Biocientifica SA develops a new high sensitivity RT-PCR kit for SARS-CoV-2

The Argentinian National Administration of Drugs, Food and Medical Technology (ANMAT) approved New kitfor the qualitative detection of the SARS-CoV-2 virus based on Real-Time RT-PCR technology.

The Argentinian National Administration of Drugs, Food and Medical Technology (ANMAT) approved Schep SARS-CoV-2 RT-PCR Duo Biocientfica SA, an Argentinian biotechnology company developed this sensitive in vitro diagnostic kit for the detection of the SARS-CoV-2 virus by reverse transcription polymerase chain reaction (RT-PCR) in real time technique, the gold standard method for SARS-CoV-2 detection.

Biocientífica SA conducted the whole R&D process and manufactured the product in its Buenos Aires headquarters under international Good Manufacturing Practices (GMP) standards. The initial production is of 20,000 tests per month, scalable in the coming months.

The SchepSARS-CoV-2 RT-PCR Duo kit allows the specific detection of the SARS-CoV-2 virus from viral RNA (ribonucleic acid) with high sensitivity, due to the fact that it simultaneously detects twotarget sequences of SARS- CoV-2. One target is in the region of the E gene, common to the viruses of the Sarbeco genus, which allows ascreening test. The other target is in the region of the RdRp gene, specific for SARS-CoV-2, for which is a confirmatory test. This way, the kit yields both results simultaneously in approximately 90 minutes.

The design of the kit Schep SARS-CoV-2 RT-PCR Duo kit follows a double premise: first, to provide the highest quality and precision in diagnosis, 100% sensitivity and 100% specificity. Second, to facilitate the operation by the professionals in the diagnostic laboratories which are on the front line against the pandemic. All reagents in the kit are ready to use, requiring no previous preparations. The kit provides controls to ensure the quality of the assay. The design of the product also took in consideration its use in most of the simple and inexpensive format real-time PCR machines, since it requires the use of a single detection channel.

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Para el desarrollo y elaboración del kit se recurrió a una cadena de proveedores nacionales, posibilitando la reducción de los costos de producción, promoviendo el fortalecimiento de las capacidades de la industria sanitaria nacional y contribuyendo a una mayor autonomía para asegurar el derecho a la salud. Esto además consolida a la firma y al país como jugadores activos en la economía del conocimiento a nivel internacional. El desarrollo contó con el apoyo del Fondo Nacional de Desarrollo Productivo del Ministerio de Desarrollo Productivo de la Nación.

El kit Schep SARS-CoV-2 RT-PCR Duo está orientado a organizaciones del ámbito público, semipúblico, privado y del tercer sector, incluyendo ministerios, hospitales, obras sociales, laboratorios privados y fundaciones, para lograr un acceso rápido y a un costo significativamente menor que el de los kits que se encuentran actualmente disponibles. El kit será comercializado a un precio casi al costo de producción, para transformarlo en un insumo accesible a todas las instituciones de salud.

Biocientifica S.A., an Argentinian biotechnology company with over 35 years in the in vitro diagnostics market, contributes this way to the fight against the pandemic and consolidates itself as an active player in the biotechnology industry at an international level.

ANMAT