Intended Use of MICA Test Kits
The Molecular Isothermal SARS CoV-2 Assay (MICA) Test is a reverse transcription and isothermal amplification assay intended for the qualitative detection of SARS CoV-2 nucleic acid in nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, and nasal washes collected from individuals suspected of COVID-19 by a healthcare provider.
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Isothermal assay designed to replace PCR while working with existing instruments and workflows
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30-minute instrument time (1 hour faster than most RT-PCR tests)
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Fraction of the cost of most commercial COVID-19 PCR tests
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Highly Sensitive: 0.42 copies/µL Limit of Detection
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MICA Test Kits detect SARS CoV-2 ORF1ab and N genes, providing accurate detection across variants and mutations
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CE-Marked IVD Test Kits and Cloud-based Software
Features and Advantages
MICA-Standard
Test Kit
MICA-High Throughput
Test Kit
Software
Detection of SARS CoV-2 from nasopharyngeal (NP) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, and nasal washes.
Analysis of specimens and controls from compatible nucleic acid amplification tests (NAAT). MICA Software analyzes and interprets NAAT Test results.
MICA–Direct Kit
Reagents to extract nucleic acids are intended to be used in conjunction with compatible nucleic acid amplification tests (NAAT) for the qualitative detection of nucleic acid from SARS-CoV-2 and other validated upper respiratory pathogens.