Quick Operation HCV Rapid Test Kit 4mm Cassette 24 Months Shelf Life FDA

Product Specification

High Accuracy HCV Rapid Diagnostic test 4mm Cassette, detecting Hepatitis C virus antibody easily and quick operation
 
 

INTENDED 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.

PRINCIPLE

The HCV Rapid Test Device (Whole Blood /Serum/Plasma) has been designed to detect antibodies to HCV through visual interpretation of color development in the internal strip. The membrane was immobilized with protein A on the test region. During the test, the specimen is allowed to react with colored recombinant HCV antigens colloidal gold conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interacts with reagents on the membrane. If there were enough HCV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

TEST PROCEDURE

 
1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open the pouch until ready
to perform the assay.
2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.
3. Use the pipette packed in the pouch to draw and slowly add 1 drop of whole blood specimen to the sample well.
Hold the buffer bottle vertically and add 1 drop to the sample well. / If using a pipette, change a new one to avoid
cross-contamination. Draw and transfer 2 drops of buffer to the sample well.
4. Wait for 10-15 minutes and read results. Do not read results after 20 minutes.
Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is
significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

INTERPRETATION OF RESULTS

Positive:
Two colored lines should be observed in the result window, one in the test region and another one in the control region.

Negative:
Only the control line appears in the result window.

Invalid:
No line appears in the control region regardless of the presence or absence of the line in the test region.

PERFORMANCE CHARACTERISTICS

NOTE: Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.