Search

Introduction: We performed a multicentre evaluation of the Elecsys®Anti-SARS-CoV-2 immunoassay (Roche Diagnostics), an assay utilising a recombinant protein representing the nucleocapsid (N) antigen, for the in vitro qualitative detection of antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods: Specificity was evaluated using serum/plasma samples from blood donors and routine diagnostic specimens collected before September 2019 (i.e., presumed negative for SARS-CoV-2-specific antibodies); sensitivity was evaluated using samples from patients with polymerase chain reaction (PCR)-confirmed SARS-CoV-2 infection. Point estimates and 95% confidence intervals (CIs) were calculated. Method comparison was performed versus commercially available assays. Results: Overall specificity for the Elecsys Anti-SARS-CoV-2 immunoassay (n= 9575) was 99.85% (95% CI 99.75–99.92): blood donors (n= 6714; 99.82%), routine diagnostic specimens (n= 2861; 99.93%), pregnant women (n= 2256; 99.91%), paediatric samples (n= 205; 100.00%). The Elecsys Anti-SARS-CoV-2 immunoassay demonstrated significantly higher specificity versus LIAISON SARS-CoV-2 S1/S2 IgG (99.71% vs. 98.48%), EUROIMMUN Anti-SARS-CoV-2 IgG (100.00% vs. 94.87%), ADVIA Centaur SARS-CoV-2 Total (100.00% vs. 87.32%) and iFlash SARS-CoV-2 IgM (100.00% vs. 99.58%) assays, and comparable specificity to ARCHITECT SARS-CoV-2 IgG (99.75% vs. 99.65%) and iFlash SARS-CoV-2 IgG (100.00% vs. 100.00%) assays. Overall sensitivity for Elecsys Anti-SARS-CoV-2 immunoassay samples drawn at least 14 days post-PCR confirmation (n= 219) was 93.61% (95% CI 89.51–96.46). No statistically significant differences in sensitivity were observed between the Elecsys Anti-SARS-CoV-2 immunoassay versus EUROIMMUN Anti-SARS-CoV-2 IgG (90.32% vs. 95.16%) and ARCHITECT SARS-CoV-2 IgG (84.81% vs. 87.34%) assays. The Elecsys Anti-SARS-CoV-2 immunoassay showed significantly lower sensitivity versus ADVIA Centaur SARS-CoV-2 Total (85.19% vs. 95.06%) and iFlash SARS-CoV-2 IgG (86.25% vs. 93.75%) assays, but significantly higher sensitivity versus the iFlash SARS-CoV-2 IgM assay (86.25% vs. 33.75%). Conclusion: The Elecsys Anti-SARS-CoV-2 immunoassay demonstrated very high specificity and high sensitivity in samples collected at least 14 days post-PCR confirmation of SARS-CoV-2 infection, supporting its use to aid in determination of previous exposure to SARS-CoV-2.

Zusammenfassung.Bis Anfang der 1990er Jahre waren Blutprodukte nicht selten mit HIV oder HCV kontaminiert, was zu vielen transfusionsbedingten Infektionen führte. Seither wurde die Sicherheit von Blutprodukten in Bezug auf die Infektionsübertragung mit aufwendigen Massnahmen stark erhöht. Aktuell stehen sogenannte (re)emerging-Infektionserreger im Fokus, beispielsweise West Nile-, Zika- und Hepatitis-E-Viren. Ob und wie sich neue Massnahmen, die eine Übertragung dieser Viren verhindern sollen, kosteneffizient einführen lassen, muss mit klar definierten Vorgaben abgeklärt werden. Der entsprechende Entscheid muss gemeinsam mit den involvierten Stakeholdern und auch aufgrund von Kosten-Nutzen-Überlegungen getroffen werden. Grundsätzlich gilt, dass es eine 100-prozentige Sicherheit in Bezug auf die Übertragung von Infektionserregern mit Blutprodukten nie geben wird.

Swiss transfusion medicine currently encompasses 13 Regional Blood Transfusion Services (RBTS) under the Blood Transfusion Service of the Swiss Red Cross Ltd (BTS SRC) which is responsible for quality standards, logistics, and reference activities in immunohaematology and testing for infectious diseases, as well as haematological divisions of several university hospitals. Switzerland covers currently its own needs of labile blood components. According to the law, blood components are drugs and must comply with the actual legal requirements. Furthermore, the BTS SRC has published mandatory guidelines for all RBTS to ensure the standardisation of used methods. Haemovigilance is in charge of Swissmedic and covers all aspects of transfusion medicine, from donor selection to blood transfusion. Measures for preventing immunological and non-immunological risks as well as transfusion-transmitted diseases are also implemented at all stages of the process. The last preventive measures are universal pre-storage leucocyte depletion (in 1999), exclusion from blood donation of individuals who stayed longer than 6 months in the UK (in 2002) or have previously been transfused (in 2004). Mandatory screening of blood donations includes anti-HIV 1/2, HIV NAT, anti-HCV, HCV NAT, HBsAg, anti-Treponema pallidum and alaninaminotransferase. In the last years the calculated residual risk for transfusion-transmitted HIV or HCV was approximately 1:2-3 million and for HBV approximately 1: 200,000-300,000. Future challenges are the maintenance of self-sufficiency, the sustained recruitment of dedicated staff and the rising costs.

Lacerations in alpine ski racers caused by the sharp metal edge of the ski are potentially severe and even life-threatening injuries. To date, there has been little published on these injuries. This case series reports on 5 cases of severe lacerations in alpine ski racers and details slope side management, initial evaluation, and definitive treatment. By publishing this case series, it is hoped to promote further investigation into the mechanism of these injuries and strategies for prevention.Study Design: Case series.Level of evidence: Level 4C.