Description of the goods or services required
The agency is planning to establish a human reference serum containing anti-C. burnetii IgG and IgM antibodies, with the objective to validate this material as a WHO international standard. To establish this human reference serum, we require the collection of serum that meets the inclusion criteria detailed below. Suppliers that can meet the requirements below are invited to register their interest for the supply and testing of serum samples for the development of a WHO standard for Q fever. Suppliers must be able to:
1. Evaluate the exact requirements for the development of a WHO standard for Q fever. To enable this in a timely fashion, the supplier should have an established network in the Q fever community to engage with
2. Identify subjects with different stages of Q fever infection (convalescing, actively infected or very recent (chronic) infection)
3. Access a large collection of banked samples from a well characterised cohort of past Q fever (exposed) patients for selection of convalescing subjects
4. Actively recruit subjects with active or very recent infection (unless already identified through recent/ongoing efforts)
5. Selected subjects should be aware that serum may be characterised and evaluated in an in vivo potency model for experimental vaccines.
6. Re-test /verify sero-positivity in selected patient to ensure fitness for purpose for this study (seropositivity confirmed by the most commonly used laboratory assays (IFA, ELISA, CFT)
7. Characterize donors with independent measures (other than serology) for confirmation of exposure to C. burnetii, such as PCR, IGRA or testing for cellular recall responses
8. Select at least 5 appropriate donors (defined in the evaluation) for large volume serum collection
9. Arrange plasmapheresis of the 5 donors
10. Prepare serum from donor samples
11. Test/arrange testing of serum samples for blood borne pathogens (HIV, HBV and HCV)
12. Supply NIBSC with a small sample, 25mL, for additional testing
13. Ship 500 ml serum samples from each donor to NIBSC
The supplier should have the capability of supplying the collected and tested Q fever seropositive samples within 6 months of establishing the requirements.
As far as we are aware there is only one supplier who is able to meet this very specific request. Potential suppliers if they feel they can meet the requirement should email Nawaz.email@example.com to register an interest.