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One Step Drug Test:  Cocaine (Page 2)

1-Panel - COC
One Step Cocaine Test Device

Page 1

Accuracy

A side-by-side comparison was conducted by laboratory personnel using the COC One Step Cocaine Test Device and a commercially available rapid test. Testing was performed on specimens previously collected from subjects presenting for Drug Screen Testing. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:

Method Other COC Rapid Test Total Results
COC One Step Test Device Results Positive Negative
Positive 136 0 136
Negative 7 157 164
Total Results 143 157 300
% Agreement With Commercial Kit 95% >99% 98%

When compared to the GC/MS lab testing method at the cutoff concentration of 300 ng/ml, the following results were tabulated:

Method GC/MS Total Results
COC One Step Test Device Results Positive Negative
Positive 119 17 136
Negative 5 159 164
Total Results 124 176 300
% Agreement With GC/MS Analysis 96% 90% 93%

Eighty (80) of these clinical samples were also run using the COC One Step Cocaine Test Device by an untrained operator at a different site. Based on GC/MS data, the operator obtained a statistically similar Positive Agreement, Negative Agreement and Overall Agreement rate as the laboratory personnel.

Sensitivity

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A drug-free urine pool was spiked with Benzoylecgonine at the following concentrations: 0 ng/ml, 150 ng/ml, 225 ng/ml, 300 ng/ml, 375 ng/ml and 450 ng/ml. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:

Benzoylecgonine Concentration (ng/ml) Percent of Cutoff n Visual Result
Negative Positive
0 0% 30 30 0
150 -50% 30 30 0
225 -25% 30 30 0
300 Cutoff 30 4 26
375 +25% 30 0 30
450 +50% 30 0 30

Precision

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A study was conducted at three physician's offices by untrained operators using three different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens were blind labeled and tested at each site. The results are given below:

Benzoylecgonine Concentration (ng/ml) n Site A Site B Site C
- + - + - +
0 15 14* 0 15 0 15 0
150 15 14 1 15 0 14 1
225 15 4 11 5 10 8 7
375 15 0 15 0 15 0 15
450 15 0 15 0 15 1 14
Non-Valid 15 15/15 15/15 15/15

*Note: Non-valid results were obtained in this treatment. Non-valid tests were provided as part of this study to ensure that readers would accurately identify non-valid test results.

Effect of Urinary Specific Gravity

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Fifteen (15) urine samples of normal, high, and low specific gravity ranges were spiked with 150 ng/ml and 450 ng/ml of Benzoylecgonine respectively. The COC One Step Cocaine Test Device was tested in duplicate using the fifteen neat and spiked urine samples. The results demonstrate that varying ranges of urinary specific gravity does not affect the test results.

Effect of Urinary pH

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The pH of an aliquoted negative urine pool was adjusted to a pH range of 5 to 9 in 1 pH unit increments and spiked with Benzoylecgonine to 150 ng/ml and 450 ng/ml. The spiked, pH-adjusted urine was tested with the COC One Step Cocaine Test Device in duplicate and interpreted according to the package insert. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.

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