Validation of Laboratory Techniques, Strategies, and Types of Samples for Epidemiological Control in the Covid-19 Pandemic
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

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.
    


Intervention name(s): RT-PCR; LAMP; POOL RT-PCR; POOL LAMP
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): 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.; 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.; 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.; 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 intervention name(s): Real-Time Polymerase Chain Reaction; Loop-mediated isothermal amplification; Pooled Real-Time Polymerase Chain Reaction; Pooled Loop-mediated isothermal amplification
Observational model: Other
Time perspective: Cross-Sectional
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.
      
Biospecimen description: 
      nasopharyngeal swab and saliva samples
    
Keywords: COVID 19; Bolivia; Clinical Laboratory Techniques