The specific performance characteristics of the artus HHV-6 RG PCR Kit were determined using HHV-6A-specific DNA (strain GS) and HHV-6B-specific DNA (strain Z-29) of known concentrations.
The analytical sensitivity of the artus HHV-6 RG PCR Kit, determined by probit analysis, for detection of HHV-6A-specific DNA is 1.46 copies/µl eluate [95% confidence interval (CI): 0.72–4.57 copies/µl] and the analytical sensitivity for detection of HHV-6B-specific DNA is 2.58 copies/µl eluate (95% CI: 1.44–6.30 copies/µl).
The analytical specificity of the artus HHV-6 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 HHV-6 genotypes are detected. In addition, the specificity of the artus HHV-6 RG PCR Kit was evaluated by testing a panel of genomic DNA/RNA extracted from other herpesviruses and pathogens that are relevant to immunocompromised patients. No cross-reactivity was shown.
The linear range of the artus HHV-6 RG PCR Kit was evaluated by analyzing a logarithmic dilution series of HHV-6A- and HHV-6B-specific DNA using concentrations ranging from 108 copies/µl to 1 copy/µl. At least six replicates per dilution were analyzed. The linear range of the artus HHV-6 RG PCR Kit extends over an interval of at least seven orders of magnitude for HHV-6A- and HHV-6B-specific DNA.
The diagnostic sensitivity and specificity of the artus HHV-6 RG PCR Kit are regularly evaluated by analyzing reference and diagnostic samples previously analyzed with reference methods.
| || HHV-6A || HHV-6B || Negative |
| HHV-6A || 8 || 0 || 0 |
| HHV-6B || 0 || 19 || 0 |
| Negative || 0 || 0 || 3 |