Diagnostic Kit for IgG HEV Antibody to Hepatitis E virus

Specifications

1.EIA HEV IgG ELISA TEST KIT
2.Capture EIA to detect Anti-Hepatitis E Virus IgG
3.Used for early diagnosis of HEV infection

 

Certificate

GMP

SFDA

ISO13485

ISO9001:2008

 

ELISA Kit for Antibody to Hepatitis E Virus (HEV)

CatalogNo. NAME PACKAGE SIZE:

BE401A ELISA Kit for Antibody IgG to Hepatitis E Virus (HEV) 96 tests/Kit

 

 

 

 

 

 

Hepatitis E virus (HEV) is a non-enveloped; single- stranded RNA virus identified in 1990. Infection with HEV induces acute or sub-clinical liver diseases similar to hepatitis A. HEV infections, endemic and frequently epidemic in developing countries, is seen also in developed countries in a sporadic form with or without a history of traveling to endemic area. The overall case-fatality is 0.5~3%, and much higher (15~25%) among pregnant women. A hypothesis that

 

HEV infection is a zoonosis was presented in 1995. Then a swine HEV and later an avian HEV were identified and sequenced separately in 1997 and 2001. Since then, HEV infection include anti-HEV, viremia and feces excretion of HEV was seen in a wide variety of animals, i.e., swine, rodents, wild monkeys, deer, cow, goats, dogs and chicken in both the developing and developed countries. A direct testimony was reported that the consumption of uncooked dear meat infected with HEV led to acute hepatitis E in human. And HEV genome sequences can be detected in pork livers available in the supermarkets in Japan.

 

With the discovery of conformational epitopes in HEV, HEV serology was further explored and understood. The phenomenon of long-lasting and protective antibodies to HEV was observed which greatly enhance the understanding to the diagnosis, epidemiology, zoonosis-related studies and vaccine development.

 

 

 

PRINCIPLE OF THE ASSAY

 

 

 

This test employs chromatographic lateral flow device in a cassette format.Colloidal gold conjugated recombinant antigens (Au-Ag) corresponding to HEV antigens are dry-immobilized at the end of nitrocellulose membrane strip.Anti-human IgG (anti-μ chain) are bond at the Test Zone (T) and goat anti-mouse IgG antibodies are bond at the Control Zone (C). When the sample is added, it migrates by capillary diffusion rehydrating the gold conjugate. If present in sample, HEV IgG antibodies will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by anti-human IgG (anti-μ chain) generating a visible red line. If there are no HEV IgG antibodies in sample, no red line is formed in the Test Zone (T). The gold conjugate will continue to migrate alone until it is captured in the Control Zone(C) by the goat anti-mouse IgG antibodies aggregating in a red line, which indicates the validity of the test.

 

PRECAUTIONS AND SAFETY

 

This test is for In Vitro Use only

FOR PROFESSIONAL USE ONLY

• All the waste and sample should be treated in case of transmitting disease and must be properly disinfected (autoclaving is preferred) before disposal.
• Once taking the cassette out of the pouch, carry out your testing as early as possible (no more than 20 minutes) to avoid moisture. The nitrocellulose membrane can absorb water, which can affect the test chromatography performance.
• To obtain accurate assay results, the test results must be read within 15-20 minutes. Results obtained after 20 minutes can lead to incorrect interpretation.
• Detection of high rate diluted samples (e.g. quality control materials diluted more than 100 times), please directly dispense 50μL diluted samples for testing.
• Make sure that the test is within the indicated validity.
• If automatic pipette is used, calibrate it frequently to assure the accuracy of dispensing. Use different disposal pipette tips for each specimen in order to avoid cross-contaminations.
• Do not modify the test procedure.
• Do not reuse the test cassettes. Autoclave before disposal

 

ASSAY PROCEDURE

 

Allow the test cassette to reach room temperature (appropriately 30minutes) before opening the pouch. Add one drop (approximately 50μL) serum/plasma sample into the sample dilution tube by using the sample dispenser and mix completely. Open the pouch and pipette 50μL diluted sample into the sample well. Avoid dropping sample in the observation window. Do not allow the sample to overflow.

Place the cassette on flat surface and read the results within15-20 minutes. DO NOT INTERPRET RESULT AFTER 20 MINUTES.

 

1 block (96wells) 1 bottle (12ml) 1 vial(1ml) 1 vial (1ml) 1 bottle(30ml) 1 bottle (12ml) 1 bottle (6ml) 1 bottle (6ml) 1 bottle (6ml) 1 bag 3 pieces 1 each

1. Antigen Coated Microwell Plate

2. Specimen Diluent

3. Negative Control

4. Positive Control

5.20 X Wash Buffer (dilution prior to use)

6. Enzyme Conjugant (anti human IgG -HRP)

7. Substrate A

8. Substrate B

9. Stop Solution (2M H₂SO₄)

10. Plastic Bag

11. Seal Paper

12. Manual