16-Apr-2020: Chitra GeneLAMP-N makes confirmatory tests results of COVID 19 possible in 2 hours
Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, an Institute of National Importance, of the Department of Science and Technology (DST), has developed a diagnostic test kit that can confirm COVID19 in 2 hours at low cost.
The confirmatory diagnostic test, which detects the N Gene of SARS- COV2 using reverse transcriptase loop-mediated amplification of viral nucleic acid (RT-LAMP), will be one of the world’s first few if not the first of its kinds in the world.
The test kit, funded by the DST called Chitra GeneLAMP-N, is highly specific for SARS-CoV-2 N-gene and can detect two regions of the gene, which will ensure that the test does not fail even if one region of the viral gene undergoes mutation during its current spread.
The tests performed at NIV Alappuzha (authorized by ICMR) show that Chitra GeneLAMP- N has 100% accuracy and match with test results using RT-PCR. This has been intimated to ICMR, the authority to approve it, for COVID-19 testing in India, following which License needs to be obtained from CDSCO for manufacture.
Current PCR kits in India enable detection of E gene for screening and RdRp gene for confirmation. Chitra GeneLAMP-N gene testing will allow confirmation in one test without the need for a screening test and at much lower costs.
The detection time is 10 minutes, and the sample to result time (from RNA extraction in swab to RT-LAMP detection time) will be less than 2 hours. A total of 30 samples can be tested in a single batch in a single machine allowing a large number of samples to be tested each day.
"Development of a novel, inexpensive, rapid confirmatory for the diagnosis of COVID1-9 by Sree Chitra in record time is a compelling example of how a creative team of clinicians and scientists working together seamlessly can leverage knowledge and infrastructure to make relevant breakthroughs. Establishment of a Technology Research Center at SCTIMST and four other DST institutions has brought rich dividends by conversion of basic research into important technologies", said Prof Ashutosh Sharma, Secretary, DST.
The testing facility can be easily set up even in the laboratories of district hospitals with limited facilities and trained laboratory technicians. The results can be read from the machine from the change in fluorescence. The cost of testing with the new device for LAMP testing and the test kit for 2 regions of N gene( including RNA extraction) will be less than Rs 1000/test for the laboratory.
Sree Chitra has also additionally developed the specific RNA extraction kits along with GeneLAMP-N test kits and testing devices. The technology was transferred in for manufacture to M/S Agappe Diagnostics Ltd, Ernakulam, a leading company in In-vitro diagnostics with national and international operations.
Dr. Anoop Thekkuveettil, a senior Scientist of the Biomedical Technology Wing of the Institute and Scientist-in -charge of the division of molecular medicine under the Department of Applied Biology and his team developed the kit in the last 3 weeks.
11-Apr-2020: Exploring novel blood plasma therapy for COVID-19
Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) an Institution of National Importance under the Department of Science and Technology has obtained a go-ahead for taking a bold step to provide innovative treatment to patients suffering from COVID-19 disease. Technically called “convalescent-plasma therapy”, the treatment aims at using the immune power gained by a recovered person to treat a sick person. Indian council for medical research (ICMR) the top authorising body in India has given approval to the SCTIMST for carrying out the novel treatment. “We have applied for age cut off to the Drug Controller General of India (DCGI) for permissions for relaxation of the norms for blood donation,” said Dr Asha Kishore Director, SCTIMST.
What is convalescent-plasma therapy?: When a pathogen like novel coronavirus infects, our immune systems produce antibodies. Like the police dogs, the antibodies span out to identify and mark the invading virus. White blood cells attach the identified intruders, and the body gets rid of the infection. The therapy, like blood transfusion, harvests the antibody from a recovered patient and ingest into a sick person. Helped by the antibody, the immune system mounts robust combat on the virus.
What are antibodies?: Antibodies are one of the front-line immune response to an infection by a microbe. They are a particular type of proteins secreted by immune cells called B lymphocytes when they encounter an invader, such as a novel coronavirus. The immune system designs antibodies that are highly specific to each invading pathogen. A particular antibody and its partner virus are made for each other.
How the treatment is given?: Blood is drawn from a person who has recovered from COVID-19 sickness. The serum is separated and screened for virus-neutralizing antibodies. Convalescent serum, that is the blood serum obtained from one who has recovered from an infectious disease and especially rich in antibodies for that pathogen, is then administered to a COVID-19 patient. The sick acquires passive immunisation. “Potential donor would be examined before the blood serum is extracted and given to a sick person. First, the swab test must be negative and the potential donor has to be declared as cured. Then the recovered person has to wait for two weeks. Or else the potential donor should be asymptomatic for at least 28 days. Either of the two is mandatory” said Dr Kishore while speaking with India Science Wire.
Who will be receiving the treatment?: “Initially we will try in a small number of patients. At present it is permitted as an experimental therapy for restricted use for severely affected patients only. We will be getting the informed consent before they are recruited. This will be conducted as a clinical trial” said Dr Kishore. COVID clinics of five medical college hospitals will be partnering”.
How is it different from vaccination?: This therapy is akin to passive immunization. When a vaccine is administrated, the immune system produces the antibodies. Thus, in a later date, when the vaccinated person is infected by that pathogen, the immune system releases the antibodies and neutralise the infection. Vaccination provides lifelong immunity. In the case of passive antibody therapy, the effect lasts only up to the time the antibodies injected remain the bloodstream. The protection given is temporary. The mother transfers antibodies through breast milk to an infant before the child could build her own immunity.
History: Way back in 1890, Emil von Behring, a German physiologist, discovered that the serum obtained from a rabbit infected with diphtheria was effective in preventing the diphtheria infection. Behring was awarded the first-ever Nobel prize for medicine in 1901. Antibodies were not known at that time. Convalescent serum therapy was less effective and had substantial side effects. It took many years before the antibody fraction could be separated. Still, the unintended antibodies and impurities caused side effects.
Is it effective?: We have effective antibiotics against bacterial infection. However, we do not have effective antivirals. Whenever a new viral outbreak takes places, there are no drugs to treat it. Hence, the convalescent serum has been used during past viral epidemics. During the outbreak of 2009–2010 H1N1 influenza virus pandemic, patients with an infection requiring intensive care were used. After the passive antibody treatment, the serum-treated individuals showed clinical improvement. The viral burden reduced, and the death rate could be lowered. The procedure was also useful during the Ebola outbreak in 2018.
Is it safe?: With modern blood banking techniques that screen for blood-borne pathogens is robust. It is not difficult to match the blood type of donors and recipients. Therefore the risks of inadvertently transferring known infectious agents or triggering transfusion reactions are low. “Just as we do in case of blood donation one has to look for the blood groups and Rh compatibility. Only people whose blood group matches can donate or receive blood. The donor will be stringently examined and tested for certain mandatory factors before they will be permitted to donate the blood. They will undergo tests for hepatitis, HIV, malaria, and so on to ensure that they do not pass on a different pathogen to the receiver” said Dr Asha Kishore, Director, SCTIMST.
How long the antibodies will remain in the recipient?: After the antibody serum is given, it will stay on the recipient for at least three to four days. During this period, the sick person will recover. Research reports from the USA and China indicate that the beneficial effect of transfusion plasma is obtained in the first three to four days and not later.
Challenges: This therapy is not simple to harness, primarily due to the difficulty of obtaining significant amounts of plasma from survivors. In diseases like COVID-19, where most of the victims are aged, suffering from other medical conditions such as hypertension, diabetes, and so on, not all recovered patients can volunteer to donate blood.
2-Apr-2020: Naval Dockyard Mumbai designs low cost Temperature Gun
Naval Dockyard, Mumbai has designed and developed its own handheld IR based temperature sensor for undertaking screening of large number of personnel at the entry gates of the yard reducing the load on the security sentries at the gate. The instrument has been manufactured under Rs. 1000/ - through in-house resources (which is fraction of the cost of the Temperature Guns in the market).
The ongoing pandemic of COVID-19 has led to one of the biggest medical emergencies the world has witnessed in the recent times. View massive surge in the number of infected patients, the medical infrastructure of the nation is being put to its ultimate test.
The 285 year old Naval Dockyard (ND) of Western Naval Command (WNC) has an average influx of around 20,000 personnel entering its premises every day. In view of COVID-19, initial screening of these personnel entering the dockyard was essential to prevent the spread of COVID-19 within the yard and the Western Fleet. The most preliminary method to screen a probable patient is to check for body temperature by a non-contact means.
Since the outbreak, the non-contact thermometers or temperature guns have become scarce in the market and are being sold at a very high cost. To overcome the scarcity and requirement of large numbers, ND (Mumbai) has designed and developed its own handheld IR based temperature sensor with accuracy of 0.02 deg Celsius. The non-contact thermometer has a Infrared sensor and an LED display integrated with a microcontroller which runs on a 9V battery. This initiative has provided a tool for undertaking screening of large number of personnel at the entry gates of the yard thereby reducing the load on the security sentries at the gate.
With the manufacturing cost of less than Rs 1000/- the dockyard has the capability to scale up production of these if required towards which sourcing of the components is in progress.