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| 1-Panel - MTD |
| One Step Methadone Test Device (Page 2) |
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| Page
1 |
| A side-by-side comparison was conducted using the MTD One Step Methadone Test Device and a leading commercially available MTD 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 MTD Rapid Test |
Total
Results |
MTD
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
132 |
0 |
132 |
| Negative |
0 |
168 |
168 |
| Total Results |
132 |
168 |
300 |
% Agreement With
This Commercial Kit |
>99% |
>99% |
>99% |
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| When compared to GC/MS at the cut-off of 300 ng/mL, the following
results were tabulated: |
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| Method |
GC/MS |
Total
Results |
MTD
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
122 |
10 |
132 |
| Negative |
1 |
167 |
168 |
| Total Results |
123 |
177 |
300 |
% Agreement With
GC/MS Analysis |
99% |
94% |
96% |
| A drug-free urine pool was spiked with Methadone 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 cut-off concentration. The data are summarized below: |
|
Methadone
Concentration (ng/mL) |
Percent
of
Cutoff |
n |
Visual
Result |
| Negative |
Positive |
| 0 |
0% |
30 |
30 |
0 |
| 150 |
-50% |
30 |
30 |
0 |
| 225 |
-25% |
30 |
26 |
4 |
| 300 |
Cutoff |
30 |
16 |
14 |
| 375 |
+25% |
30 |
4 |
26 |
| 450 |
+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 Methadone, 25% Methadone above and below the cut-off and 50% Methadone above and below the 300 ng/mL cut-off was provided to each site. The following results were tabulated: |
|
Methadone
Concentration
(ng/mL) |
n |
Site
A |
Site
B |
Site
C |
| - |
+ |
- |
+ |
- |
+ |
| 0 |
15 |
15 |
0 |
15 |
0 |
15 |
0 |
| 150 |
15 |
10 |
5 |
13 |
2 |
14 |
1 |
| 225 |
15 |
4 |
11 |
13 |
2 |
13 |
2 |
| 375 |
15 |
0 |
15 |
1 |
14 |
0 |
15 |
| 450 |
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 Methadone to 150 ng/mL and 450 ng/mL of Methadone respectively. The MTD One Step Methadone 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 Methadone to 150 ng/mL and 450 ng/mL. The spiked, pH-adjusted urine was tested with the MTD One Step Methadone 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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