scholarly journals Clinical performance of the Roche Elecsys SARS-CoV-2 antigen fully automated electrochemiluminescence immunoassay

2022 ◽  
pp. e00265
Author(s):  
Gian Luca Salvagno ◽  
Laura Pighi ◽  
Simone De Nitto ◽  
Giuseppe Lippi
Keyword(s):  
Clinical Performance ◽  
Electrochemiluminescence Immunoassay

scholarly journals Clinical performance of the Roche Elecsys SARS-CoV-2 Antigen fully automated electrochemiluminescence immunoassay

2021 ◽  
Author(s):  
Gian Luca Salvagno ◽  
Laura Pighi ◽  
Simone De Nitto ◽  
Giuseppe Lippi
Keyword(s):  
Sensitivity And Specificity ◽  
Clinical Performance ◽  
Area Under The Curve ◽  
Molecular Testing ◽  
Molecular Test ◽  
Rt Pcr ◽  
Antigen Concentration ◽  
Cycle Threshold ◽  
Electrochemiluminescence Immunoassay ◽  
Design And Methods

Abstract Objective: We assessed the clinical performance of novel Roche Elecsys SARS-CoV-2 Antigen fully automated electrochemiluminescence immunoassay (ECLIA). Design and Methods: We tested 160 subjects, 110 (68.8%) with positive molecular test for SARS-CoV-2 infection in nasopharyngeal samples with Altona Diagnostics RealStar SARS-CoV-2 RT-PCR Kit and Roche Elecsys SARS-CoV-2 Antigen. The local imprecision was validated by analyzing three nasopharyngeal samples with different antigen concentration (1.84, 9.51 and 423.30 TCID50/mL) for 20 consecutive times (intra-assay imprecision) or for 10 consecutive working days (inter-assay imprecision).Results: The local intra- and inter-assay imprecision of Elecsys SARS-CoV-2 Antigen ECLIA was found to be comprised between 2.0-2.0% and 5.8-7.6%, yielding to a total imprecision of 6.2-7.8%. Highly significant correlation was found between Elecsys SARS-CoV-2 Antigen ECLIA and cycle threshold (Ct) values of SARS-CoV-2 S and E genes (both r=-0.91; p<0.001). The area under the curve (AUC), sensitivity and specificity of Elecsys SARS-CoV-2 Antigen ECLIA were 0.83, 0.43 and 1.00 in all samples, 0.99, 0.87 and 0.99 in those with both Ct values <30, as well as 1.00, 1.00 and 0.89 in samples with both Ct values <25. Conclusion: Roche Elecsys SARS-CoV-2 Antigen ECLIA may be a surrogate of molecular testing for identification of super-spreaders.

578 Analytical and clinical performance of NT-proBNP immunoassay

2003 ◽  
Vol 2 (1) ◽  
pp. 125-126
Author(s):  
C PRONTERA ◽  
C PASSINO ◽  
A IERVASI ◽  
G ZUCCHELLI ◽  
A CLERICO ◽  
...  
Keyword(s):  
Clinical Performance

Use of Receiver Operating Characteristic (ROC) Curves to Evaluate Computer Confidence Threshold and Clinical Performance in the Diagnosis of Appendicitis

1978 ◽  
Vol 17 (03) ◽  
pp. 157-161 ◽  
Author(s):  
F. T. De Dombal ◽  
Jane C. Horrocks
Keyword(s):  
Receiver Operating Characteristic ◽  
Operating Characteristic ◽  
Clinical Performance ◽  
Roc Curves ◽  
Final Diagnosis ◽  
Confidence Threshold ◽  
Computer Aided ◽  
Computer Confidence ◽  
Overall Performance ◽  
Receiver Operating

This paper uses simple receiver operating characteristic (ROC) curves (i) to study the effect of varying computer confidence of threshold levels and (ii) to evaluate clinical performance in the diagnosis of acute appendicitis. Over 1300 patients presenting to five centres with abdominal pain of short duration were studied in varying detail. Clinical and computer-aided diagnostic predictions were compared with the »final« diagnosis. From these studies it is concluded the simplistic setting of a 50/50 confidence threshold for the computer program is as »good« as any other. The proximity of a computer-aided system changed clinical behaviour patterns; a higher overall performance level was achieved and clinicians performance levels became associated with the »mildly conservative« end of the computers ROC curve. Prior forecasts of over-confidence or ultra-caution amongst clinicians using the computer-aided system have not been fulfilled.

The Role of Stent Design and Polymers in Safety Outcomes – A Review

2012 ◽  
Vol 8 (1) ◽  
pp. 63
Author(s):  
Carlo Zivelonghi ◽  
Giulia Geremia ◽  
Michele Pighi ◽  
Flavio Ribichini ◽  
◽  
...  
Keyword(s):  
Clinical Performance ◽  
Drug Carrier ◽  
Chemical Properties ◽  
Vascular Wall ◽  
Radial Force ◽  
Vascular Trauma ◽  
Polymer Composition ◽  
Drug Eluting Stent ◽  
Stent Design ◽  
Drug Elution

Each component of a drug-eluting stent (DES) contributes to the safety of the device. Continuous efforts are being dedicated to the search of the optimal compromise between facility of use, safety and long-term efficacy. Shorter balloons reduce the vascular trauma beyond the stent struts; the metallic composition of the stent platform and the platform itself interact with the vascular wall in a long-lasting equilibrium between radial force, vessel patency and reparative cellular regrowth. The modality of drug elution is largely regulated by the chosen drug carrier, rather than by the chemical properties of the drug itself. Drug elution can be accomplished by permanent polymers that remain in the vessel wall forever, by biodegradable polymers that leave the naked metallic structure behind after their complete absorption, or even by direct release of the drug from stent reservoirs. The clinical performance of DESs has been exhaustively assessed in a large number of studies that have showed rapid and continuous improvements, from the first-generation DESs to the latest devices, based on substantial changes in stent design and polymer composition.

Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry

2020 ◽  
Vol 22 (2) ◽  
pp. 94-100 ◽  
Author(s):  
Bernardo Cortese ◽  
Luca Testa ◽  
Gaetano Di Palma ◽  
Tay M. Heang ◽  
Irene Bossi ◽  
...  
Keyword(s):  
Coronary Artery Disease ◽  
Coronary Artery ◽  
Clinical Performance ◽  
Artery Disease
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