Archive · 21 Sep 2025
Govt. Introduces New Accuracy Standards for Disease Diagnostic Kits
The Indian government is making sure that tests for diseases like dengue and TB are accurate.
They are setting new rules for the test kits used in labs.
These kits must meet specific standards to ensure reliable results.
For example, a dengue test needs to correctly identify the disease at least 80% of the time and correctly identify those without the disease 95% of the time.
This is to help doctors give the right treatment and build trust in healthcare.
It is also expected to boost the quality of tests and help local companies compete globally.
The government introduced performance standards for diagnostic kits.
Standards apply to in-vitro diagnostic (IVD) kits for 39 critical diseases.
The new framework aims for accuracy and reliability in testing.
Dengue test kits must meet at least 80% sensitivity and 95% specificity.
Experts believe this will enhance public health and empower domestic manufacturers.
- Who
- Indian government (ICMR and CDSCO)
- What
- Introduced new performance standards for diagnostic kits.
- When
- Not specified
- Where
- India
- Why
- To improve accuracy, consistency, and reliability of test results.
- Governing Bodies
- ICMR and CDSCO
- Kits Covered
- IVD kits
- Diseases Tested
- 39 critical diseases including dengue, TB, and malaria
- Dengue Kit Sensitivity
- Minimum 80%
- Dengue Kit Specificity
- Minimum 95%
- Market Size (FY23)
- $1.72 billion