COVID-19 Tests: Nasopharyngeal Swab vs Saliva Collected With Salivette® Cortisol for Viral RNA Sampling for RT-qPCR

N/ACompletedNCT04599959

Boehringer Ingelheim151 enrolled

Overview

The main objective of the tests is to establish saliva collection with Salivette® Cortisol.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

151

Conditions

Covid-19

Interventions

Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette CortisolDIAGNOSTIC_TEST

Kylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Informed consent form signed and dated before any samples have been taken. 2. Suspected or confirmed SARS-CoV-2 infection by PCR within the past five days. 3. Male and/or female patients aged 18 years and over.

Locations (1)

Instituto Nacional de Enfermedades Respiratorias Ismael Cosío Villegas

México, Mexico

Outcomes

Primary Outcomes

Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico

Number of participants testing positive or negative for SARS-CoV-2 virus from sample collected via swab versus saliva sample collected from Salivette® Cortisol, which samples were processed in Mexico.

Time frame: At baseline (the test day), up to one day.

Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany

Percentage of participants testing true positive or true negative for SARS-CoV-2 virus from Swab and Saliva samples being processed in Germany was reported. The swab sample was used as the reference. Among participants who were tested positive from swab samples, those who were tested positive from saliva samples were classified as "true positive". Among participants tested negative from swab samples, those who were tested negative from saliva samples were then classified as "true negative".

Time frame: At baseline (the test day), up to one day.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.