COVID-19

Testing Solutions

The Biomiga™ system is a manual RNA purification and extraction kit used to extract RNA from the collection swab in transport media and combined with a Real Time-PCR Test Kit (i.e. GeneFinder) to determine if someone has the novel coronavirus. Biomiga’s RNA Purification & Extraction kit is ISO Certified (9001:215) and registered with the FDA (registration#: D408356). The kit produces high-quality extraction of more complete RNA in fewer steps than other systems and will work with most RT-PCR Test Kits and Lab Analyzers except automated systems (i.e. Roche Magna 96).

• Easy and reliable method for isolating total viral RNA from plasma, serum, nasopharyngeal, or oropharyngeal aspirates or washes, swabs, aspirates, and sputum.
• Ability to complete 96 preps ready for RNA amplification using RT-PCR (manual).
• Stable material; can be used at room temperature.
• Highly efficient process takes 20-30 minutes (including purification) and saves up to 40% of base reagents compared to other RNA extraction systems.
• Independent verification showing higher quality RNA extraction from the Biomiga™ System compared to the market leading viral RNA mini kit.
• 250 ‘preps’ mini columns with waste collection tubes all shipped together.
• Proteinase K and L solutions are stable at 59-77 F (15-25 °C) and are shipped in a Styrofoam box in case temp exceeds 25 °C during transit.

The Bio-RAD CFX 96 Touch RT-PCR Analyzer is a high-output, fully automated, single-run lab analyzer for Real-Time Reverse Transcription (RT) Polymerase Chain Reaction (PCR). The CFX 96 Touch runs a 96 well plate in 120 minutes with each well having a reagent load of 20 microliters. The reagent is provided in the GeneFinder™ COVID-19 Plus RealAmp Kit. The Master Mix (with positive 3 and negative controls) of 15 microliters + 5 microliters of extracted viral RNA, are put into each of the 96 wells for subsequent RNA amplification in the CFX 96 Touch. Test results are captured as a digital signal in spreadsheet or data log format which can then be interpreted on the analyzer or uploaded onto a cloud platform to be accessed by Providers and the microbiology lab. The Bio-RAD CFX 96 Touch RT-PCR Analyzer is ISO Certified (9001:215) and FDA/CE Registered.

• The Bio-RAD CFX 96 Touch RT-PCR Analyzer is ISO Certified (9001:215) and FDA/CE Registered.
• High-output, fully automated, single-run lab analyzer runs a 96 well plate in 120 minutes.
• Purchasing and leasing options are available.

Analyzer Components:

1. CFX 96 Touch Real-Time PCR Detection System.
2. CFX Maestro Software.
3. CFX Qualification Plate.
4. Hard-Shell 96-Well PCR Plates.
5. Microseal ‘B’ PCR Plate Sealing Film.
6. IQOQ, CFX 96 Touch System.
7. ENP, Real Time PCR OS (service plan).

Helpful Resources:

CFX 96 Touch Product Description & Specifications

Real-Time PCR Applications Guide

Process for RT-PCR in COVID-19 Testing