Kim Hyun Soo, Kang Hee Jung, Whang Dong Hee, Lee Seong Gyu, Park Min Jeong, Park Ji-Young, Lee Kyu Man
Department of Laboratory Medicine, Hallym University College of Medicine, Seoul, 150-719, Korea.
Ann Clin Lab Sci. 2012 Spring;42(2):165-73.
We investigated the degree of lot-to-lot reagent variation for 5 common immunoassay items. We measured the commercial as well as in-house controls for α-fetoprotein (AFP), ferritin, CA19-9, quantitative hepatitis B surface antigen (HBsAg), and hepatitis B surface antibody (anti-HBs) 10 times each by using both the old and the new lot of reagents whenever a reagent lot was changed, over a period of 10 months. The differences in the mean control values, the percent difference (% difference), and the difference to between-run standard deviation ratio (D:SD ratio) between successive lots were calculated. The % difference in mean control values between 2 reagent lots ranged from 0.1 to 17.5% for AFP, 1.0 to 18.6% for ferritin, 0.6 to 14.3% for CA19-9, 0.6 to 16.2% for HBsAg, and 0.1 to 17.7% for anti-HBs except negative controls of HBsAg and anti-HBs. The maximum D:SD ratios between 2 lots were 4.37 for AFP, 4.39 for ferritin, 2.43 for CA19-9, 1.64 for HBsAg, and 4.16 for anti-HBs. Thus, we have experienced extensive variability in lot-to-lot reagent variation for 5 immunoassay items, indicating that reagent lot-to-lot comparability tests should be continuously performed and that laboratories should determine their own acceptance criteria for each item.
我们调查了5种常见免疫测定项目的试剂批次间差异程度。在10个月的时间里，每当更换试剂批次时，我们使用新旧两个批次的试剂，对甲胎蛋白（AFP）、铁蛋白、CA19-9、定量乙肝表面抗原（HBsAg）和乙肝表面抗体（抗-HBs）的商业对照品和自制对照品各进行了10次测量。计算了连续批次间平均对照值的差异、差异百分比（%差异）以及差异与批间标准差的比值（D:SD比值）。除HBsAg和抗-HBs的阴性对照外，2个试剂批次间平均对照值的%差异在AFP中为0.1%至17.5%，铁蛋白中为1.0%至18.6%，CA19-9中为0.6%至14.3%，HBsAg中为0.6%至16.2%，抗-HBs中为0.1%至17.7%。2个批次间的最大D:SD比值在AFP中为4.37，铁蛋白中为4.39，CA19-9中为2.43，HBsAg中为1.64，抗-HBs中为4.16。因此，我们发现5种免疫测定项目的试剂批次间差异很大，这表明应持续进行试剂批次间的可比性测试，并且实验室应针对每个项目确定自己的验收标准。
