% within runs, 1.41% - 2.73% between runs and a total imprecision of 2.54% - 4.10%. The limit of blank, limit of detection and limit of quantitation concentrations were 0.19 U/mL, 0.21 U/mL, and 0.21 U/mL. Linearity was confirmed across the entire measurable range. Additionally, the carryover was less than 0.065%. Interferences with hemoglobin, conjugated bilirubin and lipemia were acceptable with changes of less than 10%. A correlation coefficient of 0.9450 was determined through the method comparison experiment (95% CI 0.9318 - 0.9557). The RI for serum CA72-4 in the Han population was established as an upper limit, 11.13 U/mL (90% CI 9.39 - 12.99) by using the Abbott Architect i2000sr system. This study establishes a RI for the Chinese Han population in Wuhan using the Abbott Architect i2000sr CA72-4 assay and demonstrates an analytical performance for clinical use.

ASSOCIATION OF VITAMIN D AND INSULIN RESISTANCE IN GESTATIONAL DIABETES

ABSTRACT
 Objective: To determine the association of vitamin D deficiency with insulin resistance among women diagnosed with gestational diabetes.
 Study Design: Cross sectional study.
 Place and duration of study: This study was conducted from January 2021 to December 2021 at Combined Military Hospital (CMH) Lahore.
 Methodology: Two hundred pregnant women in the age group 20-35 years with gestational diabetes diagnosed by using 75-gram oral glucose tolerance test were included. Fasting blood specimens for glucose, insulin and vitamin D were obtained and analyzed on Roche Cobas c501 and Cobas e411. Based on the vitamin D level, enrolled patients were classified as vitamin D sufficient and vitamin D deficient using vitamin D cut off 20 nmol/L. Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) was calculated for estimation of insulin resistance. Fasting glucose, fasting insulin and HOMA IR were compared between the two groups.
 Results: In this study, 200 pregnant women were inducted. Median age was 28 years (IQR 24-31). Median fasting plasma glucose, Vitamin D levels and HOMA-IR of the study population were 5.3 mmol/L, 19.5 nmol/L and 2.7 respectively. Mann-Whitney U test showed a significant difference (p<0.001) of vitamin D levels among insulin resistant and non- resistant patients. A strong association (p<0.001) between insulin resistance and vitamin D deficiency was established by Chi-square test. Spearman correlation between insulin resistance and vitamin D levels showed negative correlation between insulin resistance and vitamin D levels (r = -0.89).
 Conclusion: A strong association was found between vitamin D deficiency and gestational diabetes mellitus (GDM). The negative correlation (r=-0.89) indicated that severe the deficiency of vitamin D, more pronounced the insulin resistance among pregnant women having GDM.

The acute postprandial response of homocysteine to multivitamin and mineral supplementation with a standard meal is not impaired in older compared to younger adults.

B vitamins are required for the complex regulation of homocysteine and one-carbon (1C) metabolism. Nutritional supplements are frequently used by older adults to counter nutritional inadequacies. However, the postprandial use of B vitamins from supplements in 1C metabolism may be altered with age owing to impaired nutrient absorption and metabolic regulation. Despite implications for health and nutritional status, postprandial 1C metabolite responses have not been characterised in older adults. Healthy older (n = 20, 65-76years) and younger (n = 20, 19-30years) participants were recruited through online and printed advertisements in Auckland, New Zealand. Participants consumed a multivitamin and mineral supplement with a standard breakfast meal. Blood samples were collected at baseline and hourly for 4h following ingestion. Plasma 1C metabolites (betaine, choline, cysteine, dimethylglycine, glycine, methionine, serine) were quantified using liquid chromatography coupled with mass spectrometry. Serum homocysteine, folate and vitamin B12 were quantified on a Cobas e411 autoanalyzer. Older adults had higher fasting homocysteine concentrations (older: 14.0 ± 2.9µmol/L; younger: 12.2 ± 2.5µmol/L; p = 0.036) despite higher folate (older: 36.7 ± 17.4nmol/L; younger: 21.6 ± 7.6nmol/L; p < 0.001) and similar vitamin B12 concentrations (p = 0.143) to younger adults. However, a similar postprandial decline in homocysteine was found in older and younger subjects in response to the combined meal and supplement. Except for a faster decline of cystathionine in older adults (p = 0.003), the postprandial response of other 1C metabolites was similar between young and older adults. Healthy older adults appear to maintain postprandial responsiveness of 1C metabolism to younger adults, supported by a similar postprandial decline in homocysteine concentrations.

Study of Serum Leptin Level in Patients DiabetesMellitusType2: in Relation with Insulin Level

Leptin is a food intake hormone. Informed leptin diet provides adequate nutrition. Leptin plays an important role in T2DM. Having high leptin and being in love is not a reason for preference. Evaluation of serum and ptin levels in T2DM patients and healthy patients, and the relationship between serum fasting insulin and leptin in T2DM. In the endocrine and market cross-sectional education, a total of 92 serums were studied, including 70 patients with T2DM and 22 patients who were not healthy. Serum leptin was measured by ELISA, serum insulin autoanalyzer Cobas E411. Hemoglobin was studied with HPLC D10. Posting regarding serum leptin and insulin, fasting and BMI. In this study, a significant relationship was observed between leptin and insulin and T2DM, and a significant positive relationship between leptin and insulin (p

Biochemical factors in the blood serum of neuroendocrine tumor patients with carcinoid syndrome

Introduction. Carcinoid syndrome is the most common functional syndrome in patients with neuroendocrine tumors. More than 40 biochemical factors are responsible for the manifestation of carcinoid syndrome, among which serotonin is the most important. The study of biochemical markers of carcinoid syndrome and associated carcinoid heart disease is an important aim of laboratory examination in neuroendocrine tumors patients.Aim. Analysis of levels and diagnostic efficiency evaluation of chromogranin A (CgA), serotonin, pro-brain natriuretic peptide (proBNP) and platelet-derived growth factor (PDGF-BB) in the blood serum of neuroendocrine tumors patients with various clinical manifestations, including carcinoid syndrome and carcinoid heart disease.Materials and methods. 66 patients with neuroendocrine tumors of various localizations were examined (pancreas – 24 cases, small intestine – 21, large intestine – 6, lungs – 10, unkown primary focus – 5). 38 patients had liver metastases. In 43 patients, a clinic of carcinoid syndrome was observed, 16 had signs of carcinoid heart disease. The control group consisted of 30 practically healthy people. Serum levels of CgA, serotonin, and PDGF-BB were determined by enzyme immunoassay in microplate format: Chromogranin A NEOLISA (Eurodiagnostica, Sweden), Serotonin ELISA (IBL, German), and PDGF-BB ELISA Kit (Invitrogen, USA). The proBNP analysis was performed on a Cobas e601 automated analyzer (Roche, Switzerland).Results. In carcinoid syndrome, the medians of CgA, serotonin, and proBNP were the highest, differing statistically significantly from the control group. In patients with G3 tumors, the median PDGF-BB was statistically significantly higher than in controls, in contrast to G1 and G2. The highest diagnostic sensitivity in the general neuroendocrine tumors group was in CgA – 63.6 %, with a specificity of 100 %. In patients with carcinoid syndrome, the highest diagnostic sensitivity was characteristic of serotonin and chromogranin A (79 %), while in patients with CAD clinic, proBNP had the highest sensitivity – 93.8 %.Conclusion. The study revealed the high efficiency of СgA, with the highest sensitivity in common forms and tumors with high biological activity. Serotonin can be used in the diagnosis of carcinoid syndrome, associated with cardiofibrosis development. Pro-brain natriuretic peptide is a highly sensitive and specific marker of carcinoid heart disease. The highest levels of PDGF-BB are associated with a high grade of neuroendocrine tumors malignancy.

The Influence of Two Priming Doses of Different Anti-COVID-19 Vaccines on the Production of Anti-SARS-CoV-2 Antibodies After the Administration of the Pfizer/BioNTech Booster.

A global vaccination program was implemented in late 2020 to end the pandemic caused by the SARS-CoV-2 virus. However, the immune response elicited by the vaccines proved to be insufficient due to the rapid emergence of new viral mutations. Therefore, the factors influencing cellular and humoral immune responses after the administration of different vaccines against SARS-CoV2 need to be identified. In the present study, anti-SARS-CoV-2 antibody titers were analyzed 20 to 50 days after the administration of a third (booster) dose of the BNT162b2 vaccine in 192 residents of the city of Olsztyn (Poland) primed with two AstraZeneca or Pfizer/BioNTech vaccines. Antibody titers were determined in venous blood serum in the ECLIA test using the Cobas e411 Roche analyzer. The study revealed that persons who received three doses of the Pfizer/BioNTech vaccine had significantly higher antibody titers than those who received two doses of AstraZeneca and a booster dose of Pfizer/BioNTech.

The Sequence of Prostaglandin-Endoperoxide Synthase 2 Gene in Women with Cervicitis

Cervicitis is a clinical syndrome characterized by inflammation of primarily the columnar epithelium of the uterine endocervix. It can be acute or chronic. Prostaglandin endo peroxide synthase2 (Cyclooxygenase-2) is a key enzyme in prostaglandin synthesis, which is coded by the PTGS2 gene, and recognized as the master switch that activates the inflammatory response; its induction leads to the biosynthesis of prostaglandins. The current study aims to determine the CA125, CA 19.9, and, CA 15.3 markers level and their relationship with the COX-2 gene. Venous blood samples were obtained from 100 women with cervicitis whose ages ranged from 18 to 60 years, and 100 healthy women as a control group. Detection of CA19-9, CA- 125 and CA 15-3 markers was performed by using Cobas E411 analyzer while the CRP test was detected by using Afias CRP instrument. The conventional PCR was used for gene detection and DNA sequencing. The mean± SD of Ca125, CA15.3 and CRP showed a highly significant differences between patient (30.33±1.09), (22.82±1.07), (88.06±5.88) respectively and the healthy control (19.40±0.68), (18.34±0.77), (6.73±0.12) respectively-value &gt;0.001. The mutation in PTGS2 gene with highly CA125 marker 100(100%) and CRP levels 20(80%), while in CA15.3 marker 3(15%) and CA19.9 marker 1(5%). The mutation occurrence in analysis of rs20417 NSP of PTGS2 gene with wild CC GG and the variation C&gt;G G&gt;C.

Managing the impact of inter-method bias of prostate specific antigen assays on biopsy referral: the key to move towards precision health in prostate cancer management.

We assessed the inter-method bias of total (tPSA) and free (fPSA) prostate-specific antigen (PSA) immunoassays to establish if tPSA-based risk thresholds for advanced prostate cancer (PCa), obtained from one method (Roche) can be converted into the corresponding concentrations assayed by other methods. Then we evaluated the impact of the bias of tPSA and fPSA on theestimation of the %f/tPSA ratio and performed a re-calibration of the proposed thresholds for the %f/tPSA ratio according to the assay used. tPSA and fPSA were measured in 135 and 137 serum samples, respectively by Abbott Alinity i, Beckman Access Dxl, Roche Cobas e801, and Siemens Atellica IManalytical platforms. Scatterplots, Bland-Altman diagrams, Passing-Bablok (PB) were used to inspect and estimate the systematic and proportional bias between the methods. The linear equations with confidence intervals of the parameter estimates were used to transform the tPSA risk thresholds for advanced PCa into the corresponding concentrations measurable by the other analytical methods. To construct a correction coefficient for converting the %f/tPSA ratio from one method to the other, PB and non-parametric boostrapping were used. The inter-method bias is not constant but strictly linear allowing the conversion of PSA results obtained from Roche into the other assays, which underestimate tPSA vs. Roche. Siemens and Abbott vs. Roche and Beckman assays, being characterized by a positive and a negative proportional bias for tPSA and fPSA measurements, tend to overestimate the %f/tPSA ratio. There is a consistent risk to miss advanced PCa, if appropriate conversion factors are not applied.

Comparison between liquid chromatography-tandem mass spectrometry and immunoassay methods for measurement of plasma 25 (OH) vitamin D

Abstract Objectives Vitamin D is one of the major hormones involved in the metabolism of calcium (Ca) and phosphorus (P). In the present study, we aimed to determine the analytical performance of the immunoassay method used for determining plasma 25-hydroxyvitamin D [25(OH)D] levels in routine clinical practice in laboratories. Methods Venous blood samples were collected from 156 patients for the comparisons and were analyzed with Siemens ADVIA Centaur XPT, the Roche Cobas 6,000’s module e601, Abbott Architect i2000, and the liquid chromatography with tandem mass spectrometry (LC-MS/MS). Results The four methods were analyzed and compared through the Passing-Bablok regression for 25(OH)D, and the highest correlation was found at LC-MS/MS and Cobas 6,000’s module e601 (r=0.799), LC-MS/MS/Abbott Architect i2000, and LC-MS/MS/Siemens ADVIA Centaur XPT as r=0.736, 0.721, respectively. The correlation coefficient was found between Abbott Architect i2000 with Roche Cobas e601 and Siemens ADVIA Centaur XPT as r=0.934 and r=0.907, respectively. Also, the correlation coefficient was found between Roche Cobas e601 and Siemens ADVIA Centaur XPT as r=0.906. Conclusions The Roche Cobas assay showed better performance, compared with the other assays. Based on our findings, the chemiluminescence methods in automated systems seem to be expedient.

Association of Vitamin B12 deficiency with long-term PPIs use: A cohort study.

BackgroundProton Pump inhibitors are widely used among the majority of the world's population as acid-suppressing medications. Proton Pump Inhibitors have been reported to cause intestinal damage and adverse gut microbiota changes affecting several mechanisms, including malabsorption, etc.AimIn order to gain a deeper understanding, we conducted a cohort analysis to assess the prevalence & association of Vitamin B12 deficiency in patients on long-term use of PPIs.MethodsThis single-center cohort study was conducted at the Department of Internal Medicine, KRL hospital in Islamabad, Pakistan from May 2021 to May 2022. Rao soft calculator with a 95% confidence interval and 5% error margin was used to find the estimated sample size. Vitamin B12 levels were analyzed using the Cobas e411 analyzer. Chi-square test, odds ratio, and t-tests were used for analysis.ResultsAmong the 1225 participants, more than half of the men (55.10%) had low levels of vitamin B12. Vit B12 levels were observed to be significantly lower in Omeprazole patients than in Pantoprazole patients. A vitamin B12 deficiency is 0.5 times more likely in patients taking PPIs. There is a substantial difference between the early and final levels of B12 indicated by the t-test.ConclusionAccording to our findings, long-term usage of PPIs is linked to an increased risk of vitamin B12 insufficiency specifically in men falling under the ages of 18 and 40.

Ultrasensitive and Rapid Detection of N-Terminal Pro-B-Type Natriuretic Peptide (NT-proBNP) Using Fiber Optic Nanogold-Linked Immunosorbent Assay.

The N-terminal pro-brain natriuretic peptide (NT-proBNP) is considered an important blood biomarker for heart failure. Herein, we report about a fiber optic nanogold-linked immunosorbent assay (FONLISA) method for the rapid, sensitive, and low-cost detection of NT-proBNP. The method is based on a sandwich immunoassay approach that uses two monoclonal NT-proBNP antibodies, a capture antibody (AbC), and a detection antibody (AbD). AbD is conjugated to a free gold nanoparticle (AuNP) to form the free AuNP@AbD conjugate, and AbC is immobilized on an unclad segment of an optical fiber. The detection of analyte (A), in this case NT-proBNP, is based on the signal change due to the formation of an AuNP@AbD–A–AbC complex on the fiber core surface, where a green light transmitted through the optical fiber will decrease in intensity due to light absorption by AuNPs via the localized surface plasmon resonance effect. This method provides a wide linear dynamic range of 0.50~5000 pg·mL−1 and a limit of detection of 0.058 pg·mL−1 for NT-proBNP. Finally, the method exhibits good correlation (r = 0.979) with the commercial central laboratory-based electrochemiluminescent immunoassay method that uses a Roche Cobas e411 instrument. Hence, our method is potentially a suitable tool for point-of-care testing.

Reference intervals of the sex hormonal profile in healthy women: A retrospective single-center study in Peru

The female hormonal profile is of utmost importance for the assessment of the endocrinological functional status and the diagnosis of diseases. The analysis must delimit their normality intervals based on the manufacturer's cut-off points. Due to not all intervals can be evaluated before use, it is imperative to verify the reference intervals to achieve uniformity in the interpretation of results in the female population. We determine the reference intervals of five female sex hormones [Follicle Stimulating hormone (FSH), Estradiol, Luteinizing Hormone (LH), Prolactin, and progesterone] using electrochemiluminescence in the Cobas e411 (Roche). We included female patients >18 years old, between the 3rd and 15th day of the menstrual cycle (follicular phase) and had no previous medical history or recent medication. For reference intervals analysis, we followed the recommendations of the CLSI C28-A3 guideline. The average concentration for FSH, progesterone, LH, prolactin and estradiol were 11.48 ± 21.10 mIU/ml, 8.19 ± 11.90 ng/ml, 10.98 ± 11.55 ng/ml, 25.05 ± 32.74 ng/mL, and 147.08 ± 473.8 pmol/mL, respectively. Eighty per cent of parameters showed a satisfactory transfer for the manufacturer's reference intervals, except for estradiol, which had 85.5% of transferred values. Our results suggest that 4/5 sex hormones were found within the manufacturer's reference intervals and can be quantified in Peruvian women, ensuring the quality of their results. However, it is necessary to determine the estradiol with other reagents and assays since we show errors in the transfer of intervals.

Beyond the method change in clinical practice: evaluation of insulin-like growth factor I assay.

Insulin-like growth factor I (IGF-I) is the preferred biomarker for diagnosing and monitoring growth-related disorders but its serum quantification presents several difficulties since different IGF-I assays still leads to different IGF-I concentrations, especially when results are either above or below the normal range. We conducted a prospective study between November and December 2020 at a tertiary University Hospital with 212 serum samples to determine the analytical performance of the IGF-I assay on the Cobas e411 (Roche Diagnostics) and compare it with that of the Immulite 2000XPi (Siemens). In this work, we report for the first time the existence of discrepancies between IGF-I levels measured by Immulite 2000XPi and Cobas e411. Deming regression model provided a slope of 1.570 (95% CI: 1.395-1.745) and an intercept of-58.591 (95% CI:-89.151 to-28.030), with R2=0.967 and average bias of +53.061 with overestimation of IGF-I. It was found that Cobas e411 provides abnormally high IGF-I concentrations, but further studies are required to elucidate the cause of the discrepancies. Our data can alert clinicians and laboratory professionals of this situation and avoid misinterpretation of increased IGF-I levels as a therapeutic failure rather than as a problem associated with this method change.

Comparison between two automated immunoassay methods for total 25-hydroxyvitamin D: Architect ci8200 ® versus Cobas e411®

The purpose of this work is to present the results of a comparative study between the 25-Hydroxyvitamin D [25 (OH) vitamin D] assay on Architect ci8200® (Abbott) and Cobas e411® (Roche Diagnostics). 100 samples of venous blood were randomly selected from routine vitamin D tests. The assay for 25 (OH) vitamin D was performed on Architect ci8200® (Abbott) and Cobas e411® (Roche Diagnostics) controller in the same day. The resulting data were analyzed by the MedCalc Version 15.1.0 statistical software. The statistical analysis of the results showed a good correlation between the two methods studied with a concordance correlation coefficient r = 0.91. The Bland-Altman diagram showed that the higher the level of 25 (OH) vitamin D in the serum, the greater the difference between the two assays. As for the equation of the Passing-Bablok line, it is of type Y (Architect ci8200®) = 0.7158.11 X (Cobas e411®) + 5.9815. Our study showed a good agreement between the results of the 25 (OH) vitamin D assay between the Architect ci8200® automaton and the Cobas e411®, the immunological methods can give different results. Several factors must be taken into account when interpreting a value of 25 (OH) vitamin D in particular: dietetics, vitamin D supplementation and drug interactions.

Beyond hemoglobin: uncovering iron deficiency and iron deficiency anemia using serum ferritin concentration among pregnant women in eastern Ethiopia: a community-based study

BackgroundAlthough the high burden of anemia among pregnant women in low-resource settings like Ethiopia is well documented, evidence is scarce on the underlying causes using biochemical tests. Therefore, this study assessed the iron status and factors associated with iron deficiency (ID) using serum ferritin concentration among pregnant women in Haramaya district, eastern Ethiopia.MethodsA community-based cross-sectional study was conducted among randomly selected pregnant women in Haramaya district, eastern Ethiopia. The serum ferritin (SF) concentration was measured in the National Biochemical Laboratory of Ethiopia on a fully automated Cobas e411 (German, Japan Cobas 4000 analyzer series) immunoassay analyzer using the electro-chemiluminescence (ECL) method and standard procedures. A log-binomial regression analysis identified variables associated with iron deficiency, and defined as serum ferritin concentration < 15 μg/L (per the World Health Organization recommendation in developing countries). An adjusted risk ratio (aRR), and a 95% confidence interval (CI), were used to report associations. Finally, the p-value < 0.05 was the cut-off point for the significant association.ResultsA total of 446 pregnant women with a mean age of 24.78 (+ 5.20) were included in the study. A total of 236 (52.91%; 95% CI: 48.16–57.63) had iron deficiency. The overall prevalence of anemia and iron deficiency anemia (IDA) was 45.96% (95% CI: 41.32–50.71) and 28.03% (95% CI: 21.27–32.44), respectively. The risk of iron deficiency was more likely among women with low dietary diversity (aRR = 1.36; 95% CI = 1.07–1.72) and those who skipped meals (aRR = 1.29; 95% CI = 1.05–1.57), but less among women who had antenatal care (aRR = 0.73 (95% CI = 0.61–0.88).ConclusionMore than half of the pregnant women in eastern Ethiopia had iron deficiency. Improving dietary diversity, meal frequency, and prenatal follow-up is essential to improve the high burden of ID and the adverse effect on pregnant women and the fetus. Moreover, a prospective study comparing maternal and perinatal outcomes among these spectra—iron depletion, ID, and IDA—is crucial for understanding their impact on maternal and perinatal mortality and morbidity.

Vitamin D Deficiency among Well Nourished and Malnourished Children of School Going age at District Tharparkar

Objective: The most frequent type of nutrient shortage is Vitamin D deficiency, which affects about of half of the world’s population. Vitamin D deficiency responsible for numerous acute and chronic conditions not only in malnourished children but also in well-nourished children. Our objective was to determine vitamin D levels among malnourished and well-nourished school going children at district Tharparkar Pakistan. Design: Cross-sectional study Setting: This study was conducted in Mithi, District Tharparkar among school age-children (between 10-18 years). Vitamin D was estimated by Cobas e411 analyzer Roche (made in Japan). Results were descripted as mean ± SD. Students t test was used to find out the significant of results. A 0.05 or lower p -value was judged as meaningful. Results: 300 children were divided in malnourished and well-nourished groups. Vitamin D deficiency affected 74% of school age children. Boys accounted for 30% of the group, while girls made up 44%. We noticed that 4 girls had severe vitamin D deficiency. Conclusion: Vitamin D deficiency is more prevalent in school going children. Even well-nourished girls are more vitamin D deficit than boys. Children are seen as important members of society and are regarded as the country's future architects. As a result, investing in children's health is the most important factor in improving Pakistan's economic, political, and social conditions, because malnutrition has a significant impact on mental and physical inadequacy. Keywords: Vitamin D, Malnutirion, school going children