Since Dec 2019, over 70000 novel coronavirus infection pneumonia (NCIP) patients were confirmed. 2019 novel coronavirus (2019 nCoV) is a RNA virus, which spread mainly from person-to-person contact. Most of the symptoms are non-specific, including fever, fatigue, dry cough. Sever NCIP patients may have shortness of breath and dyspnea, and progress to acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The mortality is reported to be around 2.3%. Thus, early detection and early treatment is very important to the improvement of NCIP patients' prognosis. At present, NCIP RNA detection of pharyngeal swab specimen by RT-PCR is recommended. However, due to the universal susceptibility to 2019 nCoV in general population and limited number of NCIP RNA detection kits available, to identify an efficient screening strategy is urgently needed. This study aim to develop and validate the diagnostic accuracy and screening efficiency of a new NCIP screening strategy, which can benefit the disease prevention and control.
This clinical trial is designed to compare the screen accuracy and efficiency of two
screening strategies. Considering that the general population is susceptible to 2019 nCoV, a
great number of people need to be screened for NCIP. The new screening strategy of minipool
testing may not only obtain a comparable accuracy to the standard individual testing, but
also save time and money, which may benefit the current clinical practice.
Diagnostic Test: Standard screening strategy
The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by individual testing.
Diagnostic Test: New screening strategy
The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by minipool testing.
- Who agree to participate in the study and sign written informed consent
- Confirmed NCIP patients
the Fifth Medical Center of Chinese PLA General Hospital
Beijing, Beijing, China
Investigator: Yan Liu, Ph.D.
Yan Liu, Principal Investigator
Beijing 302 Hospital