Saliva-based COVID-19 DNA Aptamer Test

Covid19 Clinical Trial

Official title:

Saliva-based COVID-19 DNA Aptamer Test: Formative Usability and Internal Validation Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04974203
• Other study ID #: 2021.03.3.0102
• Status: Recruiting
• Phase: N/A
• Start date: July 2021
• Est. completion date: August 2021

Study information

• Verified date: July 2021
• Source: Achiko AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Covid19

Intervention

Device:
• AptameX
DNA aptamer-based test using patient's saliva

Locations

Country	Name	City	State
Indonesia	Udayana University Hospital	Badung	Bali

Sponsors (2)

Lead Sponsor	Collaborator
Achiko AG	Udayana University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hands-On-Time (HOT)	Total time (seconds) spent by the Operator(s) to process one test	1 month
Primary	Time-To-Result (TTR)	Instrument readout, from loading the cuvette in the spectrophotometer, up to recording the test as Positive / Negative	1 month
Primary	Testing Centre First-Time-Hit percentage (FTH)	The FTH percentage measures proportion of test kits that will be correctly processed with no single mistake, from the opening of the test kit to recording the test result.	1 month
Primary	Technician Subjective elements	Aspects of the workflow liked/not liked by the technicians	1 month
Primary	Patient subjective elements	Aspects of the workflow liked/not liked by the patient during saliva collection	1 month
Secondary	Sensitivity	The ability of a test to correctly identify those with the disease (true positive rate)	1 month
Secondary	Specificity	The ability of the test to correctly identify those without the disease (true negative rate)	1 month
Secondary	Positive Predictive Value	The proportions of positive results that are true positive results	1 month
Secondary	Negative Predictive Value	The proportions of negative results that are true negative results	1 month