SARS-CoV-2
Conditions
Interventions
None listed
Sponsors
National Center for Global Health and Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Those assessed by the investigator or sub-investigator(s) to have symptoms of SARS-CoV-2 infection based on the national guideline for COVID-19 in each country (Indonesia/The Philippines).14,15 2) Those from whom nasopharyngeal swab sample can be collected. 3) Those whose written consent is voluntarily provided or legally represented to participate in the study. 4) Those who are 18 years or older.
Exclusion criteria
Exclusion criteria: 1) Patients with mucosal damage or nasopharyngeal lesions. 2) Patients with nasopharyngeal pain, trauma or nasal surgery within the last 1 month, significantly deviant nasal septum, history of chronically obstructed nasal passages, and severe coagulation disorders. 3) Patients suspected of having used an illicit drug within the last 12 months. 4) Patients determined to be ineligible by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary: 100 positive and 100 negative test results from whom nasopharyngeal swabs were collected as samples. The overall agreement rate of 90% or greater between the test results of RT-PCR test and the LAMP kit should be achieved. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: Similar sensitivity and specificity results in the two countries. At least 90% agreement should be achieved. | — |
Countries
Asia(except Japan)
Contacts
Public ContactMaria Ruriko Umano
National Center for Global Health and Medicine Department of International Trials
Outcome results
None listed