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| 1-Panel - MDMA |
| One Step Ecstasy Test Device (Page 2) |
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1 |
| A side-by-side comparison was conducted using the MDMA One Step Ecstasy Test Device and a leading commercially available MDMA rapid test. Testing was performed on 240 clinical specimens. Ten percent of the positive specimens employed were either at -25% or +25% level of the cut-off concentration of 500 ng/mL Methylenedioxymethamphetamine. Presumptive positive results were confirmed by GC/MS. Approximately 10% of the negative clinical samples were also confirmed with GC/MS. The following results were tabulated: |
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| Method |
Other MDMA Rapid Test |
Total
Results |
MDMA
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
90 |
1 |
91 |
| Negative |
0 |
149 |
149 |
| Total Results |
90 |
150 |
240 |
% Agreement With
This Commercial Kit |
100% |
99% |
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| MDMA One Step Ecstasy Test Devices were also tested with 93 MDMA positive and 147 MDMA negative urine samples in a clinical study. Nine of these positive urine samples in the +/-25% cut-off range were derived from the concentrated MDMA clinical specimens; the rest were true clinical specimens. All positive samples used in this study were confirmed by GC/MS. Negative clinical samples were screened by a commercial MDMA rapid test kit. Approximately 10% of these negative samples were confirmed by GC/MS. The following results were tabulated: |
|
| |
Negative |
-25%
Cutoff to
Cutoff |
Cutoff
to +25%
Cutoff |
>+25%
Cutoff |
MDMA One Step
Test Device |
Positive |
0 |
3 |
6 |
82 |
Negative |
147 |
2 |
0 |
0 |
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| Eighty (80) of these samples were also run using the MDMA One Step Ecstasy 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 Methylenedioxymethamphetamine at the following concentrations: 0 ng/mL, 250 ng/mL, 375 ng/mL, 500 ng/mL, 625 ng/mL and 750 ng/mL. The result demonstrates >99% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below: |
|
MDMA
Concentration
(ng/mL) |
Percent
of
Cutoff |
n |
Visual
Result |
| Negative |
Positive |
| 0 |
0% |
30 |
30 |
0 |
| 250 |
-50% |
30 |
30 |
0 |
| 375 |
-25% |
30 |
23 |
7 |
| 500 |
Cutoff |
30 |
15 |
15 |
| 625 |
+25% |
30 |
6 |
24 |
| 750 |
+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 Methylenedioxymethamphetamine, 25% Methylenedioxymethamphetamine above and below the cut-off and 50% Methylenedioxymethamphetamine above and below the 500 ng/mL cut-off was provided to each site. The results are given below: |
|
MDMA
Concentration
(ng/mL) |
n |
Site
A |
Site
B |
Site
C |
| - |
+ |
- |
+ |
- |
+ |
| 0 |
15 |
15 |
0 |
15 |
0 |
15 |
0 |
| 250 |
15 |
15 |
0 |
15 |
0 |
14 |
1 |
| 375 |
15 |
10 |
5 |
11 |
4 |
11 |
4 |
| 625 |
15 |
2 |
13 |
2 |
13 |
0 |
15 |
| 750 |
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 250 ng/mL and 750 ng/mL of Methylenedioxymethamphetamine respectively. The MDMA One Step Ecstasy 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 Methylenedioxymethamphetamine to 250 ng/mL and 750 ng/mL. The spiked, pH-adjusted urine was tested with the MDMA One Step Ecstasy 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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