The Basis of Classification of Biochemistry Medical Diagnostic Tests and Kits

Medical diagnostic laboratories use ready-to use kits to standardize methods and facilitate tests. In spite of the diversity of the manufacturers, the kits are generally prepared using the same methods and solutions. The International Federation of Clinical Chemistry and Laboratory Medicine acts as one of the authorities for evaluating, setting goals and providing recommendations for choosing test methods, but organizations such as the International Association for Laboratory Accreditation have also published guidelines in the form of the ISO 15189 standard. Familiarity with the molecular basis of kits enables the lab technician to identify possible errors and troubleshooting them. Therefore, in addition to practical skills, it is necessary for the technician to be familiar with the details of the testing method. Common methods can be traced back to the 18th century. The pervious literatures focused on specific analyt and presents their differences in terms of sensitivity and specificity while we reclassified the methods based on mechanism of actions.

We searched PubMed, MEDLINE and the other databases for the most common articles discussing the basis and theory of testing and the technical details of the testing method and reviewed the literature by focusing on current Kit mechanisms.

The review on the methodology of current medical diagnostic kits showed that they are based on several methods but could be categorized into peroxidase-based detection, chemical reaction, complex formation, enzymatic assays, and immune assays.

In general, the method of performing a reaction depends on the type of analyte. Therefore, it is obvious that the method of measuring rare metal elements is different from the method of measuring enzymes. The classification of these methods can promote the laboratory science significantly.