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Clinical trial of an antigen based rapid diagnostic kit for detection of Dengue, Chikungunya and Malaria.

Performance Evaluation of ASSURED rapid antigen based diagnostic kit for detection of Dengue, Chikungunya and Malaria.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/11/029287
Enrollment
185
Registered
2020-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A920- Chikungunya virus disease Health Condition 2: A90- Dengue fever [classical dengue] Health Condition 3: R508- Other specified fever Health Condition 4: B54- Unspecified malaria

Interventions

Intervention1: ASSURED rapid antigen based diagnostic kit: ASSURED is a simple, rapid and an invitro qualitative screening test to diagnose dengue, chikungunya and malaria infection, even for 1st day

Sponsors

Ameliorate Biotech Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Sensitivity and specificity of the test device will be evaluated against the subsequent equivalent. The results obtained from test and the reference device will be evaluated by the physician and will be classified as Negative or Positive.Timepoint: same day—

Secondary

MeasureTime frame
1. The ease of use of the test device will be accessed through a Usability questionnaire. 2. Turnaround time (TAT) will be calculated and compared for the following parameters for test and the reference device a. Device setup (installation) time b. Per-cycle loading and unloading time c. Overall time for the testTimepoint: same day—

Countries

India

Contacts

Public ContactSubham Dutta

Ameliorate Biotech Pvt. Ltd.

rashbehari@amelioratebiotech.com9901551514

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026