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which is immobilized on the membrane, for the limited antibodiespresent in the form of dye-antibody conjugate. When a sufficientamount of drug or drug metabolite above the cutoff level is present, the drug will saturate the antibodies, thus inhibiting the binding ofdye-antibody conjugate to the drug conjugate on the membrane.
This prevents the formation of a line on the membrane. Therefore,a drug-positive urine sample will not generate a line at the Test position in the Result Window, indicating a positive result frompositive drug competition, while a negative urine sample will generate a line at the Test position in the Result Window, indicatinga negative result from an absence of competition with free drug.
In addition to the Test line that may appear in the Result Window,a Control line is present at the Control position (C) to confirm the viability of the test. This Control line (validation line) should always appear if the test is conducted properly. The Control line isimmobilized with monoclonal anti-mouse antibody; therefore, itwill capture the monoclonal antibody-dye conjugates that pass theregion, producing a colored line at the Control position (validationline). This works as a procedural control, confirming that proper sample volume was used and the reagent system worked. If insuf- ficient sample volume is used, there may not be a Control line,indicating the test is invalid.
AccuSign® PCP is a simple, one-step immunochromatographic
The AccuSign® PCP test kit contains all the reagents necessary to
assay for the rapid, qualitative detection of phencyclidine at a cutoff concentration of 25 ng/mL in human urine.
AccuSign® PCP device. The test device contains a membrane
The AccuSign® PCP test provides only a preliminary analytical
strip coated with PCP drug conjugate and a pad containing result. A more specific alternative chemical method must be used
monoclonal anti-phencyclidine antibody-dye conjugate in a in order to obtain a confirmed analytical result. Gas chromatog-
raphy, mass spectrometry (GC/MS) is the preferred confirmatory
method. Other chemical confirmatory methods are available.
Clinical consideration and professional judgment should be
applied to any drug of abuse test result, particularly when
preliminary positive results are used.1
For in vitro diagnostic use only.
Avoid cross contamination of urine samples by using a newurine specimen container and dropper for each urine sample.
Phencyclidine is an arylcyclohexylamine that is used as a veteri- The test kit does not contain any HIV or hepatitis infective nary anesthetic. It is used illegally as a hallucinogen, and is commonly referred to as PCP, angel dust, love boat, hog, or killer Urine specimens are potentially infectious. Proper handling weed. PCP can produce lethargy, euphoria, ataxia, nystagmus and and disposal methods should be followed according to good coma. Phencyclidine is readily absorbed when smoked or ingested, or even through skin contact. It is metabolized in the liver. About10% of the dose is excreted in urine as the parent compound, The AccuSign® device should remain in its original sealed
pouch until ready for use. Do not use the test if the pouch isdamaged or the seal is broken.
Do not use the test kit after the expiration date.
The AccuSign® PCP test uses solid-phase immunoassay technol-
ogy for the qualitative detection of phencyclidine in human urine.
The test is based on the principle of the highly specific immu- The AccuSign® PCP test kit should be stored at 2–30°C (35–86°F)
nochemical reactions between antigens and antibodies which are in the original sealed pouch. The expiration dating was established used for the analysis of specific substances in biological fluids. The test relies on the competition for binding to the antibodies betweendrug conjugates and drugs which may be present in the urine sample. In the test procedure, a sample of urine is placed in the Approximately 110 µL of urine sample is required for each test.
Sample well of the device and is allowed to migrate upward. If drug Fresh urine specimens do not require any special handling or is present in the urine sample, it competes with the drug conjugate, pretreatment. Specimens should be collected in a clean glass or CONTROL (VALIDATION) LINE (C).
The Control/Validation line indicates:1.
If the procedure was followed properly.
If no control line appears, the test is NOT VALID.
Repeat the test using a new device, and follow theprocedure carefully.
Negative (–) = Control line and Test line
Positive (+) = Control line only; No Test line plastic container. If testing will not be performed immediately, of the level of intoxication or urinary concentration of the drug in specimens should be refrigerated (2–8°C) or frozen. Frozen speci- the sample; it only indicates the sample contains drug above the mens must be completely thawed and thoroughly mixed before cutoff level in qualitative terms. Invalid: A distinct Control line (C) should always appear. The
Specimens containing a large amount of particulate matter may test is invalid if no Control line forms at the C position. Such tests
give inconsistent test results. Such specimens should be clarified should be repeated with a new AccuSign® PCP test device.
by centrifuging or allowing to settle before testing.
The test is designed for use with unadulterated urine only.
The test procedure consists of adding the urine sample to the There is a possibility that factors such as technical or proce- Sample well of the device and watching for the appearance of dural errors, as well as other substances in the urine sample which are not listed in Table 4 below, may interfere with thetest and cause erroneous results.
Adulterants, such as bleach and/or alum, in urine specimens 1. For each test, open one AccuSign® PCP may produce erroneous results. If adulteration is suspected, the and label the AccuSign® with the patient ID.
test should be repeated with a new sample.
This test detects only the presence of phencyclidine in human 2. Holding the dropper vertically, dispense 3 drops urine. A positive test result does not provide any indication of (110 µL) of the urine sample into the Sample well the level of intoxication or urinary concentration.
The test result read after 10 minutes may not be consistent with 3. Read the result after 3 minutes, but within 10 the original reading obtained within the 10 minute readingperiod. The test must be read within 10 minutes of sample Negative: The appearance of a reddish-purple Control line (C)
Internal Control: Each AccuSign® test device has built-in con-
and a line next to T indicates a negative test result; i.e., no drug trols. The Control line is an internal positive procedural control. A above the cutoff level has been detected. The color intensities of the distinct reddish-purple Control line should always appear at the C Control line and the Test line may not be equal. Any faint line at the position, if the test procedure is performed properly, an adequate T position in the Result window, visible in 10 minutes, should be sample volume is used, the sample and reagent are wicking on the interpreted as negative. A negative test result does not indicate the membrane, and the test reagents at the control line and the conju- absence of drug in the sample; it only indicates the sample does not gate-color indicator are reactive. In addition, if the test has been contain drug above the cutoff level in qualitative terms. performed correctly and the device is working properly, the back- Positive: The appearance of only a reddish-purple Control line
ground in the result window will become clear and provide a and no distinct line next to T indicates the test result is positive for distinct result. This may be considered an internal negative proce- PCP (i.e., the specimen contains PCP at a concentration above the cutoff level). A positive test result does not provide any indication The positive and negative procedural controls contained in each AccuSign® test device satisfy the requirements of testing a positive
control and a negative control on a daily basis. If the Control line
The precision of the AccuSign® PCP assay was determined by
does not appear at the Control position, the test is invalid and a new carrying out the test with serially diluted standard drug solutions.
test should be performed. If the problem persists, contact PBM for About 95% of the samples containing phencyclidine concentra- tions 25% over the cutoff level consistently showed positiveresults.
External Control: External controls may also be used to assure
that the reagents are working properly and that the assay procedure
The study also included over 40 samples ± 25% cutoff level. These is followed correctly. It is recommended that a control be tested at results were found to be consistently in agreement with expected regular intervals as good laboratory testing process. For informa- tion on how to obtain controls, contact PBM’s Technical Services.
Distribution of Random Error:
Twenty (20) blind samples prepared by spiking various concentra-tions of phencyclidine were separately tested by two operators. The AccuSign® PCP is a qualitative assay. The amount of phencycli-
test results from the two operators showed complete agreement.
dine present in the urine cannot be estimated by the assay. Theassay results distinguish positive from negative samples. Positive results indicate the samples contain phencyclidine above thecutoff concentration.
The reproducibility of the test results of the AccuSign® PCP assay
was examined at three different sites using a total of 15 blind
controls, consisting of 5 negative samples, 5 moderately positivesamples (50-70 ng/mL phencyclidine), and 5 strongly positive The AccuSign® PCP test has been shown to detect phencyclidine
samples (100-200 ng/mL phencyclidine). The results obtained at at an average cutoff of 25 ng/mL in urine.
these three sites with these controls demonstrated 100% agreement The accuracy of AccuSign® PCP was evaluated in comparison to
a commercially available immunoassay (Abuscreen ONLINE™PCP Assay) at a cutoff of 25 ng/mL. A total of 157 samples was tested by both procedures. Complete agreement was observed in Compounds that are detected by the AccuSign® PCP test are listed
98.7% of the samples as shown below (Table 1).
below. The specificity of the AccuSign® PCP test was determined
Table 1. Accuracy: Comparison of AccuSign® PCP with
by adding the drugs and drug metabolites listed to drug-negative Abuscreen ONLINE™ PCP
urine specimens and testing with the AccuSign® PCP test kit. The
results are expressed in terms of the concentration required to
Abuscreen ONLINE™ PCP
produce a positive result (Table 3).
Table 3. Specificity
AccuSign®
Concentration
Compound
reactivity
Relative Sensitivity Relative Specificity The following compounds show no cross-reactivity when tested Analysis of discrepant samples for PCP showed they were within with AccuSign® PCP at a concentration of 100 µg/mL (Table 4).
Table 4. Non Cross-Reacting Compounds
In a separate study, AccuSign® PCP was evaluated against speci-
mens confirmed as positive by GC/MS. The results below demon-
strate the excellent correlation of AccuSign® PCP with GC/MS (>
Table 2. Accuracy: Comparison of AccuSign® PCP with
GC/MS Assay
AccuSign®
1. Hawks RL, Chiang CN, eds. Urine Testing for Drugs of Abuse.
Rockville, MD: National Institute on Drug Abuse (NIDA), Re- 2. Baselt RC. Disposition of Toxic Drugs and Chemicals in Man. 2nd Ed., Davis, CA: Biomedical Publ.;1982;p. 488.
In Vitro Diagnostic Medical Device “Use By” date in year-month-day format AccuSign® is a Registered Trademark of Princeton BioMeditech Corporation.
MT Promedt Consulting GmbH
Princeton BioMeditech Corporation

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