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任何質(zhì)控物質(zhì)中的目標(biāo)核酸，無論是來自于患者樣品還是替代品（人工制造），都會隨著時間的推移而降解。由于核酸酶、凍融循環(huán)或其他影響，質(zhì)控物質(zhì)可能發(fā)生降解。一般來說，質(zhì)控物質(zhì)存檔的時間越長，樣品中可用的目標(biāo)核酸的數(shù)量就越少。根據(jù)對照品的穩(wěn)定性，可能需要定期開發(fā)新的對照或從制造商那里重新供應(yīng)對照。

參考文獻(xiàn)

[1] ISO. Medical devices – Application of risk management to medical devices. ISO 14971. Geneva, Switzerland: International Organization for Standardization; 2007.

[2] Millar BC, Xu J, Moore JE. Risk assessment models and contamination management: Implications for broad-range ribosomal DNA PCR as a diagnostic tool in medical bacteriology. J Clin Microbiol. 2002;40(5):1575-1580.

[3] Dowell SF, Peeling RW, Boman J, et al, and the C. pneumoniae workshop participants. Standardizing Chlamydia pneumoniae assays: Recommendations from the Centers for Disease Control and Prevention (USA) and the Laboratory Centre for Disease Control (Canada). Clin Infec Dis. 2001;33(4):492-503.