BD Diagnostics - Women's Health & Cancer, 4025 Stirrup Creek Dr., Suite 400, Durham, NC 27703, USA. Eric
J Clin Virol. 2010 May;48(1):31-5. doi: 10.1016/j.jcv.2010.02.010. Epub 2010 Mar 15.
The AMPLICOR HPV Test has been validated for use with cervical cells collected in liquid-based preservative fluids, such as BD SurePath. It is currently recommended, however, that residual BD SurePath samples be stored at 4 degrees C prior to testing.
The aim of this study was to demonstrate that DNA isolated from SurePath cervical cytology specimens and stored at ambient temperature was also compatible with the AMPLICOR HPV Test.
DNA was extracted using the AmpliLute Media Sample Preparation Kit. Amplification and detection of HPV was performed both as directed by the manufacturer and with minor protocol modifications.
Cervical specimens collected in SurePath preservative fluid remained stable for testing with the AMPLICOR HPV Test for at least 21 days. The performance of DNA extracted from specimens stored at room temperature was equivalent to DNA extracted from specimens stored at 4 degrees C. The beta-globin internal control was detected in all of the 146 residual SurePath cervical cytology specimens tested using the AMPLICOR HPV Test, and high-risk HPV was detected in 46.2% (18/39) of ASCUS cases, in 63.3% (19/30) of LSIL cytology specimens, and 92.3% (24/26) of HSIL cases. Concordance of AMPLICOR HPV Test results with Hybrid Capture II was 83.9%.
The AMPLICOR HPV Test can be successfully and reproducibly performed from DNA isolated from residual SurePath cervical cytology specimens stored at ambient temperature for at least 21 days. This provides clinical laboratories flexible storage conditions for residual SurePath cytology specimens.
AMPLICOR HPV 测试已通过验证，可用于收集在液体基础保存液（如 BD SurePath）中的宫颈细胞。然而，目前建议在检测前将剩余的 BD SurePath 样本储存在 4°C。
本研究旨在证明从 SurePath 宫颈细胞学标本中分离的 DNA 并在室温下储存也与 AMPLICOR HPV 测试兼容。
使用 AmpliLute 介质样本制备试剂盒提取 DNA。按照制造商的指示以及对方案进行少量修改进行 HPV 的扩增和检测。
SurePath 保存液中收集的宫颈标本在 AMPLICOR HPV 测试中至少可稳定测试 21 天。从室温下储存的标本中提取的 DNA 的性能与从 4°C 储存的标本中提取的 DNA 相当。在使用 AMPLICOR HPV 测试测试的 146 例剩余 SurePath 宫颈细胞学标本中，均检测到了 beta-球蛋白内对照，在 ASCUS 病例中 46.2%（18/39）、LSIL 细胞学标本中 63.3%（19/30）和 HSIL 病例中 92.3%（24/26）检测到高危型 HPV。AMPLICOR HPV 测试结果与 Hybrid Capture II 的一致性为 83.9%。
从室温下储存至少 21 天的剩余 SurePath 宫颈细胞学标本中分离的 DNA 可以成功且可重复地进行 AMPLICOR HPV 测试。这为临床实验室提供了剩余 SurePath 细胞学标本的灵活储存条件。
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