Scientists studying the mutation of the SARS-CoV-2 virus are constantly discovering more and more new strains of this virus. A new coronavirus “Arcturus” (XVV 1.16) has been discovered – a new, more contagious and rapidly spreading mutation of Covid-19.
Arcturus is a variant of the Omicron variant and is characterized by a high rate of spread from person to person. According to the complex of Arcturus symptoms, covid is almost impossible to distinguish from a standard ARVI, so many people continue to lead a normal life, not paying attention to malaise, thereby becoming active spreaders of the infection.
Reagent kits for molecular genetic diagnostics of the SARS-CoV-2 virus produced by “ROSSA”:
– “ROSSAmed COVID-19 RT-PCR”
– “ROSSAmed EXPRESS COVID 19 RT-PCR”
– “ROSSAmed COVID-19 ISOTHERM”
identify all relevant (according to WHO), including “Arcturus'” (HVV 1.16) strains of SARS coronavirus – CoV-2.

The “ROSSAmed AFP”  kit is designed for the quantitative determination of alpha-fetoprotein (AFP) in human blood serum by senzyme-linked immunosorbent assay (ELISA).

AFP is a glycoprotein with a molecular weight of about 70 OOO Da. During human development, AFP is formed mainly in the yolk sac and the embryonic liver and to a lesser extent in the gastrointestinal tract. AFP reaches its maximum concentration (up to 240 OOO IU/ml) in fetal blood serum during 12-15 weeks of intrauterine development, after which its level decreases and reaches normal (0-16 IU/ml) by the end of the second year of life. Within such limits, this indicator normally persists throughout life.

AFP, being the main protein of the early fetal blood serum, is secreted by the fetal kidneys into the amniotic fluid and from there through the placenta and umbilical cord penetrates into the mother’s circulatory system. The level of AFP in the blood of pregnant women is constantly increasing and reaches a maximum (up to 400 IU /ml) by the middle of the third trimester of pregnancy.

The change in the concentration of AFP in the blood serum of pregnant women is an important indicator of the prenatal diagnosis of certain congenital diseases (open defects of the medullary tube, Down syndrome). In addition, this method is widely used in obstetrics in the diagnosis of multiple pregnancies, intrauterine fetal death and the threat of miscarriage. Determining the level of AFP can also be used in the diagnosis and monitoring of various types of cancer. For example, a high and persistent level of AFP (800-80000 IU/ml and higher) very often accompanies primary hepatoma, testicular teratomas and tumors of the endodermal sinus of the ovaries.

“ROSSAmed HBsAg” is designed for qualitative and quantitative determination of the surface antigen (HBsAg) of hepatitis B virus (HBV) in human serum and plasma by senzyme-linked immunosorbent assay (ELISA).

HBsAg is a glycosylated HBV envelope protein. HBsAg contains the determinant “a”, common to all subtypes of the virus, and additional subdeterminates (d and y), determining the immunological differences of subgroups (ad and au). Currently, it is the main marker in determining hepatitis B virus infection. HBV causes acute and chronic viral hepatitis and is more often transmitted by blood transfusion than other viral hepatitis. It causes a whole spectrum of manifestations, ranging from mild, asymptomatic form to lightning-fast hepatitis, serious liver damage and cirrhosis. In addition, the role of HBV in the development of primary liver cancer has been clearly proven.

Quantitative determination of HBsAg in the blood seems appropriate when correcting the diagnosis and selecting treatment. When screening for hepatitis B, a qualitative determination of HBsAg in the blood is sufficient.

On January 30, 2023, ROSSA’s management was awarded ISO 9001 and ISO 13485 certificates.

ISO is an international quality standard. They are being developed for various fields: medicine, IT security, environmental management or energy consumption. Each area has its own designation of standards. The ISO certificate helps the company to set up business processes and work more efficiently.

ISO 9001 – Quality management system Sets requirements for company management and quality management. The main principle is customer orientation. It is important for the company that its customers remain satisfied with the products and service, therefore, the main attention in the regulation is paid to the “company → consumer” bundle.

ISO 13485 – quality system of medical products Medical devices are medical devices that are needed to help patients. The ISO 13485 series is aimed at reducing the risks of producing low-quality materials.

The certificate specifies the requirements for quality management systems in the medical equipment industry. The rules are suitable for the production of different types of products, including reagents. In addition to quality control, the standards prescribe after-sales control, complaints handling and the creation of a suitable infrastructure for the production of sterile medical products.

ISO certificates are reputation. People and corporations tend to trust more those who work according to the rules and comply with the norms of international standards.

Chronic hepatitis B is one of the main etiological causes of liver failure, cirrhosis and hepatocellular carcinoma worldwide. This condition cannot be completely cured by currently available medications due to the constant existence of the ring covalently closed DNA (ccDNA) of the hepatitis B virus (HBV) in infected hepatocytes, which is the matrix for transcription of HBV RNA. Since the quantitative assessment of CDDNA itself requires an invasive procedure (liver biopsy), serum biomarkers reflecting intrahepatic activity of CDDNA are needed. Recently, more and more studies show that circulating HBV RNA can serve as a serum biomarker of infection, treatment and prognosis of HBV. Serum RNA is transcribed directly from cDNA, so serum RNA levels may indicate the presence of transcriptional activity of the virus.

HBV RNA levels correlate with HBV DNA levels and are associated with serum HBsAg and ALT levels. HBV RNA levels vary depending on the infection phase — they are highest in the immunotolerant phase and lowest in patients with inactive HBV infection. In patients receiving treatment with nucliazide analogues (the main group of drugs used to treat chronic viral hepatitis B), HBV RNA levels are higher than HBV DNA levels. In general, HBV RNAs in serum indicate transcriptional activity of CDDNA. This biomarker (in combination with HBV DNA and HBsAg levels) can be used to monitor the response to treatment in patients receiving therapy with nucliazide analogues.

It can also be used to identify patients who can safely stop taking nucleazide analogues and/or achieve the disappearance of HBsAg (functional cure).Serial evaluation of intrahepatic HBV cDNA is not possible, therefore, measurement of HBV RNA together with analysis of viral activity can be used to determine the activity of HCDNA, especially when developing treatment methods aimed at elimination and/or functional cure.

ROSSA has developed a set of reagents “ROSSAmed HBV-RNA” for the detection of Hepatitis B virus RNA by polymerase chain reaction in real time. The kit is suitable for tablet-type devices: “DTprime”, “Dtlight”, “DT-96” (NPO DNA Technology LLC), or CFX96 (Bio-Rad), qTOWER (Analytik Jena), as well as for a rotary-type detecting amplifier, for example, Rotor-Gene Q (QIAGEN).

The ROSSAmed HBV- RNA kit was tested in the reference laboratory of the M.Z. RUz Virology Research Institute, and also received a registration certificate of the “State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment” of the Republic of Uzbekistan. The kit set received positive conclusions and was recommended for use in laboratory practice. There are no analogues of the ROSSAmed HBV- RNA kit in Uzbekistan at the moment.

The recommended system for isolating RNA/DNA from biological material is “MagSorb Plasma” (manufactured by OOO “ROSSA”).

“ROSSAmed HBV-RNA” kit designed for qualitative detection of hepatitis B virus RNA by PCR with detection of results in “real time” mode. RNA samples isolated from blood plasma serve as the material for PCR.