Throw Away Your Columns and Beads
MICA–Direct™ reagents lyse pathogens without losing RNA during isolation
Simple MICA–Direct™ Protocols
RNA isolations require 25x more sample volume!
MICA–Direct™ Kit Performance
MICA–Direct™ Kits were tested using pooled NP swab samples that were previously tested by a US CLIA-certified laboratory. Pooled positive samples were quantified using ddPCR by an independent laboratory. Negative NP swab samples were used to dilute pooled positive samples to evaluate multiple concentrations of SARS-CoV-2.
This study used three concentrations of SARS-CoV-2 to capture a broad range of clinical samples (undiluted positive samples, 10x the LoD, and 5x the LoD). The study evaluated multiple runs on multiple instruments, resulting in a total of 180 contrived samples (60 positive samples and 120 negative samples).
Cross-Reactivity and Interference
Cross-Reactivity
Other microbes do not cause false positive MICA test results.
Microbial Interference
Other microbes do not interfere with the ability to detect low levels of SARS-CoV-2.
Intended Purpose for MICA–Direct™ Kit
The MICA–Direct Kit provides reagents to extract nucleic acids and is intended to be used in combination with compatible in vitro nucleic acid amplification tests.The MICA–Direct Kit is intended for use by qualified professionals. The MICA–Direct Kit is not intended for self testing or point-of-care use.
MICA–Direct is compatible with nasopharyngeal swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, and nasal washes. The Instructions For Use lists the NAATs that are compatible with the MICA–Direct Kit.
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
Ernst-Heckel-Straße 7 66386 St. Ingbert, Germany. Phone: +49 6894 581020
