TB Specimen Bank
New diagnostic tests for TB suitable for low-income settings are urgently needed. Current methods of diagnosis (based on sputum smear microscopy) are both labour-intensive and insensitive.
An important obstacle to the development of new diagnostics tests for TB is the lack of access to reference materials. The TDR TB Specimen Bank addresses this need by providing an invaluable, growing resource of well-characterized clinical materials for use by academic and commercial test developers.
Formally launched by TDR in June 2000, the TDR TB Specimen Bank contains samples from symptomatic respiratory patients with and without TB, from different areas of the world. Aliquots of sputum, serum, saliva and urine are frozen on site, and maintained at a central distribution site at -70 °C. Each sample is linked to detailed clinical and microbiological information (1). A final diagnosis is assigned according to a standardized classification scheme (2).
The specimen bank is intended 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
- simplify direct comparison of new and existing diagnostic kits.
The TDR TB Specimen Bank is continuously replenishing and expanding its Geographic diversity. Presently specimens are collected in Lusaka, Zambia.
Who can request specimens?
Samples are available at low cost to commercial and academic researchers working towards the development of TB diagnostics suitable for low-income settings.
Who approves the requests?
A committee of six highly qualified members involved in diagnostics development and TB control will review and approve or reject applications from requesting parties.
What kind of samples can be requested?
The samples (serum, urine, saliva, sputum) are sold in sets of 20 or 200.
Sets of 20 are composed of:
- specimens will originate from > or = 2 countries
- all specimens will be from HIV negative patients
- specimens will be 50% TB positive (final diagnosis code 1,2 or 3) and 50% TB negative (final diagnosis code 4)
For sets of 200:
- specimens will originate from > or = 2 countries
- specimens will originate from 25% HIV positive and 75% HIV negative
- specimens will be 30% (60) TB positive (final diagnosis code 1, 2 or 3) and 70% (140) TB negative (final diagnosis code 4).
What does it cost?
The end users pay the shipping cost from the bank plus a handling fee for the specimens. Please contact TDR for prices.
How to request specimens?
Requests should be made using the Materials Request Form available in:
Further information
For additional information, please contact InfoSpecimen@who.int