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| 1-Panel - OPI |
| One Step Opiate Test Device (Page 2) |
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1 |
| A side-by-side comparison was conducted using the OPI One Step
Opiate Test Device and a leading commercially available OPI 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 OPI Rapid Test |
Total
Results |
OPI
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
150 |
0 |
150 |
| Negative |
0 |
150 |
150 |
| Total Results |
150 |
150 |
300 |
% Agreement With
This Commercial Kit |
>99% |
>99% |
>99% |
|
| When compared to GC/MS at the cut-off of 2,000 ng/mL, the
following results were tabulated: |
|
| Method |
GC/MS |
Total
Results |
OPI
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
134 |
16 |
150 |
| Negative |
0 |
150 |
150 |
| Total Results |
134 |
166 |
300 |
% Agreement With
GC/MS Analysis |
>99% |
90% |
95% |
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| Eighty (80) of these samples were also run using the OPI One Step
Opiate 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 Morphine at the following
concentrations: 0 ng/mL, 1,000 ng/mL, 1,500 ng/mL, 2,000 ng/mL,
2,500 ng/mL and 3,000 ng/mL. The result demonstrates >99%
accuracy at 50% above and 50% below the cut-off concentration. The
data are summarized below: |
|
Morphine
Concentration
(ng/mL) |
Percent
of
Cutoff |
n |
Visual
Result |
| Negative |
Positive |
| 0 |
0% |
30 |
30 |
0 |
| 1,000 |
-50% |
30 |
30 |
0 |
| 1,500 |
-25% |
30 |
30 |
0 |
| 2,000 |
Cutoff |
30 |
5 |
25 |
| 2,500 |
+25% |
30 |
4 |
26 |
| 3,000 |
+50% |
30 |
0 |
30 |
| A study was conducted at 3 geographically distinct 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 was blind labeled
and tested at each site. The results are given below: |
|
Morphine
Concentration (ng/mL) |
n |
Site
A |
Site
B |
Site
C |
| - |
+ |
- |
+ |
- |
+ |
| 0 |
15 |
15 |
0 |
15 |
0 |
15 |
0 |
| 1,000 |
15 |
15 |
0 |
15 |
0 |
14 |
1 |
| 1,500 |
15 |
13 |
2 |
10 |
5 |
6 |
10 |
| 2,500 |
15 |
4 |
11 |
0 |
15 |
3 |
12 |
| 3,000 |
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 1,000 ng/mL and 3,000 ng/mL of
Morphine respectively. The OPI One Step Opiate 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 Morphine to
1,000 ng/mL and 3,000 ng/mL. The spiked, pH-adjusted urine was
tested with the OPI One Step Opiate 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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| Specificity and Cross-reactivity:
See Page 1. |
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