Performance verification and evaluation of self - built microfluidic chip for Brucella detection
Objective To detect positive strains,and positive/negative serum samples of Brucella collected and stored in our laboratory from May 2021 to August 2022,to verify whether the self-built system met the standards for detecting Brucella nucleic acid. Methods The selt-built microfluidic chip detection system was evaluated and verified for its coincidence rate,repeatability,detection-limit,cross-reaction,anti-interference ability,sensitivity,and specificity. This evaluation was conducted according to the CNAS-GL039:2019, Expert Consensus on Basic Requirements of Laboratory Self-Built Molecular Diagnostic Projects and Expert Consensus on Brucellosis Diagnosis and Treatment. Results The selt-built microfluidic chip detection system showed a 100％coincidence rate for detecting positive Brucella strains,and negative samples from physical examiners when compare to blood culture. The repeatability of detecting positive Brucella samples with 1.50 × 108 CFU/mL and 500 CFU/mL was 100％. The detection-limit concentration(1000 copies/mL)of the enterprise reference material was successfully detected in all 20 repeated tests. No Brucella nucleic acids were detected in the detection of seven cross-reaction pathogens. However,Brucella nucleic acids were detected in the detection of weakly positive Brucella samples mixed with interfering substances. The sensitivity and specificity of detecting Brucella were 89.88％and 95.74％,respectively. Conclusion The selt-built microfluidic chip detection system demonstrated a high coincidence rate,repeatability,detection-limit,and anti-interference ability,lack of cross-reaction,and satisfactory sensitivity and specificity. Therefore,this system can be applied for clinical detection.
万方数据
维普
