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NCT Number: NCT04581083

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universidad Autónoma Juan Misael Saracho

Tarija, 00000, Bolivia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: Real-Time Polymerase Chain Reaction

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.

Other names: Loop-mediated isothermal amplification

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.

Other names: Pooled Real-Time Polymerase Chain Reaction

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

Other names: Pooled Loop-mediated isothermal amplification

Primary outcomes

  1. Validation

    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.

Secondary outcomes

  1. RT- PCR (Saliva)

    Time frame: 1 week

    Validate the use of molecular testing based on the PCR method using Saliva samples

  2. LAMP

    Time frame: 1 week

    Validate the use of the molecular test based on the LAMP method using saliva and nasopharyngeal samples

  3. POOL PCR

    Time frame: 1 week

    Validate the use of molecular tests with Pool PCR strategy using saliva samples

  4. POOL LAMP

    Time frame: 1 week

    Validate the use of molecular tests with Pool LAMP strategy using saliva samples

Sponsors and collaborators

Lead sponsor

Hunter College of City University of New York

Other

Collaborators

  • CAINCO - Bolivia
  • Gobierno Autonomo Departamental De Tarija
  • SEDES - Tarija
  • Universidad Autonoma Juan Misael Saracho
  • Universidad Mayor de San Simon

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2020
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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