artus JCV RG PCR Kit CE

• Compliance with EU IVD Directive 98/79/EC
• Detection and quantification of JCV DNA
• High reliability using the Internal Control
• Highly sensitive and specific
• Covers a broad linear range

Performance evaluation of the artus JCV RG PCR Kit was carried out using quantified JCV-specific DNA isolated from JCV strain MAD-1 (ATCC number: 45027).

Analytical sensitivity

The analytical sensitivity of the artus JCV RG PCR Kit, determined by probit analysis, for detection of JCV-specific DNA is 0.033 copies/µl (95% confidence interval [CI]: 0.013–0.175 copies/µl).

Analytical specificity

The analytical specificity of the artus JCV RG PCR Kit is ensured by careful selection of the oligonucleotides (primers and probes). The oligonucleotides are checked by sequence comparison analysis against publically available sequences to ensure that all relevant JCV genotypes are detected. In addition, the specificity of the artus JCV RG PCR Kit was evaluated by testing a panel of genomic DNA/RNA extracted from other pathogens. No cross-reactivity was shown.

Linear range

The linear range of the artus JCV RG PCR Kit was evaluated by analyzing a logarithmic dilution series of DNA from JC virus strain MAD-1 using concentrations ranging from 1 x 10⁹ to 0.1 copies/µl. At least six replicates per dilution were analyzed. The linear range of the artus JCV RG PCR Kit extends over an interval of at least eight orders of magnitude for JCV-specific DNA.

Sample DNA is first extracted in a separate process e.g., using the QIAamp DNA Mini Kit (recommended extraction method). This is followed by detection of JCV-specific DNA using the Rotor-Gene Q.

The JCV RG Master A and JCV RG Master B contain reagents and enzymes for the specific amplification of target regions within the JCV genome and for the direct detection of the specific amplicon in fluorescence channel Cycling Green of Rotor-Gene Q instruments.

In addition, the artus JCV RG PCR Kit contains a heterologous amplification system (Internal Control) to identify potential failures during the assay process. The Internal Control is measured in the fluorescence channel Cycling Yellow of Rotor-Gene Q instruments.

Probes specific for JCV DNA are labeled with the fluorophore FAM. The probe specific for the Internal Control (IC) is labeled with the fluorophore JOE. The use of probes labeled with spectrally distinguishable fluorophores enables simultaneous detection and quantification of JCV DNA as well as detection of the Internal Control in the corresponding channels of the Rotor-Gene Q instrument.

The artus JCV RG PCR Kit is for in vitro diagnostic use for detection and quantification of JC Virus (JCV) specific DNA.