COVID-19 Novel Molecular Point of Care Diagnostics Evaluation
Evaluation of the Performance of Novel Molecular Point of Care Diagnostics for SARS-CoV-2
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Geneva, Switzerland, 1211
- University Hospital of Geneva
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Kampala, Uganda, 759125
- Central Public Health Laboratories
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Liverpool, United Kingdom, L35QA
- Liverpool school of Topical Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Participants and specimens are eligible to be included in the study only if all the following inclusion criteria apply:
- Adult individuals (≥18 years of age) with symptoms suggesting plausible COVID-19 infection (as per WHO or national clinical case definitions)
- Individuals who have voluntarily given written consent to participate in this study or who have given their written consent for their specimen to be used for future research studies
- Individuals able to provide the specimens required for the study
Exclusion Criteria:
- Individuals on oxygen therapy
- Individuals with recent history of excessive nose bleeds
- Individuals with hemodynamic instability as determined by their treating physician
- Individuals already enrolled in other clinical studies, where similar respiratory specimens are collected on the same day.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sensitivity and Specitivity
Time Frame: at enrollement
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Point estimates of sensitivity and specificity of molecular POC platforms
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at enrollement
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Sensitivity and specificity in specific subgroups
Time Frame: at enrolment
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Point estimates of sensitivity and specificity of molecular POC platforms for SARS-CoV-2, with 95% confidence intervals, using RT-PCR as reference standard.
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at enrolment
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Collaborators and Investigators
Investigators
- Study Chair: Camille Escadafal, FIND Diagnostics
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CV010
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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