Clinical Efficacy of Temocillin Standard Dosing in Patients Treated with Outpatient Antimicrobial Therapy.

In 2020, EUCAST introduced breakpoints for temocillin. Based on these guidelines, reporting of temocillin susceptibility of Enterobacterales in the context of complicated urinary tract infections (cUTI) implicates the use of a high dose of temocillin (2 g q8h) constantly. We aimed to evaluate the clinical outcome of patients treated with the standard dose (4 g/day) of temocillin in outpatient parenteral antimicrobial therapy (tOPAT). Demographics, clinical and treatment parameters, and late clinical cure (at day 30 after tOPAT completion) were recorded. Univariate generalised estimating equation analyses, with clinical cure as outcome variable, were performed to evaluate covariate associations. Fifty-seven tOPAT episodes in 50 patients were included with a median antimicrobial treatment duration of 21 (range 10-228) days, and cUTI was the main indication (87.7%). Late clinical cure was achieved in 85.7% of the tOPAT episodes. Non-disseminated infections and minimal inhibitory concentrations (MIC) values ≤ 8 mg/L were associated with good late clinical outcome. In conclusion, a standard temocillin dose (4 g/day) results in good clinical outcomes in the treatment of cUTIs in tOPAT patients. Therefore, our centre concluded that the use of standard temocillin dosing should be continued instead of the high dose for cUTI in non-critically ill patients infected with Enterobacterales with an MIC ≤ 4 mg/L.

Diagnostic and analytical performance evaluation of ten commercial assays for detecting SARS-CoV-2 humoral immune response.

OBJECTIVE: Analytical validation of newly released SARS-CoV-2 antibody assays in the clinical laboratory is crucial to ensure sufficient performance in respect to its intended use. We aimed to assess analytical and diagnostic performance of 8 (semi-)quantitative assays detecting anti-nucleocapsid IgG (Euroimmun, Id-Vet) or total Ig (Roche), anti-spike protein IgG (Euroimmun, Theradiag, DiaSorin, Thermo Fisher) or both (Theradiag) and 2 rapid lateral flow assays (LFA) (AAZ-LMB and Theradiag). METHODS: Specificity was evaluated using a cross-reactivity panel of 85 pre-pandemic serum samples. Sensitivity was determined at both the manufacturer's and a 95% specificity cut-off level, using 81 serum samples of patients with a positive rRT-PCR. Sensitivity was determined in function of time post symptoms onset. RESULTS: Specificity for all assays ranged from 92.9% to 100% (Roche and Thermo Fisher) with the exception of the Theradiag IgM LFA (82.4%). Sensitivity in asymptomatic patients ranged between 41.7% and 58.3%. Sensitivity on samples taken <10 days since symptom onset was low (23.3%-66.7%) and increased on samples taken between 10 and 20 days and > 20 days since symptom onset (80%-96% and 92.9%-100%, respectively). From 20 days after symptom onset, the Roche, Id-vet and Thermo Fisher assays all met the sensitivity (>95%) and specificity (>97%) targets determined by the WHO. Antibody signal response was significantly higher in the critically ill patient group. CONCLUSION: Antibody detection can complement rRT-PCR for the diagnosis of COVID-19, especially in the later stage, or in asymptomatic patients for epidemiological purposes. Addition of IgM in LFAs did not improve sensitivity.

Circulating calprotectin as biomarker in neutrophil-related inflammation: Pre-analytical recommendations and reference values according to sample type.

BACKGROUND: Calprotectin (CLP) is a promising biomarker for the evaluation of neutrophil-related inflammation. Our aim was to establish reference values for circulating CLP in different sample types and to study the effect of pre-analytical variables. METHODS: Reference values were determined in 100 healthy individuals. Pre-analytical variables were evaluated in 10 healthy controls and four rheumatoid arthritis patients with active disease and covered sample type (serum with/without gel separator, heparin, EDTA and citrate plasma), pre-centrifugation time (<2 h, 6 h, 24 h), storage condition (2-8 °C, 18-25 °C, 30 °C) and storage time (24 h, 72 h, 7 days). CLP measurements were performed with the EliA™Calprotectin 2 assay on Phadia™200 (Thermo Fisher Scientific). RESULTS: In healthy controls, baseline CLP concentrations in serum were more than double the concentration in EDTA and citrate plasma (0.909 µg/mL versus 0.259 µg/mL and 0.261 µg/mL respectively). Heparin, EDTA and citrate stabilized CLP concentrations for up to 6 h before centrifugation, whereas significant increases in CLP levels were observed when serum was left untreated during that time period. CONCLUSION: Clinical studies on circulating CLP need to apply sample type-specific reference values and decision limits. To obtain reproducible CLP results in serum, more stringent pre-analytical sample handling instructions are needed.