Originally Published IVD Technology October 2005
In this section
1. Amplification technologies are those used to multiply over several orders of magnitude the DNA or RNA molecule of interest, or the probe that binds to that DNA or RNA molecule, and are responsible for the extremely high sensitivity of molecular IVDs. The necessary instruments, reagents, and methods are unique to molecular diagnostics and tend to be foundations upon which small biotechnology companies are built.
2. Detection equipment includes methods and instrumentation for visualizing the DNA or RNA sequences of interest. Such products tend to be shared with other nonmolecular technologies, and are often supplied by companies with broader interests and markets.
3. DNA sequencing refers to the research technique used by basic scientists to determine the sequence of a DNA molecule of interest. An IVD can subsequently be developed to recognize and detect that sequence.
4. Electrophoresis and other types of analytical equipment and associated reagents listed in this subcategory are used primarily by R&D scientists to develop and test molecular diagnostics.
5. Probe design is one of the key steps required to uniquely identify a DNA or RNA sequence of interest in a sample, and to tag or modify it in some way so as to be detectable. Probes for IVDs tend to be procured from outside suppliers who specialize in DNA synthesis rather than being made in-house.
6. Protein sequencing may be used in the research lab to decipher the DNA code that will ultimately be used for the probe in a molecular diagnostic, especially when the biochemistry and clinical relevance of the protein is already well established and a convenient source of protein is available.
7. Sample collection and preservation is typical for IVD applications and is not unique to molecular diagnostics, with minor exceptions.
8. Software has been developed to help individual scientists manage and manipulate the immense databases of DNA sequence information generated by public and private laboratories. DNA sequences are represented as a series of As, Cs, Gs, and Ts. To illustrate the complexity, human DNA contains an estimated 6 billion of these letters in a specific order; and a scientist may be faced with the need to find a particular sequence (e.g., CAATTGGGCTAACGT) residing somewhere in the human genome.
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