How accurate are diagnostic tests for dengue that are available in the Indian market?

Evaluation of commercial rapid diagnostic test kits for dengue infections in India

Status

Recruiting

Phases

Phase 2

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/05/008699

Enrollment

300

Registered

2017-05-30

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: null- Archived blood samples of patients with a confirmed diagnosis of dengue

Interventions

Intervention1: NIL: NIL

Eligibility

Inclusion criteria

Inclusion criteria: All archived samples of patients with confirmed Dengue by MAC ELISA stored at the CSTM, and stored samples of healthy patients. Stored samples of patients with other conditions to determine cross reactivity will also be used.

Exclusion criteria

Exclusion criteria: No exclusion criteria.

Design outcomes

Secondary

Measure	Time frame
1) To describe operational characteristics including clarity of kit instructions, ease of interpretation of results and its technical complexity using an operational characteristics form 2) To assess the results of the IgG marker from the RDTs and its relationship with other recorded markers Timepoint: Not applicable	—

Primary

Measure	Time frame
To estimate and compare the sensitivity and specificity of six combination RDT kits that include a NS1 antigen and IgM antibody tests on a panel of well-characterised serum samples archived at a reference laboratory in India.Timepoint: Not applicable	—

Countries

India

Contacts

Public ContactSakib Burza

Medecins Sans Frontieres

sakib.burza@barcelona.msf.org9871258886

Outcome results

None listed

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