Once relegated to the domain of research laboratories, molecular methods for diagnosing infectious diseases had little, if any, place in a clinical diagnostic laboratory before 1985.
Procedurally, molecular methods were:
- very complex,
- required specialized instrumentation, and
- dedicated laboratory space.
They were also initially susceptible to the influence of variation in technique. Although they represented valuable research tools and were helpful as esoteric testing for unique clinical situations, their performance characteristics did not fit well into most clinical laboratories. The subsequent introduction of closed systems, where instrumentation performed many tasks previously performed by the user, mitigated many but not all technique-associated concerns.
Specific pathogens were logical targets for development. Organisms of concern for significant patient populations were complex to sustain in transport and/or were difficult to cultivate and detect by traditional methods, representing some of the first targets of commercially offered molecular-based assays.
Sexually transmitted diseases affecting significant numbers of people, with key pathogens affected by lability in transport or poor sensitivity to traditional cultivation or antigen detection methods, were among the first targets for development.
