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RAPID HIV Ag/Ab
Registration Certificate: No. RZN 2024/22068
a lateral flow immunoassay for qualitative simultaneous detection of HIV-1 p24 antigen and total antibodies to HIV-1 and/or HIV-2 including group O in human serum, plasma, or whole blood.
The Current Diagnostic Landscape
The Russian Ministry of Health prioritizes HIV prevention under the Government Order (21.12.2020). This comprehensive strategy aims to curb the epidemic and minimize infection risks nationwide.
A key target is ensuring that 95% of people living with HIV know their status. To achieve this, screening programs are rapidly expanding, with an emphasis on rapid diagnostic testing.
This landscape drives the demand for simple, fast, and reliable solutions. Rapid Bio diagnostic tools address this need, supporting national efforts to increase testing coverage at the point of care.
This landscape drives the demand for simple, fast, and reliable solutions. Rapid Bio diagnostic tools address this need, supporting national efforts to increase testing coverage at the point of care.
Clinical Impact & Benefits
01
PEAK INFECTIVITY IN EARLY STAGES
The viral load is at its maximum during the acute phase, making individuals highly infectious while appearing asymptomatic. Early detection is critical to break the chain of transmission.
02
ASYMPTOMATIC PROGRESSION
Early-stage HIV often progresses without visible clinical symptoms. Without proactive testing, patients frequently seek medical care only after developing signs of immunodeficiency.
03
ADDRESSING THE DIAGNOSTIC GAP
With over 1.1 million registered cases and estimates reaching 1.5 million, a significant number of people remain unaware of their status or are diagnosed at late clinical stages.
04
HIV IS A MANAGEABLE CONDITION
Modern antiretroviral therapy (ART) enables most patients to achieve an undetectable viral load, ensuring a full life expectancy with zero risk of transmitting the infection.
Key Advantages
Optimized for anonymous and voluntary screening, ensuring high patient accessibility and compliance.
Eliminates the dependency on specialized equipment or high-cost laboratory instrumentation.
Ensures full diagnostic coverage across all regions, including remote and resource-limited settings.
Fully supports national healthcare mandates and the global WHO strategy for HIV elimination.
Identifies the p24 antigen as early as 14 days post-exposure, effectively narrowing the diagnostic window.
Technical Specifications
Time to Result:
8 minutes
Result Stability:
50 minutes
Reproducibility:
100%
Limit of Detection (LOD):
2 IU/mL
Interpretation
NEGATIVE RESULT
Appearance in the test window of only the control line “C”. Staining of the test lines “AG” and/or “AB” does not occur.
Positive result
Appearance in the test window of colored lines: the control line “C” and the test lines “AG” and/or “AB”.
The color intensity of the test lines may vary.
The color intensity of the test lines may vary.
Invalid result
In the test window, the control line “C” does not appear, regardless of the presence of the test lines “AG” and “AB”
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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