ISO13485 HBc IgM Test Kit Hepatitis B Core Antibody Igm Test

HBc-IgM ELISA Kit
Catalog No.: BE106A

1. SUMMARY

Hepatitis B is an infectious illness caused by hepatitis B virus (HBV) which is an enveloped, double-stranded DNA virus belonging to the Hepadnaviridae family and is recognized as the major cause of blood transmitted hepatitis together with hepatitis C virus (HCV).

HBV is excreted in body fluids such as semen, saliva, blood and urine in persons with acute or chronic infection. The hepatitis B virus is known as a blood-borne virus because it is transmitted from one person to another via blood or fluids contaminated with blood. Transmission of hepatitis B virus results from exposure to infectious blood or body fluids.When HBV invades the body it causes liver damage through induction of auto-immunity.

Three immunity has been found, surface antigen (HBsAg)/HBsAb, core antigen (HBcAg)/HBcAb and e antigen(HBeAg)/HBeAb. As it is difficult to detect the core antigen in the serum, the other five are been done to diagnosing HBV.

2. MATERIALS PROVIDED

1. Microplate 1 block (96wells)
2. Negative Control 1 ml ×1
3. Positive Control 1 ml ×1
4. Conjugate 6 ml ×1
5. Substrate Solution A 6 ml ×1
6. Substrate Solution B 6 ml ×1
7. 20×Wash Buffer 40 ml ×1
8. Stop Solution 6 ml ×1
9. Plate Cover 3 piece
10. Insert 1 copy

3. TEST PROCEDURE

1. Dilute samples: Use the Normal Saline(0.9% NaCl) to dilute the samples(The samples must be diluted 1:999 before use.). The Positive Control and Negative Control have no use for dilution.
2. Add samples:Open the foil pouch and remove the microplate. Dispensing 50μl of diluted samples , Positive Control and Negative Control to each well except the blank well. Gently vibrating the microplate. Cover and incubate for 30 minutes at 37℃.
3. Wash the plate:Dilute 1 volume of wash buffer concentrate with 19 volumes of distilled water, mix well. Remove the solutions from all the wells. Fill the wells with the diluted wash solution (at least 20 seconds to soak) then remove the diluted wash buffer from the wells. Repeat the procedure for 5 times. Make sure that the rest volume is minimal, by blotting dry by tapping plate onto absorbent paper.
4. Add conjugate:Add the 50μl of conjugate to each well (except the blank well). Cover and incubate for 30 minutes at 37℃.
5. Wash the plate:Repeat the wash procedure as in step 2.
6. Add 50μl of Substrate Solution A and 50μl of Substrate Solution B to each well, mix well. Cover and incubate for 10 minutes at 37℃.
7. Stop reaction:Add 50μl stop solution to each well, mix well.
8. Read the absorbance at 450 nm. If a dual wavelength measurement is used, the reference wavelength should be selected from 620nm to 690nm.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world