The Fourth Universal Definition of Myocardial Infarction Global Taskforce recommends the use of high sensitive troponin (hs-Tn) assays in the diagnosis of acute myocardial infarction. We evaluated ...the analytical performance of the Atellica IM High-sensitivity Troponin I Assay (hs-TnI) (Siemens Healthcare Diagnostics Inc., Tarrytown, USA) and compared its performance to other hs-TnI assays (Siemens Advia Centaur, Dimension Vista, Dimension EXL, and Abbott Architect (Wiesbaden, Germany)) at one or more sites across Europe.
Precision, detection limit, linearity, method comparison, and interference studies were performed according to Clinical and Laboratory Standards Institute protocols. Values in 40 healthy individuals were compared to the manufacturer’s cut-offs. Sample turnaround time (TAT) was examined.
Imprecision repeatability CVs were 1.1–4.7% and within-lab imprecision were 1.8–7.6% (10.0–25,000 ng/L). The limit of blank (LoB), detection (LoD), and quantitation (LoQ) aligned with the manufacturer’s values of 0.5 ng/L, 1.6 ng/L, and 2.5 ng/L, respectively. Passing-Bablok regression demonstrated good correlations between Atellica IM analyser with other systems; some minor deviations were observed. All results in healthy volunteers fell below the 99th percentile URL, and greater than 50% of each sex demonstrated values above the LoD. No interference was observed for biotin (≤ 1500 µg/L), but a slight bias at 5.0 g/L haemoglobin and 50 ng/L Tn was observed. TAT from was fast (mean time = 10.9 minutes) and reproducible (6%CV).
Real-world analytical and TAT performance of the hs-TnI assay on the Atellica IM analyser make this assay fit for routine use in clinical laboratories.
The SARS-CoV-2 virus has caused tremendous healthcare burden worldwide. Our focus was to develop a practical and easy-to-deploy system to predict the severe manifestation of disease in patients with ...COVID-19 with an aim to assist clinicians in triage and treatment decisions. Our proposed predictive algorithm is a trained artificial intelligence-based network using 8,427 COVID-19 patient records from four healthcare systems. The model provides a severity risk score along with likelihoods of various clinical outcomes, namely ventilator use and mortality. The trained model using patient age and nine laboratory markers has the prediction accuracy with an area under the curve (AUC) of 0.78, 95% CI: 0.77–0.82, and the negative predictive value NPV of 0.86, 95% CI: 0.84–0.88 for the need to use a ventilator and has an accuracy with AUC of 0.85, 95% CI: 0.84–0.86, and the NPV of 0.94, 95% CI: 0.92–0.96 for predicting in-hospital 30-day mortality.
Display omitted
•Algorithm using 9 laboratory markers & age may predict severity in patients with COVID-19•Model was trained and tested on a multicenter sample of 10,937 patients•Algorithm can predict ventilator use (NPV, 0.86) and mortality (NPV, 0.94)•High NPV suggests utility as an adjunct to aid in triaging of patients with COVID-19
Classification Description: Virology; Diagnostics; Artificial intelligence; Machine learning
The contribution of the clinical laboratory to diagnostics is increasingly important since a great deal of clinical decisions rely on laboratory test results.
Parathyroid hormone (PTH) measurement ...presents a considerable analytical variability due to the heterogeneity of its circulating forms and the antigenic configuration of the different assays commercially available. Such variability may have an impact on pathological conditions associated with significant increases in circulating PTH, as it is the case of chronic kidney disease (CKD).
Despite the recent identification of new molecules involved in bone and mineral disorders associated with CKD, such as klotho or the fibroblastic factor 23 (FGF23), nephrologists still base their clinical decisions on PTH concentrations. The problem is that unawareness of these analytical considerations may cause errors in the clinical interpretation of test results.
This systematic review addresses these issues from the clinical laboratory perspective and proposes new approaches related to PTH method selection and result expression. These new strategies will help laboratory medicine specialists and nephrologist better determine the status of CKD patients.
To assess the impact of the COVID-19 pandemic on the activity of clinical laboratories in Spain.
A descriptive, observational, retrospective, multicenter study.
Between March and December 2020, there ...was a statistically significant decrease in the number of test requests (-17.7%, p=<0.001) and total tests performed (-18.3%, p<0.001) with respect to the same period in 2019. A decrease was observed in the number of requests from primary care (-37.4%) (p<0.001) and in the number of foecal occult blood (-45.8%); qualitative urine (-30.1%); PSA (-28.5%); TSH (-27.8%); total cholesterol (-27.2%) and HbA
(-24.7%) tests performed, p<0.001. A significant increase was found in the number of requests from ICUs (76.6%, p<0.001) and number of IL-6 (+22,350.9), D-dimer (+617.2%), troponin (+46.8%) and arterial blood gas (+3.9%) tests carried out, p<0.001. During the first months of 2021, there were significant changes in the number of requests for qualitative urine (-8.7%, p<0.001), PSA (-6.3%, p=0.009), IL-6 (+66,269.2, p<0.001), D-dimer (+603.6%, p<0.001), troponin (+28.7%, p<0.001), arterial blood gas (+26,2%, p=0.014) and ferritin (+16.0%, p=0.002) tests performed.
There were changes in the origin and number of test requested to clinical laboratories in Spain. The number of requests for the evaluation and monitoring of COVID-19 patients increased, whereas requests for the control of non-COVID patients and for population screening decreased. Long-term analysis reveals that the volume of tests performed for the control of chronic diseases returned to normal over time, whereas the increase observed in the volume of tests performed for the management of COVID-19 patients is maintained.
The use of specific test panels (STP) for heart failure (HF) could help improve the management of this condition. The purpose of this study is to gain an insight into the level of implementation of ...STPs in the management of HF in Spain and gather the opinions of experts, with a special focus on parameters related to iron metabolism.
The opinions of experts in HF were gathered in three stages STAGE 1 as follows: level of implementation of STPs (n=40). STAGE 2: advantages and disadvantages of STPs (n=12). STAGE 3: level of agreement with the composition of three specific STPs for HF: initial evaluation panel, monitoring panel, and
panel (n=16).
In total, 62.5% of hospitals used STPs for the clinical management of HF, with no association found between the use of STPs and the level of health care (p=0.132) and location of the center (p=0.486) or the availability of a Heart Failure Unit in the center (p=0.737). According to experts, the use of STPs in clinical practice has more advantages than disadvantages (8 vs. 3), with a notable positive impact on diagnostics. Experts gave three motivations and found three limitations to the implementation of STPs. The composition of the three specific STPs for HF was viewed positively by experts.
Although the experts interviewed advocate the use of diagnostic and monitoring STPs for HF, efforts are still necessary to achieve the standardization and homogenization of test panels for HF in Spanish hospitals.
Growth Differentiation Factor 15 (GDF-15) is a marker of inflammation and oxidative stress that has been associated with multiple age-related chronic diseases. Since lifestyle is key for preventing ...these adverse health outcomes, we examined the association between a Mediterranean lifestyle and GDF-15 serum concentrations in Spanish older adults.
We used cross-sectional data from 2502 older adults participating in the Seniors ENRICA-2 cohort. Adherence to the Mediterranean lifestyle was assessed with the 27-item MEDLIFE index, divided into three blocks: 1) “Mediterranean food consumption, 2) Mediterranean dietary habits, 3) Physical activity, rest, social habits, and conviviality”. Analyses of the association between the MEFLIFE index and GDF-15 concentrations were performed using multivariable linear regression models adjusting for the main potential confounders.
The MEDLIFE index was inversely associated with GDF-15. Compared with participants in the lowest quartile of the MEDLIFE score, GDF-15 mean percentage differences (95% CI) were −3.0% (−8.0, 2.3) for the second quartile, −8.7% (−13.0, −4.1) for the third quartile, and −10.1% (−15.0, −4.9) for the fourth quartile (p-trend<0.001). Block 3 of MEDLIFE, and particularly doing sufficient physical activity, adequate sleep duration, and participating in collective sports, was individually linked to lower concentrations of GDF-15. Results remained similar after excluding participants with cardiovascular disease, type 2 diabetes, or obesity.
A Mediterranean lifestyle was associated with reduced levels of GDF-15, suggesting that a combination of multiple lifestyles may be an integral approach to reduce chronic inflammation and disease burden in older adults.
Display omitted
•Adherence to MEDLIFE index was associated with lower GDF-15 levels in older adults.•Physical activity, rest, social habits and conviviality was the main contributor.•Combining lifestyle factors may be an integral approach to reduce inflammaging.•Modest improvements in circulating GDF-15 may have public health relevance.
Growth differentiation factor 15 (GDF-15) is a biomarker for aging and chronic disease burden that may capture the anti-inflammatory and antioxidant effects attributed to healthy diets.
The aim was ...to examine whether several healthy dietary patterns and a lower inflammatory potential of diet are associated with lower concentrations of GDF-15 in older adults.
We used cross-sectional data from 2501 older adults participating in the Seniors-ENRICA-2 study. Four diet indices were derived from habitual food consumption estimated with a validated diet history: Mediterranean Diet Adherence Screener (MEDAS), Alternate Healthy Eating Index–2010 (AHEI-2010), Dietary Approaches to Stop Hypertension (DASH), and Dietary Inflammatory Index (DII). Associations of these indices with GDF-15 concentrations were analyzed using linear regression models and adjusted for risk factors and biomarkers associated with chronic disease.
There was a clear dose–response association between all dietary patterns and serum GDF-15 concentrations; the GDF-15 mean reductions (95% CI) per 1-SD increment in the diet indices were 1.6% (0.1%, 3.1%) for the MEDAS, 2.1% (0.5%, 3.7%) for the AHEI-2010, and 1.6% (0.1%, 3.2%) for the DASH, whereas a mean GDF-15 increase of 1.7% (0.2%, 3.4%) was observed per 1-SD increment in the DII. In analyses excluding fruit and vegetable components from the diet indices, the association for the MEDAS and the AHEI-2010 remained but was attenuated for the DASH. Analyses excluding participants with cardiovascular disease or diabetes rendered very similar results.
A higher adherence to several healthy dietary patterns and a lower inflammatory potential of diet were related to lower concentrations of GDF-15 in older adults, suggesting that improving diet quality may reduce inflammation and possibly promote healthy aging.
▪
When using biological variation (BV) data, BV estimates need to be robust and representative. High-endurance athletes represent a population under special physiological conditions, which could ...influence BV estimates. Our study aimed to estimate BV in athletes for metabolism and growth-related biomarkers involved in the Athlete Biological Passport (ABP), by 2 different statistical models.
Thirty triathletes were sampled monthly for 11 months. The samples were analyzed for human growth hormone (hGH), insulin-like growth factor-1 (IGF-1), insulin-like growth factor binding protein 3 (IGFBP-3), insulin, and N-terminal propeptide of type III procollagen (P-III-NP) by immunoassay. Bayesian and ANOVA methods were applied to estimate within-subject (CVI) and between-subject BV.
CVI estimates ranged from 7.8% for IGFBP-3 to 27.0% for insulin, when derived by the Bayesian method. The 2 models gave similar results, except for P-III-NP. Data were heterogeneously distributed for P-III-NP for the overall population and in females for IGF-1 and IGFBP-3. BV components were not estimated for hGH due to lack of steady state. The index of individuality was below 0.6 for all measurands, except for insulin.
In an athlete population, to apply a common CVI for insulin would be appropriate, but for IGF-1 and IGFBP-3 gender-specific estimates should be applied. P-III-NP data were heterogeneously distributed and using a mean CVI may not be representative for the population. The high degree of individuality for IGF-1, IGFBP-3, and P-III-NP makes them good candidates to be interpreted through reference change values and the ABP.
Iodine is required for the synthesis of thyroid hormone (TH), but its natural availability is limited. Dehalogenase1 (Dehal1) recycles iodine from mono- and diiodotyrosines (MIT, DIT) to sustain TH ...synthesis when iodine supplies are scarce, but its role in the dynamics of storage and conservation of iodine is unknown.
-knockout (
KO) mice were generated by gene trapping. The timing of expression and distribution was investigated by X-Gal staining and immunofluorescence using recombinant Dehal1-beta-galactosidase protein produced in fetuses and adult mice. Adult
KO and wild-type (
) animals were fed normal and iodine-deficient diets for 1 month, and plasma, urine, and tissues were isolated for analyses. TH status was monitored, including thyroxine, triiodothyronine, MIT, DIT, and urinary iodine concentration (UIC) using a novel liquid chromatography with tandem mass spectrometry method and the Sandell-Kolthoff (S-K) technique throughout the experimental period.
Dehal1 is highly expressed in the thyroid and is also present in the kidneys, liver, and, unexpectedly, the choroid plexus.
transcription of
was induced by iodine deficiency only in the thyroid tissue. Under normal iodine intake,
KO mice were euthyroid, but they showed negative iodine balance due to a continuous loss of iodotyrosines in the urine. Counterintuitively, the UIC of
KO mice is twofold higher than that of
mice, indicating that S-K measures both inorganic and organic iodine. Under iodine restriction,
KO mice rapidly develop profound hypothyroidism, while
mice remain euthyroid, suggesting reduced retention of iodine in the thyroids of
KO mice. Urinary and plasma iodotyrosines were continually elevated throughout the life cycles of
KO mice, including the neonatal period, when pups were still euthyroid.
Plasma and urine iodotyrosine elevation occurs in Dehal1-deficient mice throughout life. Therefore, measurement of iodotyrosines predicts an eventual iodine shortage and development of hypothyroidism in the preclinical phase. The prompt establishment of hypothyroidism upon the start of iodine restriction suggests that
KO mice have low iodine reserves in their thyroid glands, pointing to defective capacity for iodine storage.
Cardiotoxicity (CTox) is a major side effect of cancer therapies, but uniform diagnostic criteria to guide clinical and research practices are lacking.
We prospectively studied 865 patients, aged ...54.7 ± 13.9; 16.3% men, scheduled for anticancer therapy related with moderate/high CTox risk. Four groups of progressive myocardial damage/dysfunction were considered according to current guidelines: normal, normal biomarkers (high-sensitivity troponin T and N-terminal natriuretic pro-peptide), and left ventricular (LV) function; mild, abnormal biomarkers, and/or LV dysfunction (LVD) maintaining an LV ejection fraction (LVEF) ≥50%; moderate, LVD with LVEF 40-49%; and severe, LVD with LVEF ≤40% or symptomatic heart failure. Cardiotoxicity was defined as new or worsening of myocardial damage/ventricular function from baseline during follow-up. Patients were followed for a median of 24 months. Cardiotoxicity was identified in 37.5% patients during follow-up 95% confidence interval (CI) 34.22-40.8%, 31.6% with mild, 2.8% moderate, and 3.1% with severe myocardial damage/dysfunction. The mortality rate in the severe CTox group was 22.9 deaths per 100 patients-year vs. 2.3 deaths per 100 patients-year in the rest of groups, hazard ratio of 10.2 (95% CI 5.5-19.2) (P < 0.001).
The majority of patients present objective data of myocardial injury/dysfunction during or after cancer therapy. Nevertheless, severe CTox, with a strong prognostic relationship, was comparatively rare. This should be reflected in protocols for clinical and research practices.