国内民間分析機関によるシクロホスファミド拭き取り試験の包括的評価
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概要
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Contamination by cytotoxic drugs has been discovered in Japanese hospitals through the wipe test on cyclophosphamide (CPA). Previously, such contamination testing was mainly entrusted to laboratories in other countries but KOBELCO RESEARCH INSTITUTE (Lab-K) has begun to analyze for CPA contamination by means of the wipe test as a commercial operation using LC/MS/MS. We conducted a comprehensive evaluation of the equivalence of analysis performed by an official Japanese testing laboratory (Lab-O) and Lab-K.Diluted Sample [1] (CPA 34.4 ng/0.15 mL) or Sample [2] (CPA 103.2 ng/0.45 mL) were accurately prepared and used for the wipe test. From the analysis data produced by each laboratory, error rates and variation coefficients were calculated, and from them the accuracies and true rates obtained, having within 15% as the target range. The time taken for the analyses, their costs and other details were also checked.The results of the analyses (expressed as LabO/LabK) were: [1] 37.7 +/- 5.0/31.7 +/- 1.5 ng and [2] 93.7 +/- 3.8/89.3 +/- 9.1 ng, respectively. The respective error rates and variation coefficients were within the target range. Based on this, we considered that LC/MS/MS did not differ from other analysis techniques in terms of sensitivity with respect to wipe samples of CPA from the environment.However, the target drug of the wipe test in LabK was only CPA and it was not measured in urine. In the future, the wipe test should be extended to other drugs and urine samples analyzed for their contents as well.
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