COVID-19 (SARS-CoV-2 infection) Infections and Infestations
Conditions
Interventions
This study will be conducted at the Kamuzu University of Health Sciences (KUHes), Blantyre campus. Standard methods will be used to evaluate diagnostic test accuracy. The gold standard is RT-PCR. The
Sponsors
Fogarty International Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 1. Inability to obtain informed consent 2. Alternative non-infectious diagnosis that explains clinical symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Calculated using a 2 by 2 table (LAMP assay versus PCR) at a single timepoint (day of recruitment): 1. Sensitivity 2. Specificity | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at a single timepoint (day of recruitment) 1. Turn-around time (TAT) calculated from sample collection to the time test results are available 2. Cost per test calculated from all health services costs incurred per test | — |
Countries
Malawi
Outcome results
None listed