Test of a Covid-19 rapid test used by lay persons based on a lateral flow immuno assay compared with aPCR assay. Detection of Covid 19 antigens
Conditions
Interventions
Group 1: one arm, non intervention
The probands will perform only one self test with the Clungene Rapid Test Covid 19 under observation. The reference test is a PCR test performed by a clinical labor
Sponsors
Hangzhou Clongene Biotech Co., Ltd.No. 1 Yichuang Road, Yuhang Sub-district, Yuhang District 311121Hangzhou, China
Eligibility
Sex/Gender
All
Age
7 Years to 85 Years
Inclusion criteria
Inclusion criteria: - Persons with the ages of 7 to 85 - Persons with and without symtoms of Covid 19 and with or without confirmed Covid 19 infection -Persons with confirmed Covid 19 only until the day 7 after the positiv PCR test or the onset of clinical symptoms - written consens of the probands after elucidation, for underaged persons until age of 18 years the written consent of the parents
Exclusion criteria
Exclusion criteria: -Persons with the age of lower than 7 years or age hgher than 85 years -Persons with a bias to noose bleeding -Skilled medical staff familiar with lateral flow tests - Dylexics persons -Certifiably insane persons -Persons that had participated at the test before
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Is the CLUNGENE COVID-19 Antigen Rapid Test save and easy to handle by lay persons? Comparison of the results of the CLUNGENE COVID-19 Antigen Rapid Test with a PCR reference test. The test will be observed and recorded by skilled persons. | — |
Secondary
| Measure | Time frame |
|---|---|
| Is the CLUNGENE COVID-19 Antigen Rapid Test suitable for the usage by lay persons? Observed and recorded by a skilled person. | — |
Countries
Germany
Contacts
Public ContactMichael Zieger
SRH Wald-Klinikum Gera GmbHZentrum für klinische Studien
Outcome results
None listed