HCV Rapid Test

HCV Rapid Test

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

Product Introduction

Intended Use

 

rapid

The HCV Rapid Test Cassette (Serum/Plasma/Whole blood) is a rapid chromatographic immunoassay for thequalitative detection of antibodies to Hepatitis C Virus in serum, plasma or whole blood.Hepatitis C Virus 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 (Serum/Plasma/Whole blood) is a rapid test to qualitatively detect the presence of antibodies to HCV in Whole blood specimen. The test utilizes a combination of recombinant HCV proteins coated particles and recombinant HCV proteins coated on NC membrane to selectively detect antibodies to HCV in 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.

The HCV Rapid Test Cassette (Serum/Plasma/Whole blood) is a qualitative, membrane and double antigen based immunoassay for the detection of antibodies to HCV in serum, plasma or whole blood. The membrane is coated with recombinant HCV antigen on the test line region of the cassette. The conjugate pad is treated with gold particles which are conjugated with antigen. During testing, the specimen reacts with the recombinant 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. 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 proper volume of specimen has been added and membrane wicking has occurred.

 

Specification

 

Read time 10-20 min

Shelf life

36 months

Store temperature 2-30℃
Operation temperature 15-30℃
Sensitivity 100.0%
Specificity 99.6%
Accuracy 99.4%

 

Why To Test

1.What is HCV?

HCV (Hepatitis C Virus) is an RNA virus that primarily causes liver inflammation (hepatitis). It is a blood-borne pathogen leading to both acute and chronic infections. Chronic HCV infection may progress to liver cirrhosis or hepatocellular carcinoma (HCC). Diagnostic test strips detect antibodies against HCV in human serum or plasma, providing preliminary screening for infection. A positive result requires further confirmation via nucleic acid testing (e.g., HCV RNA).

2.How does HCV spread?

  • HCV is transmitted primarily through blood-to-blood contact. Key routes include:
  • Blood exposure: Sharing needles/syringes (e.g., injection drug use), unscreened blood transfusions, or contaminated medical equipment.
  • Mother-to-child: During childbirth if the mother is HCV-positive.
  • Sexual contact: Unprotected sex with an infected person, though risk is lower than blood exposure.

HCV is not​ spread via casual contact (e.g., hugging, sharing food)

3.What are the symptoms of HCV and severe HCV?

  • Early/Acute HCV: Often asymptomatic (70–80% of cases). Some may experience fatigue, nausea, abdominal discomfort, or jaundice (yellowing of skin/eyes) .
  • Severe/Advanced HCV: Chronic infection can lead to cirrhosis or liver failure, causing ascites (abdominal fluid accumulation), hepatic encephalopathy (confusion), or gastrointestinal bleeding. Hepatocellular carcinoma may develop in persistent cases .

 

 

Test Method

1

POSITIVE*: Two colored 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).

*NOTE: The intensity of the color in the test line region (T) may vary depending on the concentration of Strep B antigen present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

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. 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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Catalog

Product Name

Model

Catalog Number

Components

Sample Type

Strip Type

HCV Rapid Test

FS15-101

FS115-101-1

Test Cassettes

Package Insert

Droppers

Buffers

Serum/Plasma/Whole blood

Cassette

 

 

 

 

 

 

 

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