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RAPID HBV Ag
Registration Certificate: No. RK-MD (in vitro)-0№ 29 874
A lateral flow immunoassay for qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum, plasma, or whole blood.
The Current Diagnostic Landscape
Hepatitis B (HBV) remains a primary driver of cirrhosis and hepatocellular carcinoma globally. Due to its frequently asymptomatic progression, a vast majority of infected individuals remain unaware of their HBsAg status, contributing to the silent spread of the virus.
Infection is often detected incidentally during hospitalization, pregnancy, or routine medical examinations. Early identification of HBsAg is critical for preventing viral transmission and reducing the long-term clinical and economic burden on healthcare systems.
Aligned with WHO global strategies and clinical guidelines for Chronic Hepatitis B, screening for the HBsAg antigen is mandated as a standard of care, particularly during the first trimester of pregnancy to prevent vertical transmission.
Infection is often detected incidentally during hospitalization, pregnancy, or routine medical examinations. Early identification of HBsAg is critical for preventing viral transmission and reducing the long-term clinical and economic burden on healthcare systems.
Aligned with WHO global strategies and clinical guidelines for Chronic Hepatitis B, screening for the HBsAg antigen is mandated as a standard of care, particularly during the first trimester of pregnancy to prevent vertical transmission.
Clinical Impact & Benefits
01
CLINICAL TREATMENT PLANNING
Determining HBsAg status is essential for the accurate planning of medical interventions and ensuring patient safety during clinical procedures.
02
OBSTETRIC RISK MANAGEMENT
Universal screening during pregnancy is critical for preventing vertical transmission (mother-to-child) and ensuring proactive neonatal care.
03
LONG-TERM DISEASE MANAGEMENT
Early identification of patients at high risk for cirrhosis and hepatocellular carcinoma enables the development of targeted, individualized treatment pathways.
04
MITIGATING LATE-STAGE RISKS
Every undiagnosed or late-stage case significantly increases the risk of severe complications, including liver failure and liver cancer.
Key Advantages
Suitable for point-of-care screening (outside of healthcare facilities)
Seamless integration into health examination programs
No additional equipment required
Lower diagnostic costs compared to standard laboratory testing
Nationwide coverage, including remote and hard-to-reach regions
Technical Specifications
Time to Result:
9 minutes
Analytical Sensitivity / Limit of Detection (LoD):
0.5 IU/ml
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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