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Yuwen L, Zhang S, Chao J. Recent Advances in DNA Nanotechnology-Enabled Biosensors for Virus Detection. BIOSENSORS 2023; 13:822. [PMID: 37622908 PMCID: PMC10452139 DOI: 10.3390/bios13080822] [Citation(s) in RCA: 8] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Subscribe] [Scholar Register] [Received: 07/15/2023] [Revised: 08/05/2023] [Accepted: 08/12/2023] [Indexed: 08/26/2023]
Abstract
Virus-related infectious diseases are serious threats to humans, which makes virus detection of great importance. Traditional virus-detection methods usually suffer from low sensitivity and specificity, are time-consuming, have a high cost, etc. Recently, DNA biosensors based on DNA nanotechnology have shown great potential in virus detection. DNA nanotechnology, specifically DNA tiles and DNA aptamers, has achieved atomic precision in nanostructure construction. Exploiting the programmable nature of DNA nanostructures, researchers have developed DNA nanobiosensors that outperform traditional virus-detection methods. This paper reviews the history of DNA tiles and DNA aptamers, and it briefly describes the Baltimore classification of virology. Moreover, the advance of virus detection by using DNA nanobiosensors is discussed in detail and compared with traditional virus-detection methods. Finally, challenges faced by DNA nanobiosensors in virus detection are summarized, and a perspective on the future development of DNA nanobiosensors in virus detection is also provided.
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Affiliation(s)
- Lihui Yuwen
- State Key Laboratory of Organic Electronics and Information Displays, Jiangsu Key Laboratory for Biosensors, Institute of Advanced Materials (IAM), Nanjing University of Posts and Telecommunications, Nanjing 210023, China; (L.Y.); (S.Z.)
| | - Shifeng Zhang
- State Key Laboratory of Organic Electronics and Information Displays, Jiangsu Key Laboratory for Biosensors, Institute of Advanced Materials (IAM), Nanjing University of Posts and Telecommunications, Nanjing 210023, China; (L.Y.); (S.Z.)
| | - Jie Chao
- School of Geography and Biological Information, Nanjing University of Posts and Telecommunications, Nanjing 210023, China
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Rapid vertical flow technique for the highly sensitive detection of Brucella antibodies with Prussian blue nanoparticle labeling and nanozyme-catalyzed signal amplification. World J Microbiol Biotechnol 2022; 39:23. [PMID: 36422675 DOI: 10.1007/s11274-022-03462-7] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/13/2022] [Accepted: 11/07/2022] [Indexed: 11/25/2022]
Abstract
Brucellosis is a chronic infectious disease caused by Brucella, which is characterized by inflammation of reproductive organs and fetal membranes, abortion, infertility, and local inflammatory lesions of various tissues. Due to the widespread prevalence and spread of brucellosis, it has not only caused huge losses to animal husbandry, but also brought serious impacts on human health and safety. Therefore, rapid and accurate diagnosis is of great significance for the effective control of brucellosis. Therefore, we have developed a rapid vertical flow technique (RVFT) using Prussian blue nanoparticles (PBNPs) as a marker material for the detection of brucellosis antibodies. Lipopolysaccharide (LPS) was purified and used to detect brucellosis antibodies to improve the sensitivity of this technique. To enhance the sensitivity of serum antibody detection, a single multifunctional compound buffer was created using whole blood as a biological sample while retaining the advantages of typical lateral flow immunoassays. After signal amplification, standard Brucella-positive serum (containing Brucella antibody at 4000 IU mL-1) could be detected in this system even at a dilution factor of 1 × 10-2. The detection limit was 40 IU mL-1, which is ten times that before signal amplification. This RVFT displayed good specificity and no cross-reactivity. This RVFT effectively avoided the false negative phenomenon of lateral flow immunoassays, was easy to operate, had a short reaction time, has good repeatability, and could elicit results that were visible to the naked eye for 2 ~ 3 min without any equipment. Since this method is very important for controlling the prevalence of brucellosis, it holds great promise for application in primary medical units and veterinary brucellosis detection.
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Tessema B, Boldt A, König B, Maier M, Sack U. Flow-Cytometry Intracellular Detection and Quantification of HIV1 p24 Antigen and Immunocheckpoint Molecules in T Cells among HIV/AIDS Patients. HIV AIDS (Auckl) 2022; 14:365-379. [PMID: 35958525 PMCID: PMC9359413 DOI: 10.2147/hiv.s374369] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 05/12/2022] [Accepted: 07/22/2022] [Indexed: 11/23/2022] Open
Affiliation(s)
- Belay Tessema
- Department of Medical Microbiology, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia
- Institute of Clinical Immunology, Faculty of Medicine, University of Leipzig, Leipzig, Germany
- Institute of Medical Microbiology and Virology, Faculty of Medicine, University of Leipzig, Leipzig, Germany
- Correspondence: Belay Tessema, Department of Medical Microbiology, College of Medicine and Health Sciences, University of Gondar, 196, Gondar, Ethiopia, Tel +251-91-930-6918, Email
| | - Andreas Boldt
- Institute of Clinical Immunology, Faculty of Medicine, University of Leipzig, Leipzig, Germany
| | - Brigitte König
- Institute of Medical Microbiology and Virology, Faculty of Medicine, University of Leipzig, Leipzig, Germany
| | - Melanie Maier
- Department of Virology, Institute of Medical Microbiology and Virology, Faculty of Medicine, University of Leipzig, Leipzig, Germany
| | - Ulrich Sack
- Institute of Clinical Immunology, Faculty of Medicine, University of Leipzig, Leipzig, Germany
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Gold Nanoparticles Prepared with Cyclodextrin Applied to Rapid Vertical Flow Technology for the Detection of Brucellosis. BIOSENSORS 2022; 12:bios12070531. [PMID: 35884334 PMCID: PMC9312826 DOI: 10.3390/bios12070531] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Subscribe] [Scholar Register] [Received: 06/06/2022] [Revised: 07/09/2022] [Accepted: 07/10/2022] [Indexed: 11/17/2022]
Abstract
Currently, brucellosis seriously threatens the health of humans and animals and hinders the development of animal husbandry. However, the diagnostic methods for brucellosis have some disadvantages, such as low sensitivity, long detection time, professional operation, and high cost. This study aims to establish a convenient, fast, effective, and inexpensive detection method for brucellosis. Gold nanoparticles with β-cyclodextrin as a reducing agent were prepared and optimized, applied to rapid vertical flow technology (RVFT), and used to establish a kit for the detection of brucellosis. In this study, gold nanoparticles prepared from β-cyclodextrin were applied to RVFT for the first time, and on this basis, silver staining amplification technology was introduced, which further improved the sensitivity and reduced the detection limit of this method. Standard Brucella-Positive Serum (containing Brucella antibody at 4000 IU/mL) could be detected in this system even for a dilution factor of 1 × 10−3. The detection limit was 4 IU/mL. RVFT is simple to operate, has a short reaction time, and is 5–6 min visible to the naked eye, without any equipment.
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He Q, Chen X, He Y, Guan T, Feng G, Lu B, Wang B, Zhou X, Hu L, Cao D. Spectral-optical-tweezer-assisted fluorescence multiplexing system for QDs-encoded bead-array bioassay. Biosens Bioelectron 2019; 129:107-117. [PMID: 30685705 DOI: 10.1016/j.bios.2019.01.004] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/23/2018] [Revised: 12/29/2018] [Accepted: 01/03/2019] [Indexed: 01/01/2023]
Abstract
As an efficient tool in the multiplexed detection of biomolecules, bead-array could achieve separation-free detection to multiple targets, making it suitable to analyze valuable and scarce samples like antigen and antibody from living organism. Herein, we propose a spectral-optical-tweezer-assisted fluorescence multiplexing system to analyze biomolecule-conjugated bead-array. Using optical tweezer, we trapped and locked beads at the focus to accept stimulation, offering a stable and optimized analysis condition. Moving the system focus and scanning the sample slide, we achieved emissions collection to QDs-encoded bead-array after the multiplexed detection. The emission spectra of fluorescence were collected and recorded by the spectrometer. By recognizing locations of decoding peaks and counting the intensities of label signals of emission spectra, we achieved qualitative and quantitative detection to targets. As proof-of-concept studies, we use this system to carry out multiplexed detection to various types of anti-IgG in the single sample and the detection limit reaches 1.52 pM with a linear range from 0.31 to 10 nM. Through further optimization of experimental conditions, we achieved specific detection to target IgG with sandwich method in human serum and the detection limit reaches as low as 0.23 pM with a linear range from 0.88 to 28 pM, validating the practical application of this method in real samples.
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Affiliation(s)
- Qinghua He
- Shenzhen Key Laboratory for Minimal Invasive Medical Technologies, Institute of Optical Imaging and Sensing, Graduate School at Shenzhen, Tsinghua University, Shenzhen 518055, China; Department of Physics, Tsinghua University, Beijing 100084, China
| | - Xuejing Chen
- Shenzhen Key Laboratory for Minimal Invasive Medical Technologies, Institute of Optical Imaging and Sensing, Graduate School at Shenzhen, Tsinghua University, Shenzhen 518055, China; Department of Physics, Tsinghua University, Beijing 100084, China
| | - Yonghong He
- Shenzhen Key Laboratory for Minimal Invasive Medical Technologies, Institute of Optical Imaging and Sensing, Graduate School at Shenzhen, Tsinghua University, Shenzhen 518055, China; Department of Physics, Tsinghua University, Beijing 100084, China
| | - Tian Guan
- Shenzhen Key Laboratory for Minimal Invasive Medical Technologies, Institute of Optical Imaging and Sensing, Graduate School at Shenzhen, Tsinghua University, Shenzhen 518055, China; School of Medicine, Tsinghua University, Beijing 100084, China.
| | - Guangxia Feng
- Shenzhen Key Laboratory for Minimal Invasive Medical Technologies, Institute of Optical Imaging and Sensing, Graduate School at Shenzhen, Tsinghua University, Shenzhen 518055, China; School of Medicine, Tsinghua University, Beijing 100084, China
| | - Bangrong Lu
- Shenzhen Key Laboratory for Minimal Invasive Medical Technologies, Institute of Optical Imaging and Sensing, Graduate School at Shenzhen, Tsinghua University, Shenzhen 518055, China
| | - Bei Wang
- Shenzhen Key Laboratory for Minimal Invasive Medical Technologies, Institute of Optical Imaging and Sensing, Graduate School at Shenzhen, Tsinghua University, Shenzhen 518055, China
| | - Xuesi Zhou
- Shenzhen Key Laboratory for Minimal Invasive Medical Technologies, Institute of Optical Imaging and Sensing, Graduate School at Shenzhen, Tsinghua University, Shenzhen 518055, China
| | - Liangshan Hu
- Department of Laboratory Medicine, Guangdong Second Provincial General Hospital, Guangzhou 510317, China
| | - Donglin Cao
- Department of Laboratory Medicine, Guangdong Second Provincial General Hospital, Guangzhou 510317, China.
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Parsa SF, Vafajoo A, Rostami A, Salarian R, Rabiee M, Rabiee N, Rabiee G, Tahriri M, Yadegari A, Vashaee D, Tayebi L, Hamblin MR. Early diagnosis of disease using microbead array technology: A review. Anal Chim Acta 2018; 1032:1-17. [PMID: 30143206 PMCID: PMC6152944 DOI: 10.1016/j.aca.2018.05.011] [Citation(s) in RCA: 48] [Impact Index Per Article: 6.9] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/18/2017] [Revised: 04/30/2018] [Accepted: 05/02/2018] [Indexed: 12/31/2022]
Abstract
Early diagnosis of diseases (before they become advanced and incurable) is essential to reduce morbidity and mortality rates. With the advent of novel technologies in clinical laboratory diagnosis, microbead-based arrays have come to be recognized as an efficient approach, that demonstrates useful advantages over traditional assay methods for multiple disease-related biomarkers. Multiplexed microbead assays provide a robust, rapid, specific, and cost-effective approach for high-throughput and simultaneous screening of many different targets. Biomolecular binding interactions occur after applying a biological sample (such as blood plasma, saliva, cerebrospinal fluid etc.) containing the target analyte(s) to a set of microbeads with different ligand-specificities that have been coded in planar or suspension arrays. The ligand-receptor binding activity is tracked by optical signals generated by means of flow cytometry analysis in the case of suspension arrays, or by image processing devices in the case of planar arrays. In this review paper, we discuss diagnosis of cancer, neurological and infectious diseases by using optically-encoded microbead-based arrays (both multiplexed and single-analyte assays) as a reliable tool for detection and quantification of various analytes.
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Affiliation(s)
- Sanam Foroutan Parsa
- Biomaterials Group, Faculty of Biomedical Engineering, Amirkabir University of Technology, Tehran, Iran
| | - Atieh Vafajoo
- Biomaterials Group, Faculty of Biomedical Engineering, Amirkabir University of Technology, Tehran, Iran
| | - Azin Rostami
- Biomaterials Group, Faculty of Biomedical Engineering, Amirkabir University of Technology, Tehran, Iran
| | - Reza Salarian
- Biomedical Engineering Department, Maziar University, Noor, Royan, Iran
| | - Mohammad Rabiee
- Biomaterials Group, Faculty of Biomedical Engineering, Amirkabir University of Technology, Tehran, Iran
| | - Navid Rabiee
- Department of Chemistry, Shahid Beheshti University, Tehran, Iran
| | - Ghazal Rabiee
- Department of Chemistry, Shahid Beheshti University, Tehran, Iran
| | | | - Amir Yadegari
- Marquette University School of Dentistry, Milwaukee, WI 53233, USA
| | - Daryoosh Vashaee
- Electrical and Computer Engineering Department, North Carolina State University, Raleigh, NC 27606, USA
| | - Lobat Tayebi
- Marquette University School of Dentistry, Milwaukee, WI 53233, USA; Biomaterials and Advanced Drug Delivery Laboratory, School of Medicine, Stanford University, Palo Alto, CA 94304, USA
| | - Michael R Hamblin
- Wellman Center for Photomedicine, Massachusetts General Hospital, Boston, MA 02114, USA; Department of Dermatology, Harvard Medical School, Boston, MA 02115, USA; Harvard-MIT Division of Health Sciences and Technology, Cambridge, MA 02139, USA.
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Gray ER, Bain R, Varsaneux O, Peeling RW, Stevens MM, McKendry RA. p24 revisited: a landscape review of antigen detection for early HIV diagnosis. AIDS 2018; 32:2089-2102. [PMID: 30102659 PMCID: PMC6139023 DOI: 10.1097/qad.0000000000001982] [Citation(s) in RCA: 35] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/05/2023]
Abstract
: Despite major advances in HIV testing, early detection of infection at the point of care (PoC) remains a key challenge. Although rapid antibody PoC and laboratory-based nucleic acid amplification tests dominate the diagnostics market, the viral capsid protein p24 is recognized as an alternative early virological biomarker of infection. However, the detection of ultra-low levels of p24 at the PoC has proven challenging. Here we review the landscape of p24 diagnostics to identify knowledge gaps and barriers and help shape future research agendas. Five hundred and seventy-four research articles to May 2018 that propose or evaluate diagnostic assays for p24 were identified and reviewed. We give a brief history of diagnostic development, and the utility of p24 as a biomarker in different populations such as infants, the newly infected, those on preexposure prophylaxis and self-testers. We review the performance of commercial p24 assays and consider elements such as immune complex disruption, resource-poor settings, prevalence, and assay antibodies. Emerging and ultrasensitive assays are reviewed and show a number of promising approaches but further translation has been limited. We summarize studies on the health economic benefits of using antigen testing. Finally, we speculate on the future uses of high-performance p24 assays, particularly, if available in self-test format.
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Affiliation(s)
- Eleanor R Gray
- London Centre for Nanotechnology, Faculty of Maths and Physical Sciences, University College London
| | - Robert Bain
- Department of Materials, Department of Bioengineering and Institute of Biomedical Engineering, Imperial College London
| | | | | | - Molly M Stevens
- Department of Materials, Department of Bioengineering and Institute of Biomedical Engineering, Imperial College London
| | - Rachel A McKendry
- London Centre for Nanotechnology, Faculty of Maths and Physical Sciences, University College London
- Division of Medicine, University College London, London, UK
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Bystryak S, Ossina N. A rapid ultrasound particle agglutination method for HIV antibody detection: Comparison with conventional rapid HIV tests. J Virol Methods 2017; 249:38-47. [PMID: 28843787 DOI: 10.1016/j.jviromet.2017.08.015] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 04/14/2017] [Revised: 08/15/2017] [Accepted: 08/18/2017] [Indexed: 01/05/2023]
Abstract
We present the results of the feasibility and preliminary studies on analytical performance of a rapid test for detection of human immunodeficiency virus (HIV) antibodies in human serum or plasma that is an important advance in detecting HIV infection. Current methods for rapid testing of antibodies against HIV are qualitative and exhibit poor sensitivity (limit of detection). In this paper, we describe an ultrasound particle agglutination (UPA) method that leads to a significant increase of the sensitivity of conventional latex agglutination tests for HIV antibody detection in human serum or plasma. The UPA method is based on the use of: 1) a dual mode ultrasound, wherein a first single-frequency mode is used to accelerate the latex agglutination process, and then a second swept-frequency mode of sonication is used to disintegrate non-specifically bound aggregates; and 2) a numerical assessment of results of the agglutination process. The numerical assessment is carried out by optical detection and analysis of moving patterns in the resonator cell during the swept-frequency mode. The single-step UPA method is rapid and more sensitive than the three commercial rapid HIV test kits analyzed in the study: analytical sensitivity of the new UPA method was found to be 510-, 115-, and 80-fold higher than that for Capillus™, Multispot™ and Uni-Gold™ Recombigen HIV antibody rapid test kits, respectively. The newly developed UPA method opens up additional possibilities for detection of a number of clinically significant markers in point-of-care settings.
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Affiliation(s)
- Simon Bystryak
- Allied Innovative Systems, 13 Watchung Ave., ste 102, Chatham, NJ 07928, USA.
| | - Natalya Ossina
- Allied Innovative Systems, 13 Watchung Ave., ste 102, Chatham, NJ 07928, USA
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Dot immunogold filtration assay (DIGFA) for the rapid detection of specific antibodies against the rat lungworm Angiostrongylus cantonensis (Nematoda: Metastrongyloidea) using purified 31-kDa antigen. J Helminthol 2013; 88:396-401. [PMID: 23710755 DOI: 10.1017/s0022149x13000321] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
A rapid dot immunogold filtration assay (DIGFA) was adopted for specific immunodiagnosis of human cerebral angiostrongyliasis, using purified 31-kDa glycoprotein specific to Angiostrongylus cantonensis as diagnostic antigen and protein A colloidal gold conjugate as antigen-antibody detector. A total of 59 serum samples were assayed - 11 samples from clinically diagnosed patients with detectable A. cantonensis-specific antibody in immunoblotting; 23 samples from patients with other related parasitic diseases, i.e. gnathostomiasis (n= 8), cysticercosis (n= 5), toxocariasis (n= 2), filariasis (n= 4), paragonimiasis (n= 2) and malaria (n= 2); and 25 samples from normal healthy subjects. The sensitivity and specificity of DIGFA to detect anti-A. cantonensis specific antibodies in serologically confirmed angiostrongyliasis cases, were both 100%. No positive DIGFA was observed in cases with other parasitic diseases, and the healthy control subjects. The 3-min DIGFA is as sensitive and specific as the 3-h immunoblot test in angiostrongyliasis confirmed cases that revealed a 31-kDa reactive band. The gold-based DIGFA is more rapid and easier to perform than the traditional enzyme-linked immunosorbent assay (ELISA). The test utilizing purified A. cantonensis antigen is reliable and reproducible for specific immunodiagnosis of human infection with A. cantonensis - thus can be applied as an additional routine test for clinical diagnostic support. Large-scale sero-epidemiological studies in endemic communities in north-east Thailand are under way to evaluate its usefulness under field conditions.
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Gilliam BL, Patel D, Talwani R, Temesgen Z. HIV in Africa: Challenges and Directions for the Next Decade. Curr Infect Dis Rep 2012; 14:91-101. [PMID: 22143960 DOI: 10.1007/s11908-011-0230-8] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/15/2022]
Abstract
Africa carries a disproportionate burden of the global HIV endemic, accounting for two thirds of the global 33.3 million people living with HIV. While tremendous advances have been made in addressing the HIV epidemic in Africa, considerable challenges remain. Testing for HIV increased by 86% from 2007 to 2009 but more than 75% of people 15-49 years remain unaware of their HIV status. CD4 count at diagnosis tends to be low and linkage to care and treatment is suboptimal. The scale-up of antiretroviral therapy is ongoing but is hampered by the lack of diagnostic capability to monitor response to therapy and a substantial healthcare workforce shortage. Prevention strategies such as male circumcision, pre-exposure prophylaxis, and antiretroviral therapy for prevention have generated great excitement but cost and healthcare infrastructure deficiencies may limit their widespread applicability. Operational research to validate and inform treatment decisions, health care policies, and prevention strategies is sorely needed.
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Affiliation(s)
- Bruce L Gilliam
- Institute of Human Virology, University of Maryland School of Medicine, 725 West Lombard Street, Baltimore, MD, 21201, USA,
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Pavie J, Rachline A, Loze B, Niedbalski L, Delaugerre C, Laforgerie E, Plantier JC, Rozenbaum W, Chevret S, Molina JM, Simon F. Sensitivity of five rapid HIV tests on oral fluid or finger-stick whole blood: a real-time comparison in a healthcare setting. PLoS One 2010; 5:e11581. [PMID: 20657834 PMCID: PMC2906506 DOI: 10.1371/journal.pone.0011581] [Citation(s) in RCA: 121] [Impact Index Per Article: 8.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/13/2010] [Accepted: 05/27/2010] [Indexed: 11/24/2022] Open
Abstract
Background Health authorities in several countries recently recommended the expansion of human immunodeficiency virus (HIV) antibody testing, including the use of rapid tests. Several HIV rapid tests are now licensed in Europe but their sensitivity on total blood and/or oral fluid in routine healthcare settings is not known. Methods and Findings 200 adults with documented HIV-1 (n = 194) or HIV-2 infection (n = 6) were prospectively screened with five HIV rapid tests using either oral fluid (OF) or finger-stick whole blood (FSB). The OraQuick Advance rapid HIV1/2® was first applied to OF and then to FSB, while the other tests were applied to FSB, in the following order: Vikia HIV 1/2®, Determine HIV 1–2®, Determine® HIV-1/2 Ag/Ab Combo® and INSTI HIV-1/HIV-2®. Tests negative on FSB were repeated on paired serum samples. Twenty randomly selected HIV-seronegative subjects served as controls, and the results were read blindly. Most patients had HIV-1 subtype B infection (63.3%) and most were on antiretroviral therapy (68.5%). Sensitivity was 86.5%, 94.5%, 98.5%, 94.9%, 95.8% and 99% respectively, with OraQuick OF, OraQuick FSB, Vikia, Determine, Determine Ag/Ab Combo and INSTI (p<0.0001). OraQuick was less sensitive on OF than on FSB (p = 0.008). Among the six patients with three or more negative tests, two had recent HIV infection and four patients on antiretroviral therapy had undetectable plasma viral load. When patients positive in all the tests were compared with patients who had at least one negative test, only a plasma HIV RNA level <200 cp/ml was significantly associated with a false-negative result (p = 0.009). When the 33 rapid tests negative on FSB were repeated on serum, all but six (5 negative with OraQuick, 1 with INSTI) were positive. The sensitivity of OraQuick, Determine and Determine Ag/Ab Combo was significantly better on serum than on FSB (97.5%, p = 0.04; 100%, p = 0.004; and 100%, p = 0.02, respectively). Conclusion When evaluated in a healthcare setting, rapid HIV tests were less sensitive on oral fluid than on finger-stick whole blood and less sensitive on finger-stick whole blood than on serum.
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Affiliation(s)
- Juliette Pavie
- Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Université Paris Diderot, Paris, France
| | - Anne Rachline
- Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Université Paris Diderot, Paris, France
| | - Bénédicte Loze
- Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Université Paris Diderot, Paris, France
| | - Laurence Niedbalski
- Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Université Paris Diderot, Paris, France
| | - Constance Delaugerre
- Service de Microbiologie, Hôpital Saint-Louis, Université Paris Diderot, Paris, France
| | - Eric Laforgerie
- Agence Française de Sécurité Sanitaire et des Produits de Santé, Saint Denis, France
| | - Jean-Christophe Plantier
- Laboratoire Associé du Centre National de Référence sur le VIH, CHU Charles Nicolle, Rouen, France
| | - Willy Rozenbaum
- Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Université Paris Diderot, Paris, France
| | - Sylvie Chevret
- Département de Biostatistique et Informatique Médicale, Hôpital Saint-Louis, Université Paris Diderot, Paris, France
| | - Jean-Michel Molina
- Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, Université Paris Diderot, Paris, France
| | - François Simon
- Service de Microbiologie, Hôpital Saint-Louis, Université Paris Diderot, Paris, France
- * E-mail:
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Enhancement of Dot-Immunogold Filtration Assay (DIGFA) by Activation of Nitrocellulose Membranes with Secondary Antibody. FOOD ANAL METHOD 2010. [DOI: 10.1007/s12161-010-9137-5] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/19/2022]
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Krishhan VV, Khan IH, Luciw PA. Multiplexed microbead immunoassays by flow cytometry for molecular profiling: Basic concepts and proteomics applications. Crit Rev Biotechnol 2009; 29:29-43. [PMID: 19514901 DOI: 10.1080/07388550802688847] [Citation(s) in RCA: 75] [Impact Index Per Article: 4.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/07/2023]
Abstract
Flow cytometry was originally established as an automated method for measuring optical or fluorescence characteristics of cells or particles in suspension. With the enormous increase in development of reliable electronics, lasers, micro-fluidics, as well as many advances in immunology and other fields, flow cytometers have become user-friendlier, less-expensive instruments with an increasing importance for both basic research and clinical applications. Conventional uses of flow cytometry include immunophenotyping of blood cells and the analysis of the cell cycle. Importantly, methods for labeling microbeads with unique combinations of fluorescent spectral signatures have made multiplex analysis of soluble analytes (i.e. the ability to detect multiple targets in a single test sample) feasible by flow cytometry. The result is a rapid, high-throughput, sensitive, and reproducible detection technology for a wide range of biomedical applications requiring detection of proteins (in cells and biofluids) and nucleic acids. Thus, novel methods of flow cytometry are becoming important for diagnostic purposes (e.g. identifying multiple clinical biomarkers for a wide range of diseases) as well as for developing novel therapies (e.g. elucidating drug mechanisms and potential toxicities). In addition, flow cytometry for multiplex analysis, coupled with automated sample handling devices, has the potential to significantly enhance proteomics research, particularly analysis of post-translational modifications of proteins, on a large scale. Inherently, flow cytometry methods are strongly rooted in the laws of the physics of optics, fluidics, and electromagnetism. This review article describes principles and early sources of flow cytometry, provides an introduction to the multiplex microbead technology, and discusses its applications and advantages in comparison to other methods. Anticipated future directions, particularly for translational research in medicine, are also discussed.
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Affiliation(s)
- V V Krishhan
- Department of Chemistry, California State University, Fresno, CA 93740, USA.
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Sui J, Lin H, Cao L, Li Z. Dot-immunogold filtration assay for rapid screening of three fluoroquinolones. FOOD AGR IMMUNOL 2009. [DOI: 10.1080/09540100902889936] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 10/20/2022] Open
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Wang JS, Kee MK, Suh SD, Shin HS, Kim HS, Kim SS. Post-evaluation of rapid HIV kits in the Korean market by an anti-HIV EQAS panel. J Virol Methods 2007; 141:141-5. [PMID: 17241675 DOI: 10.1016/j.jviromet.2006.11.036] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 07/21/2006] [Revised: 11/23/2006] [Accepted: 11/27/2006] [Indexed: 11/19/2022]
Abstract
This study aimed to provide evaluation information about rapid HIV kits by the anti-HIV External Quality Assessment Schemes (EQAS) panel of the Korea National Institute of Health (KNIH) and the rapid HIV test panel of the US Centers for Disease Control and Prevention (CDC). Each KNIH anti-HIV EQAS panel from 2003 to 2005 consisted of four or five samples of plasma obtained from blood donors with a strong positive or negative reaction to HIV. KNIH delivered each panel to public health centers for analysis of the HIV test results, and the reactivity of the five rapid HIV kits currently used in the Korean market were compared with that of a CDC reference. The analytic sensitivity and specificity of the rapid HIV kits for the KNIH anti-HIV EQAS in 2005 were 99.3 and 99.1%, respectively; in 2004, 98.8 and 97.1%; and in 2003, 94.8 and 95.9%. Five HIV kits from the CDC panel consistently showed positive reactivity for strong positive samples in all kits, but some showed erratic reactivity for weakly positive samples. This is the first report on post-evaluation of rapid HIV kits in the Korean market by an anti-HIV EQAS panel. It was found that the quality of performance of the rapid HIV tests had improved each year but should be interpreted with caution for weakly positive samples.
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Affiliation(s)
- Jin-Sook Wang
- Division of AIDS, Center for Immunology and Pathology, Korea National Institute of Health, 5, Nok-bun, dong Eunpyung-Gu, Seoul 122-701, South Korea
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16
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Gasasira AF, Dorsey G, Kamya MR, Havlir D, Kiggundu M, Rosenthal PJ, Charlebois ED. False-positive results of enzyme immunoassays for human immunodeficiency virus in patients with uncomplicated malaria. J Clin Microbiol 2006; 44:3021-4. [PMID: 16891532 PMCID: PMC1594619 DOI: 10.1128/jcm.02207-05] [Citation(s) in RCA: 44] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
Malaria may impact upon human immunodeficiency virus (HIV) test results. We evaluated two HIV enzyme immunoassays (EIAs) by testing 1,965 Ugandans with malaria. We found poor positive predictive values (53% and 76%), particularly with younger age. Combining EIAs eliminated false positives but missed 21% of true positives. Performance of HIV EIAs in malaria may be unsatisfactory.
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Affiliation(s)
- Anne F Gasasira
- Department of Medicine, Makerere University Medical School, Kampala, Uganda
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17
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Wen LY, Chen JH, Ding JZ, Zhang JF, Lu SH, Yu LL, Shen LY, Wu GL, Zhou XN, Zheng J. Evaluation on the applied value of the dot immunogold filtration assay (DIGFA) for rapid detection of anti-Schistosoma japonicum antibody. Acta Trop 2005; 96:142-7. [PMID: 16207482 DOI: 10.1016/j.actatropica.2005.07.025] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/19/2022]
Abstract
The dot immunogold filtration assay (DIGFA) is a rapid technique for the detection of anti-Schistosoma japonicum antibody. Its sensitivity with regard to sera obtained from patients with acute or chronic schistosomiasis was shown to be 100 and 96.9%, respectively. The specificity when using sera of people living in an area non-endemic for schistosomiasis japonica was 100%. Cross-reaction rates for paragonimiasis and clonorchiasis patients were 14.3% and 0%, respectively. Parallel serum tests of 1091 residents from an area endemic for S. japonicum by means of DIGFA, enzyme-linked immunosorbent assay and indirect haemagglutination test resulted in positive rates of 9.3%, 11.5% and 11.0%, respectively. Thus, there was a high level of agreement between the sets of results (P>0.05). In conclusion, DIGFA holds considerable promise for rapid and accurate diagnosis of S. japonicum, as it does not require any specific instruments and can be applied with ease. DIGFA has therefore several advantages over conventional diagnostic approaches and is useful not only for screening and sero-epidemiological surveys in the field, but also in clinical settings.
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Affiliation(s)
- Li-Yong Wen
- Research Laboratory of Molecular Immunoparasitology, Nanjing Medical University, Nanjing 210029, China.
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18
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Foglia G, Royster GD, Wasunna KM, Kibaya R, Malia JA, Calero EK, Sateren W, Renzullo PO, Robb ML, Birx DL, Michael NL. Use of rapid and conventional testing technologies for human immunodeficiency virus type 1 serologic screening in a rural Kenyan reference laboratory. J Clin Microbiol 2004; 42:3850-2. [PMID: 15297547 PMCID: PMC497567 DOI: 10.1128/jcm.42.8.3850-3852.2004] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
We report a prospective comparison of human immunodeficiency virus type 1 testing by enzyme immunoassay and Western blot with four rapid tests of 486 subjects performed in rural Kenya. Rapid test sensitivity was 100%. Specificity ranged from 99.1 to 100%. Combined use of two Food and Drug Administration-approved rapid tests yielded a single false-positive result.
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Xiang X, Tianping W, Zhigang T. Development of a rapid, sensitive, dye immunoassay for schistosomiasis diagnosis: a colloidal dye immunofiltration assay. J Immunol Methods 2003; 280:49-57. [PMID: 12972187 DOI: 10.1016/s0022-1759(03)00196-0] [Citation(s) in RCA: 35] [Impact Index Per Article: 1.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/26/2022]
Abstract
The colloidal dye immunofiltration assay (CDIFA) combines the concepts of the double-antigen sandwich assay, the Dot immunofiltration assay, and colloidal dye-linked antigen technique to produce a new dye immunoassay for antibody detection in schistosomiasis. The CDIFA consisted of soluble egg antigen (SEA) of Schistosoma japonicum coated onto nitrocellulose membrane, mounted on a flow-through test device to provide the assay capture matrix. SEA absorbed to a red colloidal dye, R-3, produced in China, served as the antigen-antibody complex detecting reagents. The results showed that the sensitivity of the CDIFA was 100% in 35 cases of acute schistosomiasis (35/35), 98% in 50 cases of chronic schistosomiasis (49/50). The specificity of the assay was 99.4% in 180 healthy individuals (179/180). The cross-reaction was 13.3% in 30 cases of paragonimiasis, 2.6% in 38 cases of clonorchiasis sinensis and 0% in 20 cases of hookworm infection, 20 cases of fasciolopsiasis and 16 cases of ascariasis. The results were similar to those detected by routine enzyme-linked immunosorbent assay (ELISA). In a field evaluation of the CDIFA kit, the positivity rate of the CDIFA was 97.5% in 157 cases of schistosomiasis, compared with 91.1% with the circumoval precipitin test (COPT). The dye-labeled SEA conjugate was stable at room temperature for at least 6 months. The results indicated that the CDIFA provided an economic, simple, rapid, robust test for the detection of schistosome infection, suitable for a wide variety of field applications without any instrumentation.
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Affiliation(s)
- Xiao Xiang
- Institute of Immunology, School of Life Sciences, University of Science and Technology of China, 443 Huangshan Road, Hefei, Anhui 230027, China
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20
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Gupta A, Chaudhary VK. Whole-blood agglutination assay for on-site detection of human immunodeficiency virus infection. J Clin Microbiol 2003; 41:2814-21. [PMID: 12843006 PMCID: PMC165333 DOI: 10.1128/jcm.41.7.2814-2821.2003] [Citation(s) in RCA: 21] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022] Open
Abstract
Simple and rapid diagnostic tests are needed to curtail human immunodeficiency virus (HIV) infection, especially in the developing and underdeveloped nations of the world. The visible-agglutination assay for the detection of HIV with the naked eye (NEVA HIV, which represents naked eye visible-agglutination assay for HIV) is a hemagglutination-based test for the detection of antibodies to HIV in whole blood. The NEVA HIV reagent is a cocktail of highly stable recombinant bifunctional antibody fusion proteins with HIV antigens which can be produced in large quantities with a high degree of purity. The test procedure involves mixing of one drop of the NEVA HIV reagent with one drop of blood sample on a glass slide. The presence of anti-HIV antibodies in the blood sample leads to clumping of erythrocytes (agglutination) that can be seen with the naked eye. Evaluation with commercially available panels of sera and clinical samples has shown that the performance of NEVA HIV is comparable to those of U.S. and European Food and Drug Administration-approved rapid as well as enzyme-linked immunosorbent assay kits. The test detects antibodies to both HIV type 1 (HIV-1) and HIV-2 in a single spot and gives results in less than 5 min. The test was developed by keeping in mind the practical constraints of testing in less developed countries and thus is completely instrument-free, requiring no infrastructure or even electricity. Because the test is extremely rapid, requires no sample preparation, and is simple enough to be performed by a semiskilled technician in any remote area, NEVA HIV is a test for the hard-to-reach populations of the world.
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Affiliation(s)
- Amita Gupta
- Department of Biochemistry, University of Delhi South Campus, New Delhi 110 021, India
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21
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Branson BM. Point-of-Care Rapid Tests for HIV Antibodies/Patientennahe Schnelltests für den Nachweis von HIV-Antikörpern. ACTA ACUST UNITED AC 2003. [DOI: 10.1515/labmed.2003.041] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
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22
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Jani IV, Janossy G, Brown DWG, Mandy F. Multiplexed immunoassays by flow cytometry for diagnosis and surveillance of infectious diseases in resource-poor settings. THE LANCET. INFECTIOUS DISEASES 2002; 2:243-50. [PMID: 11937424 DOI: 10.1016/s1473-3099(02)00242-6] [Citation(s) in RCA: 66] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/15/2022]
Abstract
An accurate, rapid and cost-effective diagnosis is the cornerstone of efficient clinical and epidemiological management of infections. Here we discuss the relevance of an emerging technology, multiplexed immunoassays read by flow cytometry, for the diagnosis of infectious diseases. In these assays, multiple fluorescent microspheres, conjugated to different antigens or antibodies, constitute the solid phase for detecting antibodies or antigens in biological samples. These assays seem to be more sensitive than traditional immunoassays, have a high throughput capacity, and provide a wide analytical dynamic range. Additionally, they have multiplexing ability-ie, they are capable of measuring multiple antibodies or antigens simultaneously. We discuss four different areas where this technology could make an impact in resource-poor settings: (i) infections causing rash and fever in children; (ii) sero-epidemiological studies on vaccine-preventable diseases; (iii) management of genital ulcers and vaginal discharge; and (iv) screening of infections in blood banking. We predict a widespread use for a new breed of small, affordable, practical flow cytometers as field instruments for replacing ELISA and RIA tests, which will also be capable of doing cellular immunological tests such as CD4+ T-cell enumeration and Plasmodium falciparum detection in whole blood.
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Affiliation(s)
- Ilesh V Jani
- Department of Immunology, Instituto Nacional de Saúde, Mozambique
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23
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Mylonakis E, Paliou M, Lally M, Flanigan TP, Rich JD. Laboratory testing for infection with the human immunodeficiency virus: established and novel approaches. Am J Med 2000; 109:568-76. [PMID: 11063959 DOI: 10.1016/s0002-9343(00)00583-0] [Citation(s) in RCA: 73] [Impact Index Per Article: 2.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
The enzyme-linked immunosorbent assay (ELISA) and the Western blot are the primary tests for the diagnosis and confirmation of human immunodeficiency virus (HIV) infection. The ELISA, an inexpensive screening test for antibodies to HIV-1, is both sensitive and specific. The HIV-1 Western blot is a reliable confirmatory test following a repeatedly reactive ELISA. False-positive HIV-1 results with this sequence of tests are extremely rare but can occur, and test results that are inconsistent with clinical or other laboratory information should be questioned, repeated, or supplemented. The US Food and Drug Administration has also approved rapid and more accessible testing methods. Oral mucosal transudate and urine testing are noninvasive testing methods; rapid and home sample collection kits offer easier access to testing.
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Affiliation(s)
- E Mylonakis
- Infectious Disease Division, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts 02114-2696, USA
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24
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Han FC, Hou Y, Yan XJ, Xiao LY, Guo YH. Dot immunogold filtration assay for rapid detection of anti-HAV IgM in Chinese. World J Gastroenterol 2000; 6:400-401. [PMID: 11819608 PMCID: PMC4688762 DOI: 10.3748/wjg.v6.i3.400] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
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25
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Dax EM, O'Connell R. Standardisation of subjectively scored HIV immunoassays: developing a quality assurance program to assist in reproducible interpretation of results using an anti-HIV particle agglutination assay as a model. J Virol Methods 1999; 82:113-8. [PMID: 10894627 DOI: 10.1016/s0166-0934(99)00082-8] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
Immunoassays such as particle agglutination assays, rapid tests and western or line blots are scored or read subjectively. These readings display intra- and inter-reader variability, as well as intra- and inter-laboratory variability. In the present study the consistency of scoring was assessed between readers both within and between two groups of scientists using the Serodia anti-HIV particle agglutination assay as an example of an assay scored subjectively. An anti-HIV positive sample in eight serial dilutions made to yield a full range of results expected for the assay was presented 12 times (96 test wells). Each dilution was placed randomly in a plate and tested with the Serodia anti-HIV particle agglutination assay then photographed. Participants in the two groups each scored the photographed plate independently and twice, 2 h apart. Each well was assigned a status (the consensus result of the four most experienced Australian readers) and each participant's results were compared with this status. The average percentage of wells assessed as 'correct' for the Group A participants was 86% (range 56-98%) and for the Group B participants was 67% 'correct' (range 46-88%). In general, strongly positive and negative wells were scored 'correctly'. The highest variations between scores were seen in the borderline positive dilutions +/- region. A quality assessment program based on the method used to obtain these results will be instituted in order to improve the consistency of scoring assays read subjectively.
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Affiliation(s)
- E M Dax
- National Serology Reference Laboratory, Fitzroy, Australia.
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26
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Xiao LY, Yan XJ, Mi MR, Han FC, Hou Y. Preliminary study of a dot immunogold filtration assay for rapid detection of anti-HCV IgG. World J Gastroenterol 1999; 5:349-350. [PMID: 11819464 PMCID: PMC4695551 DOI: 10.3748/wjg.v5.i4.349] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
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27
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Wu W, Xu DZ, Yan YP, Zhang JX, Liu Y, Li RL. Evaluation of dot immunogold filtration assay for anti-HAV IgM antibody. World J Gastroenterol 1999; 5:132-134. [PMID: 11819411 PMCID: PMC4688524 DOI: 10.3748/wjg.v5.i2.132] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 02/06/2023] Open
Abstract
AIM To detect hepatitis A virus-specific immunoglobulin M (IgM) antibody rapidly.
METHODS Colloidal gold with an average dia-meter of 15 nm was prepared by controlled reduction of a boiling solution of 0.2 g/L- chloroauric acid with 10 g/L-sodium citrate and labeled with anti-HAVIgG as gold probe. Dot immunogold filtration assay (DIGFA) has been developed by coating anti-human μ chain on nitrocellulose membrane (NCM) for capturing the anti-HAV IgM in serum, then using cultured hepatitis A antige n as a “bridge”, connecting anti-HAV IgM in sample and anti-HAV IgG labeled colloidal gold. If there was anti-HAV IgM in sample, gold probes would concentrate on NCM, which will appear a pink dot.
RESULTS A total of 264 serum samples were comparatively detected with both DIGFA and ELISA by “blind” method. Among them, 88 were positive and 146 were negative with the two methods. The sensitivity and the specificity of DIGFA were 86.27% and 90.12%, respectively. Fifteen negative serum samples and 15 positive serum samples were detected 3 times repeatedly, the results were the same.
CONCLUSION DIGFA is a simple, rapid, sensitive, specific and reliable method without expensive equipment and is not interfered with rheumatoid factor (RF) in serum. It is suitable for basic medical laboratories. The test could be applied for diagnosis and epidemiological survey of hepatitis A. It has a broad prospect in applica-tion
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28
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Downing RG, Otten RA, Marum E, Biryahwaho B, Alwano-Edyegu MG, Sempala SD, Fridlund CA, Dondero TJ, Campbell C, Rayfield MA. Optimizing the delivery of HIV counseling and testing services: the Uganda experience using rapid HIV antibody test algorithms. JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES AND HUMAN RETROVIROLOGY : OFFICIAL PUBLICATION OF THE INTERNATIONAL RETROVIROLOGY ASSOCIATION 1998; 18:384-8. [PMID: 9704945 DOI: 10.1097/00042560-199808010-00011] [Citation(s) in RCA: 65] [Impact Index Per Article: 2.4] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 11/25/2022]
Abstract
The AIDS Information Center (AIC) was established in Kampala, Uganda in 1990 in response to increasing interest by members of the general public who wished to know their HIV serostatus. By 1996, >300,000 clients had been seen. HIV serologic testing was performed at a central laboratory and results reported back to AIC after 2 weeks. Approximately 25% of clients failed to learn their HIV serostatus as a result of failure to return or late arrival of results. To address these issues, AIC carried out an evaluation of 3 rapid HIV assays, Sero-Strip, SeroCard, and Capillus, against a standard criterion to identify a testing algorithm that could be used as an on-site confirmatory testing strategy. The study was carried out over a period of 5 working days and 325 clients were seen. An algorithm was identified, which gave no indeterminate results with unambiguously positive or negative specimens, which was 100% sensitive and specific, and which could be integrated with minimal disruption into existing counseling procedures. All clients left AIC knowing their HIV serostatus and having spent <2 hours at the Center. The results of this evaluation demonstrate that "same-day" results can be provided in counseling and testing settings without compromising the quality of counseling or the accuracy of HIV testing.
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Affiliation(s)
- R G Downing
- Centers for Disease Control and Prevention/Uganda Virus Research Institute Research Collaboration, Entebbe.
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Madebo T, Nysaeter G, Lindtjørn B. HIV infection and malnutrition change the clinical and radiological features of pulmonary tuberculosis. SCANDINAVIAN JOURNAL OF INFECTIOUS DISEASES 1997; 29:355-9. [PMID: 9360249 DOI: 10.3109/00365549709011830] [Citation(s) in RCA: 16] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Subscribe] [Scholar Register] [Indexed: 02/05/2023]
Abstract
Patients with HIV infection have atypical clinical features of pulmonary tuberculosis; however, our knowledge on how malnutrition affects the clinical presentation is limited. We studied the influence of malnutrition and HIV infection on the clinical and radiological features of pulmonary tuberculosis (TB). We studied 239 consecutive acid fast bacillus-positive adult patients. Patients were investigated by clinical, radiological, anthropometric and laboratory methods. 78% of the patients were malnourished (BMI < 18.5) and 43% were severely malnourished (BMI < 16). 20% were HIV-positive. HIV-positive TB had significantly more oral candidiasis (OR = 3.72), diarrhoea (OR = 2.71), generalized lymphadenopathy (OR = 2.63), skin disorders (OR = 2.27), neuropsychiatric illness (OR = 2.44), hilar lymphadenopathy (OR = 2.07), but less cavitation (OR = 0.64) and upper lung lobe involvement (OR = 0.70). HIV-negative and severe malnourished patients presented more often with dyspnoea (OR = 1.44), diarrhoea (OR = 1.64), night sweat (OR = 1.83), and less with haemoptysis (OR = 0.58) and cavitation (OR = 0.64). The size of Mantoux was associated with HIV infection and malnutrition. In a logistic regression analysis both HIV status and malnutrition were associated with atypical presentation of pulmonary tuberculosis. Malnutrition and HIV infection both contribute for atypical presentation of pulmonary tuberculosis. The risk of such atypical presentation is particularly high among the severely malnourished HIV-infected patients.
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Affiliation(s)
- T Madebo
- Centre for International Health, University of Bergen, Norway
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30
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McMahon EJ, Fang C, Layug L, Sandler SG. Pooling blood donor samples to reduce the cost of HIV-1 antibody testing. Vox Sang 1995; 68:215-9. [PMID: 7660639 DOI: 10.1111/j.1423-0410.1995.tb02575.x] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/26/2023]
Abstract
Accurate, low cost testing of donated blood is a goal of the global effort to reduce the spread of the human immunodeficiency virus (HIV-1). We describe a modified enzyme immunoassay (EIA) method for detecting HIV-1 antibody (anti-HIV-1) in 15-sample pools. In this preliminary study, the modified EIA was as sensitive for detecting weakly seropositive samples, and as specific for testing HIV-1 Western blot-negative or Western blot-indeterminate results, as testing individual samples by the standard EIA. A simulation of field operations was conducted using pools of blood donor samples collected in the United States and in Shanghai, People's Republic of China. Implementation of the modified EIA method and testing 15-sample pools for anti-HIV-1 is a reliable strategy for reducing the cost of large scale testing of donated blood for anti-HIV-1 in areas of low seroprevalence.
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Affiliation(s)
- E J McMahon
- Department of Pathology, Georgetown University Medical Center, Washington, D.C. 20007, USA
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31
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Acaye GL, Ansaloni L, Tocalli E. Evaluation of performance of reused HIVCHEK 1 + 2 test blocks which have shown negative result: a reliable method for rural hospital? Trop Doct 1995; 25:54-5. [PMID: 7778194 DOI: 10.1177/004947559502500203] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/27/2023]
Abstract
The performance of the reusing of test membranes which have been used previously for negative tests for the detection of antibody to HIV (HIVCHEK 1 + 2 of Ortho Diagnostic Systems, Paris, France) was evaluated under field conditions. The sensitivity and specificity of the reusing strategy compared with a HIV determination obtained by using new HIVCHECK 1 + 2 tests were 89.1% and 100%, respectively. The positive predictive value was 100% and the negative predictive value was 91.5%. The authors conclude that the reduction in sensitivity of the reusing strategy in comparison with the use of new tests makes this strategy ethically unacceptable for the detection of HIV infection in blood donors. On the other hand, the reusing strategy could be very useful for diagnostic purpose and for epidemiological HIV surveillance in resource-poor countries.
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Affiliation(s)
- G L Acaye
- Dr Ambrosoli Memorial Hospital, Kalongo, Kitgum District, Uganda
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32
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Vercauteren G, Beelaert G, van der Groen G. Evaluation of an agglutination HIV-1 + 2 antibody assay. J Virol Methods 1995; 51:1-8. [PMID: 7730430 DOI: 10.1016/0166-0934(94)00092-u] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/26/2023]
Abstract
Studies have shown that an HIV (HIV-PA) agglutination assay (Serodia) for the detection of antibody to human immunodeficiency virus (HIV) can be as sensitive and as specific as enzyme-linked immunosorbent assay (ELISA). However, since this HIV assay was designed to detect antibody to the HIV-1 virus, a substantial number of HIV-2 positive sera are missed by this assay. Since the HIV-2 has now been found throughout the world this test is becoming less suitable. The new HIV-1 + 2 assay version (HIV-1 + 2 PA) was evaluated in 300 sera, which contained 50 HIV-1, 40 HIV-2 and 10 HIV-1/HIV-2 antibody positive samples, and a sensitivity and specificity of 100% and 99%, respectively, was obtained. Whereas all HIV-2 positive sera were detected by the new HIV-1 + 2 version, 26% (13/50) were missed by the old version of the agglutination test. It is concluded that the HIV-1 + 2 PA assay is a promising instrument free assay which can be used for screening purposes in areas where both HIV-1 and HIV-2 are present.
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Affiliation(s)
- G Vercauteren
- Institute of Tropical Medicine, Department of Microbiology, Antwerp, Belgium
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Abstract
This study, based on responses to a questionnaire, was undertaken to define problems in and formulate solutions for improving blood safety in developing countries as part of an effort to monitor the status of blood transfusion services globally. Despite improvements between 1988 and 1992, only 66% of developing countries (DGCs) and 46% of least developed countries (LDCs) screen all blood donations for antibodies to human immunodeficiency viruses; 72% DGCs and 35% LDCs test all donations for hepatitis B surface antigen and 71 and 48%, respectively, for syphilis. The antihuman globulin test is performed routinely in 62% DGCs and 23% LDCs, and inadequate quality assurance in all aspects of preparatory testing is a major weakness in many countries. The blood supply is usually insufficient: none of the LDCs and 9% of the DGCs collect 30 units or more per 1,000 of the population annually. Blood donor systems are totally voluntary and non-remunerated in 15% DGCs and 7% LDCs; 80% DGCs and 93% LDCs rely totally or partially on replacement donors and 25% of both groups on paid donations. The proportion of repeat donors is low (medians: 47% in DGCs, 20% in LDCs), and discard rates for collected blood are often high (up to 33%). Most of the blood collected is transfused as whole blood, and most DGCs and LDCs have inadequate supplies of plasma substitutes for management of acute haemorrhage. The reasons for these problems and suggested solutions are discussed.
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Affiliation(s)
- W N Gibbs
- Unit of Health Laboratory Technology and Blood Safety, World Health Organization, Geneva, Switzerland
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34
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Asihene PJ, Kline RL, Moss MW, Carella AV, Quinn TC. Evaluation of rapid test for detection of antibody to human immunodeficiency virus type 1 and type 2. J Clin Microbiol 1994; 32:1341-2. [PMID: 8051264 PMCID: PMC263692 DOI: 10.1128/jcm.32.5.1341-1342.1994] [Citation(s) in RCA: 9] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/28/2023] Open
Abstract
The Genie HIV-1/HIV-2 rapid assay was compared with an enzyme-linked immunosorbent assay and Western blot (immunoblot) by using 540 serum specimens from four different populations. The Genie HIV-1/HIV-2 assay was easy to perform, required no equipment, provided visual results within 10 min, and demonstrated excellent sensitivity and specificity compared with the Western blot.
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Affiliation(s)
- P J Asihene
- Division of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, MD 21205-2196
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35
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Strecker W, Gürtler L, Schilling M, Binibangili M, Strecker K. Epidemiology and clinical manifestation of HIV infection in northern Zaire. Eur J Epidemiol 1994; 10:95-8. [PMID: 7957799 DOI: 10.1007/bf01717460] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/28/2023]
Abstract
1275 patients were evaluated for HIV-1 + 2 seroprevalence and its association with clinical symptoms of HIV infection. Of 667 apparently healthy subjects, 8.2% had anti-HIV-1 antibodies. In 465 patients with clinical signs of AIDS, 39.4% were seropositive. 143 patients with miscellaneous symptoms had positive predictive values for HIV infection between 67% (vaginal ulcerations) and 20% (profound pyogenic abscesses). The WHO definition for AIDS had a specificity of 78.3%, a sensitivity of 72.2% and a predictive value of 61.6%.
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Affiliation(s)
- W Strecker
- Department of Traumatology, University of Ulm, Germany
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Suarez MA, Blanco B, Brion LP, Schulman M, Calvelli TA, Youchah J, Devash Y, Rubinstein A, Goldstein H. A rapid test for the detection of human immunodeficiency virus antibodies in cord blood. J Pediatr 1993; 123:259-61. [PMID: 8345422 DOI: 10.1016/s0022-3476(05)81698-1] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/30/2023]
Abstract
A commercially available rapid test (HIVCHEK) was compared with an enzyme-linked immunosorbent assay (ELISA) for identifying human immunodeficiency virus type 1 in the serum of newborn infants. Of 1309 cord blood samples tested, the HIVCHEK test detected all the true-positive samples detected by ELISA. Of the 35 samples with positive ELISA results, six had negative results on Western blot; only 1 of the 30 samples with positive HIVCHEK results had negative results on Western blot. Thus the HIVCHEK test can be used to facilitate the rapid identification of HIV-1 in the serum of newborn infants.
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Affiliation(s)
- M A Suarez
- Department of Pediatrics, Albert Einstein College of Medicine, Bronx, NY 10461
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Abstract
Available tests to detect antibody to human immunodeficiency virus (HIV) have a range of applications, and injudicious selection and inappropriate use can add a significant financial burden to budgets for AIDS programmes in developing countries. There are several ways by which the cost of HIV antibody testing can be reduced; they include use of tests appropriate for existing laboratory capabilities; adoption of cost-effective testing strategies; pooling of serum samples before testing; and ensuring best possible purchase prices. Each approach can significantly reduce the cost of HIV antibody testing alone or in combination, which increases the potential sustainability of antibody testing programmes, even in settings of limited resources.
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Affiliation(s)
- H Tamashiro
- Diagnostics Unit, Global Programme on AIDS, WHO, Geneva, Switzerland
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Sirivichayakul S, Phanuphak P, Tanprasert S, Thanomchat S, Uneklabh C, Phutiprawan T, Mungklavirat C, Panjurai Y. Evaluation of a 2-minute anti-human immunodeficiency virus (HIV) test using the autologous erythrocyte agglutination technique with populations differing in HIV prevalence. J Clin Microbiol 1993; 31:1373-5. [PMID: 8501246 PMCID: PMC262943 DOI: 10.1128/jcm.31.5.1373-1375.1993] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/31/2023] Open
Abstract
A total of 1,800 blood specimens (1,000 from healthy blood donors, 300 from patients with sexually transmitted disease, and 500 from intravenous drug users) were simultaneously tested with anti-human immunodeficiency virus enzyme-linked immunosorbent assay (ELISA) kits and a newly developed 2-min test for anti-human immunodeficiency virus based on the principle of autologous erythrocyte agglutination (AGEN Biomedical Limited). We found that AGEN's rapid test was as sensitive and specific as the other ELISA kits.
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Affiliation(s)
- S Sirivichayakul
- Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand
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39
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Wannan GJ, Cranefield MJ, Cutting WA, Fischer PR, Hargreaves FD, Inglis JM. How many bloods will a 'HIVCHEK' check? Multiple tests for HIV antibody for a single screening kit. Trop Doct 1992; 22:151-4. [PMID: 1440880 DOI: 10.1177/004947559202200403] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/27/2022]
Abstract
Detection of HIV infection in blood donors or populations is usually by testing sera for antibodies to HIV-1 and HIV-2. Screening tests are now highly sensitive and specific, but still expensive and scarce in Africa. We tested the commercially available kits 'HIVCHEK 1 + 2' in two field laboratories, on specimens from blood donors and antenatal women in rural Zaire. We describe a method of using one test kit for up to five serum samples, saving money and time. In 491 antenatal mothers in Eastern Zaire, among whom the HIV seroprevalence was 3.3%, we compared 'HIVCHEK' results with results obtained by ELISA and Western blot. The 'HIVCHEK' multiple-sample method had a sensitivity of 82% and a specificity of 99.6%. In an area with an HIV seroprevalence of < 4%, using 'HIVCHEK' by the multiple sample method would lead to a saving of about 2,400 pounds for every 1000 individuals tested.
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40
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Nkengasong J, Van Kerckhoven I, Vercauteren G, Piot P, van der Groen G. Alternative confirmatory strategy for anti-HIV antibody detection. J Virol Methods 1992; 36:159-69. [PMID: 1556162 DOI: 10.1016/0166-0934(92)90147-6] [Citation(s) in RCA: 14] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/27/2022]
Abstract
Enzyme immuno assays for simultaneous screening of antibodies to HIV-1 and HIV-2 (EIA HIV-1 + HIV-2) have recently been developed. Confirming all reactive EIA HIV-1/2 screening results by Western blot (WB) for HIV-1 and HIV-2 antibodies is expensive. Six different EIA HIV-1/2 screening assays and one supplemental Line immuno assay (INNO-LIA HIV-1/HIV-2 Ab (LIA)) for confirmation of reactive EIA HIV-1/2 screening assay results were carried out on a panel of 400 sera of which 13% were HIV-1- and 2.5% were HIV-2-positive. The LIA was used as the 'gold standard'. Retrospectively, the results of the six EIA HIV-1/2 were evaluated in pairs (A and B), applying B to those sera reactive in A. A+B+ results were reported as positive. A+B- were either interpreted as negative or the LIA result of A+B- was accepted as the final result. At least seven of the EIA HIV-1/2 pairs gave rise to no false-positive or -negative results. This strategy was 5 times faster and resulted in a budget on average 50% lower than that of the conventional strategy. Further investigation of these alternative confirmatory strategies, in which the proposed algorithms are applied in sequential use of the different screening assays, are needed under field conditions in developing countries.
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Affiliation(s)
- J Nkengasong
- Department of Microbiology, Institute of Tropical Medicine, Antwerp, Belgium
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41
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Mitchell SW, Mboup S, Mingle J, Sambe D, Tukei P, Milenge K, Nyamongo J, Mubarak OK, Sankale JL, Hanson DS. Field evaluation of alternative HIV testing strategy with a rapid immunobinding assay and an agglutination assay. Lancet 1991; 337:1328-31. [PMID: 1674306 DOI: 10.1016/0140-6736(91)92991-a] [Citation(s) in RCA: 30] [Impact Index Per Article: 0.9] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/28/2022]
Abstract
A rapid immunobinding assay ('HIVCHEK', Ortho) and an agglutination assay ('Serodia-HIV', Fujirebio) were evaluated as an alternative to enzyme-linked immunosorbent assay (ELISA) and western blot under field conditions in Africa for detection of antibody to human immunodeficiency virus (HIV). 7106 specimens were tested at 25 laboratories in Kenya, Ghana, Senegal, and Zaire. HIVCHEK was used as a screening test, and serodia-HIV as a supplemental test to evaluate these assays in an alternative testing strategy to the standard ELISA/western blot testing procedure. In each country, HIVCHEK was more sensitive and specific than ELISA when compared with western blot. The sensitivity of HIVCHEK ranged from 87.0 to 96.3% and the specificity from 99.0 to 100%. The sensitivity and specificity of serodia-HIV ranged from 85 to 98% and from 88 to 98%, respectively. The sensitivity and specificity were affected by the presence of HIV-2 in Ghana and Senegal. Overall, with an HIV-1 prevalence of 14.8% in Kenya and 22.5% in Zaire, the sensitivities of the alternative strategy were 96.4% and 91.4%, the specificities 99.6% and 100%, the positive predictive values 97.6% and 100%, and the negative predictive values 99.3% and 97.9% for Kenya and Zaire, respectively. With this testing format there was an estimated average cost saving of up to 82% over the conventional strategy with ELISA/western blot. This procedure constitutes a reasonable alternative to the standard ELISA/western blot combination.
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Affiliation(s)
- S W Mitchell
- Family Health International, Research Triangle Park Branch, Durham, North Carolina 27709
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43
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Affiliation(s)
- P C Lee
- Department of Clinical Microbiology, Flinders Medical Centre, South Australia
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44
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Affiliation(s)
- P Kestelyn
- Department of Ophthalmology, Centre Hospitalier de Kigali, Rwanda
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45
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Starkey CA, Yen-Lieberman B, Proffitt MR. Evaluation of the Recombigen HIV-1 Latex Agglutination Test. J Clin Microbiol 1990; 28:819-22. [PMID: 2332477 PMCID: PMC267807 DOI: 10.1128/jcm.28.4.819-822.1990] [Citation(s) in RCA: 12] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/31/2022] Open
Abstract
The Recombigen HIV-1 Latex Agglutination (LA) Test was recently licensed by the U.S. Food and Drug Administration for use as a rapid screening assay for human immunodeficiency virus type 1 (HIV-1) antibodies. However, its performance in various settings and in different populations has not been firmly established. Consequently, we evaluated the test in the Cleveland Clinic Retrovirus Laboratory, a regional reference laboratory for HIV diagnostic testing and a testing laboratory for the Ohio Department of Health Anonymous HIV Testing and Counseling Program. Serum samples from 93 individuals presumed to be at high risk for HIV infection were evaluated. The sera were initially tested for HIV antibodies by enzyme-linked immunosorbent assay (ELISA). All repeatedly reactive sera were subjected to confirmatory Western blot (WB; immunoblot) testing. Of 97 serum specimens tested (5 were from one seroconverter), 44 were repeatedly reactive by ELISA and 53 were nonreactive. Of the reactive serum specimens, 31 were confirmed positive and 12 were indeterminate by WB. All of the sera were coded and then retested by the LA test. Of 53 serum specimens nonreactive by ELISA, 51 were also nonreactive in the LA test. Of the 44 serum specimens reactive by ELISA, 16 were nonreactive by LA; however, 3 of the latter were WB positive. No serum specimen with an ELISA ratio (specimen optical density/cutoff optical density) of less than 2.1 scored reactive in the LA test. The LA test was positive for only two of five consecutive serum specimens from a seroconverter despite the fact that all but the earliest of these were ELISA reactive and WB positive. Although the LA test appears to be an adequate first-line screening test when appropriately used according to the directions of the manufacturer, our data suggest that occasional sera with low levels of reactivity by ELISA may not be readily detected as reactive by the LA test.
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Affiliation(s)
- C A Starkey
- Department of Microbiology, Cleveland Clinic Foundation, Ohio 44195
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46
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Abstract
During the past decade, AIDS has become a global health problem with 182,000 cases reported from 152 countries. It is estimated that nearly five to ten million people are infected worldwide with the etiologic agent of AIDS, human immunodeficiency virus type 1 (HIV-1). With a mean incubation period from time of infection to the development of AIDS of eight to ten years, it is projected that nearly all HIV-1-infected individuals will develop AIDS within the next 15 years. In the United States alone, 104,210 cases of AIDS and more than 61,000 deaths have been reported. Sexual, parenteral, and perinatal transmission routes have remained the major modes of transmission, although the proportion of cases within each risk behavior category has changed. Recently, there has been a dramatic increase in the proportion of patients with AIDS who have acknowledged either IV drug use or heterosexual contact with other individuals at high risk for HIV infection. Inner-city minority populations are disproportionately represented among AIDS patients, and HIV-seroprevalence studies demonstrate significantly higher rates of infection among blacks and Hispanics compared with whites, even within the same risk category. In 1988, the US Public Health Service estimated that approximately 1.0 to 1.5 million Americans were currently infected with HIV-1 and that by the end of 1992, a cumulative total of 380,000 cases of AIDS will be diagnosed. In 1992, 80,000 cases of AIDS may be diagnosed, with 66,000 deaths occurring during that year alone.(ABSTRACT TRUNCATED AT 250 WORDS)
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Affiliation(s)
- T C Quinn
- National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland
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47
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Spielberg FA, Kabeya CM, Quinn TC, Ryder RW, Kifuani NK, Harris J, Bender TR, Heyward WL, Tam MR, Auditore-Hargreaves K. Performance and cost-effectiveness of a dual rapid assay system for screening and confirmation of human immunodeficiency virus type 1 seropositivity. J Clin Microbiol 1990; 28:303-6. [PMID: 2107202 PMCID: PMC269595 DOI: 10.1128/jcm.28.2.303-306.1990] [Citation(s) in RCA: 26] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/30/2022] Open
Abstract
Recent studies have shown that rapid, instrument-free assays for the detection of antibody to human immunodeficiency virus (HIV) can be as sensitive and specific as enzyme-linked immunosorbent assay (ELISA) for screening of donated blood in developing countries. Currently, however, specimens which test positive on a screening assay must still be confirmed by Western blot (immunoblot), a method which is not feasible in most developing-country laboratories. We examined whether a testing hierarchy which utilizes neither conventional ELISA nor Western blot can be reliably used for screening and confirmation of HIV infection in a high-risk population. In a retrospective analysis of 3,878 specimens which were screened for antibody to HIV in Kinshasa, Zaire, we observed that a testing hierarchy consisting of duplicate HIVCHEK screening assays followed by duplicate Serodia-HIV confirmatory assays resulted in correct confirmation of all ELISA- and Western blot-positive specimens. We conclude that such a testing hierarchy can produce highly accurate results for identification of positive specimens in routine HIV testing and provides a practical alternative to conventional methods of HIV screening and confirmation.
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Affiliation(s)
- F A Spielberg
- Program for Appropriate Technology in Health, Seattle, Washington 98109
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