Investigator(s)
| WHO Technical Officer |
Deepa Kailash Sharma WCO India Deepa Kailash Sharma 
|
| Principal Investigator |
Kaveri K King Institute of Preventive Medicine & Research (KIPMR), Chennai Kaveri K
|
Title(s) and abstract
| Scientific title | Operational feasibility study of Hema Spot HF devices for use in Measles Rubella Surveillance in a remote field setting in India |
| Public title | Measles Rubella DBS study, India |
| Background | Traditionally, blood sample collection is done through venipuncture, which requires a trained phlebotomist, and has been employed in serosurveys or for case diagnosis by serological assays. However, there are challenges around sample collection and testing namely, the need for trained staff, the need for temperature-controlled sample transport to laboratories, and the need to process samples soon after collection. Furthermore, venous blood collection is often challenging or not feasible especially in children under 5 years of age. As an alternative, blood sample collection as dried blood spots (DBS) by finger or heel prick could address these challenges. The present study is designed to understand the suitability of HemaSpot HF device to be included in already operational Measles Rubella surveillance programs to study the diagnostic accuracy of DBS collected on HemaSpot HF devices compared to venous blood samples for measuring measles and rubella-specific IgM antibodies and also to assess the operational feasibility of the use of HemaSpot HF devices during MR surveillance in the field setting. The study will be conducted in collaboration with KIPMR, Chennai. |
| Objectives | 1. To estimate the agreement between the DBS collected on HemaSpot HF devices and venous blood samples for measuring IgM antibodies using EIA (standard laboratory protocols) for measles 2. To assess the operational feasibility (blood collection, transportation in ambient temperature and antibody measurement in the laboratory) and utility of HemaSpot HF devices during the MR surveillance. Secondary objective 1. To estimate the per-unit cost of the standard laboratory protocol for venous blood collection and the HemaSpot HF protocol. For a better comparison, a second device used for collecting dried blood spots (a Perkin Elmer #226 protein saver card) will also be used. 2. To assess agreement between the DBS collected on HemaSpot HF devices and venous blood samples for measuring IgM antibodies using EIA for rubella and to assess the feasibility of completing the algorithm for rubella IgM testing. |
| Study Methods | The study is designed to compare the results of IgM for measles and rubella for samples taken through venous blood and dried blood spots (HemaSpot HF device and Perkin Elmer#226 card) in 15 states of India. Detailed methodology is provided in the attached protocol. |
| Expected outcomes and use of results | The study is expected to generate data on the diagnostic usefulness of the HemaSpot HF device for measles-rubella (MR) blood sample collection under ongoing MR surveillance in India. If the data indicates that the HemaSpot HF device sample collection is comparatively as good as the traditional method (venous blood) then the HemaSpot HF device method could be alternatively used in the program. |
| Keywords | HemaSpotHF, Measles rubella, India |
Research Details
| Student research | No |
| Start Date | 15-Jan-2025 |
| End Date | 15-Jul-2025 |
| Key Implementing Institution | King Institute of Preventive Medicine & Research (KIPMR), Chennai |
| Multi-country research | No |
| Nationwide research | Yes |
| Research Domain(s) | Communicable Disease Research |
| Research field(s) | Immunization/Vaccine Preventable Disease |
| Involves human subjects | Yes |
| Intervention Evaluation Research | |
| Data Collection | Primary data |
| Proposal reviewed by other Committee | Under Review |