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RAPID HIV Ab
Registration Certificate: No. RZN 2023/21 696
A lateral flow immunoassay for qualitative detection of total antibodies to type 1 and/or type 2 of Human Immunodeficiency Virus (HIV-1/HIV-2) 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.
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.
Clinical Impact & Benefits
01
Early Detection and Transmission Control
Viral load peaks during the acute phase, making early diagnosis critical. Identifying asymptomatic cases allows for immediate intervention to
02
Addressing the Diagnostic Gap
With estimates of up to 1.5 million cases in Russia, many remain undiagnosed. Rapid testing targets this "hidden reservoir," preventing late-stage immunodeficiency and delayed clinical care.
03
Effective HIV Management
Modern therapy enables patients to achieve an undetectable viral load, ensuring a normal life expectancy and zero transmission risk. Diagnosis is the essential first step to this clinical pathway
Key Advantages
Enables scalable mass diagnostics without increasing the operational burden on centralized laboratories.
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 goals and the global WHO strategy for HIV elimination.
Technical Specifications
Time to Result:
5 minutes
Reproducibility:
100%
Shelf Life
24 months
Interpretation
NEGATIVE RESULT
Appearance in the test window of only the control line “C”. Staining of the test line “T” does not occur.
Positive result
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.
Invalid result
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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