ICMR-NIV Develops Affordable Rapid Monkeypox Test Kit for Faster Detection

This development comes as a timely alternative to the more expensive and time-consuming RT-PCR tests currently used for Mpox detection.

The Indian Council of Medical Research-National Institute of Virology (ICMR-NIV) has developed a new rapid test kit for monkeypox (Mpox) that aims to significantly reducing both costs and turnaround times.

This visually interpreted kit will soon be transferred to manufacturers for large-scale production, promising faster and more affordable testing across India.

The test kit, which uses LAMP (Loop Mediated Isothermal Amplification) technology, is expected to cut the cost of testing by 60-70% while delivering results in just one hour.

"Once the technology is transferred, the kit could be commercially available within a month, priced between INR 350 and INR 400," a senior ICMR-NIV official revealed.

This development comes as a timely alternative to the more expensive and time-consuming RT-PCR tests currently used for Mpox detection.

Unlike PCR tests, which cost between INR 600 to INR 800 and require expensive machinery priced around INR 25 lakh, the new LAMP-based kit offers 100% sensitivity and specificity without the need for costly equipment or specialized personnel.

"The LAMP technology produces results that can be visually interpreted within an hour," said the official, adding that the quick processing and affordability of this new test make it a potential game-changer in combating Mpox outbreaks.

How the Rapid Test Kit Works

The LAMP-based technology behind the test is relatively simple yet highly effective. The test begins with a viral DNA sample extracted using a DNA extraction kit.

The DNA sample is then added to a reaction tube containing a solution. If the sample is positive for monkeypox, the solution will change color from pink to yellow, offering a clear visual confirmation of the result.

The underlying science involves the release of protons during the virus amplification process. As amplification occurs, the protons cause the solution to become more acidic, which triggers the color change from pink to yellow.

This pH-dependent color shift is the hallmark of LAMP technology and allows for quick, reliable detection.

According to ICMR-NIV, the test employs four to six LAMP primers, making it more sensitive than traditional real-time PCR tests. It has demonstrated 100% sensitivity and 100% specificity in detecting Mpox, ensuring that the results are both accurate and reliable.

ICMR-NIV's Role in Development & Validation

The development of the LAMP-based technology was spearheaded by Dr Shyam Sundar Nandi at ICMR-NIV’s Mumbai unit. Validation of the test was carried out at the institute’s BSL-4 lab in Pune.

ICMR has applied for a patent for the kit, aiming to secure exclusive rights over this pioneering technology.

"This is the first Mpox detection kit developed in India," said an ICMR-NIV official.

A team of ICMR-NIV scientists, including Sonali Sawant, Dr Upendra Lambe, Dr Pragya Yadav, Dr Anita Aich Shete, and Dr Jagadish Deshpande, collaborated on the development of the LAMP technology for monkeypox detection.

Global Impact

The development of this rapid test kit is particularly significant as Mpox continues to spread globally.

On August 14, 2024, the World Health Organization (WHO) declared Mpox a Public Health Emergency of International Concern (PHEIC) due to its rapid spread across several African nations and other countries.

Since January 2022, Mpox cases have been reported in 121 countries, including India, which has documented three cases—two in Kerala and one in Delhi.

Last week, WHO approved a real-time PCR test for Mpox detection for emergency use, manufactured by Abbott. While this test is useful, the ICMR-NIV kit offers a cheaper and faster alternative.

The LAMP-based kit is expected to play a crucial role in India’s response to the disease, particularly in reducing testing costs and improving access to rapid diagnostics.

For monkeypox detection, the recommended sample is a viral swab taken from a lesion, such as a rash or growth, which is placed in a viral transport medium (VTM). WHO also recommends skin lesion material as the primary specimen for laboratory confirmation.

Other samples like saliva, blood, urine, and anal swabs may also contain detectable viral DNA, but lesion-based samples remain the most reliable for testing.

With its affordability, accuracy, and ease of use, the new ICMR-NIV rapid test kit is poised to make a significant impact on Mpox detection in India, helping health authorities respond more effectively to future outbreaks.

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