Most glycated hemoglobin A1c (HbA1c) analytical reagents used were obtained from the analyzer's manufacturer. However, clinical laboratories need more choices for HbA1c analytical reagents to overcome the limitations of dedicated reagents for special analyzers. We developed new mobile phase buffers as HbA1c diagnostic reagents and evaluated their analytical performance for the HbA1c assay. Different mobile phase buffers used as HbA1c diagnostic reagents were prepared using different concentrations of sodium salts. According to the Clinical and Laboratory Standards Institute (CLSI) recommendation guidelines, the analytical performances of the newly developed mobile phase buffers were evaluated on an ARKRAY HA-8160 Analyzer. Both quality controls and clinical blood samples were used in these experiments. To assess the quality of the newly developed mobile phase buffers, precision, accuracy, linearity, carryover, interference, bias, correlation with commercial reagents, and stability were analyzed. The CVs of intra-assay precision and interassay precision of quality control and clinical. There were fewer than 1.00 % blood sample assays using the newly developed mobile phase buffer. The RDs of accuracy were less than 1.00 %. Linearity: R² = 0.9998 in the concentration range of 4.40%–17.30 %. Carryover: 0.00 %. Reagent comparison revealed that the Pearson regression equation was Y = 0.9884x+0.05692 (R² = 0.9977), and the Bland-Altman mean difference was −0.02650 % (CI: −0.2121 %–0.1591 %) between the two analytical reagents. Stability was also acceptable within 12 months. This mobile phase buffer showed good anti-interference ability. The newly developed mobile phase buffers demonstrated good analytical performance and were suitable for clinical HbA1c assays on an ARKRAY HA-8160 Analyzer.

Screening for high-risk human papillomavirus (HR-HPV) is a pivotal strategy for the prevention of invasive cervical cancer, particularly in resource-constrained settings. In this study, we developed a CRISPR-based compact automated real-time detection system, termed Ccard, for rapid testing of HPV16, HPV18, and the internal reference gene GAPDH through a streamlined workflow. A simple room-temperature treatment efficiently releases nucleic acids directly from swab samples, bypassing the need for extraction. The mixture was driven through the channels and loaded into the reaction chambers on the microfluidic chip by a vacuum pump. The lyophilized reagents in the reaction zone of the microfluidic chip were redissolved. The system subsequently performs a single-step RPA-CRISPR/Cas13a reaction, with real-time detection enabled by an Internet of Things device. The assay achieved detection within 30 min, with a limit of detection (LOD) of 5 copies/µL for both HPV16 and HPV18. Validation with clinical samples demonstrated high sensitivity (96.8% for HPV16 and 100% for HPV18) and 100% specificity. These results highlight the reliability, precision, and strong potential of the Ccard system for rapid testing of HR-HPVs.