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

Hunter College of City University of New York

Status

Completed

Conditions

Covid19

Treatments

Diagnostic Test: RT-PCR

Diagnostic Test: LAMP

Diagnostic Test: POOL LAMP

Diagnostic Test: POOL RT-PCR

Study type

Observational

Funder types

Other

Identifiers

NCT04581083

PROY - UAJMS001/2020

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

21 to 64 years old

Volunteers

Accepts Healthy Volunteers

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.