With accuracy equivalent to the one used in the RT-PCR method, the gold standard of diagnosis, the new technique is more efficient and is capable of analyzing up to 16 times more samples in the same time interval. This new resource appears as a viable option for mass testing, representing a huge advance in the pandemic fight and it is expected to be available to enter Einstein Laboratory’s routine within three weeks.
The used technique
Varstation developed, in partnership with Hospital Israelita Albert Einstein, the world’s first diagnostic test for the new coronavirus based on Next Generation Sequencing (NGS) with 100% specificity – in other words, that does not present false positive cases.
The NGS technique consists of reading small fragments of DNA to identify diseases or genetic mutations. The great innovation developed by the Varstation researchers was to have adapted the method to detect RNA, the other biological molecule that, together with DNA, makes up the genetic material of all living beings. Like several types of viruses, Sars-Cov-2 has only RNA. “Until now, the only way to register its presence within human cells was by the RT-PCR technique”, explains pathologist João Renato Rebello Pinho, coordinator of the Special Techniques Laboratory at Hospital Israelita Albert Einstein.
The exam was developed following good practices and recommendations from respected institutions such as the United States’ Center for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA), the American agency responsible for approving drugs and technologies in Health. The first validations demonstrate a high capacity (90%) to correctly identify individuals who contracted the disease. They were performed using samples tested in the usual laboratory routine at Hospital Israelita Albert Einstein, at Morumbi (São Paulo).
The sample collection for virus detection is performed using sterile swabs in contact with the nasal or saliva region. After that, the sample is prepared according to specific protocols developed by Einstein. The results are analyzed using the Varstation® bioinformatics platform “The result is ready in up to three days, but we are already working to significantly reduce this period”, explains the bioinformator Murilo Cervato, Manager of Innovation and Data Science at the Hospital Israelita Albert Einstein and CEO of Varstation. The entire process is patented.
The test took about two months to develop. “The Einstein and Varstation team’s feat, which was carried out in such a short amount of time, is the result of the organization’s great investment in its areas of research, innovation and entrepreneurship”, says engineer Claudio Terra, director of Innovation and Digital Transformation at Hospital Israelita Albert Einstein.
What differentiates this test from others?
The test identifies the presence of the virus, functioning as a diagnostic tool to be used from the first day of infection, in the same way as the RT-PCR, which makes it a viable alternative for the adoption of mass diagnostic testing. What is currently available for testing are serological tests, known as rapid tests. However, they detect antibodies produced by the body in response to the infection, which can be observed on an average of 14 days after the contamination. Consequently, these tests should be applied only for screening and even so, they have approximately 30% false-negative rates.
When will it be available?
The test should be available for Einstein’s diagnostic operation routine by early June. It is, therefore, another advantage of the exam, since it significantly expands the testing capacity at Einstein and, potentially, to other similar laboratories in Brazil and worldwide. The methodology adoption has great potential to be adopted on a large scale, since there is great availability of production in NGS laboratories, which are currently, in most cases, with low level of use due to the pandemic.
Varstation is a Hospital Israelita Albert Einstein’s platform that was created by the Hospital’s Innovation Department and aims to democratize genetics knowledge. It provides support for the processing and analysis of human genetic samples from NGS with a customizable, cloud-based, secure, centralized environment with clinical validation. In addition, it provides technological knowledge in precision medicine and high quality services, in order to enable health institutions to offer the best treatment to their patients and make it easier for researchers in the field to work.