A New Screening Strategy for 2019 Novel Coronavirus Infection

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection

Conditions
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Novel Coronavirus Infection Pneumonia

Intervention / Treatment
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* Diagnostic Test: Standard screening strategy
* Diagnostic Test: New screening strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Who agree to participate in the study and sign written informed consent Exclusion Criteria: Confirmed NCIP patients
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Screening participants<br> | Diagnostic Test: Standard screening strategy<br>* The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by individual testing.<br>Diagnostic Test: New screening strategy<br>* The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by minipool testing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening accuracy | The screening accuracy of the two screening strategies were calculated and compared. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness analysis | The costs of the two screening strategies were recorded. Cost-effectiveness analysis were performed and compared. | 1 month |