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One Step Drug Test:  Methamphetamine (Page 2)

1-Panel - mAMP
One Step Methamphetamine Test Device

Page 1

Accuracy

A side-by-side comparison was conducted using the mAMP One Step Methamphetamine Test Device and a leading commercially available mAMP rapid test. Testing was performed on 300 clinical specimens. Ten percent of the specimens employed were either at -25% or +25% level of the cutoff concentration of 1,000 ng/ml Methamphetamine. Presumptive positive results were confirmed by GC/MS. The following results were tabulated:

Method Other mAMP Rapid Test Total Results
mAMP One Step Test Device Results Positive Negative
Positive 145 0 145
Negative 3 152 155
Total Results 148 152 300
% Agreement With Commercial Kit 98% >99% 99%

When compared to the GC/MS lab testing method at the cutoff concentration of 1,000 ng/ml, the following results were tabulated:

Method GC/MS Total Results
mAMP One Step Test Device Results Positive Negative
Positive 135 10 145
Negative 1 154 155
Total Results 136 164 300
% Agreement With GC/MS Analysis 99% 94% 96%

Eighty (80) of these samples were also run using the mAMP One Step Methamphetamine 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 Methamphetamine at the following concentrations: 0 ng/ml, 500 ng/ml, 750 ng/ml, 1,000 ng/ml, 1,250 ng/ml and 1,500 ng/ml. The result demonstrates >99% accuracy at 50% above and 50% below the cutoff concentration. The data are summarized below:

Methamphetamine Concentration (ng/ml) Percent of Cutoff n Visual Result
Negative Positive
0 0% 30 30 0
500 -50% 30 30 0
750 -25% 30 30 0
1,000 Cutoff 30 18 12
1,250 +25% 30 1 29
1,500 +50% 30 0 30

Precision

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A study was conducted at 3 physician's offices by untrained operators using 3 different lots of product to demonstrate the within run, between run and between operator precision. An identical panel of coded specimens containing no Methamphetamine, 25% Methamphetamine above and below the cutoff and 50% Methamphetamine above and below the 1,000 ng/ml cutoff was provided to each site. The results are given below:

Methamphetamine Concentration (ng/ml) n Site A Site B Site C
- + - + - +
0 15 15 0 15 0 15 0
500 15 15 0 14 1 13 2
750 15 11 4 10 5 10 5
1,250 15 8 7 4 11 6 9
1,500 15 1 14 1 14 0 15

Effect of Urinary Specific Gravity

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Fifteen (15) urine samples of normal, high, and low specific gravity ranges were spiked with 500 ng/ml and 1,500 ng/ml of Methamphetamine respectively. The mAMP One Step Methamphetamine 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 Methamphetamine to 500 ng/ml and 1,500 ng/ml. The spiked, pH-adjusted urine was tested with the mAMP One Step Methamphetamine Test Device in duplicate. The results demonstrate that varying ranges of pH does not interfere with the performance of the test.

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