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Development of a diagnostic kit for simultaneous and low-cost detection of viral and bacterial agents associated with Acute Respiratory Infections

Conditions
Respiratory Infections
Registration Number
RBR-7n6n5sd
Lead Sponsor
Instituto Nacional de Controle de Qualidade em Saúde
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruitment completed
Sex
Not specified
Target Recruitment
Not specified
Inclusion Criteria

Clinical samples from participants aged 18 years or over; of both genders; samples with complete information and registered in the Sistema de Ambiente laboratorial (GAL), containing clinical data of patients who were suspected of having COVID-19; samples considered positive for SARS-CoV-2 whose ct (cyclethreshold) is =40; samples negative for SARS-CoV-2, with ct (cyclethreshold) >40; acute samples less than 10 days after the onset of respiratory symptoms; samples properly stored at -80ºC; clinical samples from participants with confirmed clinical signs of infections

Exclusion Criteria

Participants whose clinical sample does not have sufficient volume to perform the investigational test (volume less than 100 µL); samples registered in the Laboratory Environment System (GAL) with incomplete information; samples stored in conditions unsuitable for the study

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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