Objectives: Atellica Solution (AS) is a platform that incorporates immunoassay and chemistry modules. AS is fitted with a refrigerated storage module (RSM) for internal quality controls (QC). The objective of this study was to assess the maximum permissible storage time in AS for QCs.
Methods: A total of 48 analytes were tested using QC materials: Liquid Assayed Multiqual (MQ), Liquichek Immunology (LI), Liquichek Lipids (LL), and Liquichek Urine Chemistry (UC). The percentage of variation between results (Xt%) was calculated as the difference between the mean value of the triplicate performed at every time point of the study (Xt) and the average of the triplicate performed in the baseline time (Xo). Stability was assessed based on the total change limit (TCL), which combines analytical and biological variation: TCL=±√((1.65 * CVa)2 + (0.5 * CVb)2).
Results: A total of 40 of the 48 analytes tested remained stable at the end of the study. In relation to MQ and UC QCs, 32 of the 39 analytes remained stable for the whole study period (15 days) except for alkaline phosphatase, aspartate aminotransferase, calcium, lactate dehydrogenase, and total bilirubin in MQ, and chlorine and glucose in UC. In LI and LL QCs, eight of the nine analytes were stable throughout the 20 days of the study, except transferrin in LI.
Conclusions: The Atellica Solution refrigerated storage module is a reliable system for the storage of quality control materials.
Objectives: Diabetes mellitus intensify the risks and complications related to COVID-19 infection. A major effect of the pandemic has been a drastic reduction of in-person visits. The aim of this study was to evaluate the impact of the COVID-19 pandemic on HbA1c management and results among pediatric and adult outpatients with diabetes, considering the laboratory and point-of-care testing (POCT) HbA1c measurements.
Methods: Observational retrospective study including patients from pediatric and adult diabetes units was conducted. HbA1c results obtained in the laboratory and POCT over 3 years (2019-2021) were collected from the laboratory information system.
Results: After the lockdown, the number of HbA1c plummeted. Children returned soon to routine clinical practice. The number of HbA1c increased gradually in adults, especially in POCT. Globally, HbA1c results were lower in children compared with adults (p<0.001). HbA1c values in children (p<0.001) and adults (p=0.002) decreased between pre-pandemic and post-pandemic periods, though lower than the HbA1c reference change value. The percentage of HbA1c results above 8% remained stable during the study period.
Conclusions: Continuous glucose monitoring and a telemedicine have been crucial, even allowing for improvements in HbA1c results. During the lockdown, patients with better metabolic control were managed in the laboratory whereas patients with poorer control or a severe clinical situation were attended in diabetes units by POCT. Adults returned to pre-pandemic management slowly because they were more susceptible to morbidity and mortality due to COVID-19. Coordination among all health professionals has been essential to offering the best management, especially in difficult scenarios such as the COVID-19 pandemic.
Objectives: Laboratory Medicine is a crucial discipline that contributes to the diagnosis, management and monitoring of patients. This branch of medicine faces two major challenges: New technologies and increased demand. There is limited information available of the state of affairs in Laboratory Medicine in Spain. This study provides a picture of clinical laboratories and clinical laboratory professionals.
Methods: The Spanish Society of Laboratory Medicine distributed a questionnaire among the 250 most representative centers (the ones with the largest volume of determinations and training programs), of which 174 (69.6%) returned the questionnaire providing data for 2019.
Results: Laboratories were classified according to the number of determinations. In total, 37% identified themselves as small (<1 million determinations per year); 40% considered themselves medium-sized (1-5 million determinations per year) and 23% considered they were large laboratories (>5 million determinations). The level of specialization of laboratory physicians and laboratory performance were higher in large laboratories. Most requests (87%) and determinations (93%) corresponded to biochemistry and hematology. As many as 63% of physicians had an indefinite contract, and 23% were older than 60 years.
Conclusions: Laboratory medicine is a consolidated discipline that is gaining relevance in Spain. It adds value to the diagnosis, prognosis and follow-up of diseases, and to treatment response monitoring. The results of this study will help us address challenges such as the need for specialized training for laboratory professionals; the emergence of technological innovations; exploitation of Big Data; optimization of quality management systems and patient safety.
The proper clinical approach to a wide range of disorders relies on the availability of accurate, reproducible laboratory results for sexual steroids measured using methods with a high specificity and sensitivity. The chemiluminescent immunoassays currently available have analytical limitations with significant clinical implications. This position statement reviews the current limitations of laboratory techniques for the measurement of estradiol and testosterone and their impact on diverse clinical scenarios. A set of recommendations are provided to incorporate steroid hormone analysis by mass spectrometry in national health systems. International societies have recommended this methodology for a decade.
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