IN VITRO DIAGNOSTIC
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 analyzed and data compared with results obtained with reference method; this way their negativity/positivity is confirmed to assess the assay specificity and sensitivity.
QUALITY CONTROL
GEM FORLAB provides its customers with a quality control system that allows
- to detect contaminations from Mycoplasma, bacteria, viruses (case study);
- verify production processes (presence of nucleic acids, nucleases, endotoxins);
- qualitative analysis of low and high molecular weight compounds for purity/identity/homogeneity verification by mass spectrometry or HPLC-UV.
