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. 2024 Jul 19;25(14):7912.
doi: 10.3390/ijms25147912.

Evaluation of a New Closed-System Automated RT-qPCR Assay for the Rapid Detection and Monitoring of Common Nucleophosmin Mutations in Patients with Acute Myeloid Leukemia

Richard D Press  1 , Dana Dressel  2 , Michelle McBean  3 , Ing S Tiong  3 , Matthew W Anderson  4 , David Pride  5 , Aarthi Raman  6 , Rachelle R Doom  6 , Rajesh Kaldate  6
Affiliations

Evaluation of a New Closed-System Automated RT-qPCR Assay for the Rapid Detection and Monitoring of Common Nucleophosmin Mutations in Patients with Acute Myeloid Leukemia

Richard D Press et al. Int J Mol Sci. .

Abstract

Quantitative assessment of nucleophosmin 1 (NPM1) mutation status is integral to evaluating measurable residual disease (MRD) in NPM1-mutated acute myeloid leukemia (AML) patients. In a retrospective study, leftover peripheral blood (PB) specimens (n = 40) which were collected for routine clinical diagnostic evaluations of AML disease burden were tested by both a novel automated RT-qPCR quantitative NPM1 assay (Xpert NPM1 mutation assay) and the NPM1 mutA, mutB&D MutaQuant kit. Based on a Deming regression analysis, there was a high correlation (slope = 0.92; intercept = 0.12; Pearson's r = 0.982) between the quantitative results of the Xpert NPM1 mutation assay and the NPM1 mutA, mutB&D MutaQuant kit. The Xpert test quantitative results are thus highly correlated with the comparator method and the former has potential as a useful alternative for the monitoring of AML patients with a known NPM1 mutation.

Keywords: acute myeloid leukemia; minimal residual disease (MRD); monitoring; nucleophosmin (NPM1) mutation; polymerase chain reaction.

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Conflict of interest statement

R.D.P. has consulted for Cepheid; M.M. received honoraria and speaker’s fees from Cepheid; Authors A.R., R.R.D., and R.K. were employed by Cepheid. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Deming regression analysis of log-transformed quantitative results (NPM1 RNA divided by ABL1 RNA) from the Xpert NPM1 mutation test and the comparator NPM1 mutation test, using lysates derived from peripheral blood specimens. The slope, intercept, Pearson’s correlation coefficient of the LT quantitative results and the regression line (solid line) are presented. Note that the shaded blue region is the 95% CI and the red dotted line is the identity line (X = Y).
Figure 2
Figure 2
Bland-Altman bias plots showing the paired differences of the Xpert and Comparator test quantitative results on the y-axis versus the average of the pairs on the x-axis. The inter-test measurement variance was evaluated based on two standard deviations of the difference (dotted lines). The mean difference (solid red line) and the zero difference (solid black line) are presented.
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Grants and funding

The authors declare that this study received funding from Cepheid. The study sponsor (Cepheid) provided the investigational product, as well as administrative and logistical support provided to the participating clinical sites. The sponsor was involved in the design and conduct of the clinical study and assisted in the monitoring and collection of data. The sponsor participated in the interpretation of the data and preparation of the manuscript.

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