技　　　術

感染症定性検査における管理血清測定の意義
−抗 HIV 抗体測定試薬のロット差の 1 例−

佐々木　美　穂*1　佐々木　健　司*2
　　　　　　　　　　　　　　　　　　　　　　
Significance of the Control Serum Measurement in Infectious Disease Tests
−A Case of Lot-to-Lot Variation of Anti-HIV Antibody Assay Kit−

Miho SASAKI*1 and Kenji SASAKI*2

We are using infectious disease test kits consisting of positive serum diluted with negative pooled serum(P-S) and positive control(P-C). In two anti-HIV antibody tests the results for both P-S and P-C fluctuated between positive and negative depending on the lot No. of the reagent. In Western blot tests carried out to confirm the tests, the P-C was found to be positive and the P-S tests were both inconclusive. We speculated that the P-S had very weak antibodies that reacted differently from patient samples.
Manufacturers of such kits, however, must supply reagents with appropriate reactivity, so it is important that they be informed of inconsistencies that could invalidate cut-off values and lead to false-positives and false-negatives.
[Rinsho Byori 50 : 717〜720, 2002]

*1Department of Clinical Laboratory, Kanagawa Prefectural Atsugi Hospital, Atsugi 243-0004

【Key Words】infectious disease tests(感染症検査)，control serum(管理血清)，anti-HIV antibody assay(抗HIV 抗体検査)

受付2001年10月29日・受理2002年6月10日
*1神奈川県立厚木病院検査科(〒243-0004 厚木市水引1-16-36)
*2神奈川県立がんセンター検査第 2 科(〒241-0815 横浜市旭区中尾1-1-2)