Saliva-based COVID-19 DNA Aptamer Test

NCT ID: NCT04974203

Last Updated: 2021-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2021-08-31

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.

Conditions

Covid19

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

CT Value <25

Patients with CT value \<25

Group Type: EXPERIMENTAL

AptameX

Intervention Type: DEVICE

DNA aptamer-based test using patient's saliva

CT Value 25+

Patients with CT value of 25 or higher

Group Type: EXPERIMENTAL

AptameX

Intervention Type: DEVICE

DNA aptamer-based test using patient's saliva

Negative

Patients with negative PCR test result

Group Type: EXPERIMENTAL

AptameX

Intervention Type: DEVICE

DNA aptamer-based test using patient's saliva

Interventions

AptameX

DNA aptamer-based test using patient's saliva

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Udayana University

OTHER

Sponsor Role: collaborator

Achiko AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Udayana University Hospital

Badung, Bali, Indonesia

Site Status: RECRUITING

Countries

Indonesia

Facility Contacts

I Md A Wirawan, MD, PhD

Role: primary

ady.wirawan@unud.ac.id

081239394465

Other Identifiers

2021.03.3.0102

Identifier Type: -

Identifier Source: org_study_id