Why You Must Verify Manufacturer Claims
When manufacturers release new diagnostic assays, they present impressive performance data validated through rigorous testing. Yet regulatory bodies—from CLIA to CAP, Joint Commission, and international standards like ISO 15189—universally mandate that laboratories independently verify these claims before reporting patient results. This isn't bureaucratic skepticism; it's recognition of a fundamental truth about laboratory medicine.
The Manufacturer's Reality vs. Your Reality
Manufacturers validate their assays under optimal conditions that rarely exist in routine laboratories. Their climate-controlled facilities maintain perfect temperature and humidity. Their samples arrive fresh and properly collected. Their operators often developed the method themselves, possessing intimate knowledge of every nuance.
Your laboratory operates in the real world. Maybe you're in Phoenix, where summer heat strains instruments despite air conditioning. Perhaps you're in New Orleans, fighting constant humidity and salt air corrosion. Your samples travel hours through temperature excursions, sit in pneumatic tubes, and wait in receiving areas before processing.
Even your staff differs fundamentally from validation teams. Manufacturers employ doctoral scientists who spend months perfecting technique with single assays. Your medical technologists juggle dozens of methods across rotating shifts. The overnight technologist performing critical values may have learned the method last week.
Why Geography and Demographics Matter
Patient populations introduce complexity no manufacturer can fully anticipate. Methods validated on healthy Connecticut volunteers perform differently when testing Mississippi patients with high rates of hemoglobinopathies. Immunoassays standardized using Northern European samples show different cross-reactivities in predominantly Asian or African populations.
Endemic diseases, genetic variations, dietary patterns, and environmental exposures all affect assay performance. A thyroid assay perfected in iodine-sufficient regions might shift in iodine-deficient areas. Vitamin D methods validated at sea level may drift at high altitude. These aren't failures of manufacturer validation—they're the inherent limitations of centralized testing.
The Hidden Variables That Affect Performance
Two identical analyzers from the same production line can display clinically significant performance differences. These variations stem from countless factors:
- Minor manufacturing tolerances
- Shipping vibrations and installation procedures
- Local power quality and electromagnetic interference
- Water purification system differences
- Reagent storage conditions and age
- Sample collection and transport practices
Each variable alone seems trivial. Together, they create unique analytical environments that shift performance outside acceptable limits. A method achieving 2% coefficient of variation in the manufacturer's laboratory might show 5% in yours—still acceptable but different enough to affect clinical decisions if unknown.
What Verification Actually Accomplishes
Verification transforms manufacturer promises into proven performance in your specific setting. The process confirms multiple critical parameters:
Accuracy verification ensures your results align with known values, revealing any systematic bias introduced by your unique conditions. Precision studies demonstrate whether you can reproduce the manufacturer's consistency with your staff and environment. Reportable range verification confirms that extreme values measure correctly on your specific instrument. Reference interval verification ensures the manufacturer's "normal" ranges actually reflect your patient population.
Beyond regulatory compliance, verification builds essential competence. Your technologists learn the method's quirks, recognize problematic samples, and understand behavior at medical decision points. This hands-on experience transforms operators into professionals who truly understand their instruments.
When Verification Becomes Validation
Modified FDA-approved tests and laboratory-developed procedures demand more extensive validation since you've ventured beyond manufacturer-tested conditions. Perhaps you've extended collection tube types, altered incubation times, or adapted volumes for pediatric samples. Each modification potentially affects performance, transforming you from verifier to validator.
The Baseline That Protects Your Patients
Verification establishes your laboratory's baseline performance metrics—reference points invaluable for future troubleshooting. When clinicians question unexpected results or quality control shows unusual patterns, you compare against your verified specifications, not distant manufacturer claims. This local knowledge identifies subtle shifts indicating developing problems before they affect patient care.
Why This Mandate Exists Across All Accreditation Systems
The universal requirement to verify manufacturer claims—whether from CLIA, CAP, Joint Commission, state agencies, or international ISO standards—reflects mature understanding of analytical science. Context matters as much as methodology. The best-designed assay still requires local verification to ensure it performs as expected in your unique environment.
Without verification, you're assuming your laboratory matches the manufacturer's test conditions—an assumption that regulatory bodies deem unacceptable for patient care. Every reported result must be traceable to established standards, and verification creates that crucial link between manufacturer validation and your specific testing environment.
The requirement ultimately acknowledges the beautiful complexity that makes each laboratory unique and the serious responsibility we bear in generating results that guide medical decisions. Verification isn't bureaucratic overreach or distrust of manufacturers—it's recognition that excellence in one setting doesn't guarantee equivalent performance in another, and patient care demands we prove the difference.
CAP Personnel Guidance Document. (n.d.). https://documents-cloud.cap.org/appdocs/learning/LAP/TLTM/CAPPersonnelGuideDocument_2024.pdf
Clinical Laborator y Improvement Amendments (CL IA) Verifcation of Performance Specifcations. (n.d.). https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/6064bk.pdf
Abdel Ghafar, M. T. (2020). VERIFICATION OF QUANTITATIVE ANALYTICAL METHODS IN MEDICAL LABORATORIES. Journal of Medical Biochemistry, 0(0). https://doi.org/10.5937/jomb0-24764
Pearson, L. (2020). Method Validation and Verification. https://arup.utah.edu/media/pearson-method-2020/lecture-slides.pdf
Test Method Validation and Verification. (n.d.). https://documents-cloud.cap.org/appsuite/learning/LAP/FFoC/ValidationVerificationStudies/story_content/external_files/checklistrequirements.pdf