Which statement about in-house validation of new instruments is true?

• A. Rely solely on manufacturer's validation data before using the instrument.
• B. In-house validation using side-by-side comparisons before use.
• C. Validation is unnecessary for new instruments.
• D. Validation can be delayed indefinitely.

Answer: (B)

When a new instrument is introduced, you need to verify that it will perform reliably in your own lab environment. The best way is to do in-house validation using side-by-side comparisons before using the instrument clinically. This approach directly tests the new device under your actual workflow, with your reagents, technicians, and sample types, ensuring results are comparable to what the lab already achieves or to a known reference method.

Running identical samples or procedures on the current instrument (or a validated reference system) and the new instrument lets you evaluate key performance aspects—such as results accuracy, precision across runs, staining or measurement quality, artifact rates, and workflow impact. You define acceptance criteria, and only if the new instrument meets those criteria do you approve its use. If it doesn’t, you troubleshoot, adjust settings, or reconsider adoption until performance aligns.

Relying solely on manufacturer validation data ignores how the instrument behaves in your specific lab with your particular processes, so it isn’t sufficient. Validation shouldn’t be delayed indefinitely, as using an unvalidated instrument can compromise results and compliance.