锝-99m 司他比的一种替代放射化学纯度检测方法的评估。

Evaluation of an alternative radiochemical purity testing method for technetium-99m sestamibi.

作者信息

Luebke A L, Wilary D M, Mahoney D W, Hung J C

机构信息

Department of Radiology, Mayo Clinic, Rochester, Minnesota 55905, USA.

出版信息

J Nucl Med Technol. 2000 Dec;28(4):259-63.

PMID:11142328

Abstract

OBJECTIVE

Our study evaluated the accuracy and reliability of 3 radiochemical purity (RCP) measurement methods of 99mTc-sestamibi. A regular-sized (1.0 cm x 9.0 cm) Whatman 31 ET Chr paper strip (regular 31 ET) also was included in our evaluation because of its ease in handling.

METHODS

The miniaturized and regular 31 ET methods were compared with the standard RCP testing method (aluminum oxide-coated plastic thin-layer chromatography [TLC] plate, with > or = 95% ethanol as the developing solvent). A total of 30 experimental runs were performed in triplicate (n = 90) over an RCP range of 82%-98%. The 99mTc-sestamibi preparations were reconstituted purposely to ensure that 50% of the tested samples had RCP values below the 90% limit.

RESULTS

The evaluated RCP ranges were 89.9% +/- 6.3%, 91.0% +/- 3.8%, and 91.4% +/- 4.3% for the TLC, miniature 31 ET, and regular 31 ET methods, respectively (n = 30 each). A strong correlation was found between the TLC and miniature 31 ET methods (r = 0.92), as well as between the TLC and regular 31 ET methods (r = 0.94). Both alternative methods tended to overestimate RCP value as determined by the TLC method, especially in an RCP range below 95%. This resulted in a false-positive rate of 27% for the miniature 31 ET method and 33% for the regular 31 ET method. The test/retest reliability was 99% for both the TLC and regular 31 ET methods, and 91% for the TLC and miniature 31 ET methods.

CONCLUSION

The miniature and regular 31 ET methods produced a high false-positive rate, which makes them unacceptable for the determination of RCP value of 99mTc-sestamibi.

摘要

目的

我们的研究评估了99mTc-司他米比三种放射化学纯度（RCP）测量方法的准确性和可靠性。由于其操作简便，一种常规尺寸（1.0厘米×9.0厘米）的沃特曼31ET Chr纸条（常规31ET）也被纳入我们的评估。

方法

将小型化和常规31ET方法与标准RCP测试方法（涂有氧化铝的塑料薄层色谱[TLC]板，以≥95%乙醇作为展开溶剂）进行比较。在82%-98%的RCP范围内，共进行了30次实验，每次实验重复三次（n = 90）。特意配制99mTc-司他米比制剂，以确保50%的测试样品RCP值低于90%的限值。

结果

TLC、小型31ET和常规31ET方法的评估RCP范围分别为89.9%±6.3%、91.0%±3.8%和91.4%±4.3%（每种方法n = 30）。发现TLC和小型31ET方法之间存在强相关性（r = 0.92），TLC和常规31ET方法之间也存在强相关性（r = 0.94）。两种替代方法倾向于高估TLC方法测定的RCP值，尤其是在RCP范围低于95%时。这导致小型31ET方法的假阳性率为27%，常规31ET方法的假阳性率为33%。TLC和常规31ET方法的重测可靠性均为99%，TLC和小型31ET方法的重测可靠性为91%。