Saliva-based COVID-19 DNA Aptamer Test

Achiko

Status: Unknown

Conditions: Covid19

Treatments: Device: AptameX

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04974203

2021.03.3.0102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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200 participants in 3 patient groups

CT Value <25

Experimental group

Description:

Patients with CT value \<25

Treatment:

Device: AptameX

CT Value 25+

Experimental group

Description:

Patients with CT value of 25 or higher

Treatment:

Device: AptameX

Negative

Experimental group

Description:

Patients with negative PCR test result

Treatment:

Device: AptameX