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目的 建立严重急性呼吸综合征 (SARS)病毒抗体参考品 ,用于对SARS病毒抗体诊断试剂的实验室评价。方法 收集临床确诊为SARS病人血清和非SARS人群血清 ,用不同的SARS病毒抗体诊断试剂进行检测筛查 ,选择不同样品组成参考品。并用该参考品对不同试剂进行初步评价。结果 SARS病毒IgM抗体的参考品由 38份组成 ,其中包括 11份阳性参考品、2 0份阴性参考品、灵敏度样品 6份 ,精密性样品 1份 ;SARS病毒总抗体 (包括IgG)由 4 6份组成 ,其中包括 18份阳性参考品、2 0份阴性参考品、灵敏度样品 7份 ,精密性样品 1份。结论 初步应用结果显示该参考品确实能够反应不同试剂的质量差异。
Objective To establish a reference antibody against severe acute respiratory syndrome (SARS) virus for laboratory evaluation of SARS virus antibody diagnostic reagents. Methods Serum samples of SARS patients and non-SARS patients were collected and screened by different SARS antibody diagnostic reagents. Different samples were selected as reference materials. And using the reference for the initial evaluation of different reagents. Results The reference antibody of SARS virus IgM antibody consisted of 38 parts, including 11 positive reference materials, 20 negative reference materials, 6 sensitive samples and 1 precision sample. The total SARS virus antibodies (including IgG) Including 18 positive reference materials, 20 negative reference materials, 7 sensitive samples and 1 precision sample. Conclusion The preliminary application results show that the reference product can indeed reflect the difference of the quality of different reagents.