Evaluation of the Elecsys SARS-CoV-2 antigen assay for the detection of SARS-CoV-2 in nasopharyngeal swabs.

AIMS: The aim of this study was to evaluate the performance of the automated Elecsys® SARS-CoV-2 antigen assay compared to RT-PCR taken as the gold standard for SARS-CoV-2 detection. METHODS: 225 nasopharyngeal swabs were randomly collected among which 123 were tested positive and 102 negatives for SARS-CoV-2 based on RT-PCR. Antigen dosing were performed on a Cobas 8000 e801 analyzer. RESULTS: The antigen test diagnosed SARS-CoV-2 infection status with an overall sensitivity of 65,85% (95% CI 56,76-74,16%), a specificity of 100% (95% CI 96,49-100%) with a Cut-off value ≥ 1. When the cut-off value for the antigen assay was set to > 0,673 COI, the accuracy reached its highest level with a sensitivity of 74,8% (95% CI 66,2 - 82,2%) and a specificity of 97,1% (95% CI 91,6 - 99,4%). Imprecision was estimated in accordance with manufacturer's claims. CONCLUSIONS: We obtained an overall sensitivity of 65,85% (95% CI 56,76-74,16%) and a specificity of 100% (95% CI 96,49-100%), slightly higher than the results reported by the manufacturer. Yet, it remains relatively low comparatively to what is generally acceptable for these antigenic assays (a relative sensitivity of 80%). We also noticed that the accuracy could reach its highest level if the cut-off is set above 0,673 which is lower than established by the manufacturer. Thus, our results suggest that the Elecsys® SARS-CoV-2 Antigen assays, should be improved prior to be used in a SARS-Cov-2 screening strategy. However, if one antigenic assay could demonstrate acceptable performance, it might be centralized in clinical laboratories, keeping the RT-PCR in a second phase for confirmation.

Malaria in the Republic of Djibouti, 1998-2009.

Historically, native populations in the Republic of Djibouti have experienced only low and unstable malaria transmission and intermittent epidemics. In recent years, efforts at malaria control have been aggressively pursued. This study was performed to inform revised malaria prevention recommendations for military service members and international travelers to the country. Laboratory-confirmed cases of malaria documented at large medical facilities and within military and civilian health care systems in the Republic of Djibouti from 1998 to 2009 were reviewed. In recent years, fewer than 5% of febrile cases among the three largest passive surveillance systems were laboratory-confirmed as malaria, and incidence of confirmed malaria was well below 1/1,000 persons/year. As efforts in the Republic of Djibouti progress toward elimination, and in conjunction with continued efforts at surveillance, emphasizing mosquito-avoidance measures and standby emergency treatment will become reasonable recommendations for malaria prevention.

Zero-length cross-linking reveals that tight interactions between the extracellular and transmembrane domains of the luteinizing hormone receptor persist during receptor activation.

Several molecular models of glycoprotein hormone receptor activation have been proposed. It has been suggested that ligand binding to the ectodomain (ECD) leads to major changes in intramolecular interactions between the ECD and the transmembrane domain. We studied these intramolecular modifications by generating a recombinant LH/CG receptor (LHR) bearing an intramolecular cleavage site. We did this by inserting a furin site at position 316 in the hinge region of the ECD (LHR_Fur316). Affinity for human chorionic gonadotropin (hCG) and cAMP production upon hCG stimulation was identical to those of wild-type LHR. Western blot analysis showed that the LHR_Fur316 receptor was cleaved into two subunits linked by disulfide bridges. Chemical shedding of the ECD from the transmembrane domain did not increase basal adenylate cyclase activity, indicating that the first 294 residues did not act as an inverse agonist. The truncated LHR_316 was still activated by hCG but with an EC50 higher than that for the wild-type receptor. Zero length cross-linking was used to study intramolecular interactions between the two domains of LHR_Fur316. Cross-linking efficiency was similar for the basal and activated states, which indicated that the two domains interacted closely in the basal state, and this tight interaction persisted during activation. Our data suggest that activation of the LHR results from subtle modifications of intramolecular interactions between the two domains and low-affinity binding of hCG to the extracellular loops or residues preceding the first transmembrane segment.

Analytical performance of the Albumin Cobalt Binding (ACB) test on the Cobas MIRA Plus analyzer.

Recently a new biological marker, Ischemia Modified Albumin (IMA), measured by the Albumin Cobalt Binding (ACB) test, was introduced for detection of myocardial ischemia. During ischemia, the metal binding capacity of albumin for certain transition metals like cobalt is reduced. The precise mechanism of action for producing IMA is not known but appears to be related to the production of reactive oxygen species that modify the metal binding sites. The ACB test is a quantitative assay that detects IMA by measuring the cobalt binding capacity of albumin in human serum. We evaluated the analytical characteristics of the ACB test, and reagent and specimen stability, using the Cobas MIRA Plus instrument. Coefficients of variation for within-run and between-run assays were <4%. No significant interference was observed for concentrations of triglycerides and hemoglobin up to 7 mmol/l and 3.8 g/l, respectively. No interference was apparent with bilirubin. Measures from paired samples of heparinized plasma and serum were not equivalent. The assay is validated for commercial use with serum, therefore our study reported results for serum specimens only. All assays were completed within 5 hours after blood withdrawal. The one-sided upper 95th percentile, calculated for the ACB test in 150 healthy subjects, was 87.00 U/ml. There was no observed difference between men and women or with age. We conclude that the ACB test adapted on the Cobas MIRA Plus analyzer is satisfactory, but strict attention to sample handling procedures is necessary to maintain stability of the analyte.

Case report: combination artemether-lumefantrine and haemolytic anaemia following a malarial attack.

A case of a patient who was admitted to hospital in Paris, France, in February 2001 with autoimmune haemolytic anaemia, probably due to artemether-lumefantrine therapy, is presented. Such a complication has previously been observed in patients receiving drugs containing aryl-amino-alcohols but never before in a patient receiving lumefantrine and may be associated with the increase in episodes of blackwater fever seen in recent years.

Rapid identification of atypical variant of plasma butyrylcholinesterase by PCR.

Human butyrylcholinesterase is the enzyme responsible of mivacurium and succinylcholine metabolism, which may be significantly impaired when mutation Asp70Gly is found in patients. We describe a simple PCR method for the detection of this variant. Thirteen out of sixteen patients tested after prolonged apnea were positive for the presence of this mutation (50.0% homozygotes and 31.3% heterozygotes), suggesting that this test contributes to the explanation of some clinical events and to their prevention in relatives of these patients.