Validation of Laboratory Techniques, Strategies, and Types of Samples for Epidemiological Control in the Covid-19 Pandemic
NCT ID: NCT04581083
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2020-10-08
2020-10-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
CROSS_SECTIONAL
Study Groups
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Volunteer participants
Samples of volunteer participants will be collected after informed consent and classified as symptomatic, asymptomatic and negative.
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.
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.
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.
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
Interventions
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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.
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.
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.
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Asymptomatics: Subjects who have had direct contact with people infected and who have not shown any symptoms related to Covid-19.
* Negative: Individuals with negative RT-PCR testing for SARS-CoV-2 (reference test) who have not manifested any symptoms seven days prior to sampling.
Exclusion Criteria
* Subjects with a clinical history of autoimmune disease or chemotherapy treatments.
* Subjects who have received transfusions or convalescent plasma in the last month prior to enrollment.
* Subjects with prior diagnosis of other infectious diseases such as, but not limited to AIDS, Hepatitis B or C, Tuberculosis, or any other ongoing or unresolved diseases.
* Subjects with malformation or oncological pathology of the upper respiratory track that may hinder sample collection, including but not limited to deviated septum, allergic rhinitis.
* Subjects who have not signed or can not sign the informed consent form
* Subjects not able to provide their complete information or access to their clinical history.
21 Years
64 Years
ALL
Yes
Sponsors
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Universidad Autonoma Juan Misael Saracho
UNKNOWN
Gobierno Autonomo Departamental De Tarija
UNKNOWN
SEDES - Tarija
UNKNOWN
CAINCO - Bolivia
UNKNOWN
Universidad Mayor de San Simon
UNKNOWN
Hunter College of City University of New York
OTHER
Responsible Party
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Rodrigo Arce Cardozo
Adjunct Assistant Professor
Principal Investigators
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Kenji Shoji, PhD
Role: PRINCIPAL_INVESTIGATOR
Galapagos NV
Rodrigo Arce Cardozo, MD, MPH
Role: STUDY_CHAIR
City University of New York, School of Public Health
Locations
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Universidad Autónoma Juan Misael Saracho
Tarija, , Bolivia
Countries
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Related Links
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Local Sponsor University Website
Other Identifiers
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PROY - UAJMS001/2020
Identifier Type: -
Identifier Source: org_study_id
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