Saliva-based COVID-19 DNA Aptamer Test

Not Applicable

• Conditions: Covid19
• Interventions: Device: AptameX

• Registration Number: NCT04974203
• Lead Sponsor: Achiko AG

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.

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07
• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Study First Posted: 2021-07-23
• Last Update Posted: 2021-07-23
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CT Value <25	AptameX	Patients with CT value \<25
Negative	AptameX	Patients with negative PCR test result
CT Value 25+	AptameX	Patients with CT value of 25 or higher

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Udayana University Hospital; 🇮🇩 Badung, Bali, Indonesia