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RAPID HCV Ab
Registration Certificate: No. RZN 2024/22 728
A lateral flow immunoassay for qualitative detection of Hepatitis C Antibody in human serum, plasma and whole blood.
The Current Diagnostic Landscape
The elimination of Hepatitis C (HCV) is a primary objective of the World Health Organization (WHO), which aims to reduce new infections by 90% and mortality by 65% by 2030. Achieving these targets requires a massive scale-up of screening programs to identify the "missing millions" of undiagnosed individuals worldwide.
As part of the global effort to minimize transmission risks, expanded screening for HCV antibodies has become a cornerstone of public health policies. Early detection is critical, as modern antiviral therapies can now cure over 95% of patients, provided the infection is diagnosed before significant liver damage occurs.
To meet the urgent need for accessible and reliable diagnostics, Rapid Bio offers a high-performance HCV Antibody Rapid Test. Engineered for speed and accuracy, it serves as an essential tool for large-scale screening initiatives, bridging the gap between clinical suspicion and laboratory-grade confirmation at the point of care.
As part of the global effort to minimize transmission risks, expanded screening for HCV antibodies has become a cornerstone of public health policies. Early detection is critical, as modern antiviral therapies can now cure over 95% of patients, provided the infection is diagnosed before significant liver damage occurs.
To meet the urgent need for accessible and reliable diagnostics, Rapid Bio offers a high-performance HCV Antibody Rapid Test. Engineered for speed and accuracy, it serves as an essential tool for large-scale screening initiatives, bridging the gap between clinical suspicion and laboratory-grade confirmation at the point of care.
Clinical Impact & Benefits
01
Management of the "Silent Disease"
Hepatitis C (HCV) typically remains asymptomatic until advanced stages. Early detection is vital to prevent late-stage presentations such as fibrosis, cirrhosis, and hepatocellular carcinoma.
02
Addressing the Diagnostic Gap
Despite a 9% increase in newly identified cases, a significant "hidden reservoir" of undiagnosed individuals remains. Universal screening is essential to identify the 60% of people currently unaware of their infection status.
03
Curability of HCV
Modern antiviral therapies achieve cure rates exceeding 95%. Timely diagnosis transforms Hepatitis C from a life-threatening risk into a manageable and fully curable condition.
Key Advantages
Optimized for field use and mobile health initiatives outside of clinical settings.
Requires no specialized laboratory equipment or complex cold-chain logistics.
Significantly lower cost per test compared to standard laboratory screening.
Ensures diagnostic coverage in remote and hard-to-reach geographical regions.
Fully supports global and national Hepatitis C elimination targets.
Technical Specifications
Time to Result:
5 minutes
Reproducibility:
100%
Limit of Detection (LOD):
0.5 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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