The Evaluation of the Performance of a Six-fold Testing Reagent for Nucleic Acid Detection of Respiratory Viruses
Objective To evaluate the main properties of a six-fold nucleic acid test reagent for respiratory tract virus in clinical detections.Methods In accordance with the CNAS-GL039:2019 Guidance for Performance Verification of Molecular Diagnostic Test Procedures,the compliance rate,precision,minimum detection limit,cross-reaction and anti-interference ability of a respiratory virus nucleic acid hexapline were evaluated by using specific reference products and fixed quality control products with known concentrations.Results The precision of the test kit was shown to be decent(CV＜5％).The detection rate of the kit for any number of samples of any combination of six pathogens was 100％.When the detection concentration was 1.0 × 103 copies/mL,the results were all positive,which met the minimum detection limit marked in the reagent manual.There was no cross-reaction with common clinical pathogens,such as novel coronavirus,Epstein-Barr virus,mycoplasma pneumoniae,and human Boca virus.There was no significant difference between the interference group with 25％blood,0.15mg/mL oseltamivir,142ng/mL of ribavirin and the control group,so the anti-interference evaluation was passed.Conclusion The main performance indexes of the respiratory virus nucleic acid six-fold test reagent is able to meet the requirements of relevant standards,so it can be used in clinical practices.
万方数据
维普
