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Die mit Anti-Neutrophilen zytoplasmatischen Antikörpern (ANCA) assoziierten Vaskulitiden (AAV) sind eine seltene Erkrankung mit potenziell schwerem Verlauf. Betroffene Patienten sollten möglichst schnell diagnostiziert und gemäß aktueller Studienlage einer geeigneten Therapie zugeführt werden. In der Behandlung der AAV gab es in den letzten Jahren beachtliche Fortschritte, so dass mittlerweile eine weitgehend evidenzbasierte Therapie mittels Immunsuppressiva und Biologika möglich ist. Die Leitlinie zur Diagnostik und Therapie der ANCA-assoziierten Vaskulitiden wurde mit dieser Leitlinie von S1-Niveau (2017) auf S3-Niveau angehoben. Diese Leitlinie ist die erste deutsche Leitlinie zur Diagnostik und Therapie der AAV auf S3-Niveau.

Lateral-flow assays (LFAs) are quick, simple and cheap assays to analyze various samples at the point of care or in the field, making them one of the most widespread biosensors currently available. They have been successfully employed for the detection of a myriad of different targets (ranging from atoms up to whole cells) in all type of samples (including water, blood, foodstuff and environmental samples). Their operation relies on the capillary flow of the sample throughout a series of sequential pads, each with different functionalities aiming to generate a signal to indicate the absence/presence (and, in some cases, the concentration) of the analyte of interest. To have a user-friendly operation, their development requires the optimization of multiple, interconnected parameters that may overwhelm new developers. In this tutorial, we provide the readers with: (i) the basic knowledge to understand the principles governing an LFA and to take informed decisions during lateral flow strip design and fabrication, (ii) a roadmap for optimal LFA development independent of the specific application, (iii) a step-by-step example procedure for the assembly and operation of an LF strip for the detection of human IgG and (iv) an extensive troubleshooting section addressing the most frequent issues in designing, assembling and using LFAs. By changing only the receptors, the provided example procedure can easily be adapted for cost-efficient detection of a broad variety of targets. This tutorial describes how to design nanoparticle-based LFAs for detecting biomolecules. The authors provide guidance on how to select the appropriate lateral-flow strip components and bioreceptors as well as detection strategies.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a global pandemic in 2020. Testing is crucial for mitigating public health and economic effects. Serology is considered key to population-level surveillance and potentially individual-level risk assessment. However, immunoassay performance has not been compared on large, identical sample sets. We aimed to investigate the performance of four high-throughput commercial SARS-CoV-2 antibody immunoassays and a novel 384-well ELISA. We did a head-to-head assessment of SARS-CoV-2 IgG assay (Abbott, Chicago, IL, USA), LIAISON SARS-CoV-2 S1/S2 IgG assay (DiaSorin, Saluggia, Italy), Elecsys Anti-SARS-CoV-2 assay (Roche, Basel, Switzerland), SARS-CoV-2 Total assay (Siemens, Munich, Germany), and a novel 384-well ELISA (the Oxford immunoassay). We derived sensitivity and specificity from 976 pre-pandemic blood samples (collected between Sept 4, 2014, and Oct 4, 2016) and 536 blood samples from patients with laboratory-confirmed SARS-CoV-2 infection, collected at least 20 days post symptom onset (collected between Feb 1, 2020, and May 31, 2020). Receiver operating characteristic (ROC) curves were used to assess assay thresholds. At the manufacturers' thresholds, for the Abbott assay sensitivity was 92·7% (95% CI 90·2–94·8) and specificity was 99·9% (99·4–100%); for the DiaSorin assay sensitivity was 96·2% (94·2–97·7) and specificity was 98·9% (98·0–99·4); for the Oxford immunoassay sensitivity was 99·1% (97·8–99·7) and specificity was 99·0% (98·1–99·5); for the Roche assay sensitivity was 97·2% (95·4–98·4) and specificity was 99·8% (99·3–100); and for the Siemens assay sensitivity was 98·1% (96·6–99·1) and specificity was 99·9% (99·4–100%). All assays achieved a sensitivity of at least 98% with thresholds optimised to achieve a specificity of at least 98% on samples taken 30 days or more post symptom onset. Four commercial, widely available assays and a scalable 384-well ELISA can be used for SARS-CoV-2 serological testing to achieve sensitivity and specificity of at least 98%. The Siemens assay and Oxford immunoassay achieved these metrics without further optimisation. This benchmark study in immunoassay assessment should enable refinements of testing strategies and the best use of serological testing resource to benefit individuals and population health. Public Health England and UK National Institute for Health Research.

Lateral flow (immuno)assays are currently used for qualitative, semiquantitative and to some extent quantitative monitoring in resource-poor or non-laboratory environments. Applications include tests on pathogens, drugs, hormones and metabolites in biomedical, phytosanitary, veterinary, feed/food and environmental settings. We describe principles of current formats, applications, limitations and perspectives for quantitative monitoring. We illustrate the potentials and limitations of analysis with lateral flow (immuno)assays using a literature survey and a SWOT analysis (acronym for “strengths, weaknesses, opportunities, threats”). Articles referred to in this survey were searched for on MEDLINE, Scopus and in references of reviewed papers. Search terms included “immunochromatography”, “sol particle immunoassay”, “lateral flow immunoassay” and “dipstick assay”.

Establishing an effective signal amplification strategy is the key to achieving sensitive detection of analytes by electrochemical immunoassay. In this work, a novel sandwich-type electrochemical immunosensor with dual-signal amplification was successfully constructed using PtPd/Cu-TCPP(Fe) as the sensing platform and mesoporous silicon dioxide as the signal amplifier. Firstly, two-dimensional wrinkled Cu-TCPP(Fe) nanomaterials loaded with PtPd nanoparticles have strong affinity for the immobilization of capture antibodies and can generate excellent electrochemical signals. Meanwhile, the mesoporous silicon dioxide with large steric hindrance was used as signal label to further improve the sensitivity of the immunosensor by increasing the difference of the current response signal. Under optimal experimental conditions, the electrochemical immunosensor exhibited a wide linear detection range from 0.1 pg/mL to 1.0 [mu]g/mL, with a detection limit as low as 0.166 fg/mL. The experimental results showed that the constructed immunosensor has a great application prospect in clinical biomarker detection.

Ultrabright green-emissive AIE nanoparticles (AIENPs) were used as signal-amplification probes to enhance the detectability of lateral flow immunoassay (LFIA). The detection performances of the green-emissive AIENP probes in both sandwich and competitive LFIA formats were systematically evaluated. Benefiting from its remarkable fluorescent brightness, the developed AIENP-LFIA showed versatile applicability for the detection of small molecules and macromolecules by using ochratoxin A (OTA) and procalcitonin (PCT) as model analytes, respectively. Under the optimum conditions, the detection limits (LODs) of the fabricated AIENP-LFIA for OTA and PCT were 0.043 ng mL −1 and 0.019 ng mL −1 , respectively. These LOD values are significantly lower than those of conventional LFIA methods using gold nanoparticles as signal reporters. In addition, we demonstrated the practical application potential of AIENP-LFIA for the detection of OTA in real maize samples and PCT in real serum samples. These results indicated that the ultrabright green-emissive AIENPs were promising as signal output materials for building high-performance LFIA platform and broadening the application scenarios of LFIA. Graphical Abstract

This study aimed to evaluate the performance and clinical laboratory adaptability of the Mindray SAL9000 biochemical immunoassay automation system, ensuring compliance with ISO 15189 standards and relevant national requirements. We conducted comprehensive performance verification tests on 21 biochemical analytes and 15 immunoassays, including precision, accuracy, linear bias, measurement range assessments, interference testing, reference range validation, inter-instrument comparison, and carryover verification. The Mindray SAL9000 demonstrated high performance across various parameters, with all analytes showing good linearity and minimal bias. While specific interfering substances affected some analytes, the system showed excellent resistance to common interferences such as hemolysis, ascorbic acid, and jaundice. The inter-instrument comparison with the BS2000M and Roche 702 indicated a good correlation, with most parameters showing biases of less than 10%, although exceptions were noted for ALT and AST. In conclusion, the Mindray SAL9000 meets clinical requirements through its high precision, excellent accuracy, and broad measurement range, making it a reliable and adaptable choice for clinical outpatient and emergency laboratories.