CoVirED – Corona Virus Extraction and Detection kit

Product is composed from:
A.     ViRNAEx RNA Extraction Kit (96 RNA extraction reactions)
B.     SARS-CoV-2RT-PCR Detection Kit (96 PCR reactions)

Instructions For Use SARS-CoV-2RT-PCR Detection Kit

1. SARS-CoV-2 RT-PCR Detection Kit contents
    Materials supplied with the kit (4 tubes):
    • RT Mix Reverse Transcriptase(blue tube cap)
    • Enzyme Mix, DNA Polymerase, buffer and dNTPs(green tube cap)
    • Working Mix Primers and probes(amber tube cap)
    • Positive control(synthetised DNA) (orange tube cap)

2. Additional equipment & reagents required (not provided in the kit)
    •  Real-Time PCR Systems have been tested (ABI7500, SLAN 96P and Bio-Rad CFX96 Real-Time PCR System)
    • compatible real -time PCR tubes, plates and accessories should be stored
    • molecular biology grade water
    • DNase and RNase-free pipette tips with aerosol barriers
    • DNase and RNase-free tubes for preparing Reaction Mix
    • Pipettes (adjustable)
    • Vortex mixer
    • Microcentrifuge

3. Shipment and storage
    • Kit components must be shipped and stored frozen, ( -20°C or below)
    • Keep away from light to prevent photobleaching
    • Kit is after opening stable up to the expiration date indicated on the packaging, if stored as recommended
    • Avoid multiple freeze-thaw cycles

4. Description

The COVID-19 Diagnostic Kit is an in vitro real-time PCR-based test for the detection of two targets (ORF1ab and N gene) targets of SARS-COV-2 in a single tube assay. The test may be used in microbiology, molecular biology, molecular pathology laboratories or in epidemiological studies under research settings. The positive control contains synthesized nucleic acid sequences for ORF1ab and N gene of SARS-COV-2 virus.
5. Sensitivity

The assay detects from 10 genome equivalent copies per PCR –reaction.

6. Material Safety Data (MSDS)

This product is not hazardous, toxic, or IATA-restricted. This product is not from human, animal or plant origin. According EU Directive 67/548/EC any products whit less than 1% of a hazardous component do not require a Material Safety Data Sheet ( MSDS).

7. Warnings

The performance of the kit during RT-PCR may be affected by known PCR inhibitors (such as blood, excessive drugs presence–e.g.nasal sprays, eye drops and decongestants).

• The kit is designed for research use only
• The kit should be used by trained personnel with competency in real-time PCR
• Do not use any damaged kit components ( check upon arrival) as they may not perform as expected
• Do not use the product beyond its expiry date
• Do not mix reagents from different batches
• The positive control provided in the kit must be used as a control in all PCR-experiments
• Fluorescently labelled probes are sensitive to photobleaching (please check the storage conditions)
• Personal protective equipment (PPE) should be worn during the work with kit components
• Appropriate DNase-free aerosol barrier pipette tips should be used
• Decontaminate working surfaces using wipes/sprays with 0.5% Sodium Hypochlorite solution or DNA AWAY™
• Unused reagents and waste should be removed in accordance with local regulations