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

1. Email *

Please provide investigator’s email ID

2. Title *

Dr.
Prof.
Ms.
Mr.

3. Name of the Principal Investigator *

First

Last

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. Please provide the name of the Clinical Research Coordinator (CRC), who will serve as the primary contact for all study-related correspondence. *

9. Email address of the CRC *

10. Contact number of the CRC

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

Yes
No

Experience with Dengue Diagnosis and Testing

This section aims to assess your personal and site-level experience in the diagnosis and management of suspected dengue infections, as well as prior involvement with diagnostic testing for dengue. The study is a prospective performance evaluation to determine the diagnostic sensitivity and specificity of the investigational Dengue Duo rapid test when used by professional laboratory or clinical staff on patient samples.

15. Has your site previously participated in clinical performance evaluation studies for in vitro diagnostic (IVD) devices, particularly rapid tests for dengue or other infectious diseases? If yes, please briefly describe

16. During peak Dengue season (June–September), what is the estimated average monthly number of patients presenting with suspected Dengue infection (fever ≤10 days duration)? *

17. During the low Dengue season (outside June–September), approximately how many patients with Dengue or suspected Dengue do you see on average per month? *

18. How many participants do you realistically expect to enroll in this study per month? *

19. Does your institution currently perform Dengue diagnostic testing (RT-PCR and/or ELISA for NS1, IgM, IgG) in-house? *

Yes
No

20. Please specify the CE-marked kits/platforms that are presently in use? *

21. If diagnostic testing is not performed in-house, please provide details of the accredited reference laboratory used, typical turnaround time for results, and sample transport logistics: *

22. Would your laboratory be able to accommodate testing with an additional (second) ELISA brand for comparative evaluation as required by the study protocol? *

23. 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

1. what studies

24. Which Ethics Committee/Institutional Review Board typically reviews and approves clinical studies at your site? (e.g., Institutional IRB, Central Research Ethics Committee, Ethical Review Committee for Research in Human Subjects, Ministry of Public Health EC, etc.) *

25. Approximate time from submission to initial EC approval at your site (in weeks) *

26. Are there any ongoing or planned competing clinical studies (June to Dec 2026) related to Dengue at your site that might impact patient recruitment for this study? Yes (please briefly describe) *

27. Would you be interested in participating as a Principal Investigator in such a study? *

Yes, we are interested and committed to participate
Not interested at this time

28. Do you have the following resources available in-house? (Please select all that apply.)

29. Please upload PI CV *

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