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Notice Summary

UK-Potters Bar: Q Fever Collection of Patient Serum (OPEN EARLY ENGAGEMENT)
GB003ZM290267
MHRA Buyer Organisation
18 March 2019
05 April 2019
Contract Notice - Other
No

Notice Abstract

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.habib@nibsc.org to register an interest.

Notice Details

CONTRACT NOTICE – NATIONAL

SERVICES

1 Authority Details

1.1

Authority Name and Address


MHRA Buyer Organisation

NIBSC, Blanche Lane, South Mimms

Potters Bar

EN6 3QG

UK

N/A

N/A

nawaz.habib@nibsc.org

N/A

1.2

Address from which documentation may be obtained

As in 1.1

1.3

Completed documents must be returned to:

As in 1.1

2 Contract Details

2.1

Title

Q Fever Collection of Patient Serum (OPEN EARLY ENGAGEMENT)

2.2

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.habib@nibsc.org to register an interest.

2.3

Notice Coding and Classification

2.4

Total quantity or scope of tender

Location of contract: East of England

3 Conditions for Participation

3.1

Minimum standards and qualification required

4 Administrative Information

4.1

Type of Procedure

The procedure type is unknown.

4.2

Reference number attributed to the notice by the contracting authority

n/a

4.3

Time Limits

   05-04-2019  Time 12:00

4.5

Language or languages in which tenders or requests to participate can be drawn up

EN 

4.6

Tender Submission Postbox

5 Other Information

5.1

Additional Information

Please visit the following portal to view this notice:

https://www.contractsfinder.service.gov.uk/Notice/1840c47d-5fc1-4c3f-9b96-26151d7f005c?p=@FQxUlRRPT0=NjJNT08=U

If no submissions of potential interest are received by close of play 5th April 2019, it is then intended to perform a direct award without competition to the sole supplier we believe can deliver the required service.

(MT Ref:290267)

5.2

Additional Documentation

5.3

Publication date of this notice

 18-03-2019