HBsAg and HCV Combo Rapid Test

Intended Use

HBsAg and HCV Combo Rapid Test (Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of Hepatitis B surface antigen (HBsAg), and/or antibodies to HCV in human serum or plasma specimens. HBsAg and HCV Combo Rapid Test is intended for use as an aid in the diagnosis of HBV and HCV infection.

Materials

● Individually packed test devices

● Package insert

● Droppers

Test Procedure

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within an hour.

2. Using the provided dropper, carefully transfer 3 drops (75µL) of serum or plasma to the sample well (S).

Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.

As the test begins to work, sample will migrate across the membrane.

3. Read the result at 10 minutes. Do not interpret the result after 20 minutes.

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