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Immunochromatographic test for the detection of HCV antibody in the serum or plasma
Hepatitis C Virus (HCV) is a small, positive-sense, enveloped, single-stranded RNA virus. It is now known to be the major cause of parenterally transmitted non-A, B hepatitis. 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 the cell culture or visualize it by the electron microscope. Cloning of viral genome has made it possible to develop the serologic assays that use recombinant antigens. As compared to the 1st generation HCV EIAs using single recombinant antigen, multiple antigens using recombinant protein or synthetic peptides has been added in a new serologic test so as to avoid any non-specific cross-reactivity and also to increase the sensitivity of the HCV antibody tests.
HCV Rapid Test (Serum or Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in the serum or the plasma specimen. This test is based on the principle of double antigen sandwich immunoassay for the determination of anti-HCV present in the serum. The HCV proteins used in the test kit are encoded by the genes for both structural and non-structural proteins.
PRINCIPLE OF THE TEST
This test is a qualitative, membrane based immunoassay for the detection of antibody to HCV present in the serum or plasma. The membrane is coated with recombinant HCV antigen. During testing, the specimen reacts with the recombinant HCV antigen coated colloidal-gold. The mixture then migrates upward on the membrane chromatographically by capillary action to react with another recombinant HCV antigen present on the membrane and generate a colored line. Formation of this colored line indicates a positive result, while its absence indicates a negative result. A colored line will always appear at the control line region indicating that proper volume of specimen has been added and the test has been carried out properly.
An internal procedure control has been incorporated into the test kit to ensure its proper performance and reliability.
The use of control is recommended to verify proper performance. Quality control samples should be tested according to the quality control established by the testing laboratory.
The control should be used in the same manner as a specimen by following the test procedure. The results should be obtained when using the control.
For serum, collect the whole blood into a container without anticoagulant. Allow the blood to clot and separate the serum from the clot and use this serum for testing. If the specimen is not tested on the day of collection, store it in a refrigerator or freezer. Bring the specimens to room temperature before testing and do not freeze and thaw the specimen repeatedly.
Open the sealed pouch and remove the test strip from it.
Take 0.1ml (about 3 drops) sample into the pipette, and dispense it into the sample well on the cassette.
Wait for 15 to 20minutes and read the results. Do not read it after 30 minutes.
INTERPRETATION OF RESULTS
Negative: If only one colored line appears on the control (C) region and no apparent band on the test (T) region.
Positive: In addition to a pink colored control (C) line, a distinct pink colored line also appears in the test (T) region.
Invalid: Absence of colored line in both the regions is an indication of procedural error and/or the test reagent has deteriorated.
STORAGE AND STABILITY
The test kit can be stored at room temperature (18 to 30℃) in a sealed pouch until the date of expiration. It should be kept away from direct sunlight, moisture, and heat.
WARNINGS AND PRECAUTIONS
This test kit contains no infectious reagents, however, proper precautions should always be taken when handling patient specimens.
Preclude any pipetting by mouth.
Avoid smoking or eating where specimen and reagents are being handled.
Wear gloves while handling kit reagents or specimens.
Wash hands thoroughly afterward
Avoid splashing or aerosol formation.
Clean up the spills thoroughly using an appropriate intermediate-to-high level disinfectant.
Decontaminate and dispose of all the specimens and potentially contaminated materials.
Do not use reagents after its expiry date.
For in vitro diagnostic use only
LIMITATIONS OF THE TEST
The test should be used for the detection of antibodies to HCV in the serum or plasma specimen. Neither the quantitative nor the rate of increase can be determined by this qualitative test.
It will only indicate the presence of antibodies and should not be used as the sole criteria for the diagnosis of Hepatitis C viral infection.
As with all the diagnostic tests, results must be considered with other clinical information available.
If the test result is negative and clinical symptoms persist, additional follow-up testing is recommended using other clinical methods. A negative result does not preclude the possibility of Hepatitis C Virus infection.
Sensitivity: The analytical sensitivity of the HCV-Card is 2 NCU