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RAPID Syphilis Аb
Registration Certificate: No. RZN 2023/21 640
A lateral flow immunoassay for qualitative detection of total antibodies to T. pallidum in human serum, plasma, or whole blood.
The Current Diagnostic Landscape
Syphilis is a systemic infectious disease caused by the bacterium Treponema pallidum. It remains a high-priority target for global public health surveillance and screening initiatives due to its severe long-term clinical implications.
Following years of decline, syphilis incidence in Russia has surged by 39% since 2021, with a sustained upward trend continuing through 2025. This alarming rise underscores the urgent need for expanded diagnostic coverage across all healthcare sectors.
Early detection is clinically mandated as the primary factor in preventing advanced stages and congenital syphilis. Despite this, a significant proportion of cases continue to be diagnosed incidentally or at late stages, highlighting a critical gap that Rapid Bio point-of-care solutions are designed to close.
Following years of decline, syphilis incidence in Russia has surged by 39% since 2021, with a sustained upward trend continuing through 2025. This alarming rise underscores the urgent need for expanded diagnostic coverage across all healthcare sectors.
Early detection is clinically mandated as the primary factor in preventing advanced stages and congenital syphilis. Despite this, a significant proportion of cases continue to be diagnosed incidentally or at late stages, highlighting a critical gap that Rapid Bio point-of-care solutions are designed to close.
Clinical Impact & Benefits
01
PREVENTION OF SEVERE COMPLICATIONS
Early syphilis detection enables immediate targeted therapy, preventing irreversible damage to the central nervous system and internal organs.
02
PREVENTION OF CONGENITAL SYPHILIS
Comprehensive screening and treatment of pregnant women and their partners significantly mitigate the risk of fetal infection and adverse birth outcomes.
03
BREAKING THE CHAIN OF TRANSMISSION
Timely diagnosis allows for rapid identification and treatment of sexual partners, effectively curbing the spread of infection within the population.
Key Advantages
Enables decentralized screening outside of traditional clinical settings for broader community access.
Seamlessly integrates into pre-operative protocols for rapid patient clearance and risk mitigation.
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 aligns with clinical guidelines and mandates for syphilis screening, including antenatal care.
Accelerates patient enrollment and the immediate initiation of targeted antimicrobial therapy.
Technical Specifications
Time to Result:
5 minutes
Reproducibility:
100%
Limit of Detection (LOD):
0.012 IU/mL
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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