The Unitary Enterprise "Pilot Production of the Institute of Bioorganic Chemistry" offers consumers Reagent kit for syphilis diagnostics (RPR test) under a manufacturing agreement and is looking for partners to conclude a distribution services agreement.

The RPR (Rapid Plasma Reagin) test is a non-treponemal test used to diagnose syphilis. It detects reagins (antibodies to lipid antigens) produced in response to Treponema pallidum infection. RPR tests are used for both screening and monitoring treatment effectiveness.

Major global manufacturers of RPR test reagent kits:

1. Becton, Dickinson and Company (BD, USA)
- Features: The company offers high-quality syphilis diagnostic kits, including RPR test reagents.
2. Fujirebio Diagnostics (Japan)
- Features: Manufacturer of syphilis diagnostic kits, including RPR test solutions.
3. Omega Diagnostics Group (UK)
- Features: Manufacturer of diagnostic kits for infectious diseases, including syphilis.
4. Trinity Biotech (Ireland)
- Features: The company offers a wide range of diagnostic solutions, including RPR testing kits.

The diagnostic kit market also includes a large number of specialized companies from various countries.

The RPR test kit, manufactured by the Self-Supporting Pilot Production Enterprise of the Institute of Bioorganic Chemistry, is designed for the qualitative and semi-quantitative determination of reaginic antibodies to the cardiolipin antigen in human serum or plasma in vitro. In clinical settings, the PRP anticardiolipin test for syphilis is a modern analogue of the Wassermann reaction.

The RPR test is the most highly sensitive non-treponemal test (detecting antibodies to lipid antigens of host or pathogen tissues) for primary, latent, and latent syphilis.

The RPR test is used for screening, testing individuals who have had sexual or household contact with a patient with syphilis, in the presence of symptoms indicating possible disease, in testing newborns to detect congenital syphilis, and to monitor the effectiveness of therapy.

Information on the reagent kit and instructions for use are available on the Company's official website here. (in Russian)

The PRP Test reagent kit for syphilis diagnostics is designed for 100 and 500 determinations, including controls.

The 100-determination kit contains:
* Test cards - 10 pcs.;
* Suspension - 1 vial (2.5 ml);
* Positive control serum, inactivated (K+) - 1 vial (1.0 ml)
* Negative control serum, inactivated (K+) - 1 vial (1.0 ml)
* Test cards - 10 pcs.;

Assay procedure:
1) Add 50 µl of serum K+, K-, and serum (plasma) from patients to the reaction wells of the test card.
2) Add 15 µl of suspension to each well.
3) Mix the reagents by placing the test card on a horizontal shaker (100 rpm) for 8 minutes.
4) Evaluate the results immediately.
The reaction with control samples is performed in the same manner.

* Sample volume: 50 µl.
* Assay duration: 40 minutes.
* Test specificity: 96%.
* Kit shelf life: 24 months.

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 Syphilis Diagnostic Reagent Kit (RPR Test) under a manufacturing agreement.

Partners interested in purchasing the Syphilis Diagnostic Reagent Kit (RPR Test) under a distribution services agreement.