Evaluation of analytical and clinical performance of the AFIAS Tn-I plus assay - a new point-of-care.

BACKGROUND: The objective of this evaluation was to determine the analytical and clinical performance of the AFIAS point-of-care (POC) Tn-I Plus assay (Boditech Med Inc). DESIGN AND METHODS: Limit of detection (LOD), limit of quantification (LOQ), repeatability, reproducibility, inter- and intra-individual CV were evaluated using the CLSI guidelines. The study was also designed to estimate the 99th percentile upper reference limit (URL) and to assess the diagnostic sensitivity and specificity. RESULTS: The precision repeatability CVs were 6.7-8.5% and reproducibility was 7.5-7.6%. The LOD and LOQ were consistent with the manufacturer's specified values of 0.010 ng/mL and 0.030 ng/mL, respectively. The 99th percentile URLs for males (aged 18-75 years) and females (aged 17-65 years) in serum were 0.0300 ng/mL (7.8% CV) and 0.0239 ng/mL (9.4% CV) respectively. Overall 99th percentile URL was 0.0296 ng/mL (8.2% CV). For the overall apparently healthy population, the percentage of measurable cardiac troponin I (cTn-I) values below the 99th percentile (i.e. 0.0296 ng/mL) and above the assay's LOD (= 0.010 ng/mL) was 47,68% (391/820 samples). The diagnostic sensitivity and specificity were 100% with 95% CI (97% - 100%) and 95.2% with 95% CI (93.6% - 96.5%), respectively. No significant differences were observed for the diagnosis of acute myocardial infarction (AMI) between AFIAS Tn-I plus and Abbott ARCHITECT High Sensitive Troponin-I. CONCLUSION: The clinical performance of AFIAS Tn-I Plus assay for AMI is comparable to the established Abbott ALINITY STAT High Sensitive Troponin-I. This assay is suitable for routine use in clinical laboratories.

Covid-19: contribution of clinical characteristics and laboratory features for early detection of patients with high risk of severe evolution.

BACKGROUND: The aim of this study was to identify early clinical and laboratory predictive factors of a severe coronavirus disease 2019 (COVID-19). METHODS: A retrospective study was conducted on adult patients hospitalized for COVID-19 in our hospital. Diagnosis was based on a positive real-time reverse transcription-polymerase chain reaction (RT-PCR) on nasopharyngeal samples. The cohort was divided into two groups, i.e. a favorable evolution (FE) group and an unfavorable evolution (UFE) group, including intensive care unit (ICU) and deceased patients.Results: A total of 198 patients were enrolled in the study, with 138 FE (70%) and 60 UFE (30%). Older age, male gender, comorbidities and dyspnea at admission constituted significantly worse prognosis factors. Among laboratory features, lymphocyte and platelet counts as well as corrected glomerular filtration rate were significantly lower in UFE patients, while neutrophil to lymphocyte ratio, inflammation biomarkers, creatinine, aspartate aminotransferase, lactate dehydrogenase (LDH), glycemia and D-dimer were significantly higher. Procalcitonin and LDH appeared as the most accurate variables according to receiver operating characteristic curves. CONCLUSIONS: This Belgian study revealed clinical and laboratory features able to predict high risk of ICU requirement, or even death, at admission time. These results provide a potential tool for patient's triage in a context of pandemic.Abbreviations: COVID-19: coronavirus disease 2019; ARDS: acute respiratory distress syndrome; DIC: disseminated intravascular coagulopathy; MOF: multi-organ failure; RT-PCR: real-time reverse transcription-polymerase chain reaction; UFE: unfavorable evolution; ICU: intensive care unit; EDTA: ethylenediamine tetraacetic acid; WBC: white blood cell count; Hb: hemoglobin level; PCT: procalcitonin; Na: sodium; K: potassium; PT: total protein, CRP: c-reactive protein; Cr: creatinine; ALAT: alanine aminotransferase; ALAT: aspartate aminotransferase; TB: total bilirubin, LDH: lactate dehydrogenase, FERR: ferritin; hs-Tnt: high sensitive-troponin T; cGFR: corrected glomerular filtration rate; QR: quick ratio; DDIM: D-dimer; FIB: fibrinogen; SD: standard deviation; IQR: interquartile ranges; ROC: receiver operating characteristics; ECMO: extracorporeal membrane oxygenation; NLR: neutrophil to lymphocyte ratio; AUC: area under the curve; BMI: body mass index.