Hepatitis C Virus Rapid Test

Description

Intended Use

Hepatitis C Virus Rapid Test (Whole blood/Serum/Plasma) is an in vitro diagnostic rapid immunochormatographic assay for the qualitative detection of antibodies to HCV in human whole blood, serum and plasma specimens. Hepatitis C Virus Rapid Test may be used as an aid in the diagnosis of HCV infection. A reactive result should be confirmed by other supplemental assay(s).

What we should know about HCV?

Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA virus. HCV is now known to be the major cause of parenterally transmitted non-A, non-B hepatitis. Antibodies to HCV are found in over 80% of patients with well-documented non-A, non-B hepatitis. Conventional methods fail to isolate the virus in cell culture or visualize it by electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. Compared to first generation HCV EIAs using single recombinant antigens, new serologic tests include multiple antigens using recombinant protein and/or synthetic peptides to avoid nonspecific cross-reactivity and to increase sensitivity.

Test Procedure

Bring the test device, buffer and specimen to room temperature (15-30°C) prior to testing.

1. Remove the test device from its sealed pouch and use it as soon as possible. For best results, the assay should be performed within one hour.

2. Place the test device on a clean, level surface. Label with specimen ID.

For venous whole blood specimens:

Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 µL) to the sample well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) and start the timer.

For fingerstick whole blood specimens:

Dispense 2 drops of fingerstick whole blood onto the sample well (S) of the test device, then add 1 drop of buffer (approximately 40 µL) and start the timer.

For serum or plasma specimens:

Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 µL) to the sample well (S) of the test device, and start the timer.

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

3. Wait for the colored band(s) to appear. Read results at 10 minutes.