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Diagnostic Test Kit

CoMira™ Logix Smart® COVID-19 test kit

Boost speed and accuracy with real-time PCR testing

How It Works

Ready-to-use Master Mix

Includes the complete mix for convenience and an Internal Positive Control - Human RNaseP gene marker

Positive Control

Synthetic control intended to amplify all targets included in the kit to ensure integrity

Negative Control

Acts as a negative control to verify Master Mix is free from contamination

Clinical Applications

Patient Diagnosis

Accurate detection of SARS-CoV-2 infection for symptomatic and asymptomatic patients.

Screening Programs

Support population screening and surveillance efforts in healthcare and community settings.

Clinical Laboratories

Designed for use by clinical laboratories with qualified personnel following FDA authorization.

Clinical Benefits

FDA-Authorized Accuracy

Meets FDA standards for diagnostic testing performance

Enhanced Reliability

Dual-target detection reduces false negatives

Timely Results

Rapid turnaround supports effective patient management

Quality Controls

Built-in controls ensure result validity

Performance Specifications

Intended UseQualitative real-time RT-PCR test for SARS-CoV-2 RdRp detection
Sample TypesLower/upper respiratory tract fluids and swabs
Limit of Detection4.29 copies/μl
Analytical Sensitivity100% (96-100%)
Analytical Specificity100% (96-100%)
Time to Detection63-90 minutes
Extraction SystemQIAamp® RNA Viral Mini Kit
Compatible EquipmentCoMira Box™

Order Information

Contact us for ordering information and to learn more about implementing the CoMira Logix Smart COVID-19 FDA EUA test in your laboratory.

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