Simultaneous identification of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis ‒ multicenter evaluation of the Alinity m STI assay

Abstract Objectives Accurate and rapid diagnosis of sexually transmitted infections (STIs) is essential for timely administration of appropriate treatment and reducing the spread of the disease. We examined the performance of the new Alinity m STI assay, a qualitative real-time multiplex PCR test for simultaneous identification of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), and Trichomonas vaginalis (TV) run on the fully automated Alinity m platform. Methods This international, multicenter study evaluated the accuracy, reproducibility, and clinical performance of the Alinity m STI assay compared to commonly used STI assays in a large series of patient samples encountered in clinical practice. Results The Alinity m STI assay identified accurately and precisely single and mixed pathogens from an analytical panel of specimens. The Alinity m STI assay demonstrated high overall agreement rates with comparator STI assays (99.6% for CT [n=2,127], 99.2% for NG [n=2,160], 97.1% for MG [n=491], and 99.4% for TV [n=313]). Conclusions The newly developed Alinity m STI assay accurately detects the 4 sexually transmitted target pathogens in various collection devices across clinically relevant specimen types, regardless of single or mixed infection status

Improved molecular laboratory productivity by consolidation of testing on the new random-access analyzer Alinity m

Abstract Objectives Automated molecular analyzers have accelerated diagnosis, allowing earlier intervention and better patient follow-up. A recently developed completely automated molecular analyzer, Alinity™ m (Abbott), offers consolidated, continuous, and random-access testing that may improve molecular laboratory workflow. Methods An international, multicenter study compared laboratory workflow metrics across various routine analyzers and Alinity m utilizing assays for human immunodeficiency virus type 1 (HIV-1), hepatitis C virus (HCV), hepatitis B virus (HBV), high-risk human papillomavirus (HR HPV), and sexually transmitted infection (STI) (Chlamydia trachomatis [CT]/Neisseria gonorrhoeae [NG]/Trichomonas vaginalis [TV]/Mycoplasma genitalium [MG]). Three turnaround times (TATs) were assessed: total TAT (sample arrival to result), sample onboard TAT (sample loading and test starting to result), and processing TAT (sample aspiration to result). Results Total TAT was reduced from days with routine analyzers to hours with Alinity m, independent of requested assays. Sample onboard TATs for standard workflow using routine analyzers ranged from 7 to 32.5 h compared to 2.75–6 h for Alinity m. The mean sample onboard TAT for STAT samples on Alinity m was 2.36 h (±0.19 h). Processing TATs for Alinity m were independent of the combination of assays, with 100% of results reported within 117 min. Conclusions The consolidated, continuous, random-access workflow of Alinity m reduces TATs across various assays and is expected to improve both laboratory operational efficiency and patient care

Multicenter clinical comparative evaluation of Alinity m HIV-1 assay performance.

Abstract Background Accurate, rapid detection of HIV-1 RNA is critical for early diagnosis, treatment decision making, and long-term management of HIV-1 infection. Objective We evaluated the diagnostic performance of the Alinity m HIV-1 assay, which uses a dual target/dual probe design against highly conserved target regions of the HIV-1 genome and is run on the fully automated Alinity m platform. Study design This was an international, multisite study that compared the diagnostic performance of the Alinity m HIV-1 assay to four commercially available HIV-1 assays routinely used in nine independent clinical laboratories. Alinity m HIV-1 assay precision, detectability, and reproducibility was compared across four study sites. Results The Alinity m HIV-1 assay produced comparable results to currently available HIV-1 assays (correlation coefficient >0.995), with an overall bias of -0.1 to 0.10 Log10 copies/mL. The Alinity m HIV-1 assay and its predecessor m2000 HIV-1 assay demonstrated comparable detection of 16 different HIV-1 subtypes (R2 = 0.956). A high level of agreement (>88 %) between all HIV-1 assays was seen near clinical decision points of 1.7 Log10 copies/mL (50 copies/mL) and 2.0 Log10 copies/mL (200 copies/mL). Alinity m HIV-1 assay precision was 0.08 and 0.21 Log10 copies/mL at VLs of 1000 and 50 copies/mL, respectively, with a high level of detectability (≥97 % hit rate) and reproducibility across sites. Conclusions The Alinity m HIV-1 assay provides comparable diagnostic accuracy to current HIV-1 assays, and when run on the Alinity m system, has the capacity to shorten the time between diagnosis and treatment

Difficulties in the diagnosis of inclusion body myositis case report

© 2019, University of Kragujevac, Faculty of Science. All rights reserved. Inclusion body myositis belongs to the group of idiopathic inflammatory myopathies. Two processes, one autoimmune and the other degenerative, appear to occur in parallel. There are two forms of inclusion body myositis, hereditary and sporadic. Case report: 47-year-old woman with muscle weakness and atrophy of the distal and proximal muscles, and involvement of quadriceps and deep finger flexors was admitted for neuromuscular evaluation. These changes have been started gradually and insidiously over three years. Electromyography findings were nonspecific and for this reason in the beginning of the disease it was misdiagnosed as demyelization peripheral neuropathy. Muscle biopsy, with the presence of characteristic structures such as rimmed vacuoles and amyloid deposits definitely confirmed the diagnosis of inclusion body myositis. Conclusion: There are several difficulties in the diagnosis of inclusion body myositis as nonspecific EMG findings and overreliance on electrophysiology and lack of the cardinal histological features in muscle biopsy. Although this disease is rare and incurable, making the correct diagnosis is crucial to directing the patient to physical therapy for weakness and occupational therapy to improve a patient’s ability in activities of daily living

POPULATION PHARMACOKINETICS OF 25-HYDROXY VITAMIN D IN NON-ELDERLY POSTMENOPAUSAL WOMEN

Introduction/aim: The aims of this study were to develop a population pharmacokinetic (PPK) model for the clearance of 25-hydroxy vitamin D in non-elderly postmenopausal women and to identify the factors which have a significant influence on its clearance. Methods: The study population consisted of postmenopausal women who had been referred for evaluation of bone mineral density (BMD) by DEXA (dual-energy x-ray absorptiometry) scanner. The population pharmacokinetics modelling was conducted using the ADVAN 1 subroutine from a non-linear mixed effects (NONMEM) program, and thirty-two covariates were assessed. Results: A total of 75 serum concentrations were obtained from the same number of postmenopausal women and used for PPK analysis. The mean values of the participants’ age was 57.92±3.93 years and their body weight was 69.76±11.49kg. A wide range of 25-hydroxy vitamin D concentrations was observed (from 3.41 to 61.92ng/mL) with a mean value of 26.19±10.95ng/mL. A total of 32 covariates were examined and preliminary results suggested the influence of six covariates on 25-hydroxy vitamin D clearance. In the final PPK model however, only one covariate was shown to have a significant impact on the clearance value – the mean daily dietary intake dose of vitamin D (DD). Conclusions: These findings offer a preliminary basis on which to determine the level of vitamin D supplementation required by individual postmenopausal women. It could prove particularly important in achieving optimal serum levels of vitamin D in this vulnerable population

Influence of antipsychotics on metabolic syndrome risk in patients with schizophrenia

Objective: Many studies so far have shown that antipsychotic therapy may have an effect on the development of metabolic syndrome in patients diagnosed with schizophrenia. Our goal was to determine whether our respondents are at risk for developing metabolic syndrome and who is more predisposed to it. Methods: In a stable phase, 60 patients diagnosed with schizophrenia were equally divided into three groups according to the drug (risperidone, clozapine, and aripiprazole monotherapy). Control group had 20 healthy examinees. Patients were evaluated first using The Positive and Negative Syndrome Scale (PANSS). Prolactin, lipid status, glycemia, insulin, cytokine values (IL-33, TGF-β, and TNF-α) and C-reactive protein (CRP) were measured. Also, Body mass index (BMI), Homeostatic Model Assesment for Insulin Resistance (HOMA index), waist and hip circumference (WHR) and blood pressure (TA) measurement were performed in the study. Results: Patients treated with risperidone compared to healthy control subjects and aripiprazol group of patients had statistically significant difference in prolactin levels. In clozapine group compared to healthy control group values of HDL cholesterol and glucose level were statistically significant different. In aripiprazole group compared to healthy control group value of BMI was statistically significant different. Statistically significant correlations were found in TNF-α with glucose and HOMA index in risperidone treated patients and with BMI in clozapine group of patients; IL-33 with glucose in risperidone and with BMI in clozapine group of patients and TGF-β with glucose in risperidone group, with insulin and HOMA index in clozapine group and statistically significant negative correlation with LDL cholesterol in aripiprazole group of patients. Conclusion: Patients on risperidone and clozapine therapy may be at greater risk of developing metabolic syndrome than patients treated with aripiprazole. Statistically significant difference in concentration of TNF-α and TGF-β was in the group of patients treated with risperidone compared to healthy control group