Method validation is a process by which a laboratory confirms by examination, and provides objective evidence, that the particular requirements for specific uses of a method are fulfilled. It serves to demonstrate that the method can detect and identify an analyte or analytes.

• In one or more matrices to be analyzed
• In one or more instruments or platforms
• With a demonstrated sensitivity, specificity, accruacy, trueness, reproducibility, ruggedness and precision to ensure that results are meaningful and appropriate to make a decision.
• Reliably for its intended purpose.Intended purpose categories include, but may not be limited to emergency/contingency operations; rapid screening and high throughput testing; and, confirmatory analyses.
• After the method developer has conducted experiments to determine or verify a number of specific performance characteristics that serve to define and/or quantify method performance.

Why validate your test methods?

• Benefits public health and world trade
• False negative results are unacceptable
• ISO 17025 lab accreditation demands the use of validated methods

Our Method Validation Studies

With a long history in method validations, Silliker confirms your methods are suitable for their intended use. We analyze for accruacy, precision and reproducibility in quantitative methods, and sensitivity and specificity in qualitative methods

Adhering to recognize industry protocols, Silliker researchers bring years of experience to each method validation study. At each stage of our custom-designed projects, our research team will keep you informed and engaged. Our method validation studies can help:

• Assist kit manufacturers with nes proprietary testing method developments
• Compare the validation parameters of existing methods

Our Validation Programs based on:

• AOAC Microbiological Guildelines
• ISO 16150:2003
• FDA’s Guidelines for Validation of Analytical Methods for the Detection of Microbial Pathogens in Foods