ISO13485 HCV Infectious Disease Test Kit High Specificity Rapid Diagnostic Test

Product Specification

HCV Rapid Test Kits with High Specificity , rapid diagnostic test kits

Applications:

The HCV Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibody to Hepatitis C Virus in whole blood, serum or plasma.

Description: 

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. 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 electron microscope. Cloning the viral genome has made it possible to develop serologic assays that use recombinant antigens. 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.
The HCV Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid test to qualitatively detect the presence of antibody to HCV in a whole blood, serum or plasma specimen. The test utilizes colloid gold conjugate and recombinant HCV proteins to selectively detect antibody to HCV in whole blood, serum or plasma. The recombinant HCV proteins used in the test kit are encoded by the genes for both structural (nucleocapsid) and non-structural proteins.

How to use? 

Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15- 30°C) prior to testing.

1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
 

2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 25 μl) to the specimen area, then add 2 drops of buffer (approximately 80 μl),and start the timer, see illustration below.
 

For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 μl) to the specimen area, then add 2 drops of buffer (approximately 80 μl), and start the timer. See illustration below.
 

For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 50 μl of fingerstick whole blood specimen to the specimen area of test cassette, then add 2 drops of buffer (approximately 80 μl) and start the timer. See illustration below.

3. Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 20 minutes.
 

Note: It is suggested not to use the buffer, beyond 30 days after opening the vial.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE: * Two distinct colored lines appear. One color line should be in the control region (C) and another color line should be in the test region (T).
*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of HCV antibodies present in the specimen. Therefore, any shade of red in the test region should be considered positive.

NEGATIVE: One color line appears in the control region (C). No apparent red or pink line appears in the test region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

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