A reference range can be verified by

A reference range can be verified by

• A. Testing as few as 20 normal donor specimens
• B. Literature and vendor material review.
• C. Using samples from previously tested hospital patients.
• D. Using pharmacy-provided plasmanate spiked with target analyte concentrations.

Answer: (A)

Verifying a reference range means confirming that the published interval applies to your own patient population, rather than establishing a new range from scratch. For this purpose, a small, well-chosen sample of normal individuals is enough to check applicability. Testing twenty normal donor specimens is the standard minimal approach. If all twenty results fall within the published reference interval, you can verify that the range works in your setting. If any result lies outside, you would investigate further—options include re-evaluating the range or proceeding to establish a lab-specific reference interval with a properly collected dataset. Why the other options aren’t suitable: relying on literature or vendor data doesn’t confirm local applicability; using samples from hospital patients may include disease states and non-normal values that aren’t representative of the reference population; and using spiked plasma is not a real patient sample and won’t reflect natural biological variation needed to verify a reference interval.

Verifying a reference range means confirming that the published interval applies to your own patient population, rather than establishing a new range from scratch. For this purpose, a small, well-chosen sample of normal individuals is enough to check applicability.

Testing twenty normal donor specimens is the standard minimal approach. If all twenty results fall within the published reference interval, you can verify that the range works in your setting. If any result lies outside, you would investigate further—options include re-evaluating the range or proceeding to establish a lab-specific reference interval with a properly collected dataset.

Why the other options aren’t suitable: relying on literature or vendor data doesn’t confirm local applicability; using samples from hospital patients may include disease states and non-normal values that aren’t representative of the reference population; and using spiked plasma is not a real patient sample and won’t reflect natural biological variation needed to verify a reference interval.