Establishing the value to the provider to determine test needs is essential. Fundamentally, a test has value if it can do one or more of the following:
- Detect if a patient has a disease
- Confirm a patient's disease or condition
- Classify a patient's disease or condition
- Monitor a patient's disease or condition
A test can do this only if it is efficient, specific, and sensitive. A test is efficient if it correctly classifies a patient as having a particular disease or condition. Sensitivity is the ability to detect a disease, and specificity is the ability to identify a disease or condition positively. Most test reagent manufacturers provide the sensitivity and specificity of their test method. Suppose the providers primarily aim to screen for a possible disease or condition. In that case, they will want a susceptible test and follow up with a specific (possibly more expensive) test to confirm the patient has a disease or condition.
The laboratory ensures that the added tests will meet the providers' needs.
An example scenario is a Family Practice Clinic that wants to add a COVID-19 SARS 2 test to screen their patients. The vendor indicated that the instrument they had would not be expensive to purchase and provided a waived testing format. Upon reviewing research data provided by the FDA for early approval of the instrument and test, the data showed 80% sensitivity and 100% specificity. This would not be a good solution for their laboratory because they wanted a test to rule out COVID-19 SARS 2.
