Architect Ci8200 Research Articles

Verification of the analytical performance of the serum magnesium assay on Abbott Architect ci8200

Magnesium is recognized as the fourth most important cation in the body and the second most abundant intracellular cation, following potassium. Its physiological significance lies in its capacity to form complexes with crucial intracellular anionic ligands, notably ATP, and its ability to compete with calcium for specific binding sites on proteins and cell membranes. Over 300 enzyme reactions rely on magnesium. The concentration of free magnesium within cells determines the magnesium content of these enzymes. Magnesium influences myocardial contraction and the electrical activity of myocardial cells, as well as the specialized conduction systems of the fetus, by modulating the transmembrane movements of ions like sodium, potassium, and calcium. Furthermore, magnesium can affect the contractility of vascular smooth muscle, and alterations in intracellular magnesium levels may impact cell proliferation or contraction. Magnesium is involved in nucleic acid and protein metabolism, intermediary metabolism, energy production, and consumption reactions, and it plays specific roles in various physiological systems such as the neuromuscular and cardiovascular systems. Our research aims to assess the analytical accuracy of the serum magnesium assay method utilizing an Abbott kit on the Architect ci8200 automated system in the biochemistry laboratory of Mohammed VI University Hospital of Oujda. The evaluation of the kit's analytical accuracy was conducted within the flexible scope A by conducting a performance analysis on the Architect ci8200. We examined repeatability, reproducibility, measurement imprecision, and compared results between two Architect ci8200 instruments. All findings align with the acceptability criteria recommended by the supplier and the Valtec protocol of the Société Française de Biologie Clinique (SFBC), indicating overall satisfactory outcomes for the study. The Architect ci8200 automated system demonstrated satisfactory analytical performance for reliably determining serum magnesium levels. Method verification in medical laboratories is essential to guarantee the accuracy, precision, and reliability of test results. Verification entails confirming that the test method used is suitable for its intended purpose, yields result consistent with the claimed performance characteristics, and meets the laboratory's quality control and quality assurance standards.

Verification of the analytical performance of serum creatinine determination by enzymatic method on Architect ci8200

Verification of the analytical performance of serum creatinine determination by enzymatic method on Architect ci8200

Monoclonal Gammopathies of Undetermined Significance and Abnormal Serum Protein Rates Prevelance in Blood Donors: For Improved Transfusion Safety

ABSTRACT Background and Objectives: Protein abnormalities include monoclonal gammopathies of undetermined significance (MGUS) and malignant lymphoplasmacytic tumors such as multiple myeloma (MM), Waldenström macroglobulinemia, and amyloid light-chain amyloidosis. MGUS prevalence increases with age, especially in individuals over 50. MGUS progresses to various lymphoplasmacytic diseases, including smoldering MM and MM. Almost all blood donors (BDs) are asymptomatic but some of them could present protein abnormalities. Our objective was to assess the prevalence and impact of protein abnormalities and monoclonal gammopathies (MGs) on transfusion safety among BDs in Morocco. Methods: Two hundred eighty-one serum samples were collected from BDs aged over 40 years old. Total serum protein measurement and protein electrophoresis were performed using the Architect ci8200 and Capillarys-2-Piercing automated systems, respectively. Immunofixation was conducted using hydrates. Results: Protein levels ranged between 59 and 87 g/L (average = 71.69 ± 4.96 g/L). Our results showed 195 (69.39%) normal profiles, 6 (2.13%) MGs, 14 (4.98%) heterogeneous restriction of γ-globulins, and 66 other abnormalities (23.48%) regarding the levels of albumin and proteins from alpha and beta fractions. Conclusion: Our preliminary results appeal to blood transfusion professionals regarding ethical considerations and transfusion safety. BDs with abnormal protein levels should benefit systematically from diagnostic tests and therapies.

A Study Estimating the Serum TSH Levels in First Trimester Pregnant Women

Background Pregnancy is a physiological condition among women. Pregnancy brings about major changes in the hormonal levels. Thyroid stimulating hormone is a hormone produced by anterior pituitary. TSH provides the most common sensitive index to reliably detect thyroid function abnormalities.ObjectiveThe goal of this study was to estimate the levels of serum TSH at first trimester in pregnant women in the department of Biochemistry St. Johnrsquos Medical College amp Hospital and compare with the biological reference intervals as established in the laboratory. Methodology This retrospective study was conducted from January to December 2021 in the department of Biochemistry St. Johnrsquos Medical College amp Hospital. Lab data review of pregnant women has been analysed for serum TSH. The study included 228 pregnant women in their first trimester aged between 20 and 35 years. Serum TSH levels were measured using the ABBOTT ARCHITECT CI8200 through Chemiluminometric Immunoassay. The collected data underwent analysis and comparison to derive descriptive statistics.Result A total of 228 pregnant women in the first trimester fulfilling the inclusion criteria were included. Maternal age of the study population was 20-35 years. Among the pregnant women 12 5.3 women showed low values for TSH lt0.35 microIUMl 11 4.8 women showed higher values for TSH gt4.94 microIUmL and 205 89.9 showed normal TSH levels during first trimester. In this study the mean TSH level in pregnant women was found to be 1.94plusmn1.50 microIUmL. The median TSH levels was 1.51 microIUmL 2.5th and 97.5th percentiles P2.5-P97.5 0.23-5.86 microIUmL.Conclusion The observed connection between aberrant TSH serum levels during the first trimester and adverse pregnancy outcomes underscores the necessity for proactive screening. Identifying pregnant women with elevated or reduced TSH levels early on holds significant potential for preventing complications. The incorporation of such screening protocols can yield a range of benefits including timely interventions and enhanced management strategies to mitigate adverse outcomes. Our research contributes to the growing body of evidence supporting TSH screening during early pregnancy emphasizing its pivotal role in safeguarding maternal and foetal health.

Verification of analytical performance of sodium assay on the Abbott architect ci8200: Experience of the central laboratory Mohammed VI Oujda

Introduction: Sodium is the main extracellular cation. It plays a fundamental role in maintaining osmotic pressure and hydroelectrolyte balance, and is therefore implicated in many pathological conditions. Sodium determination is a basic biochemistry laboratory test. Objective: the aim of our work is to verify the method of sodium determination by potentiometry on the Architect CI 8200 automated system (Abbott), in order to meet the quality requirements for laboratory accreditation under standard NF ISO 15189. Materials and methods: following the recommendations of NF EN ISO 15189, we evaluated the repeatability, intermediate precision, accuracy and uncertainty of measurement of the serum sodium assay on the Architect CI 8100 automated system, as well as a mirror comparison of the two Architect CI 8100 1 and 2. The CV values obtained were compared with those set by learned societies (SFBC and RICOS). Results and discussion: The results obtained show satisfactory repeatability for the 3 low, medium and high levels, with CV1= 1.1%, CV2=0.8% and CV3= 0.76% respectively, and satisfactory intra-laboratory reproducibility for the 3 low, medium and high levels, with CV1= 1.05%, CV2= 0.95% and CV3= 0.75% respectively. For comparison, the Bland-Altman diagram showed that the mean bias between the two automata was of the order of 0.29%, the correlation coefficient r= 0.98 with a mean difference of 0.40 mmol/l, a standard deviation of 0.675 mmol/l and a linear regression equation Y = 1.027 X - 4.073. Corrective measures were envisaged to remedy the various errors identified. To solve any malfunction in a sustainable way, it is essential to search for the anomaly by applying the Ishikawa diagram. Conclusion: The results obtained have enabled us to verify the performance of the sodium assay method and compare it with the analytical objectives set, in order to meet the regulatory and normative requirements to which our laboratory is committed.

Verification of analytical performance of the aspartate aminotransferase assay on the Abbott Alinity ci®: Experience of the central laboratory Mohammed VI Oujda

The standard NF EN ISO 15 189 mandates the verification of analytical methods. It involves evaluating an analytical method's effectiveness in accordance with a precisely laid out protocol before comparing it to previously established analytical objectives. Any biologist must be concerned with mastering this approach. In this work, we compare two automats: Alinity ci ® and Architect ci-8200® Abbott, to show the results of the protocol of verification of the method of determination of aspartate aminotransferase (AST). Aspartate aminotransferase is an enzyme found in many tissues, particularly liver and muscle, including heart muscle. Its measurement is particularly useful for diagnosing and monitoring liver disease.

Verification of the analytical performance of the serum total cholesterol assay on Abbott Architect ci8200

Serum total cholesterol measurement is an essential aspect of preventive healthcare as high levels of cholesterol are linked to various diseases such as atherosclerosis, heart attacks, and strokes. Serum cholesterol measurement is a simple blood test that assesses the levels of cholesterol in the bloodstream. It is an important diagnostic tool that helps healthcare professionals evaluate a patient's risk of developing cardiovascular disease and make decisions regarding treatment and lifestyle changes. Our study aims to verify the analytical performance of the serum total cholesterol assay method using an Abbott kit on the Architect ci8200 automated system in the biochemistry laboratory of the Mohammed VI University Hospital of Oujda. The analytical performance of the kit was verified through flexible scope A by performing a performance study on the Architect ci8200. We evaluated the repeatability, the reproducibility, the imprecision of the measurements and the comparison between two Architect ci8200 automatons. All the results obtained are in conformity with the acceptability criteria recommended by the supplier and the Valtec protocol of the ‘Société Française de Biologie Clinique’ (SFBC), and the study is globally satisfactory. The analytical performance of the Architect ci8200 automated system was satisfactory for a reliable determination of total cholesterol. Verification of methods of dosage in the medical laboratory is crucial to ensure the accuracy, precision, and reliability of laboratory test results. Verification involves confirming that the test method employed is appropriate for the intended use, produces results that are consistent with the claimed performance characteristics, and meets the laboratory's quality control and quality assurance requirements.

Verification of the analytical performance of the serum gamma-glutamyl transferase assay on the Abbott Alinity ci®: Experience of the biochemistry laboratory of the Mohammed VI university hospital of Oujda

Introduction: As part of our study, we set out to evaluate the analytical performance of the gamma-glutamyl transferase (GGT) assay using an Abbott kit on the Alinity ci® automated system in the biochemistry laboratory of the CHU Mohammed VI in Oujda. Materials and methods: This study assessed the repeatability and reproducibility of Alinity ci® and compared the results obtained by the Alinity ci® and Architect ci-8200® automated systems. Results: The results obtained met the acceptability criteria recommended by the supplier and the Valtec protocol of the Société Française de Biologie Clinique (SFBC), demonstrating overall satisfaction with the study. The Alinity ci® automated system demonstrated the analytical performance required for accurate and reliable determination of GGT levels. Discussion: Validation of an analytical method is an essential step in guaranteeing that the result obtained is as close as possible to the reference value of a sample. Several standards and technical guides set out requirements for the performance criteria of an analytical method, notably NF EN ISO 15 189. Conclusion: the verification study of the GGT assay method produced satisfactory results, providing a high level of reliability for analysis results from the central laboratory of the CHU Mohammed VI d'Ouja. This work forms an essential basis for developing an accreditation procedure, which is part of the quality approach to which our laboratory is committed.

Verification of analytical performance of the microalbumin assay on the Abbott Alinity ci®: Experience of the central laboratory Mohammed VI Oujda

The verification of analytical methods is a requirement of the standard NF EN ISO 15 189. It consists of evaluating the performance of an analytical method according to a well-defined protocol and then comparing it with pre-established analytical objectives. The mastery of this approach must be the concern of any biologist. Through this work we present the results of the protocol of verification of the method of determination of microalbumin by comparing two automats: Alinity ci ® and Architect ci-8200® Abbott. Microalbumin monitoring in urine is an important element in the treatment of diabetes mellitus types I and II. It can also be used to predict diabetic nephropathy, which is the leading cause of death in people with insulin-dependent diabetes.

Comparison of Jaffe Method and Enzymatic Method at Measuring Serum Creatinine Level, Creatinine Clearance and Estimated Glomerular Filtration Rate.

Correct measuring of blood and urine creatinine level is necessary for identification and tracking of chronic kidney disease (CKD). The aim of this study is a comparison of Jaffe and enzymatic methods for measuring creatinine in serum and in urine, in order to determine whether there are any statistical significant differences between them, and whether they are reflected on creatinine clearance calculation and estimated glomerular filtration rate (eGFR). Creatinine in serum and urine was measured for the group of patients (N=60; female=34, male=26) from 24 to 69 years of age by using Jaffe's method on Dimension RxL biochemical analyzer, and enzymatic method on integrated biochemical and immunochemical analyzer Architect ci8200, and obtained levels are used for creatinine clearance calculation and eGFR. The methods correlate well, both in measuring serum creatinine (r 1 = 0.990) and in measuring urine creatinine (r 2 =0.974). There are no statistically significant differences between them (p=0.57). Measuring creatinine using different methods showed no statistically significant differences in the calculated clearances (p=0.93), they significantly correlate (r=0.9722). eGFR, using the MDRD and CKD-EPI formulas, were not statistically significantly different, regardless of the used method. Apart from significant correlations between the used methods, the results of using the Jaffe and enzymatic methods showed no significant differences at measuring serum creatinine level, or creatinine clearance and glomerular filtration rate.

Comparison of Jaffe Method and Enzymatic Method at Measuring Serum Creatinine Level, Creatinine Clearance and Estimated Glomerular Filtration Rate.

Correct measuring of blood and urine creatinine level is necessary for identification and tracking of chronic kidney disease (CKD). The aim of this study is a comparison of Jaffe and enzymatic methods for measuring creatinine in serum and in urine, in order to determine whether there are any statistical significant differences between them, and whether they are reflected on creatinine clearance calculation and estimated glomerular filtration rate (eGFR). Creatinine in serum and urine was measured for the group of patients (N=60; female=34, male=26) from 24 to 69 years of age by using Jaffe's method on Dimension RxL biochemical analyzer, and enzymatic method on integrated biochemical and immunochemical analyzer Architect ci8200, and obtained levels are used for creatinine clearance calculation and eGFR. The methods correlate well, both in measuring serum creatinine (r 1 = 0.990) and in measuring urine creatinine (r 2 =0.974). There are no statistically significant differences between them (p=0.57). Measuring creatinine using different methods showed no statistically significant differences in the calculated clearances (p=0.93), they significantly correlate (r=0.9722). eGFR, using the MDRD and CKD-EPI formulas, were not statistically significantly different, regardless of the used method. Apart from significant correlations between the used methods, the results of using the Jaffe and enzymatic methods showed no significant differences at measuring serum creatinine level, or creatinine clearance and glomerular filtration rate.

Verification of the analytical performance of the serum aminotransferase assay on Architect ci8200

The objective of our work is the evaluation of analytical performance by verifying the method of determination of serum aminotransferases by an Abbott kit on two Architect ci8200 automatons in the biochemistry laboratory of Mohammed VI University Hospital of Oujda. The verification of the analytical performance of the aminotransferase assay kits is performed on two Architect ci8200® automatons of Abbott in the biochemistry laboratory of Mohammed VI University Hospital of Oujda. All items are checked according to the flexible scope A. We performed a performance study of each of the two automata, by evaluating the repeatability, reproducibility, measurement inaccuracy and comparison between these two automata. The results obtained for the study are satisfactory overall and meet the acceptability criteria recommended by the supplier and the French Society of Clinical Biology (FSCB) Valtec protocol. The Architect ci8200 automaton presents the analytical performances required for a reliable determination of aminotransferases. The accuracy and reliability of the results obtained during an examination are conditioned not only by the laboratory personnel, the equipment and the environmental conditions, but also by the methods and their eventual validation or verification.

The relationship between C-reactive protein, anthropometric parameters and lipids in menopausal transition.

Aim To investigate the relationship between C-reactive protein, anthropometric parameters, and lipids in women in the menopausal transition. Methods This cross-sectional study included 150 women divided into three groups: premenopausal (n=50), perimenopausal (n=50), and postmenopausal (n=50). All women were interviewed, body mass index (BMI) and waist-hip ratio (WHR) values were calculated, and a blood sample was taken for laboratory analysis. The values of the lipids were determined including triglycerides, total cholesterol, and high-density lipoprotein (HDL) cholesterol, while low-density lipoprotein (LDL) and very-low-density lipoprotein (VLDL) cholesterol values were obtained through formulas. The concentration of CRP was determined by immunoturbidimetry on the Architect ci8200 device. Results The BMI of postmenopausal women was significantly higher than that of premenopausal (p=0.025) and perimenopausal women (p=0.010). The ratio of the waist-hip circumference of postmenopausal women was significantly higher than the ratio of the waist-hip circumference of premenopausal women (p<0.001), as well as that of perimenopausal women (p<0.001). A significant difference in CRP concentration was found only between the postmenopausal and premenopausal groups (p=0.009). CRP significantly positively correlated with BMI in all three groups. A significant positive correlation was found between CRP and WHR in the perimenopause and in the postmenopause group. No significant correlation was found between CRP and lipid parameters in any group. Conclusion An increase in body weight or obesity in the postmenopausal period, increase in CRP concentration, and positive correlation between these parameters suggest that entering menopause could mean a potential increase in the risk of developing cardiovascular and metabolic diseases.

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.

Association of vitamin-D with hypothyroidism in adult female patients in north Indian population

Background: Thyroid disorder is found to be most commonly occurring endocrine disorder in females. Thyroid hormones have an imperative position in metabolic methods in human body, and several physiological and pathological stimuli are known to influence thyroid metabolism. The increased incidence of hypovitaminosis D was diagnosed in population with hypothyroidism. Objective: To check the relation of Vitamin D in adult female patients diagnosed with hypothyroidism. Method: We recruited 60 patients and divided these patients into two groups, Group-1- Hypothyroidism patients (n=30) and Group-2- Control patients (n=30). Thyroid-Stimulating Hormone (TSH), total Triiodothyronine (T3), total Thyroxine (T4), and Vitamin D levels were estimated by automated method in Abbott ARCHITECT ci8200 machine. Results: In the present study we found patients with hypothyroidism 73.3% (n=22) has low level of Vitamin D while 26.6% (n=8) of population have normal level of Vitamin D. We could not find significant association between Vitamin D and hypothyroidism (p&gt;0.05). Conclusion: Our study concluded that hypothyroidism has no significant role in lowering the levels of Vitamin D but we also emphasize the fact that Vitamin D should be done as routine investigation in healthy as well as hypothyroidism patients as its value was also less in control subjects.

Measurement of Urinary Ammonium Using a Commercially Available Plasma Ammonium Assay.

Determination of urinary ammonium excretion is helpful in evaluating patients with acid-base disorders, chronic kidney disease, and nephrolithiasis. However, urinary ammonium levels are only measured by specialized laboratories in the United States, limiting widespread implementation. We evaluated the performance of a plasma ammonium assay to quantify urinary ammonium excretion and also determined ammonium stability under a variety of conditions. An enzymatic plasma ammonium assay (Randox) was modified to measure urinary ammonium concentration. Urine samples were diluted 40-fold and then assayed on an Abbott Architect ci8200 analyzer. Assay precision, limit of quantitation, and linearity were determined. The method was compared against the formalin titration method, and stability studies were conducted at different temperatures and pH. After dilution, the assay had total precision of 18% at 2.54 mmol/L, 5% at 15.58 mmol/L, and 2% at 29.49 mmol/L, with a limit of quantitation of 2.92 mmol/L. Assay performance was linear in the range of 0.7-45 mmol/L. Method comparison against the formalin method showed a slope of 0.98 and intercept of -0.37 mmol/L. Urinary ammonium was determined to be stable for 48 hours at room temperature and for 9 days at 4°C and -20°C at pH 5.6-6.3. Ammonium was less stable at pH 3.8 and 8.5. When stored at -80°C, urinary ammonium was stable for at least 24 months. The modified enzymatic plasma ammonium assay reliably quantifies urine ammonium at physiologic concentrations. It compares well with the formalin titration method and is suitable for routine clinical use on an automated chemistry analyzer.

Relationship between serum IgE levels and psoriasis area and severity index (PASI) score in psoriasis vulgaris

Introduction: Psoriasis is an immune system-mediated inflammatory disorder characterized by skin inflammation, epidermal hyperplasia, and other comorbidities. Based on medical data from H. Adam Malik hospital in 2011, the proportion of psoriasis vulgaris incidence was 0.81%. It is important to assess the severity of the disease. The most frequently used measuring instrument is the Psoriasis Area and Severity Index (PASI) score. Elevated serum IgE levels have been reported in some cases of psoriasis. The relationship between serum IgE levels and psoriasis severity is controversial. The study aimed to determine the relationship between serum IgE levels and PASI scores in psoriasis vulgaris.Method: An observational analytic study with a cross-sectional approach to 37 subjects of psoriasis vulgaris at Haji Adam Malik General Hospital Medan. Patients who meet the criteria are recorded with basic data in personal identity, history taking, physical examination, and dermatological examination. Furthermore, the calculation of the Psoriasis Area and Severity Index (PASI) score and serum IgE levels using ARCHITECT CI8200 with Quantia IgE reagent. The data will be analyzed using SPSS.Results: Psoriasis vulgaris mostly occurs in women (54.1%) with the most age group 31-45 years (40.5%). The median age was 35 years with a range of 21-67 years. The proportion of study subjects with high serum IgE levels (?100) was 26 people (70.3%) with a median of 130 IU/ml and a range of 25-475.5 IU/ml. Based on the PASI score, the highest proportion were subjects with moderate and mild PASI scores as many as 21 people (56.8%) and 13 people (35.1%). The median PASI score was 6, with a range of 0.5 – 10.40. The results of the Pearson correlation test (p) serum IgE levels and PASI scores obtained p-value = 0.0001, which indicated that the relationship between serum IgE levels and PASI scores was significant. The value of the correlation coefficient (r) of 0.909 indicates that the direction of the positive correlation with the strength of the correlation is very strong.Conclusion: There is a relationship between serum IgE levels and Psoriasis Area and Severity Index (PASI) scores in psoriasis vulgaris.

Frequency of COVID-19 IgG Antibodies among Special Police Squad Lahore, Pakistan.

To find out the sero-prevalence of COVID-19 IgG antibodies among policemen performing duties at high risk areas of Lahore, Pakistan. Cross-sectional, observational study. Chughtai Lab Lahore from 20th to 30th May 2020. One hundred and fifty-four young policemen (mean age 27.1 ±3.8 years) were included in the study after written consent. Squad officers who had any sign of acute respiratory infection were excluded from the study. The participants were asked to fill a questionnaire regarding nature of exposure with the infected cases, kind of personal protective equipment they are provided with and living arrangements. Three ml of blood samples were collected from the participants and immediately sent to the lab for analysis. COVID-19 IgG antibodies were analysed using chemiluminescence immunoassay method on Architect Ci8200 (Abbott). SPSS 23.0 was used for data analysis. All participants were males and mean age was 27.1 ±3.8 years. Out of 154 squad members, 24 were reactive for COVID-19 IgG antibodies and performing duties at the areas of high virus exposure. None of COVID-19 IgG reactive cases exhibited symptoms and most of them performed duties at high risk areas with only masks provided as personal protective equipment. Only 10% of the participants who were exposed to confirmed cases of COVID-19 were found to have anti-COVID IgG. COVID-19 IgG antibody reactive cases may not show any symptoms. Police force is at high risk of exposure. Serosurveys can help to find the spread of infection in the community and aid in planning healthcare strategies. Key Words: COVID-19, SARS CoV-2, Seroprevalence, Pandemic, Asymptomatic cases.

Thyroid stimulating hormone values of clinical decisions of hypothyroidism measurement by three different automated immunoassays

Background: An accurate measurement of serum thyroid stimulating hormone (TSH) is crucial for a thyroid disorder diagnosis and management. We compared the values of TSH between three automated immunoassays with aims to provide insights into variations in TSH levels that are important for a clinical decision: 2.50 mIU/L, 4.00 mIU/L and 10.00 mIU/L.Methods: We measured TSH with three different fully automated immunoassays: Abbott (Architect ci8200), Siemens (ADVIA Centaur XP) and Roche (Cobas e411). Serum was collected from 110 patients between August 2018 and January 2019. The results were compared using the Passing–Bablok regression method. Additionally, linear regression coefficients were calculated after logarithmic transformation of data.Results: Although all three regression coefficients were high (r2 > 0.98), the slopes from Passing–Bablok plots for the correlation of Abbott with either Roche or Siemens were merely 0.66 and 0.73, respectively. The slope for the correlation of Roche and Siemens was 1.11. Consecutively, the results obtained by the Roche and Siemens methods were proportionally higher than those obtained by the Abbott method (38% and 52%, respectively) at all measured ranges.Conclusions: Although immunoassays correlated among themselves, they cannot achieve the same values for clinical decisions for hypothyroidism (clinical requirements). Clinicians should be conscious of these limitations. A harmonisation of the methods is needed to meet clinical requirements and to enable appropriate clinical decisions in cases of hypothyroidism.Likewise, we suggest the introduction of borderline and high risk values of TSH for hypothyroidism depending on immunoassays to avoid misdiagnosis.

Hepatitis C virus core antigen as a possible alternative for evaluation of treatment effectiveness after treatment with direct-acting antivirals

ABSTRACTBackground: Chronic hepatitis C is a major public health problem around the world. In monitoring treatment efficacy, although costly and labour-intensive methods of molecular biology are often used, much cheaper and technically easier serological methods evaluating the concentration of HCV core antigen in serum are available. We evaluated HCVcAg quantification as a possible assessment of the treatment efficacy instead of HCV RNA quantification.Methods: We collected 514 serum samples from treated HCV infected patients. Quantitative evaluation of HCV RNA and HCVcAg was carried out before treatment, at the end of treatment, and at least 12 weeks following treatment termination. HCV RNA was determined by automated assay (Roche COBAS) and HCVcAg quantitation with ARCHITECT ci8200 analyser.Results: There was a significant correlation between HCVcAg and HCV RNA concentrations at baseline and follow-up visits, but not at the end of treatment. Among samples collected before the treatment, at the end of treatment and follow-up visit, concordance of HCV RNA and HCVcAg reached level of 98.1%, 98.9% and 98.7%, respectively. Diagnostic sensitivity, specificity, positive and negative predictive values of HCVcAg detection were >97%.Conclusions: HCVcAg measurement could be an alternative for determining HCV treatment efficacy after chemotherapy and could be an option in the diagnosis of HCV infection.