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

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

Interventions

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

Sponsors & Collaborators

• Universidad Autonoma Juan Misael Saracho

  collaborator UNKNOWN

• Gobierno Autonomo Departamental De Tarija

  collaborator UNKNOWN

• SEDES - Tarija

  collaborator UNKNOWN

• CAINCO - Bolivia

  collaborator UNKNOWN

• Universidad Mayor de San Simon

  collaborator UNKNOWN

• Hunter College of City University of New York

  lead OTHER

Principal Investigators

• Kenji Shoji, PhD · Galapagos NV

• Rodrigo Arce Cardozo, MD, MPH · City University of New York, School of Public Health

Eligibility

Min Age

21 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-08

Primary Completion

2020-10-10

Completion

2020-10-30

Countries

• Bolivia

Study Locations