The Clinical Laboratory
Marcus stepped out of his car and into the sunshine, ready to head into the hospital for another day of work in
the molecular diagnostics laboratory. Having graduated six months ago from college, he felt very fortunate to have
found a great job that would give him valuable experience until he was ready to apply to medical school. Marcus had
majored in biology and spent his senior year working in a research lab studying the genes that control early embryonic
development in zebrafish. In his current job, he was studying genes again, but this time for a completely different
purpose: to genetic changes in patient DNA that could be contributing to their disease. Entefind ring the laboratory
wing of the hospital, Marcus thought, Working in the molecular diagnostics lab sure is different from when I was doing
experiments in the research lab!
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What made Marcus think that? What exactly is a molecular diagnostics lab, and how does it differ from a research lab?
A molecular diagnostics laboratory is just one of several types of laboratories that exist in hospitals. These laboratories
are also referred to as medical laboratories, or clinical laboratories. The term “clinical” refers to the actual diagnosis and
treatment of patients.
The following resources may help you to answer the questions below.
• Food and Drug Administration (FDA). Tests used in clinical care.
<https://www.fda.gov/medical-devices/vitro-diagnostics/tests-used-clinical-care>
• American Association for Clinical Chemistry (AACC). Where lab tests are performed.
<https://labtestsonline.org/articles/where-lab-tests-are-performed>
• American Association for Clinical Chemistry (AACC). Collecting samples for laboratory testing.
<https://labtestsonline.org/articles/collecting-samples-laboratory-testing>
1. What types of samples might be collected from patients to use for laboratory testing?
2. What are some examples of situations where a doctor might order a lab test to aid in the diagnosis and treatment of a patient?
3. Why does the government regulate clinical laboratories? Why is CLIA certification required?
4. How does the work of a clinical laboratory differ from the experiments being conducted in a research laboratory?Why don’t research laboratories have to comply with CLIA regulations?