Download Providing an open-access, well-characterized specimen bank

Providing an open-access, well-characterized specimen bank
S
ome critical obstacles in the development of improved assays for human African
trypanosomiasis, 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 cannot
be used for diagnostics research and development. In most of the cases, specimens
have been collected under inadequate or uncertain ethical conditions, taken from poorly
characterized subjects, or stored in unstable conditions.
The World Health Organization’s Department of Neglected Tropical Diseases (NTD),
together with FIND, is establishing a Specimen Bank to provide reference clinical
materials to facilitate the development and evaluation of these new tests. Specimens
comprising of serum, plasma, buffy coat, saliva, urine and CSF (deposit plus sediment)
will be collected from various sites in endemic countries taking into account geographical
variability and differences in patient subgroups. Sites are chosen with the control
programmes and linkages are also being established with ongoing clinical trials.
Collection will follow internationally acceptable guidelines regarding the collection,
transport, storage and use of clinical specimens, including control of confidential
information such as patient data.
The project plans to enroll around:
ƒ 840 cases, defined as persons with evidence of the parasite in their blood, lymphatic
system or cerebrospinal fluid (CSF).
ƒ 840 to 1,000 controls defined as persons with neither evidence nor suspicion of HAT
ƒ 100 to 250 suspect cases defined as persons with a serological suspicion of HAT
due to T.b.g and with no evidence of the parasite.
Participants can be enrolled only after giving informed consent to provide biological
specimens. The project has been submitted and accepted by the WHO ethical review
committee. Submission to national and institutional ethical review committees is
currently in process.
Once collected in the field, specimens will be sent to the WHO Specimen Bank.
Continuous application of cold chain is mandatory during the entire process. The
specimens must be kept under minus 70°C.
The Bank will organize efficient storage. According to researchers requests, an exit
committee led by WHO will determine the number and the types of specimen which will
be sorted by the Bank. Exit orders will be given by WHO to the bank which will organize
the shipments.