Clinical trial of an antigen based rapid diagnostic kitfor detection of Dengue, Chikungunya and Malaria.
- Conditions
- Health Condition 1: A920- Chikungunya virus diseaseHealth Condition 2: A90- Dengue fever [classical dengue]Health Condition 3: R508- Other specified feverHealth Condition 4: B54- Unspecified malaria
- Registration Number
- CTRI/2020/11/029287
- Lead Sponsor
- Ameliorate Biotech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 40
1. Male or Female, aged 10 years or above (both
inclusive).
2. Subjects suffering from fever less than 5 days
3. Subjects with any of the following conditions:
a. Subject with or without any medical
condition who agrees to participate in this
clinical trial and is afebrile.
b. Fever
c. Pre diagnosed Dengue by any antigen based
RDT
d. Pre diagnosed Chikungunya antigen by
ELISA
e. Pre diagnosed Malaria by any antigen based
RDT
f. Pre diagnosed coinfection with Dengue,
Chikungunya or malaria in combination with
each other.
4. In case subjects are not available, suitable stored blood samples can be used.
1. Uncooperative subjects.
2. Subjects not willing to sign written informed
consent.
3. Subjects on Ventilator or are terminally ill.
4. Subjects who had undergone recent surgery within
past 4 months or are about to have surgery schedule
within 10 days.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of the test device will be evaluated <br/ ><br>against the subsequent equivalent. The results obtained from <br/ ><br>test and the reference device will be evaluated by the physician <br/ ><br>and will be classified as Negative or Positive.Timepoint: same day
- Secondary Outcome Measures
Name Time Method 1. The ease of use of the test device will be accessed <br/ ><br>through a Usability questionnaire. <br/ ><br>2. Turnaround time (TAT) will be calculated and <br/ ><br>compared for the following parameters for test and <br/ ><br>the reference device <br/ ><br>a. Device setup (installation) time <br/ ><br>b. Per-cycle loading and unloading time <br/ ><br>c. Overall time for the testTimepoint: same day