Antibody to Hepatitis B Surface Antigen in Laboratory Diagnostic Sera PAMELA B. HARRISON, M.B., B.S., F.R.C.P.A., AND GRAHAME HARDY, B.Sc, F.A.C.B.S.

THE RISK to laboratory personnel using commercial diagnostic sera contaminated with hepatitis B surface antigen (HBsAg) has received well deserved publicity.2_5- 7 We included a radioimmunoassay test for antibody to hepatitis B antigen (anti-HB s ) in screening reagents used in our laboratory. In view of the high incidence of antibody found, and the fact that there is still some doubt regarding infectivity associated with the antibody, 1 we felt it worthwhile to document these results.

Royal Newcastle Hospital and District Blood Transfusion Service, Newcastle, New South Wales 2300, Australia

experience the counter-immunoelectrophoretic technic is not sensitive enough to detect antibody, and this method was not included. Any sera giving positive results to antibody or antigen were tested again and then confirmed by the appropriate neutralizing test using human and rabbit reagents. Results The findings are summarized in Table 1. Three samples gave equivocal results for anti-HB s but were regarded as negative in compilation of the table. Discussion The development of third-generation tests for Australia antigen and antibody has resulted in much more sensitive tests than were previously available. It was by the radioimmunoassay method that Wetli and associates 7 found a 33.3% incidence of HB s Ag

Materials and Methods Thirty-four commercial sera used routinely for blood grouping and phenotyping were tested for the presence of HB s Ag and anti-HB s by radioimmunoassay. The dates of manufacture or expiration of the sera ranged from 1972 to 1976. Ausria 11-125 (Abbott) assay technic was used for the antigen and Ausab (Abbott) was used for the antibody. The manufacturer's instructions were followed, and radioactivity was assessed on a Logic III Gamma counter. In this laboratory's Received January 16, 1976; received revised manuscript March 11, 1976; accepted for publication March 11, 1976. Address reprint requests to Dr. Harrison.

Table 1. Summary of Results of Testing for HB s Ag and Anti-HB S * Number of Sera Tested Manufacturer Manufacturer Manufacturer Manufacturer Manufacturer TOTAL

A B C D E

Number Positive to HBsAg

Number Positive to Anti-HBS

8 16 6 3 1

1 0 0 0 0

3 6 0 2 0

34

1 (2.9%)

11 (32.4%)

* The authors can supply, upon request, the product lot number, manufacturer, and test results of each serum used in this study.

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Harrison, Pamela B., and Hardy, Grahame: Antibody to hepatitis B surface antigen in laboratory diagnostic sera. Am J Clin Pathol 67: 104-105, 1977. Thirty-four commercial blood-grouping sera were tested for the presence of HBsAg and anti-HBs by radioimmunoassay technic. One sample (2.9% of the total) was positive for HBsAg, a marked reduction from previous reports; however, 11 sera (32.4%) were found to contain anti-HBs, a previously unreported finding. There is still some dispute as to the risk of infection from samples containing anti-HBs, which the authors hope will be resolved when tests for anti-HBc are readily available. In the meantime, the high antibody rate reflects a high rate of exposure to HBsAg of donors of commercial antisera, and laboratory personnel should be reminded of the possible risk of this less obvious source of infection. (Key words: Anti-HBS; Diagnostic sera.)

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ANTI-HBS IN DIAGNOSTIC SERA

maintaining safety precautions when handling diagnostic sera. Acknowledgment. Abbott Laboratories (Australia) provided gamma counting facilities. ADDENDUM

Since submission of this paper for publication a further seven samples of blood grouping sera have been tested. All were negative for HB s Ag, but five contained anti-HB s . Four samples were from a manufacturer (F) not included in our previous survey, and of these, three were anti-HB„positive. References 1. Alter HJ, Gocke DJ, Heisto H. et al: Does blood with antibodies against hepatitis B carry increased risk to transmit hepatitis? Vox Sang 28:460-467. 1975 2. Ginsberg AL. Conrad ME: Australia antigen in laboratory control serum solutions: An unnecessary hazard. N Engl J Med 278:1097, 1972 3. Gratten MJ: Hepatitis-associated antigen in control and grouping reagents. NZ Med J 80:443-448. 1974 4. Kreutzer HH, Rechsteiner J: Hepatitis B antigen in clinical chemistry control sera. Clin Chim Acta 60:117-120. 1975 5. Simon RG, Langhofer LA. Hendricks EJ: Australia antigen content of commercial quality-control sera. Clin Chem 19:221-222, 1973 6. Watson, PG, Watts JR, Nelson M: The incidence of Australia antigen and antibody in male prisoners of two Sydney penitentiaries. Med J Aust 2:421-423. 1973 7. Wetli CV. Heal AV. Miale JB: A previously unrecognized laboratory hazard: Hepatitis B antigen-positive control and diagnostic sera. Am J Clin Pathol 59:684-687. 1973

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FUTURE MEETINGS March 4-11, 1977—Fontainebleau, Miami Beach, Florida October 21-28, 1977—Hilton, Las Vegas, Nevada Contact at ASCP for specific program information is Patrick E. Raleigh, Director of Membership and Convention Services; at CAP, Howard E. Cartwright, Executive Director.

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in commercial control and diagnostic sera and drew attention to this previously unrecognized laboratory hazard. The extra care now taken by manufacturers in their selection of antisera was reflected in our studies, as we found only one sample to be HBsAgpositive. We were surprised to discover that 32.4% were positive for anti-HBs, and were unable to find references for any previous reports of this nature. The presence of the antibody is proof of previous exposure of the donor to hepatitis B. However, the question of infectivity of such specimens is not completely resolved. Most investigators feel that sera containing the antibody in the absence of antigen is not infective, but this has been disputed.1 A survey of incidences of anti-HBs in prisoners in two Australian penitentiaries, using an automated hemagglutination method, showed incidences of 3.52 and 2.28%. The authors commented that one prisoner with anti-HBs had elevated serum transaminases, suggesting that he had hepatitis.6 A more accurate assessment of the risk of infection from sera will be obtained when the assay of antibody to hepatitis B core antigen (anti-HBc) becomes readily available. In the meantime, documentation of this type of information may be useful for later comparisons and serve to remind laboratory staff of the importance of

Antibody to hepatitis B surface antigen in laboratory diagnostic sera.

Antibody to Hepatitis B Surface Antigen in Laboratory Diagnostic Sera PAMELA B. HARRISON, M.B., B.S., F.R.C.P.A., AND GRAHAME HARDY, B.Sc, F.A.C.B.S...
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