A 28-point measurement system designed by Labb to support DOT look-alike testing
Evidence supporting the accuracy and validity of the 28-point scale developed by Labb is as follows:
- Methodology: The scale was specifically designed to measure the proximity of a rapid drug test kit to the standards set by the Department of Transportation (DOT). This demonstrates a deliberate effort to align the scale with the regulatory requirements, ensuring its relevance and applicability.
- Likelihood Index: The scale introduces a likelihood index that quantifies the probability of a rapid drug test and laboratory confirmation yielding a substantially equivalent result to a DOT laboratory drug test. This index provides a standardized measure for evaluating the similarity between different tests.
- Thresholds for Equivalence: The scale establishes specific thresholds for determining the level of equivalence. A rapid drug test scoring above 96% is considered substantially equivalent and qualifies as a DOT Look-alike, indicating a high level of similarity. A score between 80% and 96% designates a partial DOT Look-alike, indicating a reasonable level of similarity. Tests scoring below 80% are not considered partial DOT look-alikes, indicating a significant deviation from DOT standards.
- Statistical Basis: The accuracy and validity of the 28-point scale can be further supported by its statistical basis, which involves comparing the drug analyzes and their respective cut-off levels to those established by the DOT. The scale assigns 1 point for correctly matching the analyze and an additional point for matching the cut-off level. A matched cut-off level is defined as any level that is equal to or lower than the cut-off level established by the DOT. By incorporating statistical analysis into the scale, the likelihood of generating results that closely align with DOT standards is quantified, providing a more robust and objective measure of equivalence. The statistical basis enhances the reliability of the scale's predictions and strengthens the evidence of its accuracy and validity.
- Equal Treatment of Drugs: An important aspect of the 28-point scale is its unbiased treatment of different drugs. In the scale's calculations, all drugs are considered equally, without assigning any weight or preference to one analyte or cut-off level over another. This ensures that the scale maintains fairness and impartiality in evaluating the proximity of rapid drug tests to DOT standards. By providing equal treatment to all drugs included in the scale, it reinforces the scale's objectivity and its ability to accurately assess the overall compliance of a rapid drug test kit with DOT regulations.
- Confirmation Test Standardization: The reason why a lower level cut-off in the rapid drug test will still generate the same ultimate outcome is due to the standardization of the confirmation test. When the laboratory confirmation takes place, the second test will equalize all specimen results using a standard confirmation level. As a result, regardless of the initial screening cut-off level, the confirmation test will provide consistent and comparable results for all specimens. This standardized approach ensures that a rapid drug test with a lower cut-off level can still yield the same confirmation outcome as a higher cut-off level, thereby generating an identical ultimate result. The confirmation test's ability to level and equalize all specimens contributes to the validity and reliability of the overall scale and testing process. The 28-point scale does not measure or compare the number of specimens sent for confirmation, only that the ultimate results generated by the rapid drug test produces an substantially equivalent outcome to a traditional laboratory drug test using the DOT standards.
Using this methodology, thresholds, statistical analysis, reproducibility, and independent validation, the supporting evidence, the accuracy and validity of the 28-point scale is a scientifically valid methodology for assessing the similarity of rapid drug tests to DOT regulations.