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RAPID COVID-19 Antigen
Registration Certificate: No. RZN 2023/20 186
A lateral flow immunoassay for qualitative detection of SARS-CoV-2 antigen in nasopharyngeal or oropharyngeal swab specimens
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The Current Diagnostic Landscape
Evolution of the Epidemiological Status
Following the termination of the WHO Public Health Emergency, SARS-CoV-2 has transitioned into an endemic phase—a controlled yet persistent infection. The virus continues its antigenic evolution, with novel strains driving periodic surges. Global surveillance data indicates a sustained positivity rate of 8−11%, underscoring the virus’s continuous presence in the respiratory landscape.
Integrated Respiratory Surveillance
In the 2025−2026 season, COVID-19 co-circulates alongside Influenza and other ARVIs, a trend consistently recorded by the national respiratory surveillance system in Russia. This overlap complicates clinical diagnosis and necessitates a multi-pathogen approach to testing.
The Role of Point-of-Care Testing (POCT)
The current priority for healthcare systems is the effective management of morbidity. In this context, Point-of-Care Testing (POCT) becomes indispensable. The Rapid Bio COVID-19 Test provides immediate, laboratory-grade confirmation at the patient’s side, enabling rapid clinical intervention and efficient resource allocation.
Following the termination of the WHO Public Health Emergency, SARS-CoV-2 has transitioned into an endemic phase—a controlled yet persistent infection. The virus continues its antigenic evolution, with novel strains driving periodic surges. Global surveillance data indicates a sustained positivity rate of 8−11%, underscoring the virus’s continuous presence in the respiratory landscape.
Integrated Respiratory Surveillance
In the 2025−2026 season, COVID-19 co-circulates alongside Influenza and other ARVIs, a trend consistently recorded by the national respiratory surveillance system in Russia. This overlap complicates clinical diagnosis and necessitates a multi-pathogen approach to testing.
The Role of Point-of-Care Testing (POCT)
The current priority for healthcare systems is the effective management of morbidity. In this context, Point-of-Care Testing (POCT) becomes indispensable. The Rapid Bio COVID-19 Test provides immediate, laboratory-grade confirmation at the patient’s side, enabling rapid clinical intervention and efficient resource allocation.
Clinical Impact & Benefits
01
Differential Diagnosis of Respiratory Pathogens
The co-circulation of COVID-19, Influenza, and RSV makes clinical diagnosis by symptoms alone unreliable. Rapid testing prevents diagnostic errors and antibiotic overuse, significantly reducing the burden on inpatient healthcare facilities.
02
Outbreak Prevention in Communal Settings
Timely screening in healthcare facilities, schools, and workplaces enables the immediate implementation of infection control measures. This helps contain viral transmission and protects vulnerable populations (the elderly and immunocompromised).
03
Support for Public Health Surveillance
Widespread rapid testing complements laboratory monitoring by providing real-time data on SARS-CoV-2 strain circulation. This intelligence is critical for vaccination strategy planning and efficient medical resource allocation.
Key Advantages
Optimized for early-stage screening of symptomatic patients and for monitoring individuals following confirmed exposure.
Eliminates the need for PCR laboratory infrastructure and extensive personnel training, ensuring accessibility at any facility.
Delivers diagnostic results within minutes, enabling immediate action on treatment strategies and infection control.
Ideal for large-scale screening and repeat testing without increasing the diagnostic burden on centralized laboratories.
Technical Specifications
Time to Result:
7 minutes
Result Stability:
15 minutes
Reproducibility:
100%
Analytical Sensitivity (LOD):
0.3 ng/mL
Interpretation
NEGATIVE RESULT
Appearance in the test window of only the control line “C”. Staining of the test line “T” does not occur.
Положительный результат
Appearance in the test window of two colored lines: the control line “C” and the test line “T”.
The color intensity of the test line may vary.
The color intensity of the test line may vary.
Недействительный результат
In the test window, the control line “C” does not appear regardless of the presence of the test line “T”.
The cause of an invalid result may be incorrect performance of the analysis procedure or unsuitability of the medical device. In this case, it is recommended to repeat the testing procedure.
The cause of an invalid result may be incorrect performance of the analysis procedure or unsuitability of the medical device. In this case, it is recommended to repeat the testing procedure.
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