DNA chip evaluation as a diagnostic device

Abstract

Abstract To use DNA chip as a diagnostic device, it should be evaluated and approved as a medical device. In this study, we developed a guideline for DNA chip evaluation and evaluated a commercialized DNA chip according to the guideline. This guideline consists of three parts: evaluation of quality control system, analytical performance, and clinical performance of DNA chips. First, the quality control system should be evaluated in the aspect of material, manufacturing process, and final product. In addition, the validation of expiration date, storing condition, and required reagents is needed to confirm the quality control system. Second, the analytical performance of DNA chip should be evaluated by accuracy, sensitivity, reproducibility, and cut-off value. Third, the clinical performance of DNA chip should be evaluated by clinical specificity, clinical sensitivity, positive and negative predictive value. We evaluated the accuracy and lot-to-lot reproducibility of a commercial HPV detection DNA chip. We analyzed 20 clinical samples. The accuracy of a DNA chip was evaluated by comparing the test results to DNA sequencing results. Lot-to-lot reproducibility was assessed by consistency of results from three different lots. The accuracy and reproducibility of the HPV DNA chip were almost 100%. In addition to the accuracy and reproducibility, the cut-off value of DNA chip was above 2.3 [Signal to Noise Ratio (SNR) ⩾ 2.3].