Song Junhyup, Kim Sinyoung, Kwak Eunmin, Park Younhee
Department of Laboratory Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul 03722, Republic of Korea.
Diagnostics (Basel). 2023 Sep 4;13(17):2860. doi: 10.3390/diagnostics13172860.
We evaluated the overall performance of the Cobas 6800 BKV test in detecting BK virus (BKV). We examined the imprecision of the Cobas 6800 BKV test and compared the qualitative and quantitative results obtained from the Cobas 6800 BKV test and the Real-Q BKV quantification assay. We assessed 88 plasma and 26 urine samples collected between September and November 2022 from patients with BKV infection using the Real-Q BKV quantitative assay. The lognormal coefficient of variation indicated that the inter-assay precision of the Cobas 6800 BKV test ranged from 13.86 to 33.83%. A strong correlation was observed between the quantitative results obtained using the Cobas 6800 BKV test and the Real-Q BKV quantification assay for plasma samples. The Spearman's rank correlation coefficients (ρ) for plasma, polymerase chain reaction (PCR) media-stabilized urine, and raw urine samples were 0.939, 0.874, and 0.888, respectively. Our analyses suggest that the Cobas 6800 BKV test is suitable for clinical applications owing to the strong correlation between the results obtained using this test and the Real-Q BKV quantification assay in plasma and urine samples. Furthermore, utilizing fresh raw urine samples can be a viable approach for the Cobas 6800 BKV test as it is less labor- and time-intensive.
我们评估了Cobas 6800 BKV检测在检测BK病毒（BKV）方面的整体性能。我们检查了Cobas 6800 BKV检测的不精密度，并比较了从Cobas 6800 BKV检测和Real-Q BKV定量分析中获得的定性和定量结果。我们使用Real-Q BKV定量分析评估了2022年9月至11月期间从BKV感染患者收集的88份血浆和26份尿液样本。对数正态变异系数表明，Cobas 6800 BKV检测的批间精密度范围为13.86%至33.83%。在使用Cobas 6800 BKV检测获得的血浆样本定量结果与Real-Q BKV定量分析之间观察到强相关性。血浆、聚合酶链反应（PCR）介质稳定尿液和原始尿液样本的Spearman等级相关系数（ρ）分别为0.939、0.874和0.888。我们的分析表明，由于使用该检测获得的结果与血浆和尿液样本中的Real-Q BKV定量分析之间具有强相关性，Cobas 6800 BKV检测适用于临床应用。此外，对于Cobas 6800 BKV检测而言，使用新鲜原始尿液样本可能是一种可行的方法，因为它所需的劳动力和时间较少。
