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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04581083
Enrollment
30
Registered
2020-10-09
Start date
2020-10-08
Completion date
2020-10-30
Last updated
2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID 19, Bolivia, Clinical Laboratory Techniques

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.

Interventions

DIAGNOSTIC_TESTRT-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_TESTLAMP

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_TESTPOOL 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_TESTPOOL 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

Universidad Autonoma Juan Misael Saracho
CollaboratorUNKNOWN
Gobierno Autonomo Departamental De Tarija
CollaboratorUNKNOWN
SEDES - Tarija
CollaboratorUNKNOWN
CAINCO - Bolivia
CollaboratorUNKNOWN
Universidad Mayor de San Simon
CollaboratorUNKNOWN
Hunter College of City University of New York
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Validation1 monthValidate different molecular tests and sampling and sample type strategies used in epidemiological control of COVID-19 diagnosis in Tarija, Bolivia.

Secondary

MeasureTime frameDescription
RT- PCR (Saliva)1 weekValidate the use of molecular testing based on the PCR method using Saliva samples
LAMP1 weekValidate the use of the molecular test based on the LAMP method using saliva and nasopharyngeal samples
POOL PCR1 weekValidate the use of molecular tests with Pool PCR strategy using saliva samples
POOL LAMP1 weekValidate the use of molecular tests with Pool LAMP strategy using saliva samples

Countries

Bolivia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026