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CE approved HCV rapid test kit

China

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Product Description

Intend use
The HCV Rapid Test Device (whole blood/Serum/Plasma) is a rapid visual immunoassay for the qualitative presumptive detection of antibodies to HCV in human whole blood, serum, or plasma specimens. This kit is intended to be used as an aid in the diagnosis of HCV infection.

 
 
  Introduction
 

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.

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. To obtain a best result, the assay should be performed within one hour.
Whole Blood:
  1. Transfer 2 drops (about 50µL.) of whole blood to the specimen well of the device with a disposable pipette provided in the kit then add 1 drop (about 30-50 µL) of buffer, and then start the timer.
Serum/ Plasma:
  1. Transfer 1 drop (about 25µL) of volume of serum/plasma to the specimen well of the device with a disposable pipette provided in the kit then add 1 drop  (about 30-50 µL)  of buffer, and then start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.
As the test begins to work, you will see color move across the membrane.
  1. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

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