FDA 20 Minutes Serum Plasma CIA HEV Rapid Test Cassette

Product Specification

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

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.