The ongoing Ebola outbreak in the Democratic Republic of Congo (DRC) has underscored the urgent need for effective testing solutions. The outbreak, which is linked to the Bundibugyo strain of the virus, has resulted in 363 confirmed cases and at least 62 fatalities. In response, Goa-based Molbio Diagnostics has developed a real-time PCR testing platform specifically designed to meet these challenges. This technology played a pivotal role during India’s COVID-19 response and is now being adapted to address the current public health crisis.

Molbio is collaborating closely with the World Health Organization (WHO), the Africa Centres for Disease Control and Prevention, and local authorities to validate this testing method on clinical specimens. The Truenat platform is portable, allowing for use in decentralised healthcare settings, and can provide results within roughly one hour, facilitating quicker diagnosis and intervention.

This swift response mechanism is crucial, especially in settings that often face resource constraints. Ensuring timely access to testing is a priority for healthcare providers as the epidemic evolves, with WHO Director-General Tedros Adhanom Ghebreyesus addressing the testing shortfall as a significant challenge in the ongoing response efforts.

Understanding PCR Technology in Detecting Ebola

Ebola is diagnosed using real-time polymerase chain reaction (RT-PCR) technology, recognised globally as the standard for identifying viral infections. By amplifying specific genetic markers, RT-PCR can accurately determine whether an individual is infected. While RT-PCR has been available for decades, effective implementation has been hampered by the need for advanced laboratory infrastructures and trained personnel. This has traditionally centralised testing in facilities that can handle sophisticated procedures.

These barriers can exacerbate outbreaks, particularly in remote areas where rapid diagnosis is critical. During discussions, Molbio’s president, Shiva Sriram, noted that the Truenat system is the only PCR platform globally that supports multi-disease testing with a single, portable device. Originally aimed at tuberculosis detection, this platform seeks to broaden access to molecular diagnostics in diverse healthcare environments.

The Truenat system’s versatility is among its key advantages. It can test for various infectious diseases, such as tuberculosis, COVID-19, and potentially Ebola, optimising the use of existing healthcare infrastructure. The established network of over 13,000 Truenat devices across India has already proven invaluable for timely testing during the pandemic.

Regulatory Approvals and Future Steps

The Ebola testing assay is currently under clinical validation in both the DRC and Uganda. Meanwhile, Molbio has reached out to the Indian Council of Medical Research (ICMR) for local clinical validation, a necessary step for regulatory approval by the Central Drugs Standard Control Organisation (CDSCO) in India. Obtaining these approvals is crucial for the integration of the Ebola test into the existing Truenat network for enhanced accessibility.

Recently, the WHO announced a call for applications for Emergency Use Listing (EUL) for Ebola PCR tests, prompting Molbio to initiate the application process. This regulatory pathway highlights the interconnected nature of approvals necessary for broader deployment of the technology. Achieving both WHO and CDSCO approvals will expedite the delivery of testing solutions during the ongoing health crisis.

As the situation develops, the focus remains on scaling up testing capacity, which is vital for an effective response to the Ebola outbreak. The collaborative efforts between pharmaceutical companies and health organisations may significantly alter the landscape of public health responses in outbreak scenarios.

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