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| Name | Class |
|---|---|
| Udayana University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT Value <25 | Experimental | Patients with CT value <25 |
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| CT Value 25+ | Experimental | Patients with CT value of 25 or higher |
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| Negative | Experimental | Patients with negative PCR test result |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AptameX | Device | DNA aptamer-based test using patient's saliva |
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| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Udayana University Hospital | Recruiting | Badung | Bali | 80361 | Indonesia |
Individual participant data will be managed by investigators only. Analyzed data or result summary will be shared to related researchers or other parties
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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Patients who undertake PCR test are asked to provide saliva sample
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Outcome assessors are blinded to the PCR test result
| 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 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |