Newscen Biopharm Co., Limited
Professional Manufacturer of Rapid Test Devices
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HEV(Hepatitis E Virus) Antibody Rapid Diagnostic Kit (Colloidal Gold)
For the qualitative detection of HEV antibodies in serum and plasma
Main Features
► High Sensitivity: 100%
► Specificity: 100%
► Reliable: Accuracy higher than 99%, early detection of the presence of HEV Antibody
► Convenient: Room Temperature Storage, Built-In Control
► Simple: No Instrument Required
► Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes
► Certified by Authoritative Certification System and Standards
► Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"
Intended Use
Diagnostic Kit for Hepatitis E Antibody (Colloidal Gold) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis E type virus (HEV) in human serum and plasma .
Principle
Diagnostic Kit for Hepatitis E Virus Antibody (Colloidal Gold) is a chromatographic immunoassay (CIA) for the detection of antibodies to HEV in human serum and plasma. HEV recombinant antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HEV recombinant antigens.
If antibodies to HEV are present, a pink colored band will develop on the membrane in proportion to the amount of HEV antibodies present in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence of antibodies to HEV.
Storage
Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).
Assay Procedure
Serum/Plasma
Add 70-100 ul or 2-3 drops of serum or plasma into sample well. Observe the result in 5-30 minutes.
Interpretation of Results
Negative:
No apparent band in the test region (T), a pink-colored band appears in the control region (C). This indicates that no HEV antibody has been detected.
Positive:
In addition to a pink-colored band in the control region (C), a pink-colored band will appear in the test region (T). This indicates that the specimen contains HEV antibodies.
Invalid:
If no band appears in the control region (C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.
Reagents and Materials Provided
► One sealed pouched cassette with desiccant & disposable pipe
► Blood diluent in a dropper bottle. Store at 4-30°C.
► One piece of operating instruction with 40 test pouches.
Warning and Precautions
► For in vitro diagnostic uses only.
► All patient samples should be treated as if capable of transmitting diseases.
► Do not interchange reagents from different lots. Do not use test kit beyond expiration date.
► Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.