A non-interventional, fully anonymized study for the comparative evaluation of a new direct detection methods for infection with SARS-CoV-2 (COVID-19) in clinical samples
Organizational Data
- DRKS-ID:
- DRKS00023821
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2020-12-11
- Last update in DRKS:
- 2020-12-11
- Registration type:
- Retrospective
Acronym/abbreviation of the study
LIF-nCov-2019
URL of the study
No Entry
Brief summary in lay language
The overall aim of the current study is the specific detection of SARS-Cov-2 in clinical sample material such as nasopharyngeal swabs, sputum and bronchoalveolar lavage obtained under routine conditions and according to established guidlines using deep UV autofluorescence scanning spectrometer. This methods allows a cost-effective, user friendly, and rapid (< 10 minutes) analysis without chemical consumables. LIF-nCoV-2019 shall allow a rapid diagnosis and cohort isolation and quarantine of SARS-CoV-2 infected individuals. This should facilitate a better control of virus spread and allow a rapid and specific method of virus detection even prior to the establishment of specific PCR or immunoassays also in future pandemics. The envisaged application is for emergency hospitals or test centers and associated with minimal required personal training and no need for laboratory equipment or chemical consumables.
Brief summary in scientific language
The ongoing pandemic of COVID-19 (corona virus disease, 2019) caused by the respiratory infection from the virus SARS-CoV-2 (Severe Acquired Respiratory Syndrome CoronaVirus 2) represents a global public health threat, with millions infected and eventually causing hundreds of thousands of deaths. The ability to detect SARS-CoV-2 with a rapid, highly sensitive and specific method and diagnose infected individuals plays a key role to identify individuals that can transmit the disease to help implement hygiene measures and support medical decision making. Common methods for virus detection such as virus culture or nucleic acid amplification (RT-PCR) are highly specific but time consuming (hours to days) and rapid amplification systems (PCR, isothermal amplification) are restricted due to their high costs. Other methods such as antigen-based diagnostic tests or electron microscopy are lacking sensitivity. Thus, there is an urgent need for robust and rapid, sensitive, specific, user-friendly and cheap detection methods. In studies, deep-UV LIF was successfully applied to differentiate bacteria also in a complex natural environment (Bhartia et al. 2010; Eshelman et al. 2017). Since viruses emit a spectral signature when excited by UV light from the presence of aromatic amino acid in the proteins of the cells (Herzog et al. 1977). The fluorescence cross-section of viruses is 50 to 100-times the cross-section of bacterial cells and spores (YL Pan et al., 2015; Manninen et al. 2014). The fluorescence cross-section of human cells are lower than those of bacteria cells and spores. Recent studies which utilized deep-UV LIF demonstrated the ability to detect single cells and spores in less than 1 s (Bhartia et al. 2010) and proved that bacteria (Hug et al. 2018) and viruses can be differentiated (Babichenko et al. 2018, Gabbarini et al. 2019). Subsequentially, deep-UV LIF was successfully applied to differentiate bacteria also in a complex natural environment (Bhartia et al. 2010; Eshelman et al. 2017). The above studies suggest that spatially resolved deep-UV LIF enables virus identification in nasal swabs at virus concentrations down to 103/ml or less and thus well within the range of the virus load found in patients with SARS-CoV-2.
Health condition or problem studied
- ICD10:
- J12.8 - Other viral pneumonia
- ICD10:
- J84.9 - Interstitial pulmonary disease, unspecified
- Free text:
- COVID-19
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Evaluation of diagnostic method, comparison RT-PCR versus laser-induced fluorescence spectrospcopy for the diagnosis of SARS-CoV-2 infections
- Arm 2:
- Evaluation of diagnostic method, comparison RT-PCR versus laser-induced fluorescence spectrospcopy for the diagnosis of other respiratory diseases respective in patients without respiratory disease
Endpoints
- Primary outcome:
- Detection of SARS-CoV-2 genome by reverse transcriptase polymerase chain reaction (RT-PCR) (specific signal and ct value) versus LIF (laser-induced fluorescence spectroscopy, detection of a specific fluorescence emission spectrum) in respiratory specimen from patients with clinical symptoms of a respiratory infection.
- Secondary outcome:
- -
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center RWTH Aachen
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2020-04-08
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2020-04-30
- Target Sample Size:
- 350
- Final Sample Size:
- 356
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 95 Years
- Additional Inclusion Criteria:
- Patients with respiratory symptoms
Exclusion Criteria
none
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum der RWTH AachenPauwelsstraße 3052074 AachenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukaachen.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum der RWTH AachenProf. Dr. med. Mathias HornefPauwelsstraße 3052074 AachenGermany
- Telephone:
- +49 241 80-89510
- Fax:
- +49 241 80-82483
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukaachen.de
Contact for Public Queries
- Address:
- Universitätsklinikum der RWTH AachenPD Dr. rer. nat. Michael KleinesPauwelsstraße 3052074 AachenGermany
- Telephone:
- +49 241 80-88671
- Fax:
- +49 241 80-82 512
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukaachen.de
Principal Investigator
- Address:
- Universitätsklinikum der RWTH AachenProf. Dr. med. Mathias HornefPauwelsstraße 3052074 AachenGermany
- Telephone:
- +49 241 80-89510
- Fax:
- +49 241 80-82483
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukaachen.de
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum der RWTH AachenPauwelsstraße 3052074 AachenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.ukaachen.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission an der Med. Fakultät der RWTH Aachen am Universitätsklinikum AachenPauwelsstr. 3052074 AachenGermany
- Telephone:
- +49-241-8089963
- Fax:
- +49-241-8082012
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-04-01
- Ethics committee number:
- EK 093/20
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2020-04-08
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- Due to the data protection legislation is the propagation of the orginal data not possible. A cooperation data analysis is possible upon reasonable request.
Study protocol and other study documents
- Study protocols:
- Anfrage Ethikvotum
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry