Elecsys HIV Duo试剂诊断效能评价研究

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Abstract Objective To evaluate the detection performance of human immunodeficiency virus(HIV)detection reagent Elecsys HIV Duo,and to explore the clinical application value of HIV Duo.Methods The performance of the test method was evaluated according to the performance verification guidelines of clinical chemistry quantitative test procedure.A total of 105 serum samples of HIV positive patients were collected from the Eighth Affiliated Hospital of Guangzhou Medical University in December 2020 to verify the detection ability of Elecsys HIV Duo in different stages of HIV infection.Results The intra assay precision of three concentration samples were 4.03%,0.95% and 0.81%,respectively,which were lower than 6.25%(1/4 TEa).The interbatch precision were 4.7%,1.23%,1.66%,respectively,less than 8.33%(1/3 TEa).A total of 57 samples containing potential interfering substances were detected by Elecsys HIV Duo assay,and the results showed that the specificity of the assay was 100%.The coincidence rate of p24 antigen and HIV antibody negative and positive results were both 100%.The detection limit of p24 antigen was 0.62 U/mL,while HIV-1 antibody was still detectable at the level of 1 NCU/mL.Anti-interference ability: the samples containing 20 mg/L bilirubin,800 mg/L hemoglobin,and 2000 mg/L intralipid were detected by Elecsys HIV Duo assay.The coincidence rate between measured values before and after adding interference substances was ≥80%.The detection results of 105 positive samples in different infection periods showed that the system can detect effectively.Conclusion HIV-1 p24 antigen and antibodies were detected by the Elecsys HIV Duo assay separately,and the assay has a good diagnostic value in HIV antigen and antibody detection,which has a great help in the diagnosis of early HIV-infected cases.

Key words： Elecsys HIV Duo HIV antigen and antibody detection Performance verification

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	Articles by authors
	HUANG Ji-de
	TAN Ming-kai
	HUANG Ying
	XIAO Yun-ju
	SHI Ya-ling

Cite this article:

HUANG Ji-de,TAN Ming-kai,HUANG Ying, et al. Study on evaluation of diagnostic efficacy of Elecsys HIV Duo assay[J]. 中国当代医药, 2021, 28(22): 20-23.

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http://dangdaiyiyao.com/EN/ OR http://dangdaiyiyao.com/EN/Y2021/V28/I22/20

[1]	Cribbs SK，Crothers K，Morris A.Pathogenesis of HIV-related lung disease：immunity，infection，and inflammation[J].Physiol Rev，2020，100（2）：603-632.
[2]	Monaco CL，Gootenberg DB，Zhao G，et al.Altered virom andbacterial microbiome in human immunodeficiency virus associated acquired immunodeficiency syndrome[J].Cell Host Microbe，2016，19（3）：311-322.
[3]	Rey F，Barré-Sinoussi F，Schmidtmayerova H，et al.Detection and titration of neutralizing antibodies to HIV using an inhibition of the cytopathic effect of the virus on MT4 cells[J].J Virol Methods，1987，16（3）：239-249.
[4]	郝阳，崔岩，孙新华，等.“四免一关怀”政策实施十年来中国艾滋病疫情变化及特征分析[J].中华疾病控制杂志，2014，18（5）：369-374.
[5]	Weber B，Fall EH，Berger A，et al..Reduction of Diagnostic Window by New Fourth-generation Human immunodeficiency Virus Screening Assays[J].Clin Microbiol，1998，36（8）：2235-2239.
[6]	Guertler L，Mühlbacher A，Michl U，et al..Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay[J].J Clin Microbiol，1998，36（8）：2235-2239.
[7]	Zhang B，Ma Q，Zhao B，et al.Performance evaluation of Elecsys HIV Duo on cobas e 801 using clinical samples in China[J].J Med Virol，2020，92（12）：3230-3236.
[8]	中国合格评定国家认可委员会.临床化学定量检验程序性能验证指南[Z].CNAS-GL037：2019.
[9]	Davies S，Gardner A，Vance DE，et al.Barriers to HIV Testing：Patient and Provider Perspectives in the Deep South[J].AIDS Behav，2019，23（4）：1062-1072.
[10]	Havlir D，Lockman S，Ayles H，et al.What do the Universal Test and Treat trials tell us about the path to HIV epidemic control?[J].J Int AIDS Soc，2020，23（2）：e25455.
[11]	Gardner EM，McLees MP，Steiner JF，et al.The spectrum of engagement in HIV care and its relevance to test-and-treat strategies for prevention of HIV infection[J].Clin Infect Dis，2011，52（6）：793-800.
[12]	Peacock ME，Arce RM，Cutler CW.Periodontal and other oral manifestations of immunodeficiency diseases[J].Oral Dis，2017，23（7）：866-888.
[15]	沈银忠，李兰娟.艾滋病诊疗指南（第三版）[J].中华传染病杂志，2015，33（10）：577-593.
[16]	虞洋.2016年-2018年本溪市新发现艾滋病病毒感染者/患者首次CD4+T 淋巴细胞检测结果分析[J].中国卫生检验杂志，2020，30（19）：2406-2408.
[13]	Popovic M，Sarngadharan MG，Read E，et al.Detection，Isolation and ContinousProduction of Cytopathic Retroviruses（HTLV-Ⅲ） from Patients with AIDS and Pre-AIDS[J].Science，1984，224（4648）：497-500.
[14]	Gallo RC，Salahuddin SZ，Popovic M，et al.Frequent Detection and Isolation ofcytopathic Retroviruses （HTLV-Ⅲ）from Patients with AIDS and RISk for AIDS[J].Science，1984，224（4648）：500-503.
[17]	Marsden MD，Zack JA.Humanized Mouse Models for Human Immunodeficiency Virus Infection[J].Annu Rev Virol，2017，4（1）：393-412.
[18]	Tokuhira M，Tamaru JI，Kizaki M.Clinical management for other iatrogenic immunodeficiency-associated lymphoproliferative disorders[J].J Clin Exp Hematop，2019，59（2）：72-92.
[19]	McDermott DH，Pastrana DV，Calvo KR，et al.Plerixafor for the Treatment of WHIM Syndrome[J].N Engl J Med，2019，380（2）：163-170.