Comparison of the in vivo autologous skin test with in vitro diagnostic tests for diagnosis of chronic autoimmune urticaria

2009 ◽  
Vol 30 (1) ◽  
pp. 28-34 ◽  
Author(s):  
Michelle L. Altrich ◽  
John F. Halsey ◽  
Leonard C. Altman
Keyword(s):  
Skin Test ◽  
Diagnostic Tests ◽  
Autoimmune Urticaria ◽  
In Vitro Diagnostic

scholarly journals The influence of sugar–protein complexes on the thermostability of C-reactive protein (CRP)

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Andreea Lorena Mateescu ◽  
Nicolae-Bogdan Mincu ◽  
Silvana Vasilca ◽  
Roxana Apetrei ◽  
Diana Stan ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Protein Complexes ◽  
C Reactive Protein ◽  
Time Resolved Fluorescence ◽  
Time Resolved ◽  
Reactive Protein ◽  
In Vitro Diagnostic ◽  
The Stability ◽  
Positive Controls

AbstractThe purpose of the present study was to evaluate de influence of protein–sugar complexation on the stability and functionality of C-reactive protein, after exposure to constant high temperatures, in order to develop highly stable positive controls for in-vitro diagnostic tests. C-reactive protein is a plasmatic protein used as a biomarker for the diagnosis of a series of health problems such as ulcerative colitis, cardiovascular diseases, metabolic syndrome, due to its essential role in the evolution of chronic inflammation. The sugar–protein interaction was investigated using steady state and time resolved fluorescence. The results revealed that there are more than two classes of tryptophan, with different degree of accessibility for the quencher molecule. Our study also revealed that sugar–protein complexes have superior thermostability, especially after gamma irradiation at 2 kGy, the protein being stable and functional even after 22 days exposure to 40 °C.

scholarly journals The Clinical Review Committee: Impact of the Development of In Vitro Diagnostic Tests for SARS-CoV-2 Within RADx Tech

2021 ◽  
Vol 2 ◽  
pp. 138-141
Author(s):  
Matthew Robinson ◽  
Charlotte Gaydos ◽  
Barbara Van Der Pol ◽  
Sally McFall ◽  
Yu-Hsiang Hsieh ◽  
...  
Keyword(s):  
Clinical Review ◽  
Diagnostic Tests ◽  
Review Committee ◽  
In Vitro Diagnostic

scholarly journals Isolation and Purification of Lipoarabinomannan from Urine of Adults with Active Tuberculosis

2021 ◽  
Author(s):  
Jason L. Cantera ◽  
Andrew A. Rashid ◽  
Lorraine L. Lillis ◽  
Roger B. Peck ◽  
Paul K. Drain ◽  
...  
Keyword(s):  
Diagnostic Tests ◽  
Chemical Processes ◽  
Active Tuberculosis ◽  
Cell Wall Component ◽  
Isolation And Purification ◽  
Specific Antibodies ◽  
A Cell ◽  
Urine Specimens

AbstractLipoarabinomannan (LAM) is a cell wall component of Mycobacterium tuberculosis that is excreted in the urine of persons with active tuberculosis (TB). Limited diagnostic sensitivity of LAM immunoassays has been due to selecting antibodies against LAM derived from in vitro cultured M. tuberculosis, rather than LAM purified from in vivo clinical urine specimens. Urinary LAM (uLAM) is critical to enable the development of and/or screening of novel uLAM-specific antibodies but is typically dilute and in heterogeneous mixtures with other urine components. We used physical, enzymatic, and chemical processes for the scaled isolation and purification of uLAM. The purified material may then be used to develop more sensitive uLAM diagnostic tests for active TB disease.

scholarly journals Development of a Human Gamma Interferon Enzyme Immunoassay and Comparison with Tuberculin Skin Testing for Detection ofMycobacterium tuberculosis Infection

1998 ◽  
Vol 5 (4) ◽  
pp. 531-536 ◽  
Author(s):  
Nuket Desem ◽  
Stephen L. Jones
Keyword(s):  
Enzyme Immunoassay ◽  
Skin Test ◽  
Skin Testing ◽  
Gamma Interferon ◽  
Tuberculin Skin Testing ◽  
In Vitro Test ◽  
Detection Range ◽  
Ifn Γ

ABSTRACT A sensitive two-step simultaneous enzyme immunoassay (EIA) for human gamma interferon (IFN-γ) has been developed and used as an in vitro test for human tuberculosis (TB) in comparison with tuberculin skin testing. The EIA was shown to be highly sensitive, detecting less than 0.5 IU of recombinant human IFN-γ per ml within a linear detection range of 0.5 to 150 IU/ml. The assay was highly reproducible and specific for native IFN-γ. In addition, the assay detected chimpanzee, orangutan, gibbon, and squirrel monkey IFN-γs. Cross-reactions with other human cytokines or with IFN-γs derived from mice, cattle, or Old World monkeys were not evident. The assay was used to detect TB infection by incubating whole blood overnight with human, avian, and bovine tuberculin purified protein derivatives (PPDs), as well as positive (mitogen)- and negative-control preparations. The levels of IFN-γ in plasma supernatants were then determined. Blood from 10 tuberculin skin test-positive individuals responded predominantly to the human tuberculin PPD antigen and to a lesser extent to bovine and avian PPD antigens. By contrast, blood from 10 skin test-negative individuals showed minimal responses or no response to any of the tuberculin PPDs. Detectable levels of IFN-γ were present in all blood samples stimulated with mitogen. In vivo tuberculin reactivity was correlated with IFN-γ responsiveness in vitro. These results support the further study of the blood culture–IFN-γ EIA system as an alternative to skin testing for the detection of human TB infection.

Japanese healthcare system: in vitro diagnostic tests and reimbursements

1994 ◽  
Vol 40 (8) ◽  
pp. 1663-1667 ◽  
Author(s):  
A Shimauchi
Keyword(s):  
Healthcare System ◽  
Prescription Drugs ◽  
Diagnostic Tests ◽  
Diagnostic Testing ◽  
Universal Coverage ◽  
Medical Expenditures ◽  
National Medical ◽  
Dental Procedures ◽  
In Vitro Diagnostic

Abstract In 1961, a new and mandatory National Health Insurance plan was enacted in Japan. This healthcare system has succeeded in providing universal coverage while also containing the growth of national medical expenditures (NME) to the rate of growth of the gross national product (GNP), namely, approximately 4-5% annually, for several decades. All Japanese medical procedures, including dental procedures, prescription drugs, and diagnostic tests, are reimbursed by a fee schedule set by the Ministry of Health and Welfare. The combination of strict fee control and low administration costs has kept the Japanese NME growth below that of the GNP. In 1990, NME was 20.6 trillion yen ($187 billion), total diagnostic testing expenditures (DTE) were 2.3 trillion yen, representing 11.2% of national medical expenditures (NME). Of this amount, in vitro diagnostic testing accounted for 1.4 trillion yen, representing 61% of DTE and 6.8% of NME. Annually, 1.8 billion in vitro diagnostic tests are performed.

COVID-19 Diagnostic Testing: Lessons Learned for Innovative Product Development During A Public Health Emergency

2020 ◽  
Vol 25 (3) ◽  
Author(s):  
Christopher Lamb
Keyword(s):  
Public Health ◽  
Diagnostic Tests ◽  
Financial Incentives ◽  
Diagnostic Testing ◽  
Adaptive Immune Response ◽  
Lessons Learned ◽  
In Vitro Assays ◽  
Health Crisis ◽  
In Vitro Diagnostic

In response to the Coronavirus Disease-2019 (COVID-19) pandemic, the U.S. Food and Drug Administration (FDA) used its emergency authority through Emergency Use Authorizations (EUAs) to make COVID-19 in vitro diagnostic tests widely available to both diagnose active infection and help identify individuals with an adaptive immune response indicating recent or prior infection. Hundreds of innovative tests were quickly developed under Section IV.D. of FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019. National reimbursement guidance through Centers for Medicare & Medicaid Services (CMS) provided significant financial incentives to track the endemic and enable healthcare workers and others get back to work more quickly. The US market for tests grew rapidly and the now exceeds $15 billion. However, many issues regarding product quality and availability have plagued the industry and called into question FDA’s policy and regulatory framework for allowing these tests to be commercially available. This paper analyzes the development of COVID-19 in vitro assays and the lessons learned for innovation during a public health crisis.

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