Clinical trial NCT04974203: Saliva-based COVID-19 DNA Aptamer Test
Official title: Saliva-based COVID-19 DNA Aptamer Test: Formative Usability and Internal Validation Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Covid19
Keywords: Saliva-based test
DNA aptamer
Lead sponsor: Achiko AG
Sponsor class: INDUSTRY
Collaborators: name: Udayana University
First posted: 2021-07-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Patients who undertake PCR test are asked to provide saliva sample
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to conduct formative usability and internal validation of the COVID-19 rapid diagnostic test tool based on DNA aptamers, involving 200 patients to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for clinical trials, and also assess initial accuracy by validating with the patient's PCR test results.

Detailed description: RT-PCR has several limitations that need to be considered in its role as a COVID-19 diagnostic modality, especially in areas with limited health infrastructure. Potential diagnostic tests are needed that are capable of detecting results that are fast to read, can be carried out in service locations with limited infrastructure, and have high accuracy. The DNA Aptamers-based diagnostic test has the potential to meet these criteria, as it allows the detection of infection quickly and without invasive procedures, where the examination is only on a person's saliva.

The development of diagnostic tools must be well planned including the usability and internal validation of the tools to be studied before they can be used in clinical trial settings or diagnostic accuracy tests by involving patients in health services. This study aims to conduct formative usability and internal validation of the DNA aptamer-based COVID-19 rapid diagnostic test, involving 200 patients and also laboratory personnel to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for testing in clinical trials, and also assess early indications of instrument accuracy by validating with the patient's PCR test data.

Eligibility criteria: Inclusion Criteria:

* Aged 18-59 years old
* Undertaking PCR swab test for screening, or
* In-patients undertaking PCR swab test

Exclusion Criteria:

* Unable to produce saliva
* Refusing to participate

Primary outcomes:
measure: Hands-On-Time (HOT)
timeFrame: 1 month
measure: Time-To-Result (TTR)
timeFrame: 1 month
measure: Testing Centre First-Time-Hit percentage (FTH)
timeFrame: 1 month
measure: Technician Subjective elements
timeFrame: 1 month
measure: Patient subjective elements
timeFrame: 1 month
Secondary outcomes:
measure: Sensitivity
timeFrame: 1 month
measure: Specificity
timeFrame: 1 month
measure: Positive Predictive Value
timeFrame: 1 month
measure: Negative Predictive Value
timeFrame: 1 month
Other outcomes:
Locations:
city: Badung
country: Indonesia
facility: Udayana University Hospital
state: Bali
Study officials:
References: