Saliva-based COVID-19 DNA Aptamer Test

Sponsor

Achiko AG (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04974203

Collaborator

Udayana University (Other)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

196.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Device: AptameX	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Patients who undertake PCR test are asked to provide saliva samplePatients who undertake PCR test are asked to provide saliva sample

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcome assessors are blinded to the PCR test result

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CT Value <25 Patients with CT value <25	Device: AptameX DNA aptamer-based test using patient's saliva
Experimental: CT Value 25+ Patients with CT value of 25 or higher	Device: AptameX DNA aptamer-based test using patient's saliva
Experimental: Negative Patients with negative PCR test result	Device: AptameX DNA aptamer-based test using patient's saliva

Arm

Intervention/Treatment

Experimental: CT Value <25

Patients with CT value <25

Device: AptameX

DNA aptamer-based test using patient's saliva

Experimental: CT Value 25+

Patients with CT value of 25 or higher

Device: AptameX

DNA aptamer-based test using patient's saliva

Experimental: Negative

Patients with negative PCR test result

Device: AptameX

DNA aptamer-based test using patient's saliva

Outcome Measures

Primary Outcome Measures

Hands-On-Time (HOT) [1 month]
Total time (seconds) spent by the Operator(s) to process one test
Time-To-Result (TTR) [1 month]
Instrument readout, from loading the cuvette in the spectrophotometer, up to recording the test as Positive / Negative
Testing Centre First-Time-Hit percentage (FTH) [1 month]
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.
Technician Subjective elements [1 month]
Aspects of the workflow liked/not liked by the technicians
Patient subjective elements [1 month]
Aspects of the workflow liked/not liked by the patient during saliva collection

Secondary Outcome Measures

Sensitivity [1 month]
The ability of a test to correctly identify those with the disease (true positive rate)
Specificity [1 month]
The ability of the test to correctly identify those without the disease (true negative rate)
Positive Predictive Value [1 month]
The proportions of positive results that are true positive results
Negative Predictive Value [1 month]
The proportions of negative results that are true negative results

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Udayana University Hospital	Badung	Bali	Indonesia	80361

Sponsors and Collaborators

Achiko AG
Udayana University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Achiko AG

ClinicalTrials.gov Identifier:

NCT04974203

Other Study ID Numbers:

2021.03.3.0102

First Posted:

Jul 23, 2021

Last Update Posted:

Jul 23, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Achiko AG

Saliva-based test

DNA aptamer

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Jul 23, 2021