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
30-minute instrument time (1 hour faster than most RT-PCR tests)
Fraction of the cost of most commercial COVID-19 PCR tests
Highly Sensitive: 0.42 copies/µL Limit of Detection
MICA Test Kits detect SARS CoV-2 ORF1ab and N genes, providing accurate detection across variants and mutations
CE-Marked IVD Test Kits and Cloud-based Software
Features and Advantages
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.
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.