[Performance verification and clinical application evaluation of D-dimer assay]

Current diagnostic standards rely on accurate D-dimer testing to assess thrombotic risk. While imported reagents dominate the market, domestic alternatives require rigorous validation to ensure equivalent performance. Prior research has shown that D-dimer assays must meet strict precision and accuracy thresholds to avoid misdiagnosis. However, no prior work had resolved whether domestic reagents can achieve comparable reliability. This gap motivated a detailed evaluation of a newly developed domestic D-dimer reagent. Establishing domestic alternatives could reduce costs and improve accessibility in clinical settings. Validation against established reagents is essential to confirm diagnostic equivalence. No prior work had resolved whether domestic reagents can achieve comparable reliability. This uncertainty drove the need for a comprehensive performance assessment.

The aim of this study was to evaluate the diagnostic and analytical performance of a domestic D-dimer reagent. The specific problem addressed was whether this reagent could match or exceed the performance of imported alternatives in clinical use. The motivation stemmed from the need to provide a validated domestic option for routine testing. The study focused on accuracy, precision, and interference resistance in a clinical setting. Validation against CLSI and national standards was necessary to ensure compliance. The reagent's performance was compared to two leading imported reagents. No prior work had resolved whether domestic reagents can achieve comparable reliability. This uncertainty drove the need for a comprehensive performance assessment.

The study used 546 sodium citrate plasma samples from a single hospital. Sample selection followed CLSI and national health industry guidelines. The reagent was tested on a Sysmex CS 5100 coagulation analyzer. Performance metrics included accuracy, precision, and linear range. Interference resistance was tested with bilirubin, hemoglobin, and celiac. Reference intervals were validated against manufacturer specifications. Correlation with two imported reagents was assessed using statistical methods. Diagnostic efficacy was evaluated using ELISA results as a reference standard. No prior work had resolved whether domestic reagents can achieve comparable reliability.

The linear correlation coefficient reached 0.998, meeting CLSI standards. Accuracy bias ranged from -2.8% to 8.4%, within acceptable limits. Within-run and between-day precision CVs were below 5%, satisfying requirements. The linear range was confirmed from 0.33 to 9.69 mg/L FEU. No carryover was observed in testing. Bilirubin and hemoglobin interference remained minimal at tested concentrations. Correlation with reagent A and B was strong, with r values of 0.968 and 0.975. Deviation percentages were 3.4% and 4.5%, within acceptable ranges. For 172 samples with heterophilic antibodies, correlation remained good (r=0.827). Sensitivity and specificity reached 97.4% and 77.6%, with an AUC of 0.976.

The authors state that the ADX D-dimer reagent meets clinical standards for accuracy and precision. The study confirms its suitability for routine use in clinical labs. The reagent's performance was comparable to imported alternatives in most metrics. No prior work had resolved whether domestic reagents can achieve comparable reliability. The authors propose that this reagent can serve as a reliable domestic alternative. Diagnostic efficacy was strong, with high sensitivity and AUC values. The reference interval was validated for use in this laboratory setting. The authors suggest that this reagent can meet clinical needs without compromising performance.