MOLgen

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Acute respiratory infections are common respiratory diseases that generally show minor symptoms but depending on the patient’s condition can also cause morbidity, hospitalization and death.
The pathogens that are the main infectious agents of these respiratory infections are FLU A, FLU B, RSV A, RSV B, and SARS-CoV-2.
The nature of respiratory transmission of this category of viruses has the potential for wide-ranging spread and is a major concern of both local and international public health levels.
Given that these pathogens cause respiratory syndromes with similar symptoms, it is necessary to distinguish them especially in relation to the pandemic caused by SARS-CoV-2.

Respiratory Panel (RT-5) is a multiplex real-time one step RT-PCR assay for the detection of Influenza A, Influenza B, Human Respiratory Syncytial Virus A, Human Respiratory Syncytial Virus B, SARS-CoV-2 using real time polymerase chain reaction (RT-PCR) method to quickly detect types of respiratory viruses via fluorescence detection of amplified targets. During the PCR process, if the NA of this viruses is amplified during each cycle, a hydrolysis probe method is used to determine whether genes are amplified by fluorescence of this amplified products. The detection of amplified targets fragment is performed on channel FAM (FLU), ROX/Texas Red (SARS-CoV-2), and CY5 (RSV).
The use of human β-actin as Internal Control (IC) on Cy5.5/Alexa Fluor channel ensures the correct monitoring of the cellularity of the samples. The primer and probe set is designed to detect without typing of FLU A ,FLU B ,RSV A , RSV B, SARS-CoV-2 The results of PCR analysis are considered in complex diagnostics of disease. The kit is validated for use with: AMPLIlab (Adaltis), CFX96 (Bio-Rad).

The kit contains reagents required for 100 reactions.

1. Molgen Respiratory Panel RT-5 Master Mix Ready to use reagent.
Contains reagents for reverse transcription and amplification.

2. Molgen Respiratory Panel RT-5 Probe Mix Ready to use reagent.
Contains primers and probes which are premixed to the working concentrations to identifying FLU A, FLU B, RSV A, RSV B, SARS-CoV-2.

3. Molgen Respiratory Panel RT-5 Positive Control Ready to use control.
Contains plasmids with FLU A, FLU B, RSV A, RSV B, SARS-CoV-2, sequences plus an Internal Endogenous Control (IC).

4. Molgen Respiratory Panel RT-5 Negative Control Ready to use control.
Negative Control should be included at every run as it indicates that reagents have not been contaminated.

• Nucleic Acid extraction kit intended for isolation of RNA (MOLgen Universal Extraction Kit (Adaltis) Ref. ME188830).
• Real-time PCR cycler.
• Biosafety Cabinet.
• Refrigerator.
• Microcentrifuge with rotor for 1,5 mL reaction tubes.
• 1.5 mL microcentrifuge tube for extraction.
• Plate shaker.
• Calibrated adjustable pipettes.
• Disposable pipette tips with aerosol filter.
• Strip Tubes and Caps (0.2 mL) or PCR Tubes (0.2 mL) or 96 well plate with optical caps or films.
• Disposable medical non-sterile powder-free gloves.
• Biohazard waste containers

NOTE: Automated extraction with MOLgen Universal Extraction Kit (Adaltis) Ref. ME188830 has been validated with the ELAB (Extraction) and EXTRALAB (Automated Extraction and PCR setup) available from Adaltis S.r.l.. Extraction systems are installed with the extraction protocols preloaded. 

WARNING AND PRECAUTIONS

· Strict compliance with the instructions for use is required for optimal results. Any deviation from these instructions may affect results.

· Use of this product is limited to personnel specifically instructed and trained in the techniques of real time PCR and in vitro diagnostic procedures.

· Use of this product is limited to personnel specifically instructed and trained.

· Correct Personal Protection Equipment (PPE) must be worn when handling specimens and reagents in accordance with local regulations for biosafety procedures and handling pathogens.

· Carefully read the Safety Data Sheet (SDS) and instructions for use before product use.

· Do not mix the components from kits of different lots.

· Avoid more than 3 thawing- freezing cycles.

· Treat all specimens as potentially infective using safe laboratory procedure. Refer to Interim Laboratory Biosafety Guidance for Handling and Processing Specimens Associated with 2019-nCoV.

· To prevent cross-contamination it is recommended to have dedicated work areas for sample preparation (RNA extraction) and PCR Amplification (setting up PCR reaction and thermocyclers).

· To conduct real-time amplification reaction with PCR products detection, use only disposable tips with aerosol filters.

· Dispose unused reagents and waste in accordance with country, federal, state and local regulations.

· Do not use the kit after the expiration date.

STORAGE AND TRANSPORTATION

· Transport the kit at -15°C…-25°С.

· Store the kit in the manufacturer’s packaging at -15°C…-25°С for the entire shelf life.

· Do not freeze the Kit more than 3 times.