Evaluation of the performance of novel rapid diagnostics for COVID-19 at point-of-care

Conditions

COVID-19 U07.1

Lisa J. Krüger, J. Klein, Frank Tobian, Mary Gaeddert, Federica Lainati et al. (54 authors)

Infection2021-08-1242 citations

Head-to-head performance comparison of self-collected nasal versus professional-collected nasopharyngeal swab for a WHO-listed SARS-CoV-2 antigen-detecting rapid diagnostic test.

Klein JAF, Krüger LJ, Tobian F, Gaeddert M, Lainati F, Schnitzler P, Lindner AK, Nikolai O, Knorr B, Welker A, de Vos M, Sacks JA, Escadafal C, Denkinger CM, Study Team.

2021-05-2441 citations

10.1007/s00430-021-00710-9

Evaluation of accuracy, exclusivity, limit-of-detection and ease-of-use of LumiraDx™: An antigen-detecting point-of-care device for SARS-CoV-2.

Lisa J. Krüger, J. Klein, Frank Tobian, Mary Gaeddert, Federica Lainati et al. (23 authors)

Apollo (University of Cambridge)2021-04-301 citations

10.17863/cam.75351

Interventions

Group 1: Potential study participants will be invited through phone calls by the Rhine-Neckar Health Department if they are a suspect of a COVID-19 infection and will be tested in the drive-in. In the

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Suspected COVID-19 cases; preselected by local Public Health department

Exclusion criteria

Exclusion criteria: o Hemodynamic instability as determined by the treating physician o Patient unable to cooperate with respiratory sample collection o Patient unable to give informed consent o Recent history of excessive nose bleeds

Design outcomes

Primary

Measure	Time frame
Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using an RT-PCR reference standard	—

Secondary

Measure	Time frame
1. Time to proficiency, implementation issues, design related issues at POC 2. Point estimates of sensitivity and specificity of index test, with 95% confidence intervals, using an RT-PCR reference standard 3. Survival analysis for the outcome of death within 2-3 months by COVID and Antigen test status	—

Countries

Germany

Contacts

Public ContactClaudia Denkinger

Universitätsklinikum Heidelberg Sektion Klinische Tropenmedizin

claudia.denkinger@uni-heidelberg.de+49 6221 56-36637

Outcome results

None listed