In vitro diagnostics
GEM FORLAB can give support to validation of IVD equipment and reagents
Different matrices: human whole blood, plasma, CSF, urine and nasal swab, stool and fecal swab
Different steps: extraction, amplification and result interpretation.
As regards assays, an analytical performance evaluation is executed; the method efficiency, linearity, accuracy, precision, repeatability, reproducibility and sensitivity is analyzed. Several human samples from different donors are then analyzed and data compared with results obtained with reference method; this way their negativity/positivity is confirmed to assess the assay specificity and sensitivity.
Contamination detection from Mycoplasma, bacteria, viruses (case study), production processes (nucleic acids, nucleases, endotoxins).
Qualitative analysis of low and high molecular weight compounds for purity/identity/homogeneity verification by mass spectrometry or HPLC-UV.