PUNE: A new, visually interpreted rapid monkeypox test kit developed by the Indian Council of Medical Research-National Institute of Virology (ICMR-NIV) is set to be transferred to manufacturers for large-scale production.
This innovative kit is expected to reduce both cost and turnaround time of monkeypox (Mpox) by 60-70%. “Once the technology is transferred, the kit could be commercially available within a month.It will be priced between Rs350 and Rs400 and will deliver results in just an hour,” a senior ICMR-NIV official told TOI on Wednesday.
The rapid test employs LAMP (Loop Mediated Isothermal Amplification) technology, offering 100% sensitivity and specificity without the need for costly machines like RT-PCR or specialised skills. “It produces results that can be visually interpreted in an hour,” the official said.
Last week, the World Health Organisation (WHO) approved a real-time PCR test for Mpox detection for emergency use, manufactured by Abbott. In contrast, the ICMR-NIV kit is poised to be a game-changer.
“The current PCR tests cost around Rs600 to Rs800 and require machines priced at Rs25 lakh, taking four hours to process. The new kit will cost significantly less and deliver results faster without expensive equipment or specialised personnel,” the ICMR-NIV official said.
Dr Shyam Sundar Nandi of ICMR-NIV led the development of this LAMP-based technology at NIV’s Mumbai unit, with validation carried out at the BSL-4 lab in Pune. “This is the first Mpox detection kit developed in India, and ICMR has applied for a patent to secure exclusive rights,” the official said.
Other ICMR-NIV scientists involved in the development of the LAMP technology for detection of monkeypox include scientists Sonali Sawant, Dr Upendra Lambe, Dr Pragya Yadav, Dr Anita Aich Shete and Dr Jagadish Deshpande.
WHO declared Mpox a Public Health Emergency of International Concern (PHEIC) on August 14, 2024, because of its spread across several African nations and other countries. Since January 2022, a total of 121 countries have reported Mpox cases, including three in India (two in Kerala and one in Delhi).
Indication in colour change
The test solution starts as pink
After the DNA of the virus is extracted using a DNA extraction kit, the DNA sample is added to the reaction tube
When the virus DNA sample is added to the reaction tube, the solution will turn from pink to yellow if the sample is positive
This color change is a visual indication of the result
The science behind it involves the release of protons during the virus amplification process inside the tube
As amplification occurs, protons are released, causing the solution to become more acidic, which triggers the color change from pink to yellow
Lamp technology
The pH-dependent color shift is the core of the LAMP (Loop Mediated Isothermal Amplification) technology
The rapid test employs LAMP technology
The test requires 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.
Swab sample
The recommended sample to test monkeypox is a viral swab taken from a lesion, such as a rash or growth, in viral transport medium (VTM)
WHO recommends skin lesion material as the primary specimen for laboratory confirmation
Other samples, such as saliva, blood, urine and anal swabs may also contain detectable viral DNA
(Source: ICMR, New Delhi)