Comparative performance evaluation of random access and real-time PCR techniques in the diagnosis of BK virus infections in transplant patients

Purpose

The study aims to compare random-access NeuMoDx values with artus qPCR values to validate the accuracy of NeuMoDx as an alternative to qPCR and provide an equation to convert copies/ml to IU/ml measurements.

Methods

A total of 95 samples, including 61 transplant patient samples (n = 23 urine, n = 38 plasma) as the study group, 28 BKPyV-free samples as the control group, and six quality control samples, were included. One-Way ANOVA, Pearson correlation, Bland-Altman, Passing-Bablok, Deming regression analyses were used for statistical evaluation.

Results

Of 95 samples, 46 (48 %) were positive with NeuMoDx, while 40 (42 %) were positive with artus qPCR. Both techniques were statistically similar (p > 0.05). Deming correlation analysis (r = 0.9590), Passing Bablok and Bland Altman analyses demonstrated a strong correlation between NeuMoDx and artus values. The equation that provides the conversion between NeuMoDx and artus qPCR values was NeuMoDx= (1.12965 x artus qPCR) – 0.55016. BKPyV infections remain a concern for transplant patients globally, and effective new diagnostic methods are required.

Conclusions

Consistency between the results of NeuMoDx and qPCR confirms that NeuMoDx may be a valuable alternative for detecting BKPyV to prevent viral propagation. Our findings may allow converting copy/ml results to IU/ml for diagnosing and monitoring BKPyV infections in transplant patients.