Saliva-based COVID-19 DNA Aptamer Test

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Covid19

Intervention / Treatment
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* Device: AptameX


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients who undertake PCR test are asked to provide saliva sample
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Saliva-based test, DNA aptamer