Bioneovan Co.,Ltd

This test is a single use, rapid device intended for qualitative detection of IgM-class antibodies to hepatitis E virus (HEV) in serum, plasma samples. It is intended to be used in clinical laboratories for diagnosis of acute hepatitis E and management of patients related to infection with hepatitis E virus.

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 IgM (anti-μ chain) are bond at the Test Zone (T) and goat anti-mouse IgM 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 IgM 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 IgM (anti-μ chain) generating a visible red line. If there are no HEV IgM 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 IgM antibodies aggregating in a red line, which indicates the validity of the test.

Wash your hands with soap and warm water. Choose a puncture site on the fingertip. Clean the fingertip with Alcohol Prep Pad. Place a Safety Lancet on a selected puncture site. Forcefully press the tip of the Safety Lance against your fingertip. Wipe away the first drop of blood with sterile gauze or cotton. Using Disposable Pipette, collect blood from the puncture site. Alternatively - draw blood following laboratory procedure for obtaining venous blood.

This test can be stored at room temperature (2-30°C, do not freeze!) for 12  months from the date of manufacture (see label on strip pouch). Use immediately after opening.

Allow the test cassette to reach room temperature (appropriately 30minutes) before opening the pouch. Add one drop (approximately 10μL) serum/plasma sample into the sample dilution tube by using the sample dispenser and mix completely. Open the pouch and pipette 100μL 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 within 15-20 minutes. DO NOT INTERPRET RESULT AFTER 20 MINUTES.

WHY CHOOSE US?

1:Factory direct price .price is competitive with high quality.

2: Original manufacturer provide OEM service for you.

3: Smooth delivery near beijing and tianjin Port.

4: Free samples available sent for your evalutaiton

5: GMP, ISO9001:2008, SFDA and ISO13485 certificates

Company profile

Our company is in Beijing, China beginning built in 1988.Specialized in the field of ELISA TESTS&RAPID TESTS as both supplier and manufacturer with GMP,ISO9001:2008, SFDA and ISO13485 certificates. Our company was the earliest domestic high-tech enterprise which specializes in the research, test, manufacture and sale of genetic engineering drugs and diagnostic reagent.