India’s first indigenously developed test for coronavirus disease (Covid-19) based on the genetic editing tool CRISPR/Cas-9 is likely to hit the market within the month, confirmed an official from the science ministry. The test, which was developed by researchers from the Institute of Genomics and Integrative Biology, will be marketed by Tata Sons.
The device had received the approval from the Drug Controller General of India last month. It was found to have high sensitivity of 96% and specificity of 98%, meaning it can accurately detect both positive and negative cases up to 96 or 98% of the time.
At least two other tests developed by institute from the Council of Scientific and Industrial Research have been submitted for approval and one other test has just been validated on clinical samples.
The cost-effective and quicker test has been named after the fictional Bengali detective Feluda, who stars in series of novels by filmmaker Satyajit Ray. It is also an acronym for FNCAS9 Editor Linked Uniform Detection Assay.
The test barcodes the Cas9 protein – a component of the CRISPR gene editing system – to interact specifically with the genetic material of SARS-CoV-2 virus that causes Covid-19. This complex of Cas9 and CoV2 is then applied on a paper-strip test, which gives the result in the form of two lines for a positive and a single line for a negative just like the home pregnancy test.
As the test uses a lateral flow paper-strip for giving a negative or positive result, it can be interpreted visually by anyone and does not require trained personnel.
For the new test, samples are collected using a throat and nasal swab just the way it is done for RT-PCR tests. But once the RNA is extracted from the swab, testing the sample will be faster. The thermocycler machines used to process the samples is about 100 times cheaper than the traditional RT-PCR machines and are much readily available in smaller laboratories.
