Product: Standard Preparation for Quality Control of Anti-HBc IgM

Cat.No. HRP-B601

It was found that 98% of cases with acute hepatitis B surface antigen (HBsAg) positive hepatitis type B were anti-HBc immunoglobulin M (IgM) positive. Atypical hepatitis B was detected in 33% of anti-HBc-positive HBsAg-negative cases with acute hepatitis. Anti-HBc IgM was positive for 6 months in acute resolving hepatitis type B, whereas cases resulting in chronic hepatitis B remained anti-HBc IgM-positive for up to 900 days.

Chronic HBsAg carriers with severe liver disease had anti-HBc IgM more often than individuals with minor liver damage; 83% of HBsAg-positive liver cirrhoses, 63% of chronic aggressive hepatitis, 50% of HBsAg-positive liver carcinoma, but only 17% of chronic persistent hepatitis or 7% of healthy blood donors were anti-HBc IgM-positive. Determination of anti-HBc IgM is useful in detecting atypical hepatitis B virus infections without HBsAg in serum and, with some restrictions, in discriminating acute and chronic hepatitis type B.

Figure 1: Hepatitis B markers after natural infection

Product Features

1)      Source:                                                  

• Human Plasma/Serum

2)      Marker:                                                

• anti-HBc IgM positive

3)      Definition:                                              

• by a standardized anti-HBc IgM ELISA (anti-µ)

4)      Titer:                                                      

• > 1:1,000,000
• > 1:100,000
• > 1:10,000
• > 1:1,000

5)      Viral Markers:                                      

• anti-HIV I +II and/or HIV-RNA , anti-HCV and/or HCV RNA  tested negative. Non-reactive when tested on a single donor/pooled basis by a standardized method.
• Specific testing of other markers by serological immunoassays and/or polymerase chain reaction can be required.

6)      Inactivation:                                           

• Heat inactivated at 60°C for 15 hours

7)      Application:                                            

• In-Vitro Assays by professionals only

8)      Volume:                                                 

• 5 ml/100ml/500ml/800ml/1000ml

9)      Storage:                                                 

• at -20°C/-80°C

10)  Lot Number:                                          

• 061212_B_H/M/L

11)  Expiration Date:                                    

• > 2 years after production.

Remarks

Stability:         The stability of this material following freezing and thawing has not been evaluated. It is advisable to avoid repeated thawing/freezing of this material.

Safety:                  Please be aware that the material is heat-inactivated and might still contain infectious agents. In addition, because no test method can offer complete assurance that products derived from human source will not transmit infectious agents, it is recommended that this product be handled with the same precautions used for patient specimens.

Caution:               As with all materials of biological origin, this preparation should be regarded as potentially hazardous to health. It should be used and discarded according to your own laboratory’s safety procedures. Such safety procedures probably will include the wearing of protective gloves and avoiding the generation of aerosols. Care should be exercised in opening ampoules or vials, to avoid cuts. It is the responsibility of the user to ensure that he/she has the necessary technical skills to determine the appropriateness of this product for the proposed application. Results obtained from this product are likely to be dependent on conditions of use and the variability of materials beyond the control of DR.WANG.

Liability:              DR.WANG accepts no liability whatsoever for any loss or damage arising from the use of this product, whether loss of profits, or indirect or consequential loss. In particular, DR.WANG will not be liable for any damage resulting from handling or contact with the above product. All materials and mixtures may present unknown hazards and should be used with caution.  

Product is for in-vitro and research use only

References

K. Gmelin, L. Theilmann, G. Hasche, H. Will, P. Czygan, H. W. Doerr und B. Kommerell. Anti-HBc IgM in acute and chronic hepatitis infection, J.Mol.Med. 1984; 62: 837-42

Rodella A, Galli C, Terlenghi L, Perandin F, Bonfanti C, Manca N.Quantitative analysis of HBsAg, IgM anti-HBc and anti-HBc avidity in acute and chronic hepatitis B.J Clin Virol. 2006 Nov;37(3):206-12.

Gerlich WH, Uy A, Lambrecht F, Thomssen R.Cutoff levels of immunoglobulin M antibody against viral core antigen for differentiation of acute, chronic, and past hepatitis B virus infections.J Clin Microbiol. 1986 Aug;24(2):288-93