The Unitary Enterprise "Pilot Production of the Institute of Bioorganic Chemistry" offers consumers Rapid test for the detection of the nucleocapsid antigen of the SARS-CoV-2 virus by immunochromatographic analysis: Rapid test SARS CoV-antigen under a manufacturing agreement and is looking for partners to conclude a distribution services agreement.

Rapid tests for the detection of the SARS-CoV-2 nucleocapsid antigen using immunochromatographic assay (ICA) are widely used for the rapid diagnosis of COVID-19. They enable the detection of the virus in the body in the early stages of infection using nasopharyngeal swabs or other biospecimens.

Major global manufacturers of rapid tests for the detection of SARS-CoV-2 antigen:

1. Abbott Laboratories (USA)
- Features: Manufacturer of one of the most popular rapid tests for SARS-CoV-2 and influenza virus antigens (e.g., Panbio™ COVID-19 Ag Rapid Test).
2. Roche Diagnostics (Switzerland)
- Features: The company offers solutions for the rapid diagnosis of infections, including combination tests for SARS-CoV-2 and influenza.
3. Siemens Healthineers (Germany)
- Features: The company develops highly accurate ICA tests for the diagnosis of respiratory infections.
4. LumiraDx (UK)
- Features: The company offers a rapid diagnostic platform, including SARS-CoV-2 and influenza antigen tests.
5. BioMerieux (France)
- Features: Manufacturer of the BioFire® Respiratory Panel tests, which detect a wide range of respiratory pathogens, including SARS-CoV-2 and influenza.
6. SD Biosensor (South Korea)
- Features: Manufacturer of the Standard™ Q rapid tests, which are used to diagnose SARS-CoV-2 and influenza.

The SARS-CoV-2 Antigen rapid test, manufactured by the Self-Supporting Pilot Production Enterprise of the Institute of Bioorganic Chemistry, is designed for the rapid, qualitative detection of the SARS-CoV-2 nucleocapsid antigen by immunochromatographic analysis in nasopharyngeal (nasal) swabs collected from individuals suspected of having COVID-19 during the acute phase of the disease.

When samples are processed and added to the testing device, SARS-CoV-2 virus antigens present in the sample bind to antibodies labeled with colloidal gold.

Information about the SARS-CoV-2 Antigen Rapid Test, instructions for use, a promotional leaflet, and other information are available on the Company's official website here. (in Russian)

Positive results indicate the presence of viral antigens, but comparison with other patient clinical data and other diagnostic information is necessary to determine the infection status. Positive results do not exclude bacterial infection or coinfection with other viruses.

Negative results should be considered preliminary; they do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient monitoring decisions, including infection control decisions. Negative results should be considered in the context of the patient's recent exposure, medical history, and the presence of clinical signs and symptoms consistent with COVID-19. If necessary, they should be confirmed with molecular testing for patient follow-up.

The Unitary Enterprise "Pilot Production of the Institute of Bioorganic Chemistry of the National Academy of Sciences of Belarus" was founded in 1986 as a specialized facility for the production of radioimmunoassay kits for the diagnosis of various human diseases. Today, it is a modern biotechnology enterprise with highly qualified personnel and a state-of-the-art production and technical infrastructure, enabling it to carry out complex technological processes and produce high-quality products.

The Unitary Enterprise "Pilot Production of the Institute of Bioorganic Chemistry of the National Academy of Sciences of Belarus" produces SARS-CoV-2-IgM/IgG rapid tests for the rapid detection of IgM and IgG antibodies to the SARS-CoV-2 coronavirus, which causes COVID-19.

Radioimmunoassay kits are the main type of diagnostic products manufactured. They are designed to diagnose thyroid diseases, assess the reproductive system and endocrine-metabolic processes, and identify tumor markers. The kits are equipped with solid-phase immunosorbents based on monoclonal antibodies and stabilized, ready-to-use liquid forms of standards and radioactively labeled preparations. In terms of analytical parameters and performance characteristics, these kits match the best foreign analogues.

The company, in collaboration with the Institute of Bioorganic Chemistry of the National Academy of Sciences of Belarus, develops and manufactures enzyme immunoassay kits for hormonal (for determining thyroid, steroid, and pituitary hormones) and oncology profiles, as well as kits based on lanthanide immunofluorimetric analysis for prenatal and neonatal diagnostics.

The infectious disease-specific enzyme immunoassay kits manufactured by the company through industrial cooperation are intended for the diagnosis of syphilis, viral hepatitis B and C, TORCH infections, AIDS, and coronavirus.

Official website of the Enterprise "Pilot production of the Institute of Bioorganic Chemistry."

The Enterprise has implemented a quality management system for the production of in vitro diagnostic reagent kits. In 2012, the company's quality management system was certified for compliance with the requirements of STB ISO 9001-2009 (Certificate of Conformity STB No. BY/112 05 01.002 02704). In 2017, the company's quality management system was certified for compliance with the requirements of the international standard EN ISO 13485:2012 (Certificate No. 9124.IBCN).

Consumers interested in purchasing the SARS-CoV-2 Nucleocapsid Antigen Rapid Test by Immunochromatographic Assay: SARS CoV Antigen Rapid Test under a manufacturing agreement.

Partners interested in purchasing the SARS-CoV-2 Nucleocapsid Antigen Rapid Test by Immunochromatographic Assay: SARS CoV Antigen Rapid Test under a distribution services agreement.