MICA™ Test Support
Instruction Manuals
User instructions for MICA™ Test Kits and MICA Software are available in pdf
Ongoing Analyses of Mutations and Variants
Refer to the Instructions for Use for the initial in silico analyses. Stay tuned for ongoing analyses of variants and mutations, which will be posted here.
Contact Us
Manufacturer
Clear Gene, Inc.
930 Brittan Ave.
San Carlos, CA 94070
tel: +1 (415) 742-9100
European Community Authorized Representative
MT Promedt Consulting GmbH
Altenhofstr. 80
66386 St. Ingbert, Germany
tel: +49 6894 581020
Instrument Compatibility
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Validated on BIO-RAD® CFX96™ and Applied Biosystems™ 7500 FAST Dx.
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All readouts are in one channel, meaning MICA tests are compatible with Real-Time PCR instruments with the FAM/SYBR channel. Additional instruments must be validated.
Disclaimers
For In Vitro Diagnostic Use. Available in selected countries.
Customers are responsible for compliance with regulatory requirements that pertain to their procedures, use of IVD products and reporting results to relevant health authorities.
European Community Authorized Representative: MT Promedt Consulting GmbH, Altenhofstr. 80 66386 St. Ingbert Germany. Tel: +49 6894 581020
MICA Test Kit Performance
Cross-Reactivity Studies
In silico studies and wet lab testing demonstrate that MICA Test Kits do not cross-react with common respiratory pathogens. Wetlab tests were performed in triplicate.
Analytical Sensitivity
High-Sensitivity workflow limit of detection (LoD): 0.42 copies/µL, demonstrated on actual pooled positive patient samples (synthetic materials and cultured viruses do not always represent real-world performance).
Validated workflows compatible with magnetic beads and silica spin columns.
Inclusivity Studies
MICA Test Kits are robust against mutations and emerging variants by detecting multiple SARS CoV-2 genes.
MICA Tests Kits are designed to avoid regions like the S-gene that are under high evolutionary selective pressure.
In silico studies confirm that the mutations present in WHO-designated Variants of Concern do not impact MICA Test Kit performance.
Clinical Validation
Clinical validation was performed by an independent clinical lab. MICA Test Kit performance was compared to an RT-PCR test for SARS CoV-2.
