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: B509- Plasmodium falciparum malaria, unspecified Health Condition 5: B518- Plasmodium vivax malaria with other complications
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Ameliorate Biotech PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Male or Female, aged 13 years to 80 years (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.Subject with febrile illness or malaria/dengue/chikungunya like illness. c.Pre diagnosed Dengue by any antigen based RDT/ELISA d.Pre diagnosed Malaria by any antigen based RDT/MPS e.Pre diagnosed Chikungunya antigen by ELISA or RT PCR confirmation f.Pre diagnosed coinfection with Dengue, Chikungunya or Malaria in combination with each other.
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
| Measure | Time 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 Investigator/Medical microbiologist and will be classified as Negative or Positive.Timepoint: Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The ease of use of the test device will be accessed through a Usability questionnaire. 2.To determine the complete analysis time of the study sample.Timepoint: Day 1 | — |
Countries
India
Contacts
Public ContactMr Hasan Ali Ahmed
Ameliorate Biotech Pvt. Ltd.
Outcome results
None listed