COVID-19 Novel Molecular Point of Care Diagnostics Evaluation
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|ClinicalTrials.gov Identifier: NCT06055218|
Recruitment Status : Completed
First Posted : September 26, 2023
Last Update Posted : October 5, 2023
|Condition or disease|
|COVID-19 Respiratory Infection|
The aim of this study is to independently evaluate the performance of novel molecular point-of-care (POC) assays for the direct detection of SARS-CoV-2 nucleic acid (RNA) in comparison to the current reference standard, laboratory-based real-time reverse-transcription PCR (RT-PCR), for use to diagnose COVID-19, a serious and sometimes fatal respiratory infection caused by the coronavirus SARS-CoV-2. A total of 3 molecular POC devices, detecting SARS-CoV-2 and other viral pathogens, have been selected by FIND through open calls for expressions of interest. These are Covid/RSV/Flu Nudge Test (DnaNudge Ltd, Nudge test from hereon), Test Kit for SARS-CoV-2 RNA Detection in Biological Material Using PCR Method (Mirai Genomics, Mirai test from hereon) and GenomEra (Abacus Diagnostica Oy, GenomEra test from hereon). Other molecular POC devices currently in the late development stage may become available for assessment of clinical performance at later time, should these pass FIND's selection criteria.
The COVID-19 pandemic has rapidly spread across the globe. As of 3 October 2022, there are approximately a total of 623 million confirmed cases reported worldwide, that resulted in a total of 6.55 million deaths. The current weekly incidence is on average 1 million new cases. However, the consensus among public health officials is that the number of infected individuals is far higher. Given the wide range of possible symptoms and the potential for transmission before individuals are aware that they are infected, exposure to SARS-CoV-2 is a particular hazard for health care providers. Though diagnostic capacity has greatly improved due to the introduction of novel antigen rapid diagnostic tests (Ag RDT), long turnaround times for results of the current reference standard for testing (RT-PCR) is still a major challenge. This impacts on the ability of public health officials to track and contain the disease. The lack of capacity, in turn, is due in part to the logistic challenges and global reagent shortages faced by laboratories attempting to implement new RT-PCR assays for SARS-CoV-2.
Rapid sample-in-answer-out molecular POC devices, if shown to have sufficient accuracy to aid in clinical decision-making, could contribute substantially to control the disease spread globally. Molecular POC devices might provide a source of immediate diagnostic testing in low-and middle-income countries unable to implement RT-PCR due to lack of sample transport and storage facilities at local laboratories.
|Study Type :||Observational|
|Actual Enrollment :||600 participants|
|Official Title:||Evaluation of the Performance of Novel Molecular Point of Care Diagnostics for SARS-CoV-2|
|Actual Study Start Date :||January 30, 2023|
|Actual Primary Completion Date :||April 11, 2023|
|Actual Study Completion Date :||August 30, 2023|
- Sensitivity and Specitivity [ Time Frame: at enrollement ]Point estimates of sensitivity and specificity of molecular POC platforms
- Sensitivity and specificity in specific subgroups [ Time Frame: at enrolment ]Point estimates of sensitivity and specificity of molecular POC platforms for SARS-CoV-2, with 95% confidence intervals, using RT-PCR as reference standard.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06055218
|University Hospital of Geneva|
|Geneva, Switzerland, 1211|
|Central Public Health Laboratories|
|Kampala, Uganda, 759125|
|Liverpool school of Topical Medicine|
|Liverpool, United Kingdom, L35QA|
|Study Chair:||Camille Escadafal||FIND Diagnostics|