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MOLgen - COVID-19 - 5 GENE TEST

SARS-CoV-2 Real Time RT-PCR Kit

Molecular Diagnostic Test Product Information & Purchase Order

Line Method & Sample Product Package Info
MOLgen Saliva,Nasopharyngeal swabs,Oropharyngeal swabs,Sputum,Bronchoalveolar lavage fluid (BALF) SARS-CoV-2 Real Time RT-PCR Kit Tests per Package: 100
SARS-CoV2 - COVID-19 Detection of SARS-CoV-2 Virus - 5 GENE TEST Code: MESARS-CoV-2 Package Format: Liquid Reagents
  • Stock:
  • Available
    *Usually shipping within 4 weeks
  • Min Order:
  • 100 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

  • Stock:
  • Available
    *Usually shipping within 4 weeks
  • Min Order:
  • 100 Kits
  • Shipping:
  • Not Included

For Quantity Orders: Request a Quote

Please pay attention to the revision of the document that must be the same as the revision reported in the box label.
In case of discrepancy please contact our Customer Care e-mail: info@adaltis.net.

* Other document related to the product available at Documentation Centre and it is accessible for Adaltis distributors/partners after registration only.

MOLgen SARS-CoV-2 Real Time RT-PCR Kit is used for the qualitative detection of Novel Coronavirus (SARS-CoV-2), by Reverse Transcription (RT) and Real Time Polymerase Chain Reaction (PCR) from RNA extracted from human respiratory specimens such as nasopharyngeal swabs, oropharyngeal swabs, sputum and bronchoalveolar lavage fluid (BALF).

Coronaviruses are a large family of respiratory viruses, some causing illness in human and others circulating among animals such as camels, cats and bats from common cold to severe diseases such as Middle Est Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).

SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) is a new strain of coronavirus emerged from Wuhan, China in December 2019.

The infection with SARS CoV2 virus causes Coronavirus disease (COVID-19) where "CO" stands for crown, "VI" for viruses, "D" for disease and “19'" indicates the year in which it occurred.

COVID-19 symptoms are fever, cough , pneumonia and Severe Acute Respiratory Syndrome (SARS).

MOLgen SARS-CoV-2Real Time RT-PCR Kit is intended for the detection of the New Coronavirus SARS-CoV-2RNA using reverse transcription of viral RNA and real-time polymerase chain reaction (RT-PCR) method with fluorescence detection of amplified product.

Real-time PCR is based on the detection of the fluorescence produced by a reporter molecule, which increases as the reaction proceeds. Reporter molecule is a dual-labeled DNA-probe that specifically binds to the target region of the pathogen’s cDNA. Fluorescence signal increases due to the separation of fluorescence dye and quencher owing to Taq DNA-polymerase exonuclease activity during amplification. PCR consists of repeated cycles: temperature denaturation of cDNA, primer annealing and complementary chain synthesis.

Threshold cycle value (Ct) is a cycle number, at which the fluorescence generated within a reaction crosses the threshold and the fluorescence signal rises significantly above the background. The increased signal is due to the use of a DNA hybridization probe that is specific for the given cDNA sequence: it binds to the cDNA in the course of reaction and provides additional specificity of the method. The DNA probe consists of a fluorescence dye at the 5’-end and a fluorescence quencher at the 3’-end that significantly reduces the fluorescence intensity. During the polymerase synthesis of the complementary strand, the probe is cleaved from the 5’-end due to the 5’-3’ nuclease activity of Taq DNA polymerase, the quencher and the dye become separated thus increasing the fluorescence signal due to accumulation of the reaction product. The detected fluorescence intensity depends on the initial quantity of pathogen’s cDNA template in the sample.

The primer and probe set is designed to detect SARS-CoV-2 identifyng 4 targets: 3 specific for SARS-CoV-2 (N gene, S Gene, E gene) and 1 common for sabercoviridae (RdRp gene).

The detection of amplified virus RNA fragment is performed in fluorimeter channel FAM (RdRp gene), ROX/Texas Red (E gene), Cy5.5/Alexa Fluor ( S gene) and CY5 (N gene). The use of Internal Control (IC) on HEX channel ensure the monitoring correct amplification of the samples.

The results of PCR analysis are taken into account in complex diagnostics of disease. The kitis validated for use with: AMPLIlab (Adaltis), CFX96 (Bio-Rad).

The kit contains reagents required for 100 reactions.

Component
Code
Component Description Nr Vial Volume
(μL/vial)
Lip
Color
MESARSCoV2/MM MOLgen SARS-CoV-2 Master Mix 1 1000 Green
MESARSCoV2/PM MOLgen SARS-CoV-2 Probe Mix 1 500 Yellow
MESARSCoV2/PC MOLgen SARS-CoV-2 Positive Control 1 50 Red
MESARSCoV2/NC MOLgen SARS-CoV-2 Negative Control 1 50 Clear
Number of reactions (rxns) 1 100
Reference Kit Code 1 MESARS-CoV-2

1. MOLgen SARS-CoV-2  Master Mix

Ready to use reagent.

It contains reagents for reverse transcription and amplification.

2. MOLgen SARS-CoV-2 Probe Mix

Ready to use reagent.

It contains primers and  probes which are premixed to the working concentrations.

3. MOLgen SARS-CoV-2 Positive Control

Ready to use control.

It contains  plasmids  with SARS-CoV-2 sequences (RdRP, E, S and N genes) plus an Internal Control (IC).

4. MOLgen SARS-CoV-2 Negative Control

Ready to use control.

Negative Control should be included at every run as it indicates that reagents have not been contaminated.

E. MATERIALS AND DEVICES REQUIRED BUT NOT SUPPLIED

  • Nucleic Acid extraction kit intended for isolation of RNA.
  • 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
  • Magnetic rack for tubes
  • Biohazard waste container

DIAGNOSTIC SENSITIVITY - ACCURACY - 100%

Diagnostics Sensitivity was in vitro assessed testing a Coronavirus SARS-CoV-NAT Positive Panel of 18 members tested using 2 Reference PCR methods.

ANALYTICAL SPECIFICITY (Cross-Reactivity)
Analytical Specificity was in vitro assessed testing related pathogens from the same genetic family and high priority organism likely in the circulating area.
Analytical Specificity was found 100%.

 

G. SPECIMENS COLLECTION AND STORAGE

  • Collect fresh specimen of Nasopharyngeal swabs, Oropharyngeal swab, Sputum and BALF from suspects. Refer to Interim Guidelines for
  • Collecting, Handling, and Testing Clinical Specimens from Patients Under Investigation (PUIs) for 2019 Novel Coronavirus (2019 nCoV).
  • For collection methods refer to specimen collection devices manufacturer instructions.
  • For the collection of the sample, the manufacturer of the kit MOLgen SARS-CoV-2 Real Time RT-PCR, recommends the use of the collection system in liquid transport medium.
  • Nasopharyngeal-Oropharyngeal swabs: Carefully take out the swab from package and quickly rotate it around two sides of fauces, throat and tonsila few times applying pressure to collect as much secretions as possible. Avoid touching tongue. Break the swab stick and put the head into sampling solution in specimen tubes. Screw the tube cap tightly to ensure no leakage.
  • BALF: Collect 3 ml of unprocessed BALF in sterile, dry and clean DNase/RNase free Cryotubes. Screw the tube cap tightly to ensure no leakage and seal the tube with film.


Specimens can be stored at 2…8°C for up to 72 hours after collection or at -70°C for longer periods.

 

N. 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.

 

NOTE: The extraction protocol with MOLgen Universal Extraction Kit (Adaltis) Ref. ME188830 and the PCR set-up procedure can be done in automated mode using the Adaltis EXTRAlab Instrument by executing the extraction and PCR set-up protocol preloaded in the instrument user interface.

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