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
☀ Fast: Results in 5-30 minutes, strong positive results may be
observed promptly within 3 minutes
☀ Simple: No Instrument Required
☀ Convenient: Room Temperature Storage, Built-In Control Line
☀ 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 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 .
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
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
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.
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).
