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2020-07-18 06:24
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The cassette test for the qualitative detection of HCV in serum/plasma.
HCV Rapid Hepatitis C Virus Test (Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to Hepatitis C Virus in serum or plasma. It is for professional in vitro diagnostic use only.
Hepatitis C Virus (HCV) is a small, enveloped, positive-sense, single-stranded RNA Virus. Antibody to HCV is 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 an electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens (1, 2). Compared to the first-generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein and/or synthetic peptides have been added in new serologic tests to avoid nonspecific cross-reactivity and to increase the sensitivity of the HCV antibody tests (3, 4). HCV Rapid Hepatitis C Virus Test (Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in a serum or plasma specimen. The test utilizes a combination of recombinant antigens to selectively detect elevated levels of HCV antibodies in serum or plasma.
PRINCIPLE
HCV Rapid Hepatitis C Virus Test (Serum/Plasma) is a lateral flow chromatographic immunoassay based on the principle of the double antigen–sandwich technique. The membrane is coated with recombinant HCV antigen on the test line region of the device. During testing, the serum or plasma specimen reacts with the HCV antigen-coated particles.
The mixture migrates upward on the membrane chromatographically by capillary action to react with recombinant HCV antigen on the membrane and generate a colored line. The presence of this colored line indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that the correct volume of specimen has been added and membrane wicking has occurred.
STORAGE AND STABILITY
All reagents are ready to use as supplied. Store unused test cassette unopened at 2°C-30°C.
If stored at 2°C-8°C, ensure that the test cassette is brought to room temperature before opening. The test is not stable out of the expiration date printed on the sealed pouch.
Do not freeze the kit or expose the kit over 30°C.
TEST PROCEDURE
Allow the test, specimen, and/or controls to reach room temperature (15-30°C) prior to testing.
1. Remove the test from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test cassette on a clean and level surface. Hold the dropper vertically and transfer one drop of serum or plasma (about 30μl) then add one drop (about 40μl) of sample buffer immediately. Avoid air bubbles. See illustration below.
3. Set up a timer.
4. Wait for the colored line(s) to appear. Read results in 15 minutes. Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS
Positive: Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
Negative: One colored line appears in the control line region(C). No line appears in the test line region (T).
Invalid: Control line fails to appear.
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