Pluslife Secures Indonesian Import License for Groundbreaking Mycobacterium Tuberculosis Nucleic Acid Test Card

Recently, Pluslife's self-developed rapid molecular diagnostic test card for tuberculosis, utilizing tongue swab samples, was awarded an import medical device license by the Indonesian government. This milestone marks a significant breakthrough following the earlier certification of Pluslife’s sputum sample TB diagnostic technology.

As the first company in China to achieve certification in Indonesia for dual-sample TB detection (sputum & tongue swab), Pluslife has pioneered a simpler and more accessible testing solution for populations who struggle with sputum collection. This advancement not only broadens the scope of eligible patients for TB testing but also offers more comprehensive support for global TB prevention and control efforts.

The Global Tuberculosis Report 2023 also recommends rapid molecular diagnostic technology as the preferred method for initial TB screening, due to its high sensitivity and specificity, which enable the early detection of cases, thereby improving diagnostic accuracy and reducing result turnaround times. However, there remains a global shortage of mature and affordable rapid molecular diagnostic tools suitable for proactive TB screening, especially in resource-limited primary healthcare settings and high-burden areas. The lack of decentralized diagnostic tools poses a significant barrier to progress in TB control.

To address this challenge, Pluslife has launched rapid molecular diagnostic products for tuberculosis that combine sputum and tongue swab testing. The products combine high performance, low cost, and rapid, convenient pathogen detection, making them ideal for decentralized applications and highly effective in resource-limited primary healthcare settings. Currently, Pluslife’s products stand at the forefront of global TB diagnostics and are the only mature, low-cost rapid molecular diagnostic solution for TB worldwide. Pluslife’s products have received high recognition and support from several esteemed global organizations, including the World Health Organization(WHO), the Foundation for Innovative New Diagnostics (FIND), and the Bill & Melinda Gates Foundation, due to their remarkable advantages of high performance, low cost, rapid convenience, and dual-sample detection.

Pluslife's groundbreaking dual-sample TB detection technology represents a significant shift from symptom-based diagnosis to proactive screening. This innovation marks a crucial step toward achieving the goal of ending the TB epidemic by 2035 and sets a new standard in global TB control efforts.