Department of Laboratory Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.
Nanfang college of Sun Yat-sen University, Guangzhou, China.
J Clin Lab Anal. 2020 Jul;34(7):e23280. doi: 10.1002/jcla.23280. Epub 2020 Mar 13.
The Daan HCV RNA quantitative assay was a recently developed kit with high sensitivity for the detection of HCV RNA. We aimed to evaluate the analytical performance of the Daan HCV RNA quantitative assay and compare it with the COBAS AmpliPrep/COBAS TaqMan HCV Quantitative Test, v2.0.
WHO HCV RNA standard, NIBSC 06/102 standard, and CLSI EP documents were used to evaluate the precision, accuracy, linearity, anti-interference ability, and cross-reactivity of the Daan HCV RNA quantitative assay. Overall 198 clinical serum specimens were used to make comparison between the Daan HCV RNA quantitative assay and the Roche Cobas test.
The within-run precision (S ), and total precision (S ) for 6.11 log IU/mL, 4.22 log IU/mL, and 2.32 log IU/mL HCV RNA were 0.13 and 0.15, 0.07 and 0.09, and 0.11 and 0.10, respectively. The linear range was 20-10 IU/mL, and the limit of detection was 15 IU/mL. It did not display any interference with commonly encountered conditions and cross-reactivity with some common virus. A good agreement was observed between the Daan HCV RNA quantitative assay and the Roche Cobas test.
The Daan HCV RNA quantitative assay has shown satisfactory performances and excellent agreement with COBAS HCV Quantitative Test on clinical specimens with lower cost, which provides an alternative choice for the diagnosis and monitoring of HCV infection in developing countries.
Daan HCV RNA 定量检测试剂盒是一种新近开发的试剂盒，具有高灵敏度，可用于检测 HCV RNA。我们旨在评估 Daan HCV RNA 定量检测试剂盒的分析性能，并与 COBAS AmpliPrep/COBAS TaqMan HCV 定量检测试剂盒进行比较。
使用世界卫生组织 HCV RNA 标准品、NIBSC 06/102 标准品和 CLSI EP 文件评估 Daan HCV RNA 定量检测试剂盒的精密度、准确性、线性、抗干扰能力和交叉反应性。总共使用 198 份临床血清标本对 Daan HCV RNA 定量检测试剂盒和 Roche Cobas 检测进行比较。
对于 6.11 log IU/mL、4.22 log IU/mL 和 2.32 log IU/mL HCV RNA，批内精密度（S ）和总精密度（S ）分别为 0.13 和 0.15、0.07 和 0.09，以及 0.11 和 0.10。线性范围为 20-10 IU/mL，检测限为 15 IU/mL。它没有显示出与常见条件的任何干扰，并且与一些常见病毒没有交叉反应。在临床标本中，Daan HCV RNA 定量检测试剂盒与 Roche Cobas 检测试剂盒之间观察到良好的一致性。
在成本更低的情况下，Daan HCV RNA 定量检测试剂盒在临床标本中表现出令人满意的性能和与 COBAS HCV 定量检测试剂盒的良好一致性，为发展中国家 HCV 感染的诊断和监测提供了另一种选择。
