Performance evaluation of a novel fully-automated molecular diagnostics system Molecision R8.

OBJECTIVE

To evaluate the functionality of key modules of a novel fully-automated molecular diagnostics system Molecision R8 and the performance of the integrated system.

METHODS

The nucleic acid extraction and PCR detection modules were evaluated using HBV DNA assay through precision and comparison with Molecision MP-32 and HongShi SLAN-96, respectively. Instrument comparison of R8 with an open system was conducted using Molecision HBV DNA and Chlamydia trachomatis/Ureaplasma urealyticum/Neisseria gonorrhoeae (CT/UU/NG) triplex assays. Systemic comparison of R8 and combined reagents with Sansure system were conducted on HBV DNA, CT, UU, and NG assays of their own.

RESULTS

In modular evaluation, the imprecision of both modules was all below 5% and Passing-Bablok (PB) regression and Bland-Altman (BA) analysis showed closeness to y = x and biases below 0.15 lg IU/mL. Instrument comparison obtained a regression equation of y = 0.982x + 0.084 and a bias of 0.05 lg IU/mL for HBV DNA detection in serum and agreement rates all above 96.5% for CT, UU and NG detection in genital tract samples. In the systemic comparison, the regression equation was y = 1.024x + 0.096 and the bias was 0 lg IU/mL for HBV DNA. For CT, UU and NG, the agreement rates were also all larger than 96.5%.

CONCLUSIONS

Analytical performance of Molecision R8 was superior or comparable to commercial nucleic acid purification and PCR systems. Molecision R8 alone or combined with related reagents are robust in measuring serum and genital tract samples. Overall, Molecision R8 holds strong promise for clinical use.