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 Use for MICA–Direct™ Kit
The MICA–Direct Kit provides reagents to extract nucleic acids and is 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. The MICA–Direct Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in general PCR and in vitro diagnostic procedures.
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
