Credevo: Expression of Interest to Participate in a Exploratory Study Evaluating an In Vitro Diagnostic (IVD) Test for Dengue

1. Name of the Principal Investigator *

First

Last

2. Phone

3. Work Email *

4. Degrees (comma separated, e.g., MBBS, MD, PhD, DNB) *

5. Primary specialty/therapeutic area *

6. Profile Summary

Please provide a brief overview of your clinical and/or research experience, including the total number of year of experience in clinical research.

7. Link to Site or Institution Page (Paste below). If no link is available, please write your site name. *

8. Upload Your CV (PDF)

Drag & Drop Files, Choose Files to Upload

Experience with Dengue Diagnosis and Testing

This section aims to assess your site’s experience in dengue diagnosis, molecular testing, and serotyping using RT-PCR methods. It will also evaluate the availability of archived residual serum samples and laboratory capabilities required to support an exploratory pilot feasibility study comparing an investigational Dengue Virus Serotyping Real-Time PCR assay (DENV 1–4) with a CE-marked reference assay.

9. Do you receive patients with dengue infection during the peak dengue season? *

Yes
No

10. During peak dengue season, approximately how many laboratory-confirmed dengue cases are identified per month at your site? *

11. Does your institution perform dengue RT-PCR testing in-house? *

Yes
No

(Select MD, Summary

12. If yes, does your laboratory perform serotype differentiation (DENV-1, DENV-2, DENV-3, DENV-4)? *

Yes
No

13. Please specify the CE-marked RT-PCR kits and platforms currently in use (e.g., Certest VIASURE, Bio-Rad CFX, etc.). *

14. Does your site have archived residual serum samples from laboratory-confirmed dengue cases with known serotype (DENV-1, DENV-2, DENV-3, DENV-4) that meet the following criteria: ≥500 µL available volume Stored at ≤ −70°C Documented freeze-thaw history (≤1 thaw) *

Yes – All criteria met
Yes – Partially met
No

15. Approximately how many archived residual serum samples meeting the above criteria are currently available at your site? *

<20
20–50
50–100
>100

16. Would your laboratory be able to support parallel testing using a sponsor-provided RT-PCR kit alongside routine diagnostic testing, as required by the protocol? *

Yes
No

17. Does your site have access to a dedicated −20°C or −80°C freezer with continuous temperature monitoring for long-term sample storage? *

Yes (-20°C)
Yes(-80°C)
Yes (both)
No

18. Which Ethics Committee / IRB reviews clinical studies at your site? *

19. Approximate time from submission to initial Ethics approval (in weeks)? *

20. Are there any ongoing or planned dengue-related clinical studies (June–Dec 2026) that may impact availability of archived samples or laboratory capacity? *

Yes
No

21. Do you have the following resources available in-house? (Select all that apply)

Study coordinator/ study nurse
Molecular laboratory and lab personnel
Reliable systems with internet access and operators

22. Please provide the name of the study coordinator

23. Please provide study coordinator's contact number

24. Please provide study coordinator's email address

Colleague Referral for Dengue

We would appreciate your support in referring colleagues or investigators within your network who may have relevant experience in such type of study.

25. Please provide the name of the investigator

26. Please provide the email of the investigator mail