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| Name | Class |
|---|---|
| Universidad Autonoma Juan Misael Saracho | UNKNOWN |
| Gobierno Autonomo Departamental De Tarija | UNKNOWN |
| SEDES - Tarija | UNKNOWN |
| CAINCO - Bolivia |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Volunteer participants | Samples of volunteer participants will be collected after informed consent and classified as symptomatic, asymptomatic and negative. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Validation | Validate different molecular tests and sampling and sample type strategies used in epidemiological control of COVID-19 diagnosis in Tarija, Bolivia. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| RT- PCR (Saliva) | Validate the use of molecular testing based on the PCR method using Saliva samples | 1 week |
| LAMP | Validate the use of the molecular test based on the LAMP method using saliva and nasopharyngeal samples |
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Inclusion criteria:
Exclusion criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kenji Shoji, PhD | Lakefront Biotherapeutics NV | Principal Investigator |
| Rodrigo Arce Cardozo, MD, MPH | City University of New York, School of Public Health | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Autónoma Juan Misael Saracho | Tarija | 00000 | Bolivia |
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| Label | URL |
|---|---|
| Local Sponsor University Website | View source |
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We will share deidentified data
Paper submitted for publication
Open
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 8, 2025 | |
| Reset | Sep 26, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 8, 2025 | Sep 26, 2025 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000087123 | COVID-19 Nucleic Acid Testing |
| ID | Term |
|---|---|
| D000086742 | COVID-19 Testing |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| UNKNOWN |
| Universidad Mayor de San Simon | UNKNOWN |
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nasopharyngeal swab and saliva samples
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|
| 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. |
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| 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. |
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| 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 |
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|
| 1 week |
| POOL PCR | Validate the use of molecular tests with Pool PCR strategy using saliva samples | 1 week |
| POOL LAMP | Validate the use of molecular tests with Pool LAMP strategy using saliva samples | 1 week |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008919 | Investigative Techniques |