Literature DB >> 33428663

HIV false positive screening serology due to sample contamination reduced by a dedicated sample and platform in a high prevalence environment.

Michael A Linström1,2, Wolfgang Preiser1,2, Nokwazi N Nkosi1,2, Helena W Vreede3,4, Stephen N J Korsman3,5, Annalise E Zemlin1,6, Gert U van Zyl1,2.   

Abstract

Automated testing of HIV serology on clinical chemistry analysers has become common. High sample throughput, high HIV prevalence and instrument design could all contribute to sample cross-contamination by microscopic droplet carry-over from seropositive samples to seronegative samples resulting in false positive low-reactive results. Following installation of an automated shared platform at our public health laboratory, we noted an increase in low reactive and false positive results. Subsequently, we investigated HIV serology screening test results for a period of 21 months. Of 485 initially low positive or equivocal samples 411 (85%) tested negative when retested using an independently collected sample. As creatinine is commonly requested with HIV screening, we used it as a proxy for concomitant clinical chemistry testing, indicating that a sample had likely been tested on a shared high-throughput instrument. The contamination risk was stratified between samples passing the clinical chemistry module first versus samples bypassing it. The odds ratio for a false positive HIV serology result was 4.1 (95% CI: 1.69-9.97) when creatinine level was determined first, versus not, on the same sample, suggesting contamination on the chemistry analyser. We subsequently issued a notice to obtain dedicated samples for HIV serology and added a suffix to the specimen identifier which restricted testing to a dedicated instrument. Low positive and false positive rates were determined before and after these interventions. Based on measured rates in low positive samples we estimate that before the intervention, of 44 117 HIV screening serology samples, 753 (1.71%) were false positive, declining to 48 of 7 072 samples (0.68%) post-intervention (p<0.01). Our findings showed that automated high throughput shared diagnostic platforms are at risk of generating false-positive HIV test results, due to sample contamination and that measures are required to address this. Restricting HIV serology samples to a dedicated platform resolved this problem.

Entities:  

Mesh:

Year:  2021        PMID: 33428663      PMCID: PMC7799780          DOI: 10.1371/journal.pone.0245189

Source DB:  PubMed          Journal:  PLoS One        ISSN: 1932-6203            Impact factor:   3.240


  11 in total

1.  Reliability of HIV rapid tests is user dependent.

Authors:  Dhayendre Moodley; Pravi Moodley; Themba Ndabandaba; Tonya Esterhuizen
Journal:  S Afr Med J       Date:  2008-09

2.  Using Elecsys® HIV Combi PT assay to identify acute and early HIV infection in a teaching hospital of southwest China.

Authors:  Siyuan Zhu; Dongdong Li; Jingna An; Qixia Chen; Qianqian Liu; Chuanmin Tao
Journal:  Int J STD AIDS       Date:  2015-03-29       Impact factor: 1.359

3.  Relevance of cutoff on a 4th generation ELISA performance in the false positive rate during HIV diagnostic in a low HIV prevalence setting.

Authors:  Lucía Chacón; María Luisa Mateos; África Holguín
Journal:  J Clin Virol       Date:  2017-04-26       Impact factor: 3.168

4.  A retrospective analysis of the application of the Elecsys® HIV combi PT assay in southern China.

Authors:  Shaocong Liang; Guihua Deng; Shaosong Zhou; Jing Zeng; Weiqing Tan; Xiaopeng Yuan
Journal:  J Clin Lab Anal       Date:  2017-06-26       Impact factor: 2.352

5.  Specificity of two HIV screening tests detecting simultaneously HIV-1 p24 antigen and antibodies to HIV-1 and -2.

Authors:  Annette Blaich; Andreas Buser; Marcel Stöckle; Christian Gehringer; Hans H Hirsch; Manuel Battegay; Thomas Klimkait; Reno Frei
Journal:  J Virol Methods       Date:  2017-09-08       Impact factor: 2.014

6.  Performances of four fourth-generation human immunodeficiency virus-1 screening assays.

Authors:  Eun Young Song; Mina Hur; Eun Youn Roh; Myoung Hee Park; Hee-Won Moon; Yeo Min Yun
Journal:  J Med Virol       Date:  2012-12       Impact factor: 2.327

7.  Performance evaluation of a new fourth-generation HIV combination antigen-antibody assay.

Authors:  A Mühlbacher; H Schennach; J van Helden; T Hebell; G Pantaleo; P Bürgisser; C Cellerai; P Permpikul; M I Rodriguez; A Eiras; F Alborino; P Cunningham; M Axelsson; S Andersson; O Wetlitzky; C Kaiser; P Möller; G de Sousa
Journal:  Med Microbiol Immunol       Date:  2012-06-17       Impact factor: 3.402

8.  Contamination with HIV antibody may be responsible for false positive results in specimens tested on automated platforms running HIV 4th generation assays in a region of high HIV prevalence.

Authors:  Diana Ruth Hardie; Stephen N Korsman; Nei-Yuan Hsiao; Molefi Daniel Morobadi; Sabeehah Vawda; Dominique Goedhals
Journal:  PLoS One       Date:  2017-07-31       Impact factor: 3.240

9.  Analytical and Clinical Performance Evaluation of the Elecsys HIV combi PT Assay on the cobas e 602 Analyzer for the Diagnosis of Human Immunodeficiency Virus.

Authors:  Denise L Uettwiller-Geiger; Marvin Lessig; Jie An; Tara Barsch; Susan Smith; Sharan Walker; Alexander Riedel; Yi Hao; Amin A Mohammad
Journal:  Am J Clin Pathol       Date:  2019-03-01       Impact factor: 2.493

10.  Performance of rapid point-of-care and laboratory tests for acute and established HIV infection in San Francisco.

Authors:  Christopher D Pilcher; Brian Louie; Shelley Facente; Sheila Keating; John Hackett; Ana Vallari; Chris Hall; Teri Dowling; Michael P Busch; Jeffrey D Klausner; Frederick M Hecht; Sally Liska; Mark W Pandori
Journal:  PLoS One       Date:  2013-12-12       Impact factor: 3.240

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.