Clinical value of automated EasyNAT system for the diagnosis of tuberculosis in paraffin-embedded tissues
10.19723/j.issn.1671-167X.2024.06.016
- VernacularTitle:全自动EasyNAT核酸快速检测系统检测石蜡包埋组织诊断结核病的临床价值
- Author:
Jialu CHE
1
;
Zichen LIU
1
;
Kun LI
1
;
Chen ZHANG
1
;
Nanying CHE
1
Author Information
1. 首都医科大学附属北京胸科医院/北京市结核病胸部肿瘤研究所病理科,耐药结核病研究北京市重点实验室,北京 101149
- Publication Type:Journal Article
- Keywords:
Tuberculosis;
Diagnosis;
Paraffin-embedded tissue;
Molecular pathology;
Cross-priming isothermal amplification technology
- From:
Journal of Peking University(Health Sciences)
2024;56(6):1047-1051
- CountryChina
- Language:Chinese
-
Abstract:
Objective:Assessing the accuracy of automated EasyNAT system for rapidly detecting par-affin-embedded tissue for the diagnosis of tuberculosis.Methods:A retrospective analysis was conducted on 134 patients,comprising 101 with confirmed tuberculosis and 33 without tuberculosis,treated at Beijing Chest Hospital,Capital Medical University,between 2018 and 2022.The clinical diagnostic results served as the standard for assessing the diagnostic performance of the EasyNAT system in comparison to quantita-tive real-time polymerase chain reaction(qPCR)for tuberculosis detection in paraffin-embedded tissues.The evaluation criteria included sensitivity,specificity,positive predictive value,negative predictive value,and accuracy rate.Results:Based on the clinical diagnostic results,the EasyNAT assay demonstrated a sensitivity of 87.1％(88/101,95％CI:79.2％-92.3％)and a specificity of 100.0％(33/33,95％CI:89.6％-100.0％).The positive predictive value,negative predictive value,and accuracy rate were 100％(88/88,95％CI:95.8％-100.0％),71.7％(33/46,95％CI:57.5％-82.7％),and 90.3％(121/134,95％CI:84.1％-94.2％),respectively.In comparison,the qPCR assay exhibited a sensi-tivity of 96.0％(90.3％-98.5％)and a specificity of 100.0％(89.6％-100.0％).The positive pre-dictive value,negative predictive value,and accuracy rate for qPCR were 100.0％(96.2％-100.0％),89.2％(75.3％-95.7％),and 97.0％(92.6％-98.8％).The Cohen's kappa value of 0.84 indicated substantial agreement between EasyNAT and qPCR.The detection rate of tuberculosis using this method was 86.4％(38/44,95％CI:73.3％-93.6％),while the detection rate for extrapulmonary tuberculo-sis was 87.7％(50/57,95％CI:76.8％-93.9％).In comparison,qPCR showed a detection rate of 97.7％(88.2％-99.6％)for pulmonary tuberculosis and 94.7％(85.6％-98.6％)for extrapulmonary tuberculosis.There was no statistically significant difference in the detection results between the method and qPCR for both pulmonary and extrapulmonary tuberculosis(P＞0.05).Importantly,the EasyNAT de-tection combined nucleic acid extraction,amplification,and analysis into one process.Compared with tra-ditional qPCR methods,manual operation time was reduced by 2 hours,leading to an overall reduction in total testing time by 3 hours.Conclusion:The EasyNAT nucleic acid rapid detection system can quickly,conveniently,and accurately detect Mycobacterium tuberculosis DNA in paraffin-embedded tissues,demon-strating significant clinical utility in the pathological diagnosis of tuberculosis.
