Aim of the study: Analytical and clinical diagnostic evaluation of an IVD System for the extraction, detection and quantitation of viral and bacterial DNA/RNA by PCR.
Analyte: DNA from 15 different viruses/bacteria.
Methodology: A sample-to-result solution dedicated to Molecular Diagnostics which automatically performs extraction, amplification and result interpretation.
Matrix: Human whole blood, plasma, CSF, urine and nasal swab, stool and fecal swab.
Therapeutic area: In vitro diagnostic.
Development stage: Development.
Customer: A private enterprise manufacturing and commercializing IVD equipment and reagents.
Results: For each IVD kit a PCR analytical performance evaluatio was executed; the method efficiency, linearity, accuracy, precision, repeatability, reproducibility and sensitivity were analyzed. Several human samples from different donors (previously tested negative/positive for the target by reference method) were analyzed; this way their negativity/positivity was confirmed to assess the kit diagnostic specificity and sensitivity.
Advantage of the methodology: Is a bench-top solution integrating all the steps of molecular diagnostics in a single platform with best-in-class and proven technologies for acid nucleic ex-traction and RT-PCR amplification. Moreover, within one single session one to 12 samples can be processed in 12 parallel tracks.