Diagnostics Group

Seattle, WA, United States

Diagnostics Group

Seattle, WA, United States
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Golden A.,Diagnostics Group | Steel C.,National Institute of Allergy and Infectious Diseases | Yokobe L.,Diagnostics Group | Jackson E.,Diagnostics Group | And 7 more authors.
PLoS ONE | Year: 2013

Onchocerciasis is a neglected tropical disease caused by infection with the parasite Onchocerca volvulus (Ov). An estimated 180 million people are at risk for Ov infection, and 37 million people are infected, mostly in Africa. A lateral flow-based assay to detect human IgG4 antibodies to the Ov-specific antigen Ov-16 was developed as a rapid tool to detect exposure to Ov. The test, when performed on 449 sera specimens from patients with microfiladermia and Ov-negative patients, has a sensitivity of 89.1% (95% confidence interval: 86.2%-92.0%), and specificity of 97% (95% confidence interval: 95.4%-98.6%). Because the intended use of the test is for surveillance, it is highly desirable to have a stable, long-lasting result. An extended read window is thus desirable for a high-volume, busy workflow and facilitates post-surveillance quality assurance. The main restriction on achieving an extended read window for this assay was the erythrocyte lysis that can alter the signal-to-noise ratio, especially in those with low IgG4 levels (weak positives). We describe a test housing that incorporates a user-independent feature driven by assay fluid and an expanding wick that detaches the blood separation membrane from the nitrocellulose used in the assay, but before hemolysis occurs. We demonstrated material functionality at extreme operational conditions (37°C, 80% relative humidity) and a read window of a minimum of 70 days. The fluid-driven assay device performs equally as well with whole blood as with plasma, as demonstrated with 100 spiked clinical specimens (with a correlation coefficient of 0.96). We show a novel, inexpensive, and simple approach to actuating the detachment of the blood separation membrane from the nitrocellulose test with no impact on the performance characteristics of the test.


PubMed | National Institute of Allergy and Infectious Diseases and Diagnostics Group
Type: Evaluation Studies | Journal: Clinical and vaccine immunology : CVI | Year: 2015

Elimination programs for Wuchereria bancrofti and Onchocerca volvulus are in critical need of sensitive, specific, and point-of-contact (POC) tools that can be used for surveillance years beyond cessation of mass drug administration when infection intensities are low. Previously, Wb123 and Ov16 were identified individually as potential filarial antigens for an antibody-based POC test. The present study compares single-antigen Wb123- and Ov16-based POC tests with an integrated configuration to detect antibodies to Wb123 and Ov16 simultaneously. Wb123 and Ov16 isolates were striped onto lateral flow strips containing anti-IgG4. Sera from W. bancrofti-, O. volvulus-, and other helminth-infected or -uninfected individuals were added to the strips with buffer. Strips were read for the appearance of a positive or negative test line for both antigens at 20 min and following drying. Sensitivity, specificity, and predictive values were calculated for the single-antigen and biplex strips. Single and biplex lateral flow strips showed nearly identical results, with >90% sensitivity for Ov16 and >92% sensitivity for Wb123. Overall specificities for the single and biplex tests were 98% and 96% for Ov16 and Wb123, respectively. Biplex tests performed as well as the single-antigen tests regardless of the intensity of patient IgG4 response. The high sensitivity and specificity make these new biplex tests extremely useful for POC long-term surveillance following mass drug administration in Africa that should reduce time and cost in areas where bancroftian filariasis and onchocerciasis are coendemic.


News Article | November 11, 2016
Site: www.newsmaker.com.au

Wiseguyreports.Com Adds “Breath Analyzer -Market Demand, Growth, Opportunities and analysis of Top Key Player Forecast to 2021” To Its Research Database This report studies Breath Analyzer in Global market, especially in North America, Europe, China, Japan, Southeast Asia and India, focuses on top manufacturers in global market, with Production, price, revenue and market share for each manufacturer, covering Market Segment by Regions, this report splits Global into several key Regions, with production, consumption, revenue, market share and growth rate of Breath Analyzer in these regions, from 2011 to 2021 (forecast), like North America Europe China Japan Southeast Asia India Split by product type, with production, revenue, price, market share and growth rate of each type, can be divided into Type I Type II Type III Split by application, this report focuses on consumption, market share and growth rate of Breath Analyzer in each application, can be divided into Application 1 Application 2 Application 3 Global Breath Analyzer Market Research Report 2016 1 Breath Analyzer Market Overview 1.1 Product Overview and Scope of Breath Analyzer 1.2 Breath Analyzer Segment by Type 1.2.1 Global Production Market Share of Breath Analyzer by Type in 2015 1.2.2 Type I 1.2.3 Type II 1.2.4 Type III 1.3 Breath Analyzer Segment by Application 1.3.1 Breath Analyzer Consumption Market Share by Application in 2015 1.3.2 Application 1 1.3.3 Application 2 1.3.4 Application 3 1.4 Breath Analyzer Market by Region 1.4.1 North America Status and Prospect (2011-2021) 1.4.2 Europe Status and Prospect (2011-2021) 1.4.3 China Status and Prospect (2011-2021) 1.4.4 Japan Status and Prospect (2011-2021) 1.4.5 Southeast Asia Status and Prospect (2011-2021) 1.4.6 India Status and Prospect (2011-2021) 1.5 Global Market Size (Value) of Breath Analyzer (2011-2021) 7 Global Breath Analyzer Manufacturers Profiles/Analysis 7.1 Dragerwerk 7.1.1 Company Basic Information, Manufacturing Base and Its Competitors 7.1.2 Breath Analyzer Product Type, Application and Specification 7.1.2.1 Type I 7.1.2.2 Type II 7.1.3 Dragerwerk Breath Analyzer Production, Revenue, Price and Gross Margin (2015 and 2016) 7.1.4 Main Business/Business Overview 7.2 Intoximeters 7.2.1 Company Basic Information, Manufacturing Base and Its Competitors 7.2.2 Breath Analyzer Product Type, Application and Specification 7.2.2.1 Type I 7.2.2.2 Type II 7.2.3 Intoximeters Breath Analyzer Production, Revenue, Price and Gross Margin (2015 and 2016) 7.2.4 Main Business/Business Overview 7.3 Lifeloc Technologies 7.3.1 Company Basic Information, Manufacturing Base and Its Competitors 7.3.2 Breath Analyzer Product Type, Application and Specification 7.3.2.1 Type I 7.3.2.2 Type II 7.3.3 Lifeloc Technologies Breath Analyzer Production, Revenue, Price and Gross Margin (2015 and 2016) 7.3.4 Main Business/Business Overview 7.4 America pharmaceutical 7.4.1 Company Basic Information, Manufacturing Base and Its Competitors 7.4.2 Breath Analyzer Product Type, Application and Specification 7.4.2.1 Type I 7.4.2.2 Type II 7.4.3 America pharmaceutical Breath Analyzer Production, Revenue, Price and Gross Margin (2015 and 2016) 7.4.4 Main Business/Business Overview 7.5 Akers Biosciences 7.5.1 Company Basic Information, Manufacturing Base and Its Competitors 7.5.2 Breath Analyzer Product Type, Application and Specification 7.5.2.1 Type I 7.5.2.2 Type II 7.5.3 Akers Biosciences Breath Analyzer Production, Revenue, Price and Gross Margin (2015 and 2016) 7.5.4 Main Business/Business Overview 7.6 PAS Systems International 7.6.1 Company Basic Information, Manufacturing Base and Its Competitors 7.6.2 Breath Analyzer Product Type, Application and Specification 7.6.2.1 Type I 7.6.2.2 Type II 7.6.3 PAS Systems International Breath Analyzer Production, Revenue, Price and Gross Margin (2015 and 2016) 7.6.4 Main Business/Business Overview 7.7 AlcoPro 7.7.1 Company Basic Information, Manufacturing Base and Its Competitors 7.7.2 Breath Analyzer Product Type, Application and Specification 7.7.2.1 Type I 7.7.2.2 Type II 7.7.3 AlcoPro Breath Analyzer Production, Revenue, Price and Gross Margin (2015 and 2016) 7.7.4 Main Business/Business Overview 7.8 BACtrack 7.8.1 Company Basic Information, Manufacturing Base and Its Competitors 7.8.2 Breath Analyzer Product Type, Application and Specification 7.8.2.1 Type I 7.8.2.2 Type II 7.8.3 BACtrack Breath Analyzer Production, Revenue, Price and Gross Margin (2015 and 2016) 7.8.4 Main Business/Business Overview 7.9 Guth Laboratories 7.9.1 Company Basic Information, Manufacturing Base and Its Competitors 7.9.2 Breath Analyzer Product Type, Application and Specification 7.9.2.1 Type I 7.9.2.2 Type II 7.9.3 Guth Laboratories Breath Analyzer Production, Revenue, Price and Gross Margin (2015 and 2016) 7.9.4 Main Business/Business Overview 7.10 Meretek Diagnostics Group of Otsuka 7.10.1 Company Basic Information, Manufacturing Base and Its Competitors 7.10.2 Breath Analyzer Product Type, Application and Specification 7.10.2.1 Type I 7.10.2.2 Type II 7.10.3 Meretek Diagnostics Group of Otsuka Breath Analyzer Production, Revenue, Price and Gross Margin (2015 and 2016) 7.10.4 Main Business/Business Overview


Madej R.M.,Hoffmann-La Roche | Davis J.,Diagnostics Group | Holden M.J.,U.S. National Institute of Standards and Technology | Kwang S.,Bio Rad Laboratories Inc. | And 2 more authors.
Journal of Molecular Diagnostics | Year: 2010

The utility of quantitative molecular diagnostics for patient management depends on the ability to relate patient results to prior results or to absolute values in clinical practice guidelines. To do this, those results need to be comparable across time and methods, either by producing the same value across methods and test versions or by using reliable and stable conversions. Universally available standards and reference materials specific to quantitative molecular technologies are critical to this process but are few in number. This review describes recent history in the establishment of international standards for nucleic acid test development, organizations involved in current efforts, and future issues and initiatives. Copyright © American Society for Investigative Pathology and the Association for Molecular Pathology.


Teckningsperioden för Acarix erbjudande avslutades den 7 december 2016. Redan innan teckningsperioden startade hade ett antal befintliga och nya investerare på förhand åtagit sig att teckna aktier för totalt cirka 120 miljoner SEK, vilket motsvarar cirka 86 procent av Erbjudandet. Bland investerarna kan nämnas Puhua Jingxin Guzhou Health Management Partnership, Ålandsbanken Funds Ltd, Ålandsbanken Abp, Lars Holmqvist, tidigare VD för Dako och sedermera Senior Vice President på Agilent Technologies Inc, där han även ansvarade för bolagets Life Sciences and Diagnostics Group, samt Sverker Martin-Löf, Carl Olof By och Rolf Börjesson genom bolaget Industrial Development Partners AB. Dessa investerare prioriterades vid allokeringen av aktierna. Det övergripande målet med emissionen var dock att uppnå en bred spridning av aktierna bland allmänheten för att skapa förutsättningar för likvid handel av aktien på Nasdaq First North Premier. Denna kommunikation distribueras och riktar sig enbart till personer i Storbritannien som är (i) professionella investerare som faller inom den vid var tid gällande Artikel 19(5) i U.K. Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 ("Ordern") eller (ii) subjekt med hög nettoförmögenhet och andra personer som detta meddelande lagligen kan riktas till, vilka omfattas av Artikel 49(2)(a)-(d) i Ordern (alla sådana personer benämns tillsammans "Relevanta Personer"). Personer som inte är Relevanta Personer får inte agera på eller förlita sig på informationen i denna kommunikation. En investering eller investeringsåtgärd som denna kommunikation avser är enbart möjlig för Relevanta Personer och kommer endast att fullföljas med Relevanta Personer. Personer som sprider denna kommunikation måste själva säkerställa att sådan spridning är tillåten.


Ett antal befintliga investerare, däribland Puhua Jingxin Guzhou Health Management Partnership, och externa investerare, däribland Ålandsbanken Funds Ltd, Ålandsbanken Abp, Lars Holmqvist, tidigare VD för Dako och sedermera Senior Vice President på Agilent Technologies Inc, där han även ansvarade för bolagets Life Sciences and Diagnostics Group, samt Sverker Martin-Löf, Carl Olof By och Rolf Börjesson genom bolaget Industrial Development Partners AB, har på förhand åtagit sig att teckna aktier för totalt cirka 120 miljoner SEK, vilket motsvarar cirka 86 procent av Erbjudandet. Härutöver har ett garantikonsortium, bestående av sex externa investerare, ställt emissionsgarantier till Bolaget motsvarande cirka 20 miljoner SEK eller resterande 14 procent av Erbjudandet. Denna kommunikation distribueras och riktar sig enbart till personer i Storbritannien som är (i) professionella investerare som faller inom den vid var tid gällande Artikel 19(5) i U.K. Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 ("Ordern") eller (ii) subjekt med hög nettoförmögenhet och andra personer som detta meddelande lagligen kan riktas till, vilka omfattas av Artikel 49(2)(a)-(d) i Ordern (alla sådana personer benämns tillsammans "Relevanta Personer"). Personer som inte är Relevanta Personer får inte agera på eller förlita sig på informationen i denna kommunikation. En investering eller investeringsåtgärd som denna kommunikation avser är enbart möjlig för Relevanta Personer och kommer endast att fullföljas med Relevanta Personer. Personer som sprider denna kommunikation måste själva säkerställa att sådan spridning är tillåten. Denna kommunikation kan innehålla vissa framåtriktade uttalanden. Sådana uttalanden är alla uttalanden som inte avser historiska fakta och de innehåller uttryck som "anser", "uppskattar", "förväntar", "väntar", "antar", "förutser", "avser", "kan", "fortsätter", "bör" eller liknande. De framåtriktade uttalandena i detta meddelande är baserade på olika uppskattningar och antaganden, vilka i flera fall baseras på ytterligare antaganden. Även om Bolaget anser att dessa antaganden var rimliga när de gjordes, är sådana framåtriktade uttalanden föremål för kända och okända risker, osäkerheter och andra väsentliga faktorer som är svåra eller omöjliga att förutsäga och som ligger utanför Bolagets kontroll. Sådana risker, osäkerheter och väsentliga faktorer kan medföra att de faktiska resultaten kan komma att avvika väsentligt från de resultat som uttryckligen eller underförstått anges i denna kommunikation genom de framåtriktade uttalandena. Informationen, uppfattningarna och de framåtriktade uttalandena i detta meddelande gäller enbart per dagen för detta meddelande och kan förändras utan att det meddelas.


Steel C.,National Institutes of Allergy and Infectious Diseases | Golden A.,Diagnostics Group | Kubofcik J.,National Institutes of Allergy and Infectious Diseases | LaRue N.,Diagnostics Group | And 3 more authors.
Clinical and Vaccine Immunology | Year: 2013

The Global Programme to Eliminate Lymphatic Filariasis has an urgent need for rapid assays to detect ongoing transmission of lymphatic filariasis (LF) following multiple rounds of mass drug administration (MDA). CurrentWHOguidelines support using the antigen card immunochromatographic test (ICT), which detects active filarial infection but does not detect early exposure to LF. Recent studies found that antibody-based assays better serve this function. In the present study, two tests, a rapid IgG4 enzyme-linked immunosorbent assay (ELISA) and a lateral-flow strip immunoassay, were developed based on the highly sensitive and specific Wuchereria bancrofti antigen Wb123. A comparison of W. bancrofti-infected and -uninfected patients (with or without other helminth infections) demonstrated that both tests had high sensitivities and specificities (93 and 97% [ELISA] and 92 and 96% [strips], respectively). When the W. bancrofti-uninfected group was separated into those with other filarial/helminth infections (i.e., onchocerciasis, loiasis, and strongyloidiasis) and those who were parasite uninfected, the specificities of the assays varied between 91 and 100%. In addition, the geometric mean response by ELISA of W. bancrofti-infected patients was significantly higher than the response of those without W. bancrofti infection (P<0.0001). Furthermore, the Wb123 ELISA and the lateral-flow strips had high positive and negative predictive values, giving valuable information on the size of survey population needed to be reasonably certain whether or not transmission is ongoing. These highly sensitive and specific IgG4 tests to the W. bancrofti Wb123 protein give every indication that they will serve as useful tools for post-MDA monitoring. Copyright © 2013, American Society for Microbiology.


De Luca A.,Diagnostics Group | Nardone F.,University of Naples Federico II | Lignola G.P.,University of Naples Federico II | Prota A.,University of Naples Federico II | And 2 more authors.
Advances in Structural Engineering | Year: 2013

This paper discusses the laboratory testing of wall-like reinforced concrete (RC) columns externally confined with glass fiber reinforced polymer (GFRP) laminates and subjected to pure axial load. Specimens were characterized by an overall length of 3.05 m (10 ft), cross-sectional dimensions of 356 by 1,041 mm (14 by 41 in). Three specimens were tested: one was unstrengthened (benchmark) and two were confined with GFRP laminates. Two different confining reinforcement ratios were considered. The experimental investigation aimed at characterizing: the confinement contribution in terms of axial strength and prevention of instability of longitudinal bars, and the sensitivity of any enhancement in performance to the confining reinforcement ratio. The experimental axial stress - axial strain curves are also discussed.


Pavelchak M.A.,Diagnostics Group
MATEC Web of Conferences | Year: 2015

Buildings are subjected to a myriad of vibration excitation sources including mechanical systems, human activity, vehicular traffic, and other environmental conditions. The characteristics (amplitude and frequency) of the excitation from these sources can vary significantly overtime as building use patterns change, systems age, and maintenance activities vary. Overtime many building owners/operators find themselves dealing with vibration complaints which arise unexpectedly and without obvious cause. The complexity of many modern facilities can make pinpointing the source of bothersome vibrations equivalent to finding a needle in a haystack. The objective of this paper is to explore the process of vibration source detection in complex existing facilities through three recent case studies. The vibration testing and evaluation methodologies utilized for source detection on these case studies is explored to highlight challenges faced on these types of projects. Each of the case studies involve existing buildings with many years of successful operation before bothersome vibration events were reported. The case studies presented, explore complaints related to sensitive medical equipment as well as human perception of vibrations. © 2015 Owned by the authors, published by EDP Sciences.


LaBarre P.,Diagnostics Group | Boyle D.,Diagnostics Group | Hawkins K.,Diagnostics Group | Weigl B.,Diagnostics Group
Proceedings of SPIE - The International Society for Optical Engineering | Year: 2011

Many infectious diseases that affect global health are most accurately diagnosed through nucleic acid amplification and detection. However, existing nucleic acid amplification tests are too expensive and complex for most low-resource settings. The small numbers of centralized laboratories that exist in developing countries tend to be in urban areas and primarily cater to the affluent. In contrast, rural area health care facilities commonly have only basic equipment and health workers have limited training and little ability to maintain equipment and handle reagents.1 Reliable electric power is a common infrastructure shortfall. In this paper, we discuss a practical approach to the design and development of non-instrumented molecular diagnostic tests that exploit the benefits of isothermal amplification strategies. We identify modular instrument-free technologies for sample collection, sample preparation, amplification, heating, and detection. By appropriately selecting and integrating these instrument-free modules, we envision development of an easy to use, infrastructure independent diagnostic test that will enable increased use of highly accurate molecular diagnostics at the point of care in low-resource settings. © 2011 Copyright Society of Photo-Optical Instrumentation Engineers (SPIE).

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