EXPRESSION OF INTEREST

Malaria Rapid Diagnostic Test Kits

Country: Global
Authority: USAID Contract number GPO-I-03-06-00007-00
Source/Origin: Geographic Code 935
Purchaser: John Snow, Inc.
Attn: Miguel Jaureguizar
1616 N. Fort Myer Drive 11th Floor
Arlington, VA 22209-3100

Expression of Interest No.: MAL 08-01
Response Deadline: 05:00 PM EDT Jun 13, 2008

John Snow, Inc. is requesting Expressions of Interest from suitably qualified manufacturers of Malaria Rapid Diagnostic Test Kits.

The purpose of this request is to pre-approve manufacturers of Malaria Rapid Diagnostic Tests for procurement under the USAID | DELIVER PROJECT as part of an annual review of the Malaria RDT market.

Only product from successfully pre-approved manufacturers will be considered for procurement. Requests for Quote (RFQ’s) will be issued to all pre-approved manufacturers according to project demand.

The authorized USAID Geographic Code for the USAID | DELIVER PROJECT is 935. However certain additional restrictions apply for pharmaceuticals.

The pre-approval criteria will be available free of charge, and can be obtained by emailing mjaureguizar@jsi.com or from http://deliver.jsi.com.

Phone requests will not be honored.

Technical Criteria for Malaria Rapid Diagnostic Test - Procurement Pre-Approval

The global procurement of Malaria Rapid Diagnostic Tests (RDTs) has increased rapidly as has the range of commercially available products. Our procurement exercise aims to secure Malaria RDTs of a consistent quality with regards to both sensitivity and stability in malaria endemic countries. Methods to accurately monitor the quality of these tests are required.

Speed of response to field office demands is likely to be critical. To enable this, the establishment of a list of “pre-approved” vendors is necessary. The pre-approval process will also help set up a common standard for manufacturers and their products.

USAID | DELIVER Procurement Pre Approval Criteria

1. Proof of product registration with malaria endemic country’s relevant authority, or proof that product is being provided to National Malaria Control Programmes as part of standard malaria diagnosis guidelines.

2. Evidence of third party field data testing including stability data. Demonstrate evidence of real time stability testing data of a minimum period of twenty four (24) months. Testing conditions for stability of temperature and humidity should be comparable to those found in typical malaria endemic countries.

3. Provide specificity testing results of at least 90% and sensitivity greater that 90%.

4. Provide evidence of Good Manufacturing Practices in the form of ISO 13485:2003 or 21 CFR 820 covering quality management systems for the manufacturing of medical devices.

5. Proof of production capacity such as current customers with delivered orders over 50,000 test kits, complete with contact information.

6. Demonstrated evidence of representation in-country providing product support, including names of personnel or agents, statement of capacity and nature of relationship with manufacturer.

7. Required product shelf life shall be a minimum of 18 months (15 months remaining after delivery in-country). Provide real time data to support storage temperature.

8. Test will be required to be in cassette format and include lancets, swabs, blood transfer device and buffer solution.

9. Instruction booklet shall be provided in the appropriate language.

10. Statement of willingness to accept pre-shipment QC/QA inspection and testing by independent testing agency designated by Buyer.

11. Product has been submitted to the WHO Malaria Product Testing Programme, 2008- currently underway at the Centers for Disease Control, Atlanta, GA.

Click here to download the announcement for this EOI as a Word document.
Click here to download the technical criteria as a Word document.

EXPRESSIONS OF INTEREST

1. Long Lasting Insecticide Treated Bednets (LLIN)

Pre-Approved LLIN manufacturers:

John Snow, Inc. is requesting Expressions of Interest from suitably qualified manufacturers of Long Lasting Insecticide Treated Bednets (LLIN).

The purpose of this request is to pre-qualify manufacturers of LLIN’s for procurement under the USAID | DELIVER PROJECT as part of an annual review of the LLIN market.

Only product from successfully pre-qualified manufacturers will be considered for procurement. Requests for Quote (RFQ’s) will be issued to all pre-qualified manufacturers according to project demand.

The authorized USAID Geographic Code for the USAID | DELIVER PROJECT is 935.

The pre-qualification criteria will be available free of charge, and can be obtained by emailing mjaureguizar@jsi.com or by clicking on the link below. Phone requests will not be honored.

Technical Criteria for LLIN Prequalification

2. Malaria Rapid Diagnostic Test Kits

Pre-Approved Rapid Diagnostic Test Kit Manufacturers:

John Snow, Inc. is requesting Expressions of Interest from suitably qualified manufacturers of Malaria Rapid Diagnostic Test Kits.

The purpose of this request is to pre-qualify manufacturers of Malaria Rapid Diagnostic Tests for procurement under the USAID | DELIVER PROJECT as part of an annual review of the Malaria RDT market.

Only product from successfully pre-qualified manufacturers will be considered for procurement. Requests for Quote (RFQ’s) will be issued to all pre-qualified manufacturers according to project demand.

The authorized USAID Geographic Code for the USAID | DELIVER PROJECT is 935. However certain additional restrictions apply for pharmaceuticals

The pre-qualification criteria will be available free of charge, and can be obtained by emailing mjaureguizar@jsi.com or by clicking on the link below. Phone requests will not be honored.