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《International Journal of Laboratory Medicine》 2019-10
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Performance comparison of noninvasive detection (oral mucosal transudate fluid and urine) of human immunodeficiency virus antibody reagent and the invasive (blood) test reagents

YE Li;CHEN Xiaoru;SU Ling;LIANG Shu;YANG Hong;YUAN Dan;YANG Wen;Sichuan Provincial Center for Disease Control and Prevention;Liangshan State Center for Disease Control and Prevention;  
Objective Taking Yi people of Liangshan Prefecture as the research objects,to evaluated the detection performance of three kinds of human immunodeficiency virus(HIV)antibody noninvasive(oral mucosal transudate fluid and urine)detection reagents.Methods Totally 100 HIV infectors and 200 healthy controls with unknown infectious condition in Butuo county of Liangshan Prefecture were enrolled from October2017 to March 2018,and the oral mucosal transudate fluid,urine and blood samples of the subjects were collected.Two kinds of oral mucosal exudate HIV 1/2 antibody detection reagent(A and B evaluation reagent)and enzyme-linked immunosorbent method urine HIV-1 1/2 antibody detection reagent evaluation reagent(C)were used to test the corresponding specimens,and the plasma samples of the above subjects were detected by Livzon HIV antibody enzyme-linked immunosorbent assay reagent(comparative reagent)at the same time,then the comparative reagent and the comparative reagent were compared.Results The positive coincident rate of the evaluation reagents A,B and C were 98.21%(95%CI 93.06-99.69),90.82%(95%CI 82.84-95.45)and 97.32%(95%CI 91.79-99.31)respectively,the negative coincidence rates were 98.81%(95%CI 95.32-99.79),96.24%(95%CI 91.00-98.61),95.29%(95%CI 90.61-97.80)respectively,the total coincidence rates were 98.57%(95%CI 96.13-99.54),93.94%(95%CI 89.82-96.52),96.10%(95%CI92.93-97.94)respectively.The three evaluation reagents were in good agreement with the comparison reagents(κ=0.97,0.875,0.919).The area under the ROC curve of the three evaluation reagents for detecting HIV antibodies were 0.991(95%CI 0.977-1.000),0.935(95%CI 0.897-0.973)and 0.975(95%CI0.951-0.998).Conclusion Compared with the contrast agents,the three kinds of evaluation reagents are with higher coincidence rate and better consistence.Non-invasive test sample collection is convenient and safety.In areas with limited medical conditions,it may be considered to promote the application of oral mucosal exudate or urine non-invasive detection reagent for HIV antibody screening among people with difficulty in collecting blood and ethnic minority areas with special customs and habits.
【Fund】: 十三五国家科技重大专项(2018ZX10715003-002);; 四川省科技计划项目(2017JY0302)
【CateGory Index】: R512.91;R446.6
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