Evaluation of the performance and application value of EasyNAT nucleic acid test kits for influenza A/B viruses and Mycoplasma pneumoniae based on cross-primed amplification technology
10.3969/j.issn.1673-4130.2025.17.017
- VernacularTitle:基于交叉引物恒温扩增技术的EasyNAT甲型、乙型流感病毒及肺炎支原体核酸检测试剂的性能评价及临床应用
- Author:
Shaolan YANG
1
;
Xing LI
;
Tao XIAN
;
Yafei LI
;
Li JIANG
;
Shi HUA
Author Information
1. 电子科技大学附属医院·四川省人民医院临床医学检验中心,四川 成都 610072
- Keywords:
cross-primed amplification;
influenza virus;
Mycoplasma pneumoniae;
reverse transcrip-tion quantitative polymerase chain reaction
- From:
International Journal of Laboratory Medicine
2025;46(17):2142-2147
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the performance and clinical application value of EasyNAT nucleic acid test kits for influenza A virus(Flu A),influenza B virus(Flu B),and Mycoplasma pneumoniae(MP)based on cross-primed amplification(CPA)technology.Methods In compliance with relevant standards,the detection limits,cross-reactivity,and anti-interference abilities of the EasyNAT Flu and MP nucleic acid test kits were validated using influenza(Flu)and MP reference materials.Additionally,a total of 811 suspected Flu or MP infection patients who visited the hospital from January 1 to July 5,2024 were enrolled in this study.Their oropharyngeal swabs were collected and tested using reverse transcription quantitative polymerase chain reac-tion(RT-qPCR)as the gold standard to evaluate the concordance and compliance of the EasyNAT Flu and MP nucleic acid test kits,thus assessing their clinical application value.Results The EasyNAT Flu and MP nucleic acid test kits yielded positive results in 8 repeated tests at the detection limit concentrations of the ref-erence materials.No pathogen-specific peaks were detected in Flu and MP negative samples that had been spiked with common cross-reacting pathogens.Furthermore,the detection results of Flu or MP positive sam-ples were unaffected by the presence of interfering substances.Among the 811 clinical samples,the sensitivity of the EasyNAT Flu A test was 97.33%,and the sensitivity for Flu B was 98.47%,both with a specificity of 98.04%.The EasyNAT MP nucleic acid test showed a sensitivity of 97.95%and specificity of 99.03%.The results demonstrated a high degree of agreement with RT-qPCR(Kappa values were over 0.900).Further-more,detection rates of the EasyNAT Flu test kits showed no difference in positive samples with different Ct values(Flu A:χ2=4.20,P=0.08;Flu B:χ2=2.22,P=0.31)and MP test kits showed significant differences in positive samples with different cycle threshold values(χ2=11.84,P<0.01).Conclusion The EasyNAT Flu and MP nucleic acid test kits exhibit excellent detection performance with high sensitivity and specificity.Moreover,the products are easy to operate,offer rapid detection,and provide accurate results.These features make them suitable for primary healthcare settings,with significant potential for clinical application.
