MidaSwift - SARS-CoV-2 Antigen Detection Kit
From Diagnostics Products
Nirmidas Biotech Inc. has developed an antigen test aiming for FDA EUA, MidaSwift™ SARS-CoV-2 Antigen Detection Kit, for the qualitative detection of the Nucleocapsid antigen from SARS-CoV-2. The test is curently for Research Use Only (RUO), for use with anterior nares (lower nostril) swab specimens. It can potentially be used at the Point-of-Care (POC) by licensed profesionals at CLIA waived sites or Over-the-Counter (OTC) for home-use, after regulatory approval. Below is the analytical and clinical test performance data thus far.
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Products Details
The MidaSwift™ SARS-CoV-2 Antigen Detection Kit affords a limit of detection of 100 TCID50/ml based on testing heat-inactivated SARS-CoV-2 (BEI Resouces NR-52286), which is more sensitive than competitor's tests (LOD ~ 340 TCID50/ml and ~ 800 TCID50/ml) as presented in the public documents using the same inactivated virus sample.
A clinical study was performed at a study site in Florida in 2021.
Nasopharyngeal (NP) swab specimens were collected from patients suspected of COVID-19 and were either presenting symptoms (wihtin the first 7 days) or were asymptomatic. The MidaSwift™ SARS-CoV-2 Antigen Detection Kit was compared to the RT-PCR test developed by the CDC (FDA EUA CDC 2019 Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel). For symptomatic patients, the test affords 100% Positivie Percent Agreement (PPA) and 96.7% Negative Percent Agreement (NPA) to the CDC RT-PCR Test out of a total of 31 PCR postiive and 31 PCR negative patients. In an asymptomatic cohort of 14 PCR positivie and 30 PCR negative patients, the test affords 92.9% PPA and 96.7% NPA.
The MidaSwift™ SARS-CoV-2 Antigen Detection Kit is currently being evaluated in a clinical study for an Over-the-Counter (OTC) claim with promising reuslts thus far. Nirmidas hopes to present this data to the FDA for Emergnecy Use Authorization in the near future to aid in reducing the testing strain caused by the shortage of at-home tests.
Product Name: MidaSwift™ SARS-CoV-2 Antigen Detection Kit (RUO)
Part Number: NBPC-0015
Package Unit: 2 Tests/Kit
Kit Contains*: 2 Test Cards, 2 swabs (for anterior nares specimens), 2 single-use vials filled with Extraction Buffer, and 1 Quick Reference Guide.
Kit containing 25 tests for Nasopharyngeal swab specimens are also available.
Please inquire for more details.
Key Features and Benefits
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Simple, easy to use, lateral flow-based, and no equipment needed
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For use with Anteiror Nares specimens (lower nostril swabbing)
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Detection of positive or negative result for SARS-CoV-2 in a single test
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Results ready in about 25 minutes from sample collection to results interpretation
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High sensitivity and specificity
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Room temperature shipping and storage
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