Assessment of the accuracy of a new test for COVID-19
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN29409638
- Lead Sponsor
- Fogarty International Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 600
Patients presenting with symptoms suggestive of COVID-19 will be offered SARS-CoV-2 LAMP assay testing and those participants /caregivers who give consent will be entered into the study.
1. COVID-19 patients: adults and children of any age presenting with COVID-19 symptoms which include:
1.1. Temperature =38.0°C measured at presentation or reported within the previous 24 hours
AND one of the below
1.2. Cough
1.3. Abnormal sounds on chest auscultation (crackles, reduced breath sounds, bronchial breathing, wheezing)
1.4. Clinical signs of dyspnea (chest indrawing, nasal flaring, grunting)
1.5. Signs of respiratory dysfunction: tachypnoea for age or decreased oxygen saturation (<92% in room air)
1.6. Signs of reduced general state: poor feeding, vomiting or lethargy/drowsiness
1.7. Loss of taste/smell preceding respiratory symptoms
1.8. Sore throat, nasal congestion, myalgia, fatigue
2. Asymptomatic contacts of COVID-19 patients
1. Inability to obtain informed consent
2. Alternative non-infectious diagnosis that explains clinical symptoms
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Calculated using a 2 by 2 table (LAMP assay versus PCR) at a single timepoint (day of recruitment):<br> 1. Sensitivity<br> 2. Specificity<br>
- Secondary Outcome Measures
Name Time Method <br> Measured at a single timepoint (day of recruitment)<br> 1. Turn-around time (TAT) calculated from sample collection to the time test results are available<br> 2. Cost per test calculated from all health services costs incurred per test<br>