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).