7. Are you currently engaged in research that could support new TB diagnostic assay development? Yes No

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1 Determining Future TB Reference Material Requirements WHO/TDR TB Expert & End-User Survey Properly handled samples from well-characterized patients with suspected tuberculosis from disease endemic countries are difficult for many scientists and test developers to obtain and are of critical value in the development and ultimate delivery of quality diagnostic tests. In the past, lack of such materials has led to the use of low-quality specimens of uncertain source, which has compromised the development, evaluation and quality control of new assays. In view of this problem and with the help of collaborative scientists around the world, WHO/TDR established TB Specimen and Strain Banks. The TB Specimen Bank has been disbursing well characterized specimens to scientists and test developers since Over the past 8 years, the field of TB diagnostic development has greatly expanded with more than 15 candidate technologies/products in the pipeline, some of them likely to be introduced within two years. Given the expanded interest, greater investment and changing needs of the TB diagnostics field, TDR is looking to field experts and reference bank-users to guide the future plan for its TB specimen and strain banks. To this end, we have developed the attached survey to inform our estimates of current and future demand for specimens that will promote all stages of the development pathway (from discovery research, development, evaluation, prequalification and field demonstration). We thank you in advance for your time and energy in completing this survey. Your participation is critical to the future of our reference material banks. Kindly return your responses electronically to cunninghamj@who.int or by regular mail to : Jane Cunningham WHO/TDR/PDE 20 Appia Avenue, Geneva Switzerland, 1211 or directly to Andrew Ramsay, Secretariat Stop TB Partnership Working Group on New Diagnostics. Personal details 1. Name: 2. Title: 3. Affiliation: 4. Address: Phone: 1

2 Research Interests 7. Are you currently engaged in research that could support new TB diagnostic assay development? Yes No 7.1 If yes, provide a brief description of the research and or TB diagnostic development activities? Not applicable TB Specimen Requirements 8. Do your current or future (next 5 years) research activities require well characterized specimens from respiratory (TB) symptomatics (TB and non-tb patients)? Yes No 8.1. If yes, for what purpose? (check all that apply) Discovery Evaluation Proof of principle Laboratory based/feasibility Field based Test registration Not applicable 9. If you are in test development what diagnostic platform(s) are you currently working? (check all that apply) not applicable Microarray technology Molecular Protein Immunoassay Multiplex Nucleic acid amplification system Microscopic detection Immune based (antigen, antibody, cytokine detection) ELISA ICT Skin test 2

3 Biosensor based Phage based Other: specify 10. What type of specimen(s) are required? (check all that apply) Sputum Serum Whole blood Urine Saliva Other (specify): 11. Are frozen samples acceptable for your purposes? Yes Yes but suboptimal No, fresh samples (< days old) are required 12. Do samples require special processing prior to freezing or storage? 12.1 Sputum Yes No If yes, what methods and approximate number of steps or technician time required? 12.2 Serum Yes No If yes, what methods and approximate number of steps or technician time required? 12.3 Whole blood Yes No If yes, what methods and approximate number of steps or technician time required? 12.4 Urine Yes No If yes, what methods and approximate number of steps or technician time required? 12.5 Saliva Yes No If yes, what methods and approximate number of steps or technician time required? 3

4 13. Complete the following tables to provide an estimate of your specimen requirements, over the next 2 years? 13.1 Specimen type sputum serum Whole blood Urine Saliva Minimum volume/aliquot 4

5 13.2 Indicate number of patients and aliquots/patient: Sputum Serum Whole blood Urine Saliva TB/HIV status Unique patients Aliquots/ patient Unique patients Aliquots/ patient Unique patients Aliquots/ patient Unique patients Aliquots/ patient Unique patients Aliquots/ patient Smear-pos, cul-pos Smear-pos, cul-pos, HIVneg Smear-pos, cul-pos, HIVpos cul-pos cul-pos, HIVneg cul-pos, HIVpos cul-neg, CXR-pos cul-neg, CXR-pos, HIV-neg cul-neg, CXR-pos, HIV-pos Non-TB 5

6 Non-TB, HIVneg Non-TB, HIVpos 13.3 What geographical mix would you be of most interest? Specimen sputum serum whole blood urine Other % North America %South America % Europe Geography % Middle East % Africa %Central Asia % South East Asia 14. Are there additional patient characteristics requirements? Yes No not sure 14.1 If yes, which? (check all that apply) Not applicable Age > 15 Age < 15 Pulmonary TB suspects Extrapulmonary TB suspects Latent infected, asymptomatic suspects TB patients under treatment Previous history of TB (cured) Presence of concomitant disease, if yes, specify: BCG vaccination Medication history Drug susceptibility test results on isolates from specimens collected simultaneously Other (specify): 15. Would access to specimens AND corresponding MTB isolates (from the same patient) be of utility? Yes, high utility Yes, limited utility Possibly No 6

7 16. Do you expect in the coming 5 years that your specimen needs will: Expand by % Stay the same Decrease by % No further need 17. Have you previously acquired reference specimens in the past? Yes No 17.1 If yes, from whom or how did you acquire these samples? Purchased through a commercial reference specimen provider? Specify: Provided through a not for profit reference specimen provider? Specify: Provided through a colleague or contact with a personal collection? Collected during a company/institutional sponsored clinical trial? 18. Have you been aware of the availability of specimens through the WHO/TDR TB Specimen Bank? Yes No 18.1 If yes, have you ever requested specimens? Yes No Can't remember not applicable 18.2 If yes, would you request specimens through the bank again? Yes No Maybe not applicable 18.3 Have samples provided through the bank played a role in : supporting proof of principle research advancing or arresting test development efforts leading to new discoveries ie. biomarkers providing critical data to support further investment in test development Other: specify 19. General comments/suggestions: 7

8 Mycobacteria tuberculosis Strain Requirements 20. Do your current or future (next 5 years) research or routine activities require well characterized drug resistant MTB strains? Yes No 20.1 If yes, for what purpose? (check all that apply) not applicable Molecular epidemiology MTB Phylogeny research Evaluation Proof of principle Laboratory based/feasibility Field based Test registration Internal quality control External quality control 21. What degree of characterization serves your purposes? Phenotypic only Phenotypic and genotypic confirmation of resistance Phenotypic and genotypic confirmation and associated specific mutations Phylogenetic information: specify: ie. MIRU-VNTR, spoligotyping 22. What geographical strain origin is of most interest to you? (check all that apply) Central and South America: specify North America, specify Eastern Europe, specify Western Europe, specify Africa, specify Central Asia, specify East Asia, specify 8

9 23. What phenotypic first line drug resistance patterns of resistance are of most interest to you? (check all that apply) (INH-RMP-SM-EMB S) (INH mono R) (RMP mono R) (EMB mono R) (SM mono R) (INH-RMP R) (INH-EMB R) (INH-SM R) (RMP-EMB R) (RMP-SM R) (SM-EMB R) (INH-RMP-EMB R) (INH-RMP-SM R) (INH-SM-EMB R) (RMP-SM-EMB R) (INH-RMP-SM-EMB R) 24. Is phenotypic drug resistance to second line drugs of interest, if yes, which drugs? Ofloxacin Kanamycin Amikacin Capreomycin Ethionamide, PAS Other, specify: 25. Are borderline drug resistant strains important to your work? Yes, very important Yes, limited No Not sure 26. Are laboratory-generated mono-resistant strains to specific agents desirable? Yes No Not sure 27. What genotypic patterns of resistance are of most interest to you? 27.1 Specify gene: 27.2 Specify specific mutations: 28. Is data regarding strain fitness: Essential Relevant Not relevant 29. Is data regarding patient characteristics and clinical history : Essential Relevant Not relevant 9

10 29.1 If essential or relevant, what specific information is required (check all that apply): HIV status Drug treatment regimen(s) Clinical outcome Other (specify): 30. If you are engaged in antibiotic drug susceptibility test development what diagnostic platform(s) are you currently working? not applicable Microarray technology Molecular Protein Immunoassay Multiplex Nucleic acid amplification system Immune based ELISA ICT Microscopic detection Culture based Biosensor based Phage based Other, specify: 31. Are lyophilized strains acceptable for your purposes? Yes Yes, but suboptimal No 32. Do you expect in the coming 5 years that your MTB strain needs will: Expand by % Stay the same Decrease by % No further need 10

11 33. General comments/suggestions: 11