MICA™ Test Support

Instruction Manuals

User instructions for MICA™ Test Kits and MICA Software are available in pdf

Get A Quote

The fastest way to get the ordering information you need.

Adverse Events

Report any adverse events using MICA Tests or Software

Symbols

View the symbols used in the MICA Instruction Manual and in MICA Software

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

[email protected]

tel: +1 (415) 742-9100

European Community Authorized Representative

MT Promedt Consulting GmbH 

Altenhofstr. 80

66386 St. Ingbert, Germany

[email protected]

tel: +49 6894 581020

Instrument Compatibility

  • Validated on BIO-RAD® CFX96TM and Applied Biosystems 7500 FAST Dx.

  • 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.

Clear Gene Inc.

© 2021-2022 Clear Gene Inc. All Rights Reserved. 

930 Brittan Ave.

San Carlos, California 94070