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artus Malaria RG PCR Kit CE

For quantitative detection of Plasmodium specific DNA using real-time PCR
  • Compliance with EU IVD Directive 98/79/EC
  • High reliability using the internal control
  • Highly sensitive detection of as few as 0.5 copies/µl
  • Accurate quantitation using the 4 standards supplied
The artus Malaria RG PCR Kit is a ready-to-use molecular detection kit for real-time PCR. The kit provides all necessary reagents optimized for reliable Plasmodium DNA detection and quantitation for in vitro diagnostic use.
Cat No./ID: 4601263
artus Malaria RG PCR Kit (24) CE
For 24 reactions on the Rotor-Gene Q MDx: Master, 4 Quantitation Standards, Internal Control, Water (PCR grade)

The artus Malaria RG PCR Kit CE is intended for in vitro diagnostic use in Europe.


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Reliable quantitation of Plasmodium load.
Detection of the quantitation standards (Malaria RG QS 1–4) on the Rotor-Gene 3000 using the artus Malaria RG PCR Kit. NTC: no template control.
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CE-IVD-marked.
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In vitro diagnostic medical device.
Performance

To ensure highest sensitivity, the artus Malaria RG PCR Kit has been optimized to detect low copy numbers of Plasmodium DNA. The analytical detection limit of the artus Malaria RG PCR Kit is 0.5 copies/μl in the PCR on the Rotor-Gene Q MDx.

For highest specificity, validation of the artus Malaria RG PCR Kit was carried out using various Plasmodium species, including P. falciparum, P. vivax, P. ovale, and P. malariae, and related pathogens. 

Performance characteristics of artus Malaria RG PCR Kit
Kitartus Malaria RG PCR Kit
Validated sample type EDTA blood
Analytical sensitivity 0.5 copies/µl in the PCR
 Specificity  Plasmodium species, including P. falciparum, P. vivax, P. ovale, and P. malariae

Principle

The artus Malaria RG PCR Kit is based on the amplification and simultaneous detection of a specific region of the Plasmodium genome using real-time PCR. The kit provides high levels of specificity, sensitivity, and reproducibility.

Each artus Malaria RG PCR Kit provides 4 quantitation standards (see figure "Reliable quantitation of Plasmodium load"). Use of the standards enables accurate quantitation of pathogen load. In addition, the kit contains a second heterologous amplification system to identify possible PCR inhibition. This is detected as an internal control (IC) in a different fluorescence channel from the analytical PCR. The detection limit of the analytical Plasmodium PCR is not reduced.

Specifications of artus Malaria RG PCR Kit
Kitartus Malaria RG PCR Kit
Sample type EDTA blood
Amplicon 163 bp region of the Plasmodium genome

Procedure
The artus Malaria RG PCR Kit provides all necessary reagents optimized for reliable Plasmodium DNA detection and quantitation. Simply add template DNA to the ready-to-use PCR master mix, and start the reaction on the appropriate real-time cycler using the optimized cycling program described in the kit handbook.
Applications
artus Malaria PCR Kits enable the rapid and sensitive detection of DNA of the Plasmodium species P. falciparum, P. vivax, P. ovale, and P. malariae from EDTA blood with accurate quantification. The kit is available for use on the Rotor-Gene Q MDx instrument.
Features
Specifications
Quantitative/qualitative Quantitative
RUO/CE/ASR CE
Sample type EDTA blood
Thermal cycler Rotor-Gene 3000
What detected Plasmodium DNA (P. falciparum, P. vivax, P. ovale, and P. malariae)
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