Immunoassays designed to detect antibodies and/or antigens play an important role in the laboratory diagnosis and management of patients with infectious diseases. Over the past several decades, clinical laboratories have observed a significant evolution in not only the immunoassays that are available, but also the technology that is used and the potential to automate testing and increase sample throughput. Automated platforms were initially designed to accommodate enzyme immunoassays (EIA), which represented an important advance over traditional methods such as immunofluoresence (IFA) and manual agglutination assays. A number of semiautomated and fully automated immunoassay analyzers are now commercially available for the performance of a variety of bacterial, viral, fungal, and parasitic antibody and/or antigen detection tests (Table 17.1 and Figure 17.1). Many of these systems have found particular utility in the area of clinical virology, where extensive test menus exist for the automated performance of serologic assays for human immunodeficiency virus (HIV), hepatitis viruses, the so-called TORCH (Toxoplasma gondii, rubella, cytomegalovirus, herpes simplex, and HIV) agents implicated in congenital and peripartum infections, and other viruses of clinical significance. The basic technologies used in the instruments generally involve the capture of a particular analyte (e.g., virus-specific IgM, IgG, total antibodies, and/or antigen) using coated polystyrene beads, magnetic particles, microplate wells, solid phase receptacles, or fiber matrix filters. The captured analytes are then detected by colorimetric, chemiluminescence, fluorescence, phosphorescence, and electrochemiluminescence measurements. Recent advances have been made in the development of multiplex immunoassays, which allow for the simultaneous detection of multiple analytes in a single reaction by combining immunoassay chemistries with flow cytometric analysis. In addition, new analyzers are available to automate the processing and interpretation of Western blot (WB) testing. The available automated platforms, whether designed for immunoassays, WB, or multiplex testing, are either compact benchtop units that take up a limited amount of space in the laboratory, or free-standing units with larger footprints which require more space. Many systems are formatted for batch testing only, but certain instruments provide continuous random-access and STAT-processing capabilities that allow the addition of tests and reagents without disruption of contemporaneous testing. The vast majority of the automated immunoassay analyzers provide walk-away simplicity to perform assays from sample processing through interpretation and reporting of results. The instruments can automatically generate work lists of specimens being tested, pipette specimens from primary sample tubes and then dilute the samples, dispense all reagents, time the incubations at a desired temperature, shake the assay vessels if needed, perform all washes, and read and electronically store the final results. Some analyzers have no sample-handling capabilities and perform only the post-sample analytical steps. The majority of manufacturers of automated instruments also provide software for the analysis and management of patient data and for monitoring the quality of the testing being performed. Most of the instruments can also interface with computer-based, hospital laboratory information systems for seamless and accurate reporting of results. The number and selection of automated instruments used depends primarily on the volume of specimens being tested and the number of individual tests to be performed. Some instruments will run only assay protocols developed and preset by the manufacturer, while others will permit the incorporation of user-defined protocols or are completely open systems that can be programmed to perform all analytical steps of a wide variety of manufacturers’ kits.

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Tags: Commercial Methods in Clinical Microbiology

Dec 10, 2017 | Posted by admin in MICROBIOLOGY | Comments Off on 17: Automated Immunoassay Analyzers

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Manufacturer	Product name	Selected features	Test menu*			Selected reference(s)†
			Available in United States	In development	Available outside United States
Abbott Diagnostics‡	Architect i1000SR i2000SR i4000SR	Closed system for Abbott Diagnostics products; chemiluminescence (i1000SR) or advanced chemiflex technology (i2000SR and i4000SR) with flexible protocols and magnetic particle or magnetic microparticle chemistries, respectively; free-standing units; modularity with seamless integration of multiple instruments to single workstations; supports batch and continuous random access testing; onboard capacity to run 25 (i1000SR and i2000SR) and 50 (i4000SR) different assays simultaneously and 100, 200, and 400 tests/h, respectively; primary tube sampling; STAT or standard processing; onboard dilution of samples; multiple reagent configurations; reagent and sample bar code reading; automatic detection of adequate reagent or specimen; clot detection; automatic sample rerun capability; onboard reagent refrigeration; onboard data management; onboard quality control monitoring and maintenance records; onboard instrument self diagnostics; LIS interface; autocalibration or autocalibration alert	Anti-HAV IgG, anti-HAV IgM, HBsAg, HBsAg confirmatory, anti-HBc total, anti-HBc IgM, anti-HBsAg, anti-HCV, HIV-1/2 Ag/Ab combination available on all three instruments	Anti-EBV panel on i1000SR and i2000SR	Anti-HAV IgG, anti-HAV IgM, HBsAg qualitative, HBsAg quantitative, HBsAg confirmatory, anti-HBc total, anti-HBc IgM, anti-HBsAg, anti-HBeAg, HBeAg, anti-HCV, HIV-1/2 Ag/Ab combo, anti-HTLV-I/HTLV-II, CMV IgG and IgM, CMV IgG avidity, rubella virus IgG and IgM, Toxoplasma gondii IgG and IgM, T. gondii IgG avidity, anti-Trypanosoma cruzi IgG (chagas), anti-Treponema pallidum (syphilis) IgG available on all three instruments; HCV Ag available on i2000SR and i4000SR	1, 3, 15, 22, 23, 28–31, 35, 44–46, 48, 50–55, 60, 61, 66
Alere, Inc.	DSX/ DS2	Open systems; EIA utilizing coated microplate wells and colorimetric measurement; benchtop units; full walk-away capability; modular design with flexible reagent configuration; fully automated microplate processor with precise liquid-handling capabilities; batch testing; can process up to two (DS2) or four (DSX) 96-well microplates; onboard capacity to run 12 different assays simultaneously; primary tube sampling with sample bar code reading capability; onboard dilution of samples; automatic detection of adequate reagent or specimen; clot detection; onboard data management; onboard instrument self diagnostics; LIS interface	Systems can be programmed to perform all analytical steps for virtually any EIA, including Alere’s immunoassay product lines. This includes sample dispensing, reagent addition, plate shaking, incubating and washing microplates, reading results, data reduction, and printing customized reports. DSX is best suited for medium to high throughput laboratories and the DS2 for smaller laboratories			None identified
Awareness Technology Inc.	ChemWell 2910	Open system; EIA utilizing coated microplate wells and colorimetric measurement; fully automated modular benchtop design; handles up to 27 reagents and 96 samples and 200 tests/h with multiple reagent configurations; primary tube sampling; batch, random access or STAT capabilities; can make predilutions and automatically dilutes and retests samples when needed; automatic detection of adequate reagent and specimen; onboard data management; onboard quality control monitoring; onboard instrument self diagnostics	System can be programmed to perform all analytical steps for virtually any EIA. This includes sample dispensing, reagent addition, incubating and washing microplates, reading results, data reduction, and printing customized reports. Designed to complete 200 tests/h			None identified
Beckman Coulter, Inc.	Access/ Access 2	Closed system for Beckman Coulter products; Chemiluminescence detection with magnetic particle separation; free-standing unit with continuous random access capabilities; onboard capacity to run 24 different assays simultaneously and 100 tests/h; primary tube sampling; multiple reagent configurations; reagent and sample bar code reading; automatic detection of adequate reagent or specimen; clot detection; onboard reagent refrigeration; onboard data management; onboard quality control monitoring and maintenance records; onboard instrument self diagnostics; LIS interface	Rubella virus IgG, T. gondii IgG and IgM	None identified	Rubella virus IgG, T. gondii IgG and IgM, anti-HAV, anti-HAV IgM, anti-HBc total, anti-HBc IgM, anti-HBsAg, HBsAg, HBsAg confirmatory, CMV IgG and IgM, rubella virus IgM	12, 25, 29, 34, 36, 40, 43, 47
	UniCel DxI 600 DxI 800 DxC 600i DxC 660i DxC 680i DxC 860i DxC 880i	Closed system for Beckman Coulter products. Chemiluminescence detection with magnetic particle separation; free-standing units with continuous random access capabilities; onboard capacity to run 50 different assays simultaneously and 200 (DxI600) and 400 (DxI800) tests/h, respectively; primary tube sampling; multiple reagent configurations; reagent and sample bar code reading; automatic detection of adequate reagent or specimen; clot detection; onboard reagent refrigeration; onboard dilution of patient samples; autocalibration or autocalibration alert; onboard data management; onboard quality control monitoring and maintenance records; onboard instrument self diagnostics; LIS interface; DxI 600 and DxI 800 are immunoassay analyzers only; DxC 600 and 800 series perform parallel processing of immunoassay and chemistry tests on one system	Rubella virus IgG, T. gondii IgG and IgM	None identified	Rubella virus IgG, T. gondii IgG and IgM, anti-HAV, anti-HAV IgM, anti-HBc total, anti-HBc IgM, anti-HBsAg, HBsAg, HBsAg confirmatory, CMV IgG and IgM, rubella virus IgM	12, 29, 40, 41
bioMérieux, Inc.	VIDAS/ Mini-VIDAS	Closed system for bioMérieux products; enzyme-linked fluorescence assay; automated benchtop unit; random access and batch testing; reagent and sample bar code reading; autocalibration or autocalibration alert; onboard data management; onboard quality control monitoring and maintenance records; LIS interface; VIDAS contains five sections accepting 6 tests each and can handle 60 tests/h; Mini-VIDAS has 2 sections accepting 6 tests each and can handle 24 tests/h; number of different assays that can be run simultaneously is 30 for VIDAS and 12 for Mini-VIDAS	CMV IgG and IgM, measles virus IgG, mumps virus IgG, rubella virus IgG, VZV IgG, H. pylori IgG, T. gondii IgG and IgM, T. gondii IgG and IgM competition, T. gondii IgG avidity, anti-Borrelia burgdorferi (lyme) IgG and IgM, Chlamydia trachomatis Ag, C. trachomatis blocking assay, rotavirus Ag, RSV Ag, Clostridium difficile toxin A and B	None identified	CMV IgG and IgM, measles virus IgG, mumps virus IgG, rubella virus IgG, VZV IgG, H. pylori IgG, T. gondii IgG and IgM, T. gondii IgG and IgM competition, T. gondii IgG avidity, B. burgdorferi (lyme) IgG and IgM, C. trachomatis Ag, C. trachomatis blocking assay, rotavirus Ag, RSV Ag, C. difficile toxin A and B, anti-HIV-1 and -2, HIV p24 Ag, HIV DUO (combined detection of p24 Ag and anti-HIV-1 and anti-HIV-2 Ab), EBV, anti-HAV total, anti-HAV IgM, HBsAg, anti-HBsAg, anti-HBc total, anti-HBc IgM, HBeAg, anti-HBeAg	2, 6, 10, 12, 22, 23, 26, 31, 37, 38, 40, 45–47, 49, 53, 54, 60, 65
Bio-Rad Laboratories	PhD System/ PhD Ix System	Open systems; EIA or IFA utilizing coated microplate wells or slides; benchtop units with batch testing; multiple reagent configurations; capacity to do eight different EIAs or four different IFAs simultaneously; primary tube sampling with sample bar code reading; automatic detection of adequate reagent or specimen; onboard dilution of specimens; onboard data management; LIS interface	Systems can be programmed to automate a wide variety of enzyme or immunofluorescence assays. This includes the front end processing for sample dispensing, reagent addition, and the incubating and washing of microplates and slides. Reading results and data reduction are done outside the systems using additional equipment			None identified
	BioPlex 2200	Closed system for Bio-Rad products. Multiplex flow cytometric immunoassays with magnetic particle separation; free-standing unit with batch or continuous random access capabilities; onboard capacity to run 440 different assays simultaneously and 100 tests/h; primary tube sampling; reagent and sample bar code reading; automatic detection of adequate reagent or specimen; clot detection; onboard reagent refrigeration; onboard dilution of patient samples; autocalibration or autocalibration alert; onboard data management; onboard maintenance records; LIS interface	EBV VCA IgG and IgM, EBV EA diffuse IgG, EBV EBNA IgG, heterophile IgM, T. pallidum (syphilis) IgG, T. gondii IgG, measles virus IgG, mumps virus IgG, rubella virus IgG and IgM, CMV IgG and IgM, HSV-1 and HSV-2 IgG	T. pallidum (syphilis) IgM, T. gondii IgM, HIV, hepatitis tests, B. burgdorferi (lyme) IgG	EBV VCA IgG and IgM, EBV EA diffuse IgG, EBV EBNA IgG, heterophile IgM, T. pallidum (syphilis) IgG, T. gondii IgG and IgM, measles virus IgG, mumps virus IgG, rubella virus IgG and IgM, CMV IgG and IgM, HSV-1 and HSV-2 IgG, T. pallidum (syphilis) IgM	4–7, 9, 24, 33
	EVOLIS Premium/ EVOLIS Twin Plus	Open systems; EIA utilizing coated microplate wells and colorimetric measurement; benchtop units; full walk-away capability; modular design with flexible reagent configuration; fully automated microplate processor; batch testing; onboard capacity for 180 (EVOLIS Premium) or 144 (EVOLIS Twin Plus) samples; primary tube sampling; reagent and sample bar code reading capability; onboard dilution of samples; clot detection; onboard data management; onboard quality control monitoring and maintenance records; LIS interface	Systems can be programmed to perform all analytical steps for EIA, including Bio-Rad’s immunoassay product lines. This includes sample dispensing, reagent addition, plate shaking, incubating and washing microplates, reading results, data reduction, and printing customized reports. EVOLIS Premium is best suited for medium to high throughput laboratories and the EVOLIS Twin Plus for smaller laboratories			13
Diamedix Corp.	MAGO 4S	Open systems; EIA or IFA utilizing coated microplate wells or slides; benchtop units with batch testing or continuous random access capabilities; multiple reagent configurations; capacity for 4 EIA plates, 16 IFA slides, and 120 samples; primary tube sampling; reagent and sample bar code reading capability; automatic detection of adequate reagent or specimen; onboard dilution of specimens; onboard quality control monitoring; autocalibration or autocalibration alert; onboard data management; LIS interface	System can be programmed to simultaneously process samples for EIA and IFA. This includes the front end processing for sample dispensing, reagent addition, the incubating and washing of microplates and slides, and the internal reading and data reduction of EIA results. The system supports Diamedix EIA and IFA kits as well as other manufacturers’ assays			None identified
	MAGO Plus	Open system; EIA utilizing coated microplate wells and colorimetric measurement; benchtop unit; fully automated microplate processor; batch or random access testing; can process up to four 96-well microtiter plates; onboard capacity to load 120 samples and run nine different assays simultaneously; multiple reagent configurations; primary tube sampling; reagent and sample bar code reading capability; automatic detection of adequate reagent or specimen; onboard dilution of specimens; onboard quality control monitoring; autocalibration or autocalibration alert; onboard data management; LIS interface	System can be programmed to perform all analytical steps for EIA. This includes sample dispensing, reagent addition, the incubating and washing of microplates, reading results, data reduction and printing customized reports. The system supports Diamedix EIA kits as well as other manufacturers’ assays			None identified
DiaSorin, Inc.	ETI-MAX 3000	Closed system for DiaSorin products; EIA utilizing coated microplate wells and colorimetric measurement; fully automated microplate processor; multiple reagent configurations; benchtop unit with batch or random access capabilities; onboard capacity to load 240 samples; primary tube sampling; reagent and sample bar code reading capability; automatic detection of adequate reagent or specimen; clot detection; onboard dilution of specimens; onboard quality control monitoring and maintenance records; onboard data management; LIS interface	EBV VCA IgG and IgM reverse capture, EBV EBNA IgG, measles virus IgG, mumps virus IgG, VZV IgG, HSV-1/2 IgG, CMV IgG and IgM capture, rubella virus IgG, H. pylori IgG, T. pallidum (syphilis) IgG, T. gondii IgG and IgM capture	None identified	None identified	14
	LIAISON/ LIAISON XL	Closed systems for DiaSorin products; chemiluminescence detection with magnetic particle separation; benchtop (LIAISON) or free-standing (LIAISON XL) units with batch testing or continuous random access capabilities; onboard capacity to run 15 (LIAISON) and 25 (LIAISON XL) different assays simultaneously; primary tube sampling; reagent and sample bar code reading; automatic detection of adequate reagent or specimen; clot detection; onboard reagent refrigeration; onboard dilution of patient samples; onboard data management; onboard quality control monitoring and maintenance records (LIAISON XL only); LIS interface; LIAISON XL has 50-90% more throughput capability than the LIAISON	LIAISON: EBV VCA IgG and IgM, EBV EBNA IgG, EBV EA IgG, CMV IgG and IgM, VZV IgG, HSV-1/2 type-specific IgG, rubella virus IgG, measles virus IgG, mumps virus IgG, T. gondii IgG and IgM, T. pallidum (syphilis) IgG and IgM, anti-B. burgdorferi (lyme) total, anti-HAV IgM, anti-HAV total LIAISON XL: T. pallidum (syphilis) IgG and IgM, measles virus IgG, mumps virus IgG, anti-HAV total	LIAISON: None identified LIAISON XL: anti-HCV, HIV, HBsAg	LIAISON: EBV VCA IgG and IgM, EBV EBNA IgG, EBV EA IgG, CMV IgG and IgM, VZV IgG, HSV-1/2 type-specific IgG, HSV-1/2 IgM, rubella virus IgG and IgM, measles virus IgG, mumps virus IgG, T. gondii IgG and IgM, T. gondii IgG avidity, T. pallidum (syphilis) IgG and IgM, anti-B. burgdorferi (lyme) total, anti-HAV IgM, anti-HAV total LIAISON XL: T. pallidum (syphilis) IgG and IgM, measles virus IgG, mumps virus IgG, anti-HAV total	4, 11, 17, 20, 23, 30, 32, 37–39, 49, 51, 53, 60
Dynex Technologies	Agility	Open system; EIA utilizing coated microplate wells and colorimetric measurement; benchtop unit; full walk-away capability; flexible reagent configuration; fully automated microplate processor with precise liquid-handling capabilities; batch testing; onboard capacity to run 16 different assays simultaneously and 12 plates at once; primary tube sampling; reagent and sample bar code reading capability; onboard dilution of samples; automatic detection of adequate reagent or specimen; clot detection; onboard data management; onboard instrument self diagnostics; onboard maintenance records; LIS interface	Systems can be programmed to perform all analytical steps for virtually any EIA. This includes sample dispensing, reagent addition, plate shaking, incubating and washing microplates, reading results, data reduction, and printing customized reports. Reagents provided by various manufacturers are placed in self-contained, easy-to-use, direct-load reagent kits (SmartKits) prepackaged for each assay			None identified
	DSX/ DS2