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| 1-Panel - PCP |
| One Step Phencyclidine Test Device (Page 2) |
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1 |
| A side-by-side comparison was conducted using the PCP One Step
Phencyclidine Test Device and a leading commercially available PCP
rapid test. Testing was performed on 212 clinical specimens. Ten
percent of the specimens employed were either at -25% or +25% level
of the cut-off concentration of 25 ng/mL Phencyclidine. Presumptive
positive results were confirmed by GC/MS. The following results were
tabulated: |
|
| Method |
Other PCP Rapid Test |
Total
Results |
PCP
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
56 |
0 |
56 |
| Negative |
1 |
155 |
156 |
| Total Results |
57 |
155 |
212 |
% Agreement With
This Commercial Kit |
98% |
100% |
99% |
|
| When compared at 25 ng/mL cut-off with GC/MS, the following
results were tabulated: |
|
| Method |
GC/MS |
Total
Results |
PCP
One Step
Test Device |
Results |
Positive |
Negative |
| Positive |
50 |
5 |
55 |
| Negative |
0 |
157 |
157 |
| Total Results |
50 |
162 |
212 |
% Agreement With
GC/MS Analysis |
100% |
97% |
98% |
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| Eighty (80) of these samples were also run using the PCP One Step
Phencyclidine 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 Phencyclidine at the
following concentrations: 0 ng/mL, 12.5 ng/mL, 18.75 ng/mL, 25
ng/mL, 31.25 ng/mL and 37.5 ng/mL. The result demonstrates >99%
accuracy at 50% above and 50% below the cut-off concentration. The
data are summarized below: |
|
Phencyclidine
Concentration
(ng/mL) |
Percent
of
Cutoff |
n |
Visual
Result |
| Negative |
Positive |
| 0 |
0% |
30 |
30 |
0 |
| 12.5 |
-50% |
30 |
30 |
0 |
| 18.75 |
-25% |
30 |
19 |
11 |
| 25 |
Cutoff |
30 |
16 |
14 |
| 31.25 |
+25% |
30 |
6 |
24 |
| 37.5 |
+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 Phencyclidine, 25%
Phencyclidine above and below the cut-off and 50% Phencyclidine
above and below the 25 ng/mL cut-off was provided to each site. The
following results were tabulated: |
|
Phencyclidine
Concentration
(ng/mL) |
n |
Site
A |
Site
B |
Site
C |
| - |
+ |
- |
+ |
- |
+ |
| 0 |
15 |
15 |
0 |
15 |
0 |
15 |
0 |
| 12.5 |
15 |
15 |
0 |
14 |
1 |
14 |
1 |
| 18.75 |
15 |
11 |
4 |
13 |
2 |
10 |
5 |
| 31.25 |
15 |
8 |
7 |
5 |
10 |
1 |
14 |
| 37.5 |
15 |
4 |
11 |
0 |
15 |
0 |
15 |
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| Effect of Urinary Specific Gravity |
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| Fifteen (15) urine samples with specific gravity ranges from 1.001
to 1.032 were spiked with 12.5 ng/mL and 37.5 ng/mL of Phencyclidine
respectively. The PCP One Step Phencyclidine 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
Phencyclidine to 12.5 ng/mL and 37.5ng/mL. The spiked, pH-adjusted
urine was tested with the PCP One Step Phencyclidine 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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