4 Key Parts of Validation Documents

In cannabis cultivation, vertical farming, and even controlled environment agriculture, precision and consistency produce the best results. When testing for pathogens validation documents are used to verify that analytical methods are reliable and effective. A well-constructed validation document ensures that every test delivers accurate, consistent, and actionable results. Here's a quick look at the four key components that should be included in any validation document.

A Validation Document Should Include:

1. Sensitivity/Limit of Detection (LoD): A sensitivity test, also known as the limit of detection (LoD), measures how effectively a test can detect low levels of a pathogen. This is particularly important in early-stage infections, where pathogen levels may be minimal but can rapidly increase if left unchecked.

The LoD study evaluates the lowest concentration of the pathogen that the test can still detect with a 95% success rate. And true LoD data will show the results past the test's LoD.

This ensures that even minor pathogen presence is accurately identified, providing cultivators with early warnings to address potential issues before they escalate.

2. Inclusivity: An inclusivity analysis ensures that the test is broad enough to capture various genetic strains of a target pathogen, such as different variants of Fusarium or Pythium in crops.

This analysis helps assess how effectively the test can identify all known variants of the target pathogen, ensuring that it doesn't miss strains that have undergone genetic changes in the pathogen's DNA or RNA sequence.

This helps prevent false negatives and ensures comprehensive pathogen monitoring across diverse environments.

3. Cross-reactivity: A cross-reactivity analysis determines whether a test is specific to the target pathogen (e.g., Pythium) or produces false positives due to the presence of other pathogens (e.g., Fusarium).

The test should be 100% specific for the target pathogen and less than 80% specific for contaminating pathogens, such as other viruses or fungi.

This specificity prevents unnecessary intervention based on false alarms, saving both time and resources.

It's important to showcase various organisms, and not only what is most likely to cross-reactive. Below are shown viruses and viroids. Not shown, but part of the experiment, were also Pythium and Fusarium reactions. For the entire data set, download our TUMIGlow? Validation document.

4. Accuracy: Accuracy measures how well a test correctly identifies true positives and true negatives.

A validation document should show that the test has an accuracy level of at least 95%, meaning that it produces minimal false positives and false negatives.

This accuracy is essential for building trust in the diagnostic tool's ability to provide actionable insights for managing plant health.

As shown by the table below, the TUMIGlow-HLVd assay performed with 99.1% accuracy compared to PCR. The TUMIGlow test detected 100% of HLVd(+) samples down to ~20 viroid copies/μL. Additionally, no false positive or false negative results were obtained.

In summary, a validation document with clear studies on sensitivity, inclusivity, cross-reactivity, and accuracy helps ensure that diagnostic tests are effective tools for maintaining healthy crops in cannabis cultivation, vertical farming, and CEA operations.

Additionally, qualities such as repeatability and flexibility enhance the test's reliability. Ensuring that tests can consistently deliver accurate results (repeatability) and function effectively in diverse conditions (flexibility) gives cultivators confidence in their pathogen detection tools, ultimately helping to protect and optimize their crops.

About TUMI Genomics

TUMI Genomics is advancing cannabis cultivation by bringing biological insights to help commercial growers thrive. Through comprehensive preventative solutions, superior pathogen diagnostics, and data-driven insights, TUMI Genomics is helping cultivators start clean and stay clean. The unrivaled diagnostics, transparent validation, and industry-leading pathogen detection innovations provided by TUMI Genomics are raising the standards of commercial cannabis cultivation. The team at TUMI Genomics is composed of deeply experienced Ph.D. molecular biologists, bioinformaticians, business strategists, and accomplished serial entrepreneurs. ?