Validation of Laboratory Techniques, Strategies, and Types of Samples for Epidemiological Control in the Covid-19 Pandemic

NCT04581083 | Completed

• 1 other identifier: PROY - UAJMS001/2020
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Covid19

Keywords

COVID 19; Bolivia; Clinical Laboratory Techniques

Outcome Measures

Primary Outcomes (1)

• Validation

  Validate different molecular tests and sampling and sample type strategies used in epidemiological control of COVID-19 diagnosis in Tarija, Bolivia.

  1 month

Secondary Outcomes (4)

• RT- PCR (Saliva)

  1 week

• LAMP

  1 week

• POOL PCR

  1 week

• POOL LAMP

  1 week

Study Arms (1)

Volunteer participants

Samples of volunteer participants will be collected after informed consent and classified as symptomatic, asymptomatic and negative.

Diagnostic Test: RT-PCR; Diagnostic Test: LAMP; Diagnostic Test: POOL RT-PCR; Diagnostic Test: POOL LAMP

Interventions

RT-PCR DIAGNOSTIC_TEST

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.

Also known as: Real-Time Polymerase Chain Reaction

Volunteer participants

LAMP DIAGNOSTIC_TEST

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.

Also known as: Loop-mediated isothermal amplification

Volunteer participants

POOL RT-PCR DIAGNOSTIC_TEST

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.

Also known as: Pooled Real-Time Polymerase Chain Reaction

Volunteer participants

POOL LAMP DIAGNOSTIC_TEST

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

Also known as: Pooled Loop-mediated isothermal amplification

Volunteer participants

Eligibility Criteria

• Age: 21 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Validation will be carried out using samples from volunteer adults from the municipality of Tarija, Bolivia, without gender restriction. Samples will be grouped according to the clinical classification determined above. These individuals will need to sign the informed consent form required to agree to be part of the study and provide their complete information or access to their medical history.

You may qualify if:

• Symptomatic: Subjects with signs and symptoms of respiratory infection less than or equal to 3 days, preferably with clinical and molecular diagnosis compatible with Covid-19.
• 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.

You may not qualify if:

• Adults under the age of 21 or over 65
• 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.

Sponsors & Collaborators

• Hunter College of City University of New York: lead
• Universidad Autonoma Juan Misael Saracho: collaborator
• Gobierno Autonomo Departamental De Tarija: collaborator
• SEDES - Tarija: collaborator
• CAINCO - Bolivia: collaborator
• Universidad Mayor de San Simon: collaborator

Study Sites (1)

Universidad Autónoma Juan Misael Saracho

Tarija, 00000, Bolivia

Location

Related Links

• Local Sponsor University Website

Biospecimen

Retention: SAMPLES WITH DNA

nasopharyngeal swab and saliva samples

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Nucleic Acid Testing

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

COVID-19 Testing; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Kenji Shoji, PhD

  Galapagos NV

  PRINCIPAL INVESTIGATOR

• Rodrigo Arce Cardozo, MD, MPH

  City University of New York, School of Public Health

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Assistant Professor

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: October 9, 2020
• Study Start: October 8, 2020
• Primary Completion: October 10, 2020
• Study Completion: October 30, 2020
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Paper submitted for publication
• Access Criteria: Open

Locations

BO (1)