On September 11, samples sent to Calicut Medical College for testing were confirmed as Nipah virus. But only on September 20, after 323 samples were tested for the virus, did ICMR permit Kerala to use Truenat for Nipah testing. Even the belated permission came only after Kerala “strongly demanded” for Truenat during discussions with ICMR, Health Minister Veena George said during a press conference.
Truenat for Nipah virus testing was granted an emergency use authorisation (EAU) by the Indian regulator in September 2021 days after the third Nipah outbreak in Kerala. The EAU was based on validation of the Truenat test to detect the virus and the Trueprep AUTO lysis buffer (to inactivate the virus) by NIV Pune in 2018 in Kerala and external validation at the Institute of Epidemiology Disease Control and Research, Dhaka, Bangladesh. Both human and bat samples from Kerala were used for validating the test in 2018. In 2019, NIV installed Truenat at the Government Medical College, Ernakulam during the Nipah outbreak, and at two field sites in Punjab as part of the Nipah virus surveillance in bats. Of the 120 human clinical specimens and 25 samples from bats tested in 2019, Truenat correctly diagnosed all the positive and negative samples, except for one positive human sample.
As per a 2021 paper published in the Indian Journal of Medical Research, the sensitivity of Truenat was 97% and specificity was 100%. It was able to correctly diagnose Nipah even when other viruses were present. The efficacy of the Trueprep AUTO lysis buffer for inactivating Nipah virus prior to virus detection was also tested and found to be high. The “inactivation of Nipah virus was evident by the absence of Ct value”, notes the paper. A study was carried out at NIV in April 2020 using SARS-CoV-2 virus to evaluate the virus inactivating efficiency of both the lysis buffer and the Trueprep AUTO transport medium. The study, which is yet to be published but shared with The Hindu, found high virus inactivating efficiency by both the lysis buffer and the transport medium.
