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URL: https://dx.doi.org/DOI:10.17504/protocols.io.bkwckxaw

Authors: Shripal Gandhi, Santo Purnama, Keyur Patel, Praveen Sukumara, Dr Rinu R Ravi

Group: Coronavirus Method Development Community, SensingSelfMission, XPRIZE Rapid Covid Testing

Summary: Summary:The S4 Multiplex Covid-19 /MERS-CoV/ Influenza A/B Rapid Antigens Test Kit developed by Sensing Self Pte. Ltd. can quickly and qualitatively detect Novel Coronavirus / Influenza A/ Influenza B /MERS in human saliva/sputum/stool samples. It can be used as an aid for COVID-19 diagnosis. It provides an aid in the diagnosis of infection by the above viruses.Objective:According to the clinical trial plan, the S4 Multiplex Covid-19 /MERS-CoV/ Influenza A/B Rapid Antigen test kit or “test reagent”, is to test saliva/sputum/stool samples from healthy subjects and confirmed patients with infections caused by these viruses. Test results are compared with another commercial Covid-19 /MERS-CoV/ Influenza A/B nucleic acid detection kit, which is defined as the “gold standard”. The sensitivity, specificity, and total agreement rate are used to evaluate the feasibility of the test reagent in clinical applications.Method:A collection of clinical samples were examined by the S4 Multplex Covid-19 /MERS-CoV/ Influenza A/B Rapid Antigen test kit and the gold standard SARS-COV-2/MERS-CoV/ Influenza A/B nucleic acid detection kit in parallel, to calculate the clinical sensitivity, clinical specificity and total agreement rate of the test reagent.Results:For SARS-CoV-2, compared to the gold standard:In Saliva, the clinical sensitivity of test reagent reached 88.3%, the clinical specificity reached 100.0%In Sputum, the clinical sensitivity of test reagent reached 93.3%, the clinical specificity reached 100.0% In Stool, the clinical sensitivity of test reagent reached 93.3%, the clinical specificity reached 100.0%For MERS, compared to the gold standard:In Saliva, the clinical sensitivity of test reagent reached 86%, the clinical specificity reached 100.0%In Sputum, the clinical sensitivity of test reagent reached 90%, the clinical specificity reached 100.0% In Stool, the clinical sensitivity of test reagent reached 90%, the clinical specificity reached 100.0%For Influenza Virus A, compared to the gold standard:In Saliva, the clinical sensitivity of test reagent reached 85.7%, the clinical specificity reached 98.3%In Sputum, the clinical sensitivity of test reagent reached 91.4%, the clinical specificity reached 100.0% In Stool, the clinical sensitivity of test reagent reached 90%, the clinical specificity reached 100.0%For Influenza Virus B, compared to the gold standard:In Saliva, the clinical sensitivity of test reagent reached 82.9%, the clinical specificity reached 100.0%In Sputum, the clinical sensitivity of test reagent reached 87.1%, the clinical specificity reached 96.7% In Stool, the clinical sensitivity of test reagent reached 85.7%, the clinical specificity reached 98.3%Conclusions:The performance of test reagent has a high agreement rate with the gold standard, proving its good feasibility in diagnosing suspected Covid-19 /MERS-CoV/ Influenza A/B cases.

Affiliations: Sensing Self Pte Ltd, Singapore, Sensing Self Pte Ltd, Singapore, Sensing Self Pte Ltd, Singapore, Sensing Self Pte Ltd, Singapore, Sensing Self Pte Ltd, Singapore

External URL: http://www.sensingself.me

Version: 1

Publication Date: 2020

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