Due to the increasing demand of molecular tests requested in our institution because of the added value of molecular diagnosis in a large variety of clinical situations, automation of molecular diagnosis is mandatory. Since these last ten years, we progressively upgraded our molecular system from the pre-analytical to the post analytical step. First this automated platform includes validated instruments for correct and consistent extraction of DNA or RNA from a variety of pathogens and specimens. Then all real-time PCR are either established de novo or adapted from the literature to conform to the same specifications i.e identical master mix, primers and probes adapted to 60°C annealing/synthesis temperature, initial 95°C enzyme activation and template denaturation time. These in house-developed PCRs allow flexibility in terms of pathogen diversity (bacteria, viruses, parasites and fungi) and adaptation to local needs (including novel outbreaks), but a thoughtful R&D process is necessary.
Each parameter of our portfolio is developed, standardized and validated through an R&D process according to the accreditation rules and internationally recognized recommendations. This process allows us flexibility and adaptation to local needs (including novel outbreaks) and we mainly developed in-house PCRs for intracellular bacterial (Chlamydia, Coxiella, Rickettsia, …), for parasites (Malaria, Toxoplasma, Leishmania,…), and fungi (Aspergillus, PCJ, pan-fungi, ….). With such a process of validation, we can say now that contaminations are no more a problem and that it is time now to fully acknowledge the true contribution of molecular diagnostic. Moreover we can provide quantification, thanks to a plasmid strategy, that provide key information useful to interpret clinical significance as well as to monitor treatment impact and/or disease progression.