Guardian Angel Alcohol Test

Guardian Angel Product Performance Summary
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Development Specifications
The Guardian Angel Alcohol Test was developed to meet modified US Department of Transportation (DOT) Model Specifications for performance testing of alcohol screening devices (as published in 59 FR39388). The DOT specifications were developed for work place testing at the level of 0.02% blood alcohol content (BAC).

Using the DOT Model Specifications as the basis, Guardian Angel modified the DOT Model Specifications at 0.02% BAC to apply to both the 0.04% BAC and 0.08% BAC for the Guardian Angel Alcohol Test. In addition to using the modified Model Specifications, Guardian Angel described other specifications for commercialization.

Performance of the Guardian Angel Alcohol Test Against Development Specifications
To determine the product's performance against the test requirements, the product was tested using a color chart for evaluating the test strip colors in saliva. Following the DOT Model for performance testing, saliva samples were collect from various donors and spiked with alcohol to make concentrations of 0.016%, 0.03%, 0.04%, 0.05%, 0.064%, 0.08% and 0.096% BAC.

Two test strips were evaluated at each level against the color chart for a total of 328 samples. The saliva color chart is used to evaluate the extent of variation between colors seen with saliva samples obtained from different people over the alcohol range by designating the color intensity with a numerical designation. Numerical results were documented and a statistical model was performed to describe and predict performance. The results of the analysis are summarized below.

Percent Positive Results

BAC	0.016%	0.030%	0.040%	0.050%	0.064%	0.080%	0.096%
0.04 color block	0.022%	88.47%	98.17%	99.80%	100%	99.99%	100%
0.08 color block	0.00%	0.047%	13.16%	34.11%	96.96%	99.99%	100%

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Field Use
As with any product, in the course of consumer use various factors may effect product performance. Guardian Angel conducted field tests to determine the performance of the product in the hands of the user in controlled studies. In particular, the field tests involved recording the results yielded by the product against results yielded by a breathalyzer commonly used by police departments. Of course, the breathalyzer itself measures with variability and error that must be accounted for. Though the specific standard deviations for the breathalyzer were unavailable, the manufacturer indicates on the package that the breathalyzer results must be interpreted with a margin of error of at least ą 0.005% BAC. Excerpts from the field test performance data are summarized in the table below. The ranges indicated in the table reflect the variability in the breathalyzer.

Field Test Data

GA Estimate

Breathalyzer Reading

	<.034	.035 - .045	.045 - .074	.075 - .085	.086+	Total Number
Lower Risk	10	2	4	0	0	16
Higher Risk (approx >= .04%	8	8	29	5	3	53
Highest Risk (approx >= .08%	2	0	10	15	41	68
Total	20	10	43	20	44	137

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*Chart summarizes data collected from a controlled field test indicating the number of subjects with various breathalyzer results and corresponding Guardian Angel Alcohol Test results. All chart results read by test administrator.

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