Number: 10106804
Country: Norway
Source: TED
Award of Contract: PCR Kits for Detecting and Possibly Quantifying the Herpes Virsues HHV6, EBV, VZV and HSV for Oslo University Hospital
The detection and/or quantification of the herpes viruses HHV6, EBV, VZV and HSV (1/2) are used together for the follow-up of infection status in patients who have had transplants and other patients with a weak immune system. The analyses are carried out by the Department for Microbiology, Section for Molecular Diagnostics, Virology and Serology, Unit for Virology (Rikshospitalet). The procurement is carried out on behalf of Oslo University Hospital.
The detection and/or quantification of the herpes viruses HHV6, EBV, VZV and HSV (1/2) are used together for the follow-up of infection status in patients who have had transplants and other patients with a weak immune system. The analyses are carried out by the Department for Microbiology, Section for Molecular Diagnostics, Virology and Serology, Unit for Virology (Rikshospitalet).
It is an absolute prerequisite that both the extraction of DNA/RNA and the detection/quantification of virus can be automated on the equipment that the unit already has. Furthermore, the analyses must be well-established and in general use at laboratories that it is natural to make a comparison with. In addition there are specific requirements for each analysis and for which analyses it must be possible to run together.
There are the following minimum requirements for the products:
— the kits must be CE-IVD marked for analysis on LightCycler 480 from Roche Diagnostics, as this is the only available analysis platform for this at the Unit for Virology,
— the kits must show stable good performance in QCMD, as it is this SLP programme that the Unit for Virology participates in and, thereby, has full access to all reports. QCMD has been chosen as this programme best meets the entire unit"s spectrum of molecular biological analyses,
— the kits must be either a single-plex kit or a multi-plex kit, which only includes 2 or more of the requested agents (i.e. 2 or more of EBV, HSV1, HSV2, VZV, HHV-6 or adenovirus),
— melting point analysis will not be accepted as a method due to the many problems connected to reading these types of PCR analyses,
— the EBV kit must quantify the virus amount and it must be calibrated to the WHO standard, so that the international term lU/ml can be used for the analysis goods,
— the EBV kit must be CE-IVD marked for full blood as a sample material,
— the EBV kit must be validated for extraction on MagnaPure 96,
— the plan is to run EBV and adenovirus in the same set-up on the FLOW automation system from Roche, which consists of MagnaPure96, LightCycler 480 II, etc. In order for this to be possible, the kit for adenovirus and EBV must have the same PCR programme and set-up. The supplier"s assortment must, therefore, include an adenovirus kit that fulfils this criterium and which is validated for extraction on MagnaPure96 and analysis on LightCycler 480,
— The HSV kit must quantify the virus amount and it must be calibrated to the WHO standard, so that the international term IU/ml can be used for the analysis goods. The kit must distinguish between HSV1 and HSV2,
— The HHV6 kit must distinguish between type A and type B,
— It must be possible to run/set-up HSV, VZV and HHV6 together, as these are often requisitioned together (cf. identical clinical picture). In addition, the number of samples that are received in a day is often not greater than what can be analysed in one run.
Expansion of the contract assortment with kits for the detection of the Adeno virus. Increased volume because the demand for analyses is increasing due to the increased number of patients who have transplants, increased survival amongst persons after transplants, changes to guidelines/practice for requisitioning samples etc.
PCR kits for detecting and possibly quantifying the herpes virsues HHV6, EBV, VZV and HSV for Oslo University Hospital
