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Saliva-based COVID-19 DNA Aptamer Test

Primary Purpose

Covid19

Status

Unknown status

Phase

Not Applicable

Locations

Indonesia

Study Type

Interventional

Intervention

AptameX

About this trial

This is an interventional diagnostic trial for Covid19 focused on measuring Saliva-based test, DNA aptamer

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Udayana University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

CT Value <25

CT Value 25+

Negative

Arm Description

Patients with CT value <25

Patients with CT value of 25 or higher

Patients with negative PCR test result

Outcomes

Primary Outcome Measures

Hands-On-Time (HOT)

Total time (seconds) spent by the Operator(s) to process one test

Time-To-Result (TTR)

Instrument readout, from loading the cuvette in the spectrophotometer, up to recording the test as Positive / Negative

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.

Technician Subjective elements

Aspects of the workflow liked/not liked by the technicians

Patient subjective elements

Aspects of the workflow liked/not liked by the patient during saliva collection

Secondary Outcome Measures

Sensitivity

The ability of a test to correctly identify those with the disease (true positive rate)

Specificity

The ability of the test to correctly identify those without the disease (true negative rate)

Positive Predictive Value

The proportions of positive results that are true positive results

Negative Predictive Value

The proportions of negative results that are true negative results

Full Information

NCT ID

NCT04974203

First Posted

July 20, 2021

Last Updated

July 21, 2021

Sponsor

Achiko AG

Collaborators

Udayana University

1. Study Identification

Unique Protocol Identification Number

NCT04974203

Brief Title

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

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 2021 (Anticipated)

Primary Completion Date

August 2021 (Anticipated)

Study Completion Date

August 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Achiko AG

Collaborators

Udayana University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19

Keywords

Saliva-based test, DNA aptamer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Patients who undertake PCR test are asked to provide saliva sample

Masking

Outcomes Assessor

Masking Description

Outcome assessors are blinded to the PCR test result

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CT Value <25

Arm Type

Experimental

Arm Description

Patients with CT value <25

Arm Title

CT Value 25+

Arm Type

Experimental

Arm Description

Patients with CT value of 25 or higher

Arm Title

Negative

Arm Type

Experimental

Arm Description

Patients with negative PCR test result

Intervention Type

Device

Intervention Name(s)

AptameX

Intervention Description

DNA aptamer-based test using patient's saliva

Primary Outcome Measure Information:

Title

Hands-On-Time (HOT)

Description

Total time (seconds) spent by the Operator(s) to process one test

Time Frame

1 month

Title

Time-To-Result (TTR)

Description

Instrument readout, from loading the cuvette in the spectrophotometer, up to recording the test as Positive / Negative

Time Frame

1 month

Title

Testing Centre First-Time-Hit percentage (FTH)

Description

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.

Time Frame

1 month

Title

Technician Subjective elements

Description

Aspects of the workflow liked/not liked by the technicians

Time Frame

1 month

Title

Patient subjective elements

Description

Aspects of the workflow liked/not liked by the patient during saliva collection

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Sensitivity

Description

The ability of a test to correctly identify those with the disease (true positive rate)

Time Frame

1 month

Title

Specificity

Description

The ability of the test to correctly identify those without the disease (true negative rate)

Time Frame

1 month

Title

Positive Predictive Value

Description

The proportions of positive results that are true positive results

Time Frame

1 month

Title

Negative Predictive Value

Description

The proportions of negative results that are true negative results

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Udayana University Hospital

City

Badung

State/Province

Bali

ZIP/Postal Code

80361

Country

Indonesia

Individual Site Status

Recruiting

Facility Contact: