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VITAPCRTM PLATFORM

VitaPCR™ AT A GLANCE
VitaPCR™ is a molecular point-of-care platform based on fast Real Time-PCR for rapid molecular detection, directly from oro and nasopharingeal swabs, of SARSCoV-2 and other respiratory viruses. The system combines high sensitivity with ease of use, delivering accurate and actionable results in just 20 minutes, exactly where they are needed.

PRINCIPLE OF THE TESTS
All assays running on the VitaPCR system are based on fast Real Time PCR with multicolor fluorescence detection in up to four different channels. Sample preparation includes single step lysis and extraction solutions to allow an efficient and rapid release of nucleic acids. This combination ensures sensitivity levels that closely compare to laboratory PCR tests and time to results that closely compare to rapid antigen tests.

CONVENIENT AND EFFICIENT SOLUTION
VitaPCR can be installed in minutes, doesn’t require additional laboratory equipment and thanks to the rapid turnaround time can process up to 3 samples per hour with the possibility to add more instruments working in parallel when throughput need exceeds the capacity of a single unit. Using the VitaDataLink software it is possible to connect up to 8 units to a single PC to simplify data management and connect the hub to a central LIS system.


VITAPCR KEY BENEFITS

EASY
Sample preparation is completed in 1 minute just introducing the swab into the collection buffer. In a few seconds the sample is ready to be transferred to the PCR tube.

RAPID
Results are ready in 20 minutes, for both positive and negative samples.

SENSITIVE
Based on Real Time PCR, the assay provides very high sensitvity, allowing to detect patients with moderate to low viral load.

INTUITIVE
The instrument software automatically interprets results and shows all details of the run, including curve graphics and Ct values, by means of its intuitive, user interface.

VERSATILE
The system wheighs only 1.2 Kg with very small footprint. It can be deployed anywhere and does not require additional equipment to be used. Assay reagents are for room temperature storage.

CONNECTED
VitaDataLink connection pack supports the HL7 messaging standard, allowing to interface VitaPCR™ to LIS, middleware, EMR and point of care data manager.

VitaPCR™ Product List for Orders

CODE DESCRIPTION

  • 51572 VitaPCR™ Instrument
  • 52957 SARS-CoV-2 Gen2 Assay
  • 51574 SARS-CoV-2 (Gen1) Assay
  • 51573 Flu A+B Assay
  • 52182 Influenza/SARS-CoV-2 Assay
  • 52253 Strep A Assay
  • 52254 Flu/RSV Assay
  • 52289 SARS-CoV-2 Gen2 External Control Set
  • 51699 SARS-CoV-2 (Gen1) External Control Set
  • 54373 Thermal Printer
  • 52207 Rack (tube holder)

BROCHURE AVAILABLE HERE:

VITAPCRTM TECHNICAL SPECIFICATIONS

Dimensions 15.5 x 16.5 x 20.5 cm (H*W*D)

Weight 1.2kg

Power Supply 12V, 5A

Colour Touch Screen 4" capacitive touch LCD display

Fluorescence Channel FAMTM / VIC® / ROXTM

Sample Well one

Storage Environment 15-40°C

Operating Environment 10-38°C ; 10-80%RM

Power Adapter INPUT: AC100-240V~2.0A Max, 50-60Hz

OUTPUT: DC 12V - 5A

Note: We strongly recommend using ONLY adaptor provided by Trentron Biomedical Ltd., or adaptors meet the above specifications and CE requirements (e.g.: EN 60950) in order to avoid inaccurate examination or any risk

The VitaPCR™ SARS-CoV-2 Assay is a rapid molecular diagnostic test utilizing Real-Time PCR (RT-PCR) amplification technology for the qualitative detection of SARS CoV2 viral RNA in nasopharyngeal (NP) or oropharyngeal (OP) swabs.

  • The assay includes an endogenous RNA amplicon to control all the phases of the process from sampling to amplification.

Assay Specifications

  • Specimen: NP/OP SWABS
  • Time to results: 20 min
  • Eluted specimen storage: +2°C/+8°C up to 10 hours
  • Viral inactivation: yes
  • LoD: 90 copies/reaction (3 copies/uL SCB)
  • Targets
    1) SARS-CoV-2 specific region located in N gene
    2) SARS-like conserved region located in N gene
  • Control: Assay for Betaglobin human gene transcript

The VitaPCR™ Flu A&B Assay is a rapid qualitative molecular diagnostic test utilizing Real-Time PCR (RT-PCR) amplification technology for the detection and differentiation of influenza A and influenza B viral RNA in nasal and nasopharyngeal swabs .

Assay Specifications

  • Specimen: nasal (NS) or nasopharyngeal (NP) swabs
  • Time to results: 20 min Eluted specimen storage: +2°C/+8°C up to 7 days
  • Targets
    1) Influenza A: conserved region of matrix gene (M gene)
    2) Influenza B: conserved region of non-structural protein gene (NS gene)
  • Control Synthetic RNA Internal Control

The VitaPCR™ Flu A&B – SARS CoV-2 panel assay is a rapid molecular diagnostic test utilizing Real-Time PCR (RT-PCR) amplification technology for the detection and differentiation of Influenza A, Influenza B and SARS COV-2 in nasopharyngeal swabs.

Assay Specifications

  • Specimen: nasopharyngeal (NP) swabs
  • Time to results: 20 min
  • Eluted specimen storage: +2°C/+8°C up to 7 days
  • Targets
    1) Influenza A: conserved region of matrix gene (M gene)
    2) Influenza B: conserved region of non-structural protein gene (NS gene)
    3) SARS COV-2: nucleoprotein gene (N gene)
  • Control Synthetic RNA Internal Control

The VitaPCR™ Flu A&B – RSV panel assay is a rapid molecular diagnostic test utilizing Real-Time PCR (RT-PCR) amplification technology for the detection and differentiation of Influenza A, Influenza B and Respiratory Syncytial Virus in nasal and nasopharyngeal swabs.

Assay Specifications

  • Specimen: nasal (NS) or nasopharyngeal (NP) swabs
  • Time to results: 20 min
  • Eluted specimen storage: +2°C/+8°C up to 7 days
  • Targets
    1) Influenza A: conserved region of matrix gene (M gene)
    2) Influenza B: conserved region of non-structural protein gene (NS gene)
    3) RSV: conserved region of nucleocapsid protein gene (N gene)
  • Control Synthetic RNA Internal Control

The VitaPCR™ Strep A Assay is a rapid qualitative molecular diagnostic test utilizing Real-Time PCR (RT-PCR) amplification technology for the detection of Streptococcus pyogenes (Group A β hemolytic Streptococcus, Strep A) in oropharyngeal (OP) or throat swabs.

Assay Specifications

  • Specimen: oropharyngeal (OP) or throat swabs
  • Time to results: 20 min
  • Eluted specimen storage: +2°C/+8°C up to 14 days
  • Targets
    1) Group A Streptococcus: conserved region of spy1258 gene
  • Control Synthetic RNA Internal Control

The VitaPCR™ SARS-CoV-2 Gen2 Assay is a high sensitivity, second generation rapid molecular diagnostic assay utilizing Real-Time PCR (RT-PCR) amplification technology for the qualitative detection of specific SARS-CoV-2 RNA in respiratory specimens collected via nasopharyngeal (NP) or oropharyngeal (OP) swabs.

  • Specimens eluted in the Gen2 sample collection buffer can be stored up to a week at 4C°.

Assay Specifications

  • Specimen: NP/OP SWABS
  • Time to results: 20 min
  • Eluted specimen storage: +2°C/+8°C up to 7 days
  • Viral inactivation: yes
  • LoD: 30 copies/reaction (1 copy/uL SCB)
  • Targets:
    1) SARS-CoV-2 specific region located in N gene
    2) SARS-like conserved region located in N gene

Control: Synthetic RNA Internal Control

References

1- Fournier PE, et at. Contribution of VitaPCRTM SARS-CoV-2 to the emergency diagnosis of COVID-19. Journal of Clinical Virology, 2020: 133: 104682, doi.org/10.1016/j-jcv.2020.104682

2- Fenollar F. et at. Evalutation of the Panbio Covid-19 rapid antigen detection test device for the screening of patients with Covid-19. Journal of Clinical Microbiology. 2021, 59(2):e02589-e02620. doi:10.1128/JCM.02589-20

MSDS

Safety sheets of the reagent.

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