Product Detais
The HCV Rapid Test (Whole blood/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.
-Easy to use
-Accurate result at 15 mins
-No need to send to a lab to obtain results
| Brand |
Dewei |
| Package |
1test/foil bag; 40tests/box; 1000tests/carton |
| Storage |
2~30ºC |
| Contents |
Rapid Test+Buffer+Disposable Pipettes |
| Shelf Life |
24 months |
| Certificate |
ISO13485 |
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.
PRINCIPLE
The HCV Rapid Test detects antibodies to HCV through visual interpretation of color development in the internal strip. Protein A is immobilized on the test region of the membrane. During testing, the specimen reacts with recombinant HCV antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient HCV antibodies in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
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. Test
For Serum or Plasma
Use the provided disposable pipette, transfer 2 drops of serum/Plasma to the specimen well (S) of the cassette with the provided disposable pipette, then start the timer.
For Whole Blood
Transfer 1 drop of whole blood specimen to the specimen well (S) of the device with the provided disposable pipette, then add 1 drop of buffer and 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 15 minutes. Do not interpret the result after 20 minutes.
RESULT READING
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.
QUALITY CONTROL
• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.
• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
Company Profile
Dewei Medical Equipment Co., Ltd. is a high-tech enterprise specialized in developing and marketing of Medical Consmuables like Rapid Test Kits, Clinical Laboratory analyzer and reagents, Hematology Analyzer and Reagents, Washing Solutions, Urine Sediment Reagents and DNA/RNA Preservation Kits.
Dewei products are widely used in hospital clinics, disease control centers, blood banks, veterinary clinics, scientific research center and college laboratories.
CERTIFICATES
EXHIBITIONS
PACKAGE&TRANSPORTATION
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