Covid-19
Conditions
Brief summary
The main objective of the tests is to establish saliva collection with Salivette® Cortisol.
Interventions
DIAGNOSTIC_TESTSampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol
Kylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit
Sponsors
Boehringer Ingelheim
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Comparison of SARS-CoV-2-RNA detectability in Swab and Salivette samples.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico | At baseline (the test day), up to one day. | 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. |
| Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany | 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 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. |
Countries
Mexico
Participant flow
Recruitment details
This study compared the viral Ribonucleic acid (RNA) test sample taken for Quantitative reverse transcription polymerase chain reaction (RT-qPCR) via a nasopharyngeal swab versus saliva collected with Salivette® Cortisol in the diagnosing of SARS-CoV-2 virus infection.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Overall All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry.
Two samples were taken by medical staff from each participant on the test day, one using a swab (oropharyngeal swab) and the other through saliva collected with Salivette® Cortisol. The collected samples were then shipped and analyzed in Germany.
Additional up to two samples (swab and/or saliva) were taken for each participant on the test day and analyzed in Mexico. | 151 |
| Total | 151 |
Baseline characteristics
| Characteristic | Overall | — |
|---|---|---|
| Age, Continuous | 43.4 Years STANDARD_DEVIATION 14.68 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 80 Participants | — |
| Sex: Female, Male Male | 71 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 151 |
| other Total, other adverse events | 0 / 151 |
| serious Total, serious adverse events | 0 / 151 |
Outcome results
Primary
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.
Population: All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry, and whose samples were processed in Mexico.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Swab - Processed in Mexico | Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico | Positive | 85 Participants |
| Swab - Processed in Mexico | Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico | Negative | 66 Participants |
| Swab - Processed in Mexico | Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico | Ambiguous | 0 Participants |
| Saliva - Processed in Mexico | Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico | Positive | 13 Participants |
| Saliva - Processed in Mexico | Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico | Negative | 89 Participants |
| Saliva - Processed in Mexico | Number of Participants Testing Positive or Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Mexico | Ambiguous | 1 Participants |
Primary
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.
Population: All eligible participants in this study who had been diagnosed with COVID-19 confirmed by polymerase chain reaction (PCR) test within the past 5 days before study entry, and had both swab and saliva sample that were processed in Germany.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Swab - Processed in Mexico | Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany | True positive (sensitivity) | 52.2 Percentage of participants |
| Swab - Processed in Mexico | Percentage of Participants Testing True Positive or True Negative for SARS-CoV-2 Virus From Swab and Saliva Samples - Processed in Germany | True negative (specificity) | 100.0 Percentage of participants |