Sirin Diagnostics Rapid Test for Hepatitis B Surface Antigen (HBsAg)
2. Intended Use:
For use with serum or plasma samples for the qualitative detection of Hepatitis B surface antigen (HBsAg). Intended as a screening tool for early detection of HBV infection and as an aid in diagnosing current or past HBV infection.
3. Specimen Type & Result Time:
Specimen type: Serum or plasma.
Result time: 15–20 minutes.
4. Principle:
The test is based on lateral flow immunoassay technology. If HBsAg is present, a colored line will appear in the test region (T), along with a control line (C) to indicate proper test performance.
5. Key Features:
One-step rapid test.
Results in 15–20 minutes.
High accuracy: Sensitivity 99.3% – Specificity 99.71%.
No cross-reactivity with other viral diseases.
Easy visual interpretation.
Storage at room temperature (2–30°C).
6. Target Customers:
Medical laboratories.
Blood banks and donation centers.
Hospitals and clinics.
Public health centers.
7. Kit Components:
HBsAg test strip.
Plastic dropper.
Instruction leaflet.
8. Precautions:
For professional use only.
Do not reuse the test strip.
Read instructions carefully before use.
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