This space is dedicated to providing information on Infectious Disease Specimen Banks which are essential for providing samples for the development and quality assessment of diagnostic tests. If you have any further information, or comments on the information available here, please contact the website administrator at info@globalhealthdiagnostics.org.

Malaria Specimen Bank

Website: http://www.finddiagnostics.org/scouting_support/developer-resources.html

Background

A key obstacle in the quality assessment of malaria rapid diagnostic tests (RDTs) is the lack of access to well characterized reference materials. The objective of the WHO/FIND specimen bank is to create a globally-representative reference collection of blood from individuals infected with malaria for use in the assessment of rapid diagnostic tests.

Collaborators

The specimen bank is the result of collaboration between WHO, FIND and research institutes from six different continents, including: Centres for Disease Control and Prevention (USA), Queensland Institute for Medical Research (USA), Hospital for Tropical Diseases (UK), Research Institute for Tropical Medicine (Philippines), Institut Pasteur du Cambodge (Cambodia), Kenya Medical Research Institute, University Cayetano Heredia (Peru), University of Lagos (Nigeria), the Institut Pasteur in Central African Republic, Institut Pasteur in Madagascar, Department of Medical Research (Myanmanr), Ifakara Health Research and Development Centre of Tanzania, the Centro Internacional de Entrenamiento e Investigaciones Medicas (Colombia), the Ethiopian Health and Nutrition Research Institute.

Specimen Preparation

Blood collected from malaria infected individuals are diluted to a standard concentration of malaria parasite. The concentration of malaria parasite in each sample is fixed at either low (200 parasites/ mL blood) or high (2,000 parasites/mL blood) density. Materials are characterized by PCR to establish the parasite species, and ELISA to determine the concentration of parasite antigens (HRP2, pLDH, aldolase). Nucleic acid sequencing of variable genes is also carried out. Generic characterization is carried out at the Queensland Institute for Medical Research and malaria antigen concentrations are measured at the London Hospital for Tropical Diseases. Species confirmation is performed at US CDC which is where the specimen bank is also housed.

Subsets of the global specimen bank are held at regional laboratories in Cambodia and The Philippines supported by WHO and FIND for the Rapid Diagnostic Test Lot Testing Programme. These laboratories provide a service to national governments and other agencies purchasing RDTs by testing individual production lots after procurement and shipping.

NB. Culture-derived P. falciparum samples are available to manufacturers and researchers. For more information contact Cunninghamj@who.int

 

Human African Trypanosomiasis (HAT) Specimen Bank

Website: http://www.finddiagnostics.org/programs/hat-ond/hat/specimen_bank.html

Background

A critical obstacle in the development of improved assays for Human African Trypanosomiasis (HAT) is a lack of access to quality diagnostic and clinical data, and reference materials. There is also a lack of sustained field programs with the capacity and facilities to conduct long term follow-up on patients. The specimen bank was developed as a solution to these problems by FIND and NTD/ WHO.

Objective

The HAT specimen bank was developed as a solution to the problems in developing improved assays in order to guarantee more efficient use of limited resources, reduce the need for field trials, promote product comparisons and facilitate quality control.

Specimen Preparation

The specimen bank includes samples from:

Asymptomatic people at risk of infection
HAT suspects not yet confirmed parasitologically (positive screening test but no evidence of parasites)
Patients with confirmed disease
Negative screening test results and no evidence of parasites
Samples collected in line with Good Clinical Practice (GCP) and the protocol has been approved by WHO Ethical Review Committee and relevant national committees.

The Institut Pasteur hosts the Repository Bank and is responsible for storing the samples and dispatching requests. The collection of samples is ongoing.

Inquiries and requests should be addressed be addressed to WHO (francoj@who.int) or FIND (joseph.ndungu@finddiagnostics.org)

 

TB Specimen Bank

Website:  http://apps.who.int/tdr/svc/diseases/tuberculosis/specimen-bank

Background

A key obstacle to the development of new diagnostic tests for tuberculosis is the lack of access to well characterized clinical reference materials.

Objectives

The objectives of the specimen bank are to: stimulate commercial activity; set high standards of quality for tools in development; assist in quality control; limit the need for field trials; facilitate the approval process; and simplify the direct comparison of new and existing diagnostic test kits.

Obtaining Samples from the Specimen Bank

Specimens are available at low cost to commercial developers of diagnostic tests and academic researchers for the development of tuberculosis diagnostics suitable for low-income settings. The outcome of requests for specimens is determined by a committee of six members involved in diagnostic development and tuberculosis control.  End users are responsible for paying the shipping cost from of thesamples from the Specimen Bank including a handling fee (contact TDR for prices). Requests can be made using a Materials Request Form (available for download on the above website).

Details of Samples

There are several sample types available including serum, urine, saliva, and sputum. Samples are available in sets of 20 or 200. A set of 20 includes HIV negative specimens originating from more than two countries of which 50% are TB positive and 50% are TB negative. A set of 200 includes specimens originating from more than two countries of which 25% are HIV positive and 75% are HIV negative. Of the 200 samples in this set, 30% (60) are TB positive and 70% (140) are TB negative.

Additional information available at InfoSpecimen@who.int

 

TB Strain Bank

The UNICEF/UNDP/World Bank/WHO Special Planning Agency for Tropical Disease Research and Training (TDR) TB strain bank.

The WHO/TDR-TB Strain Bank is a collection of well characterized strains of M. tuberculosis that are available to the TB research community. It is a high quality bioresource for basic science, supporting the development of new diagnostics and drug-resistant detection tools and providing reference materials for laboratory quality management programmes. It comprises clinical M. tuberculosis isolates that are available as quality controlled freeze-dried, viable strains or as heat-inactivated bacterial suspensions. Isolates originate from diverse geographical settings and were selected for their resistance profiles against first- and second-line drugs.  Genotyping data is available for each strain. Whole genome sequence data is expected by mid 2012.

Further Details:

http://www.stoptb.org/wg/new_diagnostics/assets/documents/Information_%20StrainBank_V3.pdf

Request forms and the catologue of strains are available for download from:

http://www.stoptb.org/wg/new_diagnostics/strainbank.asp

For further information email: InfoSpecimen@who.int