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COVID-19 Novel Molecular Point of Care Diagnostics Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT06055218
Recruitment Status : Completed
First Posted : September 26, 2023
Last Update Posted : October 5, 2023
Information provided by (Responsible Party):
Foundation for Innovative New Diagnostics, Switzerland

Brief Summary:
Point estimates of sensitivity and specificity of molecular POC platforms for SARS-CoV-2, with 95% confidence intervals, using RT-PCR as reference standard.

Condition or disease
COVID-19 Respiratory Infection

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.

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Study Type : Observational
Actual Enrollment : 600 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Sensitivity and Specitivity [ Time Frame: at enrollement ]
    Point estimates of sensitivity and specificity of molecular POC platforms

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Specimens to be tested for this study must originate from adult symptomatic individuals (≥ 18 years old) suspected to have COVID-19 (as per national or WHO case definitions).

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT06055218

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University Hospital of Geneva
Geneva, Switzerland, 1211
Central Public Health Laboratories
Kampala, Uganda, 759125
United Kingdom
Liverpool school of Topical Medicine
Liverpool, United Kingdom, L35QA
Sponsors and Collaborators
Foundation for Innovative New Diagnostics, Switzerland
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Study Chair: Camille Escadafal FIND Diagnostics
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Responsible Party: Foundation for Innovative New Diagnostics, Switzerland Identifier: NCT06055218    
Other Study ID Numbers: CV010
First Posted: September 26, 2023    Key Record Dates
Last Update Posted: October 5, 2023
Last Verified: October 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases