PROBLEM
SOLUTION
Addressing this need, Wobble Base Bioresearch Private Limited developed a “TBSend card” in which sputum samples can be easily and safely stored and transported. The card is a solid cellulose matrix coated with proprietary reagents which store DNA from the sputum. This sample-coated card can then be used at accredited testing laboratories to release DNA using a brief protocol and tested on any DNA testing platform for TB diagnosis. To ensure biosafety, the TBSend card has a pick-up handle and is placed in a container with an airtight lid that has absorbents beneath the lid to safeguard from spillage and contamination. To add another safety layer, the sputum is mixed with a denaturant that inactivates TB bacteria in the sample before the sample is stored on the card. The stored sample in the TBSend card is stable to be transported at room temperature and can be stored for more than 6 years without losing the viability of the sample. The product can also be repurposed for other human clinical samples that are fluid in nature such as blood, serum, and plasma. IHF has engaged with Wobble Base to evaluate the biosafety of the TBSend Card, and the Central TB Division, Govt. of India, will be an active participant in this study. Once completed, this may lead to a second phase involving manufacturing the product at scale, clinical validation through field trials, regulatory approvals and market access initiation. Owing to the limited number of accredited TB testing laboratories, there is a necessity to transport sputum samples to approved facilities for molecular testing. Sample transportation sometimes takes more than a week due to logistic constraints, leading to an increased risk of contamination of samples and loss of viable cultures. As a result, 10% of all sputum samples get contaminated during transit. Sample transportation from peripheral sites to a centralized testing laboratory also means high costs and logistical complexities such as the need for cold chain to maintain sample quality. Such challenges delay testing and also affect correct test reporting. There is a critical need for an easy-to-use, affordable and safe sample storage and transportation method that can preserve sputum for a long duration without dependency on cold chain.
