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One Step Drug Test:  Phencyclidine (Page 2)

1-Panel - PCP
One Step Phencyclidine Test Device

Page 1

Accuracy

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 cutoff 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 Commercial Kit 98% >99% >99%

When compared to the GC/MS lab testing method at the cutoff concentration of 25 ng/ml, 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 >99% 97% 98%

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.

Sensitivity

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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 cutoff concentration. The data are summarized below:

PCP 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

Precision

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A study was conducted at 3 physician's 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 cutoff and 50% Phencyclidine above and below the 25 ng/ml cutoff was provided to each site. The following results were tabulated:

PCP 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

Effect of Urinary Specific Gravity

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Fifteen (15) urine samples with specific gravity ranges from 1.007 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.

Effect of Urinary pH

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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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