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Specimen bank

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Specimen bank

Some critical obstacles in the development of improved assays for human African trypanosomiasis (HAT), or sleeping sickness, include access not only to quality diagnostic and clinical data, but also to carefully collected and stored reference materials. Sustained field programs that have the capacity and facilities for long-term follow-up constitute another important challenge. Although a number of small, independent specimen collections from HAT patients already exist, most of them may have been collected under uncertain ethical conditions, taken from poorly characterized subjects, or stored in unstable conditions.

FIND and the Department of Neglected Tropical Diseases (NTD) of the World Health Organization (WHO) have addressed these problems by establishing a HAT specimen bank, which is owned by the WHO. This has guaranteed more efficient use of limited resources, reduced the need for field trials, promoted product comparisons and facilitated quality control.

The samples that are being stored in the specimen bank will be from:

People who are asymptomatic but at risk of infection (screened populations in a HAT focus);

HAT suspects who have not been confirmed parasitologically (positive screening test results but no evidence of parasites);

Patients in whom disease has been confirmed; and

Control subjects (negative screening test results and no evidence of parasites).

Specimen collection is being carried out by a network of collaborating diagnostic centers in Africa, following internationally acceptable guidelines regarding the collection, transport, storage and use of clinical specimens, including control of confidential information such as patient data. Linkages are also being established with ongoing clinical trials and control programmes to donate sample material. Geographic variability and differences in patient subgroups is being considered when choosing collection sites.

The Pasteur Institute in France has been contracted by the WHO to manage the specimen bank, including receipt of specimens from collection sites, their storage and distribution to end-users.