New COVID-19 test submitted to Brazil’s national drug regulator

The Oswaldo Cruz Foundation (Fiocruz) announced Friday (Jan. 19) it has finished the development of two new molecular tests for the diagnosis of COVID-19. One of them had its registration request submitted to Brazil’s national drug regulator Anvisa Tuesday (18). The request concerns molecular kit Inf A/Inf B/SC2, a RT-PCR test capable of differentiating between Influenza A, B, and Sars-CoV-2, making the diagnosis of these illnesses possible with a single test.

“Whenever we talk about respiratory infections,” said Fernando Motta, virologist at the Fiocruz Laboratory of Respiratory Virus and Measles, “we’re referring to a type of disease that may be caused by an enormous range of micro-organisms.”

“As [these diseases] show similar symptoms, identifying the agent without lab diagnostics can be a huge challenge. Making these kits available at [Brazil’s unified public health care network] SUS will make the opportune viral identification possible at a low cost and with high processing. It’s a top-notch method for diagnosing illnesses caused by a respiratory virus across the world,” he said.

The other test developed, molecular kit Quadriplex SC2/VOC, should enable the detection and differentiation of Sars-CoV-2 variants Alpha, Beta, Gama, Delta, and Omicron, also by means of real time (RT) PCR. Its use is recommended for viral diagnosis and triage through the identification of what the World Health Organization terms variants of concern (VOC), potentially important for public health and epidemiological surveillance.

The result indicates whether any of these variants is present. To identify which variant it is, the sample must be subjected to genetic sequencing. The Quadriplex test is expected to the submitted for registration with Anvisa by next week.

“Both molecular kits are yet another important contribution of Bio-Manguinhos at a moment when we’re witnessing the increase in COVID-19 cases as a result of the Omicron variant, just as we’re seeing a high number of people infected with influenza. These tests attest to the institute’s expertise in diagnostics, always with quick responses at sensitive moments,” said Sotiris Missailidis, vice-director for Technological Development of the Institute for Technology in Immuno-Biologicals Bio-Manguinhos/Fiocruz.

Test production

In addition to the development of new tests to meet the country’s epidemiological monitoring demands, Fiocruz has been in charge of the production of tests for COVID-19 diagnosis ever since efforts to tackle the pandemic began.

Thus far, some 20 million RT-PCR have been provided to the Health Ministry. In August 2021, Fiocruz also started producing rapid antigen tests for public laboratories across Brazil—of these some 45 million tests have been delivered to the Health Ministry.

Today, Fiocruz is Brazil’s biggest manufacturer of rapid tests for the diagnosis of COVID-19 and the number one supplier for public hospitals in Brazil.