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原始和改良酶联免疫吸附试验中储存时间和温度对血清抗苗勒管激素测量的影响的可比性。

Comparability of the effect of storage time and temperature on serum anti-Müllerian hormone measurement between original and modified enzyme-linked immunosorbent assay.

机构信息

Department of Laboratory Medicine, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.

Department of Laboratory Medicine, Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China.

出版信息

Clin Chim Acta. 2017 Jan;464:79-84. doi: 10.1016/j.cca.2016.11.022. Epub 2016 Nov 16.

DOI:10.1016/j.cca.2016.11.022
PMID:27864099
Abstract

OBJECTIVE

To explore the effect of modified enzyme-linked immunosorbent assay on the AMH results is increased or decreased, and to investigate the effect of storage time and temperature on AMH measurements with and without sample premixing assay buffer using the Kangrun ELISA method.

METHOD

Serum AMH concentration were measured by ELISA, consistency between two kits, and comparability between original and the modified assay under different stored conditions were analyzed by Passing-Bablok regression analysis and Bland-Altman bias evaluation.

RESULT

There was a strong consistency between AMH concentrations measured in Kangrun ELISA and Ansh Labs ultra-sensitive AMH ELISA. Pre-mixing serum specimens with assay buffer gave consistent results compared with original assay. Modified protocol can reduce the amplitude of increase affected by sample aged and give the most consistent results regardless of storage conditions.

CONCLUSION

Pre-mixing protocol did not influence the results of fresh serum or frozen serum incubation <3days at 4°C and -80°C, but when specimens detected after collection and stored in other storage conditions, should be pre-mixed with assay buffer to insure its accuracy.

摘要

目的

探讨改良酶联免疫吸附试验(ELISA)对 AMH 结果的影响,以及在 Kangrun ELISA 法中,使用和不使用样品预混合检测缓冲液的情况下,储存时间和温度对 AMH 检测的影响。

方法

采用 ELISA 法检测血清 AMH 浓度,通过 Passing-Bablok 回归分析和 Bland-Altman 偏差评估,分析两种试剂盒之间的一致性、不同储存条件下原始和改良检测方法之间的可比性。

结果

Kangrun ELISA 法和 Ansh Labs 超敏 AMH ELISA 法检测的 AMH 浓度之间具有很强的一致性。与原始检测相比,将血清标本与检测缓冲液预混合可获得一致的结果。改良方案可以减少因样本老化而导致的检测结果的波动幅度,无论储存条件如何,都能得到最一致的结果。

结论

预混合方案不会影响新鲜血清或在 4°C 和-80°C 下冷藏 <3 天的冷冻血清的检测结果,但当标本采集后在其他储存条件下检测时,应与检测缓冲液预混合,以确保检测的准确性。

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