9 Ways We Prove Your Diagnostic Result Can Be Trusted

A diagnostic assay that reads correctly on the day it’s calibrated can still drift, degrade, or disagree with itself the moment a new reagent lot ships or a sample sits on the bench a little too long.

IVD and Diagnostic Device Performance Testing answers the question a single-point calibration check never can: does the assay agree with a reference method across the full clinical range, does the reagent hold its performance across its claimed shelf life, and does every new manufacturing lot deliver the same result a clinician already trusts. Our IVD and Diagnostic Device Performance Testing programme at the Oragadam laboratory covers nine checkpoints across correlation, stability, consistency, and analytical performance, referenced to the CLSI EP evaluation protocol series used across clinical laboratories worldwide.

Method comparison testing for medical device assays runs paired samples against a predicate or reference method across the full reportable range, confirming the new device agrees closely enough with an established method that a clinician can trust the switch. Reagent stability testing for medical device diagnostics holds reagents at defined storage and stress conditions and re-tests them at intervals across the claimed shelf life, catching degradation trends long before they would ever show up as an unexplained result in a live laboratory. Lot-to-lot consistency testing for medical device reagents and cartridges compares performance across multiple manufacturing batches, since a device that passes validation on one lot but drifts on the next has effectively shipped an unvalidated product.

Accuracy and precision testing establish how close a result sits to the true value and how repeatable that result is across runs, operators, and days, while linearity testing confirms the assay reports proportionally across its full claimed range rather than compressing at the high or low end. Detection limit testing establishes the smallest concentration the assay can reliably distinguish from a blank, interference testing checks that common substances in a real patient sample don’t skew the result, and carryover testing confirms residue from a high-concentration sample doesn’t contaminate the next low-concentration sample run immediately after it on a shared analyzer. Manufacturers bring their programmes to Kiyo R&D Lab because a single missed checkpoint in Medical Device Testing doesn’t surface as a bench-test footnote — it surfaces as a false result, a recalled reagent lot, or a clinical decision made on bad data. Running all nine checkpoints under one accredited scope at Oragadam, with reports formatted for direct regulatory submission, is what turns diagnostic performance testing into evidence your quality team can actually stand behind.

Kiyo R&D Lab – Oragadam

Our IVD and diagnostic device performance testing suite is based at No.13, Srinivasa Perumal Street, Panapakkam, Serapanacheri, Greater Chennai, Tamil Nadu 601301.

Book Your IVD Performance Testing Today

Talk to our Oragadam team about method comparison, reagent stability, or a full diagnostic performance study for your medical device testing programme.

Request IVD Performance Testing

Fill in your details below and our team will get back to you shortly.