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| 1-Panel - mAMP |
| One Step Methamphetamine Test Device (Page 2) |
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1 |
| 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 cut-off 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 |
147 |
0 |
147 |
| Negative |
1 |
152 |
153 |
| Total Results |
148 |
152 |
300 |
% Agreement With
This Commercial Kit |
99% |
100% |
99% |
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| When compared at 1,000 ng/mL cut-off with GC/MS, the following
results were tabulated: |
|
| Method |
GC/MS |
Total
Results |
mAMP
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
135 |
12 |
147 |
| Negative |
1 |
152 |
153 |
| Total Results |
136 |
164 |
300 |
% Agreement With
GC/MS Analysis |
99% |
93% |
96% |
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| 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. |
| 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 cut-off 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 |
24 |
6 |
| 1,000 |
Cutoff |
30 |
18 |
12 |
| 1,250 |
+25% |
30 |
1 |
29 |
| 1,500 |
+50% |
30 |
0 |
30 |
| A study was conducted at 3 physicians' 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 cut-off and 50% Methamphetamine
above and below the 1,000 ng/mL cut-off 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 |
15 |
0 |
14 |
1 |
| 750 |
15 |
10 |
5 |
2 |
13 |
13 |
2 |
| 1,250 |
15 |
0 |
15 |
0 |
15 |
1 |
14 |
| 1,500 |
15 |
0 |
15 |
0 |
15 |
0 |
15 |
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| 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. |
| 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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| Specificity and Cross-reactivity:
See Page 1. |
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