When Kerala witnessed a possible instance of Nipah this month, hinting at a second outbreak in two years, the state government sent samples of the patient to the National Institute of Virology (NIV) in Pune, the NIV in Alappuzha, as well as Manipal Institute in Karnataka. While the Alappuzha centre and the Manipal centre gave the confirmation that it was Nipah at least a day before the Pune institute did, the Kerala government did not announce a confirmation until NIV Pune gave their verdict.
The reason? Indian Council of Medical Research (ICMR) has authorised Pune as the sole institute in the country to confirm Nipah. And this means that although the Alappuzha and Manipal institutes are centres that work under NIV, Pune, only the parent institution can actually confirm the sample.
"During an outbreak, in order not to create panic among people, we don’t confirm anything until it is examined in Pune,” an expert explained to TNM, “The test can be done in other labs to examine if it's Nipah, but to confirm that it's Nipah, the NIV report is needed. Other lab reports won't be taken as a confirmation."
However, this means that Kerala has to depend on the workload of NIV, Pune, factor in travel time of samples, and wait for confirmation every time – unless it develops an institute similar to NIV, Pune, in the state.
Classification of labs
The Center for Disease Control (CDC) has classified labs into four types or levels – called biosafety levels, or BSLs. The classification is based on the organisms that are handled in each lab/institute. Only a lab certified as BSL 4 is allowed to handle extremely dangerous pathogens, such as Ebola. An institute with BSL 1 works with less risky organisms.
A BSL 3 or 4 classification is required to handle the Nipah virus.
What Kerala plans to do
Due to the experience of the last two years, the Institute of Advanced Virology (IAV) that was inaugurated at Thonnakkal in Thiruvananthapuram in February, is being planned as an institute that can become more advanced than NIV, Pune, and can secure the required ICMR classifications. IAV has been envisaged as an affiliated global virus network (that has 41 countries) with national and international certification.
"The Nipah threat is prevalent in Kerala in the country. The pressure is on us to develop it as an advanced institute in a year, since Nipah threat is seasonal; it occurred exactly a year ago. The state can't be experimental about it one more time depending on a single institute – NIV, Pune. Also, the time needed for the confirmation depends on the workload of NIV, Pune, which is not ideal,” GM Nair, the coordinator of IAV, told TNM.
“We have a moving crowd in the state. IAV is an institute under the government. The infrastructure is being developed accordingly. Former ICMR director NK Ganguly is IAV’s Research Council Chairman. Hence we are hopeful that the ICMR would give us certification for Nipah confirmation,” GM Nair added.
Nipah test: Molecular diagnostics
The test to detect Nipah includes DNA based molecular diagnostics. "What we do is to sequence the DNA of the sample and align it to the existing information. We get the homology of the DNA – isolate the DNA, purify it, and sequence it. This can be done at a very fast rate; the confirmation will be available in one or two hours,” GM Nair said.
“The other method is enzyme-linked immunosorbent assay test – or ELISA. However, that’s not a foolproof system. Molecular diagnostics is faster and more accurate," he explained. For the DNA based diagnosis, both blood sample and fluid samples are needed, because the virus may not necessarily be found in the blood.
ICMR approval for upgrading the Kozhikode institute to a level two was only received in May. Though the Alappuzha institute does not yet have BSL 3, this time examinations at a level three conducted there.