Mair D C, Brecher M E, Hom E, Owen H G, Shea T C
Department of Pathology, University of North Carolina Hospitals, Chapel Hill, USA.
Transfusion. 1996 Nov-Dec;36(11-12):948-51. doi: 10.1046/j.1537-2995.1996.36111297091735.x.
Granulocyte-colony-stimulating factor (G-CSF) is used for the mobilization of progenitor cells and granulocytes. False-positive hepatitis B surface antigen (HBsAg) enzyme-linked immunosorbent assays (ELISAs) (NML) from one manufacturer in individuals receiving G-CSF have been observed.
Sixty-six autologous peripheral blood progenitor cell donors from 1994 were retrospectively reviewed. Donors typically received 5 to 10 micrograms of G-CSF per kg subcutaneously for 5 days before collection. Additional ELISA dilutional studies (1-in-10, 1-in-100, 1-in-1000) with known HBsAg-negative serum were made with G-CSF. Testing was performed by the University of North Carolina, the American Red Cross in Charlotte, NC, or the National American Red Cross, Washington, DC.
Of the 66 patients, none reacted for antibody to hepatitis B core antigen, and 30 (45%) had a positive reaction in the ELISA. Surface antigen positivity was "confirmed" on 6 of the 30 patients by neutralizing ELISA reactivity with an antibody to HBsAg test from the same manufacturer. In all cases, the clinical presentation was not suggestive of hepatitis, and these individuals were not at high risk for hepatitis B. Twenty-seven of the 30 cases were tested with a monoclonal HBsAg ELISA (AUSZYME) from another manufacturer in the peridonation period and did not react. In 1994, 256 autologous whole-blood donors not receiving G-CSF were similarly tested and only 1 (0.4%) had a positive reaction with the second manufacturer's HBsAg ELISA (p < 0.001). Of this group, 41 patients with histories of malignancy were identified, which is comparable to the history of the peripheral blood progenitor cell donors in this study, and none of these blood donors tested positive for HBsAg (p < 0.001). Dilutional studies with G-CSF produced no reactions.
The NML HBsAg ELISA studied has an unacceptably high false-positive rate in patients or donors receiving G-CSF. The false reactivity of this assay appears to be an indirect consequence of G-CSF administration, which can also lead to spurious confirmation by the HBsAg neutralization assay from the same manufacturer.
粒细胞集落刺激因子（G-CSF）用于动员祖细胞和粒细胞。已观察到在接受G-CSF的个体中，来自一家制造商的乙型肝炎表面抗原（HBsAg）酶联免疫吸附测定（ELISA）（NML）出现假阳性。
对1994年的66名自体外周血祖细胞供者进行回顾性研究。供者通常在采集前5天皮下注射每千克5至10微克的G-CSF，持续5天。用G-CSF对已知HBsAg阴性血清进行额外的ELISA稀释研究（1:10、1:100、1:1000）。检测由北卡罗来纳大学、北卡罗来纳州夏洛特市的美国红十字会或华盛顿特区的美国国家红十字会进行。
66例患者中，无一例对乙型肝炎核心抗原抗体呈阳性反应，30例（45%）在ELISA中呈阳性反应。通过用同一制造商的HBsAg检测抗体中和ELISA反应性，在30例患者中的6例中“确认”了表面抗原阳性。在所有病例中，临床表现均不提示肝炎，且这些个体并非乙型肝炎的高危人群。30例中的27例在捐献期用另一家制造商的单克隆HBsAg ELISA（AUSZYME）进行检测，未出现反应。1994年，对256名未接受G-CSF的自体全血供者进行了类似检测，只有1例（0.4%）在第二家制造商的HBsAg ELISA中呈阳性反应（p<0.001）。在该组中，确定有41名有恶性肿瘤病史的患者，这与本研究中外周血祖细胞供者的病史相当，且这些献血者中无一例HBsAg检测呈阳性（p<0.001）。用G-CSF进行的稀释研究未产生反应。
所研究的NML HBsAg ELISA在接受G-CSF的患者或供者中具有不可接受的高假阳性率。该检测的假反应性似乎是G-CSF给药的间接后果，这也可能导致同一制造商的HBsAg中和检测出现假阳性确认。
