Covid19
Conditions
Keywords
Saliva-based test, DNA aptamer
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.
Interventions
DEVICEAptameX
DNA aptamer-based test using patient's saliva
Sponsors
Udayana University
Achiko AG
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors are blinded to the PCR test result
Intervention model description
Patients who undertake PCR test are asked to provide saliva sample
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Sensitivity | 1 month | The ability of a test to correctly identify those with the disease (true positive rate) |
Countries
Indonesia
Outcome results
None listed