This is a study of validation for diagnostic techniques used on epidemiological control in the COVID-19 pandemic. It will be carried out in accredited public, private and university clinical laboratories of the collaborator institutions of the project based in Tarija, Bolivia. It is designed as a sectional validation study, using samples from specific groups of participants from the municipality of Tarija grouped according to their category with respect to symptoms and viral load of COVID-19. The sample is selected for convenience.
Full Title of Study: “Validation of Laboratory Techniques, Strategies, and Types of Samples for Epidemiological Control in the Covid-19 Pandemic, Tarija-Bolivia”
- Study Type: Observational
- Study Design
- Time Perspective: Cross-Sectional
- Study Primary Completion Date: October 31, 2020
- Diagnostic Test: RT-PCR
- RT-PCR (Gold standard): Real-time PCR testing with reverse transcriptase (RT-PCR). The test consists of a polymerase chain reaction that has previously had a reverse transcription phase, RT. This test allows the cADN (complementary DNA) to be obtained from a RNA chain. This technique allows the detection and amplification of a sequence from a strand of RNA.
- Diagnostic Test: LAMP
- LAMP: The LAMP technique, like PCR, has the ability to amplify specific DNA fragments (target sequence), allowing for highly sensitive detection of pathogens. Unlike pcr, LAMP requires between 4 and 6 feeders, external F3 and B3 feeders, which hybridte with the outer regions of the target sequence, while the internal FIP and BIP have sequences in both ways that allow the formation of a loop. The LAMP reaction is isothermal, i.e. it takes place at a single temperature. LAMP has been successfully used to detect viral diseases as well as viral pathogens such as West Nile virus, TMR-1, Norovirus, avian influenza, foot-and-mouth disease, classical swine fever, among others.
- Diagnostic Test: POOL RT-PCR
- POOL RT-PCR: This test aims to mix in a single sample the extractions obtained from several people. The joint sample is evaluated and, if negative, it is understood that all are free of COVID-19; if it is positive, an array system is used to detect the affected person. That is, a single PCR (polymerase chain reaction), the diagnostic test used to detect the virus pathogen is applied to a group and repeated individually if positive.
- Diagnostic Test: POOL LAMP
- POOL LAMP: Like the RT-PCR pool test. This test essentially involves mixing in a single sample the extractions obtained from several people. This joint sample is tested and, if it is negative, it is understood that everyone is free of COVID-19; if it is positive, an array system is used to detect the affected person. That is: a single LAMP applies to a group
Arms, Groups and Cohorts
- Volunteer participants
- Samples of volunteer participants will be collected after informed consent and classified as symptomatic, asymptomatic and negative.
Clinical Trial Outcome Measures
- Time Frame: 1 month
- Validate different molecular tests and sampling and sample type strategies used in epidemiological control of COVID-19 diagnosis in Tarija, Bolivia.
- RT- PCR (Saliva)
- Time Frame: 1 week
- Validate the use of molecular testing based on the PCR method using Saliva samples
- Time Frame: 1 week
- Validate the use of the molecular test based on the LAMP method using saliva and nasopharyngeal samples
- POOL PCR
- Time Frame: 1 week
- Validate the use of molecular tests with Pool PCR strategy using saliva samples
- POOL LAMP
- Time Frame: 1 week
- Validate the use of molecular tests with Pool LAMP strategy using saliva samples
Participating in This Clinical Trial
Gender Eligibility: All
Minimum Age: 21 Years
Maximum Age: 64 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Hunter College of City University of New York
- Universidad Autonoma Juan Misael Saracho
- Provider of Information About this Clinical Study
- Principal Investigator: Rodrigo Arce Cardozo, Adjunct Assistant Professor – Hunter College of City University of New York
- Overall Official(s)
- Kenji Shoji, PhD, Principal Investigator, Galapagos NV
- Rodrigo Arce Cardozo, MD, MPH, Study Chair, City University of New York, School of Public Health
- Overall Contact(s)
- Rodrigo Arce Cardozo, MD,MPH, +19173620995, firstname.lastname@example.org
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