Nagpur-based National Environmental Engineering Research Institute (NEERI), which operates under the Council of Scientific and Industrial Research (CSIR) has developed an “Innovative Patient-Friendly Saline Gargle RT-PCR Testing Method.”
The Ministry of Science of Technology has termed this method of Covid testing as a “milestone”.
In this new method, a person needs to take 5 ml of saline water in his mouth, gargle it for 30 seconds and spit it back into a tube with the help of a funnel. The saline-gargle can be used to test if the person has been infected with Covid-19.
This innovation will make RT-PCR test not only easier but also much cheaper.
However, AIIMS doctors have alleged that they discovered an almost similar testing method around June last year and submitted research papers to the country’s top research body, the Indian Council of Medical Research (ICMR) a month later in July.
They have written a letter to the Union health minister in this regard and forwarded it to the Indian Council of medical Research (ICMR) and CSIR as well.
“It is quite unfortunate that the credit for the innovative work of young doctors belonging to AIIMS, New Delhi has gone to some other body” Dr Amit Malviya, an office-bearer from Resident Doctors Association (RDA) told Outlook.
However, the person behind the innovation at NEERI, Dr Krishna Khairnar, senior scientist, Environmental Virology Cell, dismissed the allegations levelled by AIIMS doctors saying, “there is a major difference between the two studies.”
Before going into the details of the differences, let’s first understand how the RT-PCR test works and what’s common between AIIMS’s claim and Dr Khairnar’s innovations.
How does RT-PCR test work?
For the Covid test, a nylon swab is inserted deep into the nose of a person so that the virus (if present) in nasal secretions gets stuck onto the swab. The swab is then put into a viral transport medium (VTM) and taken to a diagnostic lab.
Lab technicians extract the virus from the swab with the help of a chemical that comes in the form of an RNA extraction kit. The extraction is in liquid form and it is then subjected to a polymerase chain reaction (PCR) process. This finally tells whether the person’s nasal secretions contain a virus or not.
The whole process gives a CT score which indicates the viral load. A lower CT score indicates a higher load of virus in an individual.
What is NEERI’s innovative research?
In the “Saline Gargle RT-PCR Testing Method” after a person spits back into a tube as mentioned above, the tube is then transported to a diagnostic lab, kept under 4 degree Celsius.
This solution is then heated to 98 degree Celsius and subjected to RT-PCR test to get the desired result.
Dr Khairnar’s innovation eliminates two steps of RT-PCR tests – a Viral Transport Medium that costs about Rs 80 per test and an RNA extraction kit that costs about Rs 300 per test.
“The non-invasive sampling not only imparts comfort to the patient but also reduces the dependence on trained health care professionals for sample collection. This improves the overall management of sample collection for a large number of cases,” Dr Khairnar said.
What is AIIMS’ claim?
Research papers available at AIIMS’ doctors Twitter handle suggests that they also worked on the saline gargling method and submitted their paper to the Indian Journal of Medical Research (IJMR) in July last year.
The doctors too used 5 ml saline water for 30 second gargling test on Covid confirmed patients and found the method as accurate as the RT-PCR test.
“Our researchers thought for the first time to collect samples for Covid-19 diagnosis in the form of gargled-saline water. To investigate whether it works or not, they collected both nasal swabs as well as saline gargled water from 50 patients who were confirmed Covid-19 positive,” Dr Malviya said.
He added, “Both nasal swab and saline gargled water gave 100 percent similar results. Even the viral load was almost similar in samples obtained by the two methods. However, this did not garner much attention despite having the potential to revolutionize India’s testing strategy.”
In June last year, the team had presented the research to top officials at the ICMR headquarters in New Delhi.
“Based on the inputs from ICMR scientists, the same group of our researchers embarked upon another study to evaluate if the virus remains alive in normal saline for extended periods. They had submitted a follow-up research paper in October 2020. The research paper has already been accepted by IJMR for publication in April 2021,” Dr Malviya said.
AIIMS also claims that an earlier adaptation of this innovation by ICMR could have saved a lot of resources, money and manpower.
The only difference between the AIIMS method and Dr Khairnar’s research is the use of an RNA extraction kit.
Dr Khairnar’s research uses a heating method to eliminate the use of an RNA extraction kit. The AIIMS method requires the RNA extraction kit.
Dr Malviya said, “It is our collective responsibility to innovate and come up with solutions for the greater good of the country. But it is equally important to keep research ethics intact. Moreover, as has been the practice, peer-reviewed publications carry more weightage than press releases when it comes to medical science.”
“It is interesting to note that the use of Saline Gargle for Covid detection, as a reliable sampling method had also been entrusted and resonated by AIIMS, New Delhi,” Dr Khairnar’s said.
“However, the dependence of AIIMS study on commercially available RNA extraction kits for RNA extraction imparts a considerable economical burden on the system,” he added.
CSIR-NEERI also claims that its Saline Gargle technique has been developed using Phosphate Buffered Saline (PBS).
“So, there is absolutely no question of using their technique or plagiarism,” Dr Khairnar said.
He also claimed that prior to the AIIMS study, the saline gargle method had already been established for detecting respiratory pathogens.
“ICMR has bestowed the responsibility on CSIR-NEERI to train various Covid-19 testing labs across India. CSIR-NEERI has also tied up with commercial manufacturers for scaling up the manufacturing of Saline Gargle RT-PCR test kit, for fast implementation across the country,” Dr Khairnar said.