- The multiplex test “Respiratory Flow Chip” allows diagnostic laboratories to identify the virus or bacterium causing the respiratory infection from a single sample.
- Vitro S.A. is the first company worldwide to commercialize a test covering such a large respiratory viral panel, including SARS-CoV-2.
Vitro S.A., the Spanish corporate group specialized in the development, manufacture and distribution of In Vitro Diagnostic (IVD) instruments, software and reagents, has released a new In Vitro Diagnostic test, named “Respiratory Flow Chip” to detect 21 respiratory pathogens simultaneously, including 18 viral species, SARS-CoV 2 and three bacterial species. This way, it becomes the first company worldwide to commercialize a test covering such a large respiratory viral panel.
This new IVD kit for the identification of the nucleic acids of SARS-CoV-2 and other 20 pathogens causing the main acute respiratory infections is highly sensitive and specific.
It has a very high value, since it allows identifying, in a single laboratory test, the virus causing the respiratory infection, and thus shortening diagnostic times and simplifying decision-making in terms of isolation of the patient depending on the type of virus causing the infection.
The test commercialized by Vitro is performed on samples of nasopharyngeal smear or bronchoalveolar lavages from people suspected of COVID-19. Once the sample has been collected by healthcare workers with the “Respiratory Flow Chip” kit, it is processed in the diagnostic laboratories in a quick and fully automated way. This test includes all the necessary reagents to treat the sample, including the capture chip where the genome sequences specific to the 21 pathogens under study are located. Besides detecting the SARS-CoV-2, the new test also identifies the Influenza A virus. Influenza B virus, Respiratory Syncytial Virus, Rhinovirus, Enterovirus, Human Parainfluenza Virus, Adenovirus, Metapneumovirus and the bacteria Bordetella pertussis and parapertussis and Mycoplasma pneumoniae.
The “Respiratory Flow Chip” test is processed automatically by the robotized instruments hybriSpotTM, which combine the PCR technique and the reverse flow-through technology. This way, the new Vitro’s product allows analyzing up to 24 samples from patients simultaneously, issuing the result report in less than 3 hours.
The hybriSpotTM platforms offer a versatile, effective and economic solution for the simultaneous diagnosis of the genetic material from these respiratory pathogens and other panels of multiple pathogens causing diverse diseases. Moreover, these robots are enhanced and manufactured by Vitro at its facilities in Seville, where the management and analysis software for all the tests that make up its hybriSpotTM product portfolio are also developed. Vitro designs and produces all the tests and reagents by itself at its facilities in Granada. These diagnostic platforms have the CE-IVD marking and are currently commercialized both in Spain and in over 30 countries.
The “Respiratory Flow Chip” test is the third diagnostic test commercialized by Vitro in Spain aimed at fighting COVID-19. The corporate group in Seville has developed and commercializes a RT-CPR test to detect the nucleic acid of SARS-CoV-2, which was validated by the Carlos III Health Institute with 100% sensitivity and specificity. Additionally, and according to the distribution activity Vitro does selectively for some foreign manufacturers of IVD platforms and tests, the company distributes exclusively in Spain the serology-based test for the detection of IgM and IgG antibodies in blood against SARS-CoV-2 produced by the manufacturer Snibe (China). It has recently introduced in Spain the first certified kit for the detection of SARS-CoV-2 neutralizing antibodies, produced by the manufacturer Genscript and thus strengthening its portfolio of serology-based tests.
During the first three months of the health crisis, the IgM and IgG tests against the COVID-19 supplied by Vitro and manufactured by Snibe have covered 40% of the health needs in Spain. In this regard, Javier Fernandez, CEO of Vitro S.A, states: “Thanks to the infrastructure of our baseline laboratory in Granada, we are currently validating innovative diagnostic tests for SARS-CoV-2 using several technologies, including not only the PCR technologies, but also flow cytometry and other alternative technologies for the detection of both the RNA of the virus and the antibodies developed against the virus, which makes Vitro’s capacity to develop and supply different diagnostic tests and technologies for Covid-19 unique within our National Health System”. These new diagnostic tests will be available soon and will allow Spain’s hospital network to have the most cutting-edge diagnostic tools against SARS-CoV-2 currently available.
