Process More Samples, Faster, For Less Cost Than PCR
Use Your Existing PCR Instruments and Lab Workflows
Drop-in Replacement for PCR
Easy to use
Cost
Faster
Excellent Performance
Increase Throughput
Faster Sample Processing
Multiplex Performance Singleplex Output
MICA Tests are unique because they can detect multiple SARS-CoV-2 genes in a single reaction (multiplex performance), using a common fluorescence channel (singleplex output) that's widely used on existing instruments.
Detect Two SARS-CoV-2 Genes (Orf1ab & N Genes)
Singleplex Output(Common FAM/SYBR Channel)
Instrument Compatibility
Two Test Kits
MICA–Standard™ Test Kit
MICA–High Throughput™ Test Kit
Intended Use for 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.
The results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine the patient’s infection status. Positive results do not rule out bacterial infection or coinfection with other viruses. The agent detected may not be the definite cause of the disease. Laboratories are responsible for complying with their jurisdiction’s reporting requirements to the appropriate public health authorities. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
MICA Tests is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in general PCR and in vitro diagnostic procedures.
Process More Samples with Your Existing Instruments
MICA Test Kit Performance
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.
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.
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.
Ongoing Analyses of Mutations and Variants
Microbial Interference
Other microbes do not interfere with the ability to detect low levels of SARS-CoV-2.
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
