Saliva-based COVID-19 DNA Aptamer Test

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

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.

Study Overview

• Status: Recruiting
• Conditions: Covid19
• Intervention / Treatment: Device: AptameX

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • Bali
    • Badung, Bali, Indonesia, 80361
      • Recruiting
      • Udayana University Hospital
      • Contact: I Md A Wirawan, MD, PhD; Phone Number: 081239394465; Email: ady.wirawan@unud.ac.id
      • Principal Investigator: I Md Ady Wirawan, MD, Ph.D
      • Sub-Investigator: Putu Ayu Swandewi Astuti, MD, PhD
      • Sub-Investigator: I Nyoman Sutarsa, MD, PhD
      • Sub-Investigator: Cokorda Agung Wahyu Purnamasidhi, MD
      • Sub-Investigator: Ni Kadek Mulyantari, MD, Ph.D
      • Sub-Investigator: I Made Dwi Ariawan, MD
      • Sub-Investigator: Ni Made Suandewi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Achiko AG
• Collaborators: Udayana University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: July 20, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): July 23, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Saliva-based test; DNA aptamer
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2021.03.3.0102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will be managed by investigators only. Analyzed data or result summary will be shared to related researchers or other parties

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No