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Originally
Published IVD Technology
October 2004
In this section 1. Custom-molded disposables include holders for lateral-flow immunoassay devices, cuvettes for particular instruments, and specialized sample-handling devices. 2. Dishes, microwell plates, cuvettes are used as containers in assay procedures. Dishes are used for growing bacteria, microwell plates for EIA and for growing cells. Cuvettes are the containers used with spectrophotometric and fluorometric analyzers. 3. Instrument housings, custom-molded components are holders for instruments or devices that are not discarded, but are integral parts of the device. 4. Microspheres, beads, lattices are used in immunoassays to immobilize antibodies or antigens. Uses include procedures that involve washing steps and lateral-flow immunoassays in which antigen from a sample is bound to the antibody on the bead. That bead can carry the antigen-antibody complex to a colored bead that reacts to form a dot, line, or cross to indicate the presence of the antigen. Immunoassay devices use many variations of this use of beads. 5. Pipettes, syringes, droppers, tips are sample-handling devices. They may be designed for use on many types of assays, or custom designed for use with particular instruments or assays. 6. Sample-collection devices, lancets are used to obtain body fluids to be assayed. Needles and lancets are used for blood collection; other specialized devices may be used for urine collection. These devices may be of custom design to permit easy integration into the assay method or its instrumentation. 7. Slides are the sample holders for microscopic analysis of cells and tissues that are being evaluated for abnormal numbers or structures. 8. Swabs are used for preparing sites for venipuncture and for obtaining samples from internal body cavities, throat swabs being particularly common. Swabs may be constructed from specific materials suitable for the organism or cell types being sampled. 9. Tubes are general sample-handling and transport containers. 10. Contract manufacturers produce custom-designed devices for assays, instruments, and applications. Injection molding companies often possess specialized technologies for such manufacturing. (see Section 8: Contract manufacturing). 11. Stock items suppliers are the providers of the generic devices in this category. Copyright ©2004 IVD Technology |
