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 Line
☀ Certified by Authoritative Certification System and Standards
☀ Fast: Results in 5-30 minutes, strong positive results may be
observed promptly within 3 minutes
☀ Simple: No Instrument Required
☀ Winner of "the National Rapid Diagnostic Kit for Clinical
Performance Assessment"
Intended Use
Diagnostic Kit for Hepatitis E Virus 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.
Reagents and Materials Provided
☀ Blood diluent in a dropper bottle. Store at 4-30°C.
☀ One sealed pouched cassette with desiccant & disposable pipe
☀ One piece of operating instruction with 40 test pouches.
Sample Collection and Preparation
Serum
☀ Have a certified phlebotomist collect whole blood into a red top
collection tube (containing no anticoagulants) by veinpuncture.
☀ Allow the blood to clot.
☀ Separate the serum by centrifugation.
☀ Carefully withdraw the serum for testing or label and store it at
2-8°C for up to 7 days. Serum may be frozen at -20°C for at least
three month.
Plasma
☀ Have a certified phlebotomist collect whole blood into a purple,
blue or green top collection tube (containing EDTA, citrate or
heparin, respectively) by veinpuncture.
☀ Separate the plasma by centrifugation.
☀ Carefully withdraw the plasma for testing, or label and store it
at 2-8°C for up to 7 days. Plasma may be frozen at -20°C for at
least three months
Assay Procedure
Serum or Plasma Sample
Add 5ul of serum or plasma into sample well, and 80-100 ul buffer
into B well. Observe the result in 20 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. |
Storage
Store the test kits at temperature 4-30°C, in the sealed pouch for
the duration of the shelf life (24 months).
Warning and Precautions
☀ For in vitro diagnostic uses only.
☀ Do not interchange reagents from different lots. Do not use test
kit beyond expiration date.
☀ All patient samples should be treated as if capable of
transmitting diseases.
☀ Icteric, lipemic, hemolysed, heat treated and contaminated sera
may cause erroneous results.
