In vitro diagnostic tests

Device Legislation. Regulations covering medical devices define reagents used in in vitro diagnostic tests as devices (see Medical diagnostic reagents Prosthetic and biot dicaldevices). 

CAUTION Contains a biological product for investigational in-vitro diagnostic tests only . 

Reactions not mediated by IgE but produced by a pharmacologic reaction predominantly by the NSAID inhibitors COX-1 and -2 which can cause respiratory, skin or both types of reaction or severe anaphylaxis. These are the most frequent types of reaction. To date, only BAT has been validated as an in vitro diagnostic test with contrasted usefulness. In the best argued study [32], sensitivity of the test... 

Since Congress gave it authority to regulate in vitro diagnostic tests in 1976, the FDA has included assessment of clinical validity based on data made available by the test s developer (Holtzman, 2000). In view of the paucity of published data on predictive values of pharmacogenetic tests, and the likelihood that many of them will be low (Table 9.2), data on clinical validity should be required before pharmacogenetic tests are used clinically.12... 

We have exemplified BART applications in molecular IVDs and demonstrated its compatibility with various amplification methods, its ability to detect and quantify different targets, to cope with crude sample preparations and to provide rapid results under challenging conditions. Overall, BART is a universal reporter system for any molecular in vitro diagnostic tests based on isothermal nucleic acid amplification techniques. 

Visibly luminescent, NIR (980 nm) excitable Er/Yb-doped nanoparticles have been used for microscopic detection in DNA microarrays [65]. The complete absence of endogenous upconversion luminescence leads to very low backgrounds and enhanced contrast. An NIR luminescent ytterbium(III) complex based on the fluorescein-isothiocyanate motif was demonstrated to be an adequate luminescent label in a sandwich-type in vitro diagnostic test [27]. 

Iodine-129 Reactor Checking of radioactivity counters in in-vitro diagnostic testing... 

ISO 15197 2013 In vitro diagnostic test systems—requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus... 

EN 592 Instructions for use for in-vitro diagnostic instruments for self-testing... 

The p-lactams (penicillins and their derivatives) are the drugs which most frequently cause IgE-mediated anaphylactic reactions. Diagnosis is based on skin tests. To date, the best vaUdated in vitro diagnostic methods are specific IgE and BAT. As for the determination of specific IgE using ImmimoCap (Phadia AB, Uppsala, Sweden), the sensitivity of the technique in the diagnosis of immediate reaction to (3-lactams with positive skin test ranges, according to the study, from 37 to 54% with a specificity of between 83 and 100% [23,24]. 

Tumor markers are tumor-associated analytes that are used in patients with known malignancy (carcinoma, sarcoma, lymphoma, etc., which have been diagnosed and confirmed by biopsy). Tumor marker in vitro diagnostic (IVD) tests are... 

Under the Medical Device Amendments of 1976, the FDA is responsible for premarket evaluation of all laboratory testing devices (in vitro diagnostics) intended to be commercially marketed in the United States. There are two major pathways for introducing a medical device into the marketplace the premarket notification [510(k) clearance] and the premarket approval (PMA). The purpose of the 510(k) is to establish that a device is substantially equivalent (SE) to a legally marketed (predicate) device. The purpose of the PMA evaluation process is to establish the intrinsic safety and effectiveness of a new device. Unless specifically exempt, a sponsor must have an approved PMA or cleared premarket notification [510(k)] by the FDA before a device may be legally marketed for IVD use (Fig. 1). 

Directive 98/79/EC on in vitro diagnostics (TVDs ) came into force on 7 June 2000 and is mandatory from 7 December 2003. This covers products such as pregnancy tests, blood glucose monitoring and tests for transmissible diseases. 

On in vitro diagnostic medical devices. Official JL 331 1 37 Thomas L (1998) Labor und Diagnose. TH-Books, Frankfurt, Germany Jacobs DS, De Mott WR, Grady HJ, Horvat RT, Huestis DW, Kasten BL (1996) Laboratory test handbook. Lexi-Comp, Hudson, USA http //www.bipm.org/enus/ 2 Committees/JCTLM.shtml... 

Besides their utilization in the production of many compounds with therapeutic, diagnostic, and immunizing applications, animal cell cultures have undoubted utility in the performance of in vitro cytotoxicity tests. They can be used for the evaluation of potential anti-neoplastic agents and assessment of the safety of various products, such as pharmaceuticals, cosmetics, alimentary additives, pesticides, and industrial chemical products. Cell culture systems are frequently employed in the cancer chemotherapy field, in which their potential value for viability and cytotoxicity tests is largely accepted. Animal models play an important role in toxicity testing, but the pressure to adopt in vitro tests is growing since they present considerable economical advantages over in vivo tests. The use of animal models is limited to human metabolism studies, and there are... 

Kalorama. 2008. The Worldwide Market for In Vitro Diagnostic (IVD) Tests, 6th ed. (with 2009 economy preface). Kalorama Information, www.kaloramainformation.com... 

Regulatory Status of the Primary Antibody Intended use For in vitro diagnostic use. Indicates that a product meets the FDA reguirements as a clinical diagnostic product. Likewise, a CE icon indicates the reagent meets European Union reguirements. Patient test results do not reguire an FDA disclaimer. 

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