Hepatitis C Virus (HCV) Diagnostic Kit Serum Plasma Sample Rapid Test

• Customization: Available
• Type: IVD Reagent
• Certificate: ISO, CE
• Model NO.: HCV-DP02
• Shelf Life: 24 Months
• Usage: Professional Use
• Sample: Serum Plasma
• Result Time: Within 15 Mins
• Principle: Immunochromatography
• Storage: 2~30ºC
• Transport Package: Cartons
• Specification: 40test/box
• Trademark: Dewei
• Origin: China
• Production Capacity: 100, 000PCS/Day

Product Description

 

Intended Use

The HCV Rapid Test (Serum/Plasma) is a rapid visual immunoassay for the qualitative, presumptive detection of antibodies to HCV in human serum or plasma specimens. This kit is intended for use 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. Antibodies to HCV are 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 first generation HCV EIAs using single recombinant antigens, new serologic tests include multiple antigens using recombinant protein and/or synthetic peptides to avoid nonspecific cross-reactivity and to increase sensitivity.

Contents

• Rapid test cassette with desiccant. 
• Disposable pipettes.
• Package insert

Storage & Statibility

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.
• Keep away from direct sunlight, moisture and heat.
• DO NOT FREEZE

Sample Collection

 

• The HCV Rapid Test is intended for use with human serum or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

Operation

Bring tests, specimens, 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. For best results, the assay should be performed within one hour.
2. Using the provided disposable pipette, fill the narrow portion of the pipette with the serum or plasma specimen, transfer 2 drops of serum/plasma to the specimen well (S), then start the timer.  Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area. As the test begins to work, color will migrate across the membrane.
3. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

 

Detailed Photos

 

Company Profile

About Us

Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
During the special period of Corona, Dewei also develop the reagent kits, like Virus Transport Medium with swab, Rapid test and Saliva Collection Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
 

R&D team
15% annual sales amount is devoted R&D department.
With professional R&D team, Dewei is continuously making new achievements on innovation, gaining numbers of national invention patents and professional technical awards. Meanwhile, Dewei focuses on the improvement of technology to guarantee product quality and pursue product performance.

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