Phencyclidine Plus (PCP) is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on Roche/Hitachi cobas c systems at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC‑MS).

Phencyclidine Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC‑MS is the preferred confirmatory method.

The assay is based on the kinetic interaction of microparticles in a solution (KIMS)

When a urine sample contains the drug in question, this drug competes with the particle‑bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

Qualitative assay

Results of this assay distinguish preliminary positive (≥ 25 ng/mL) from negative samples only. The amount of drug detected in a preliminary positive sample cannot be estimated.

Semiquantitative assay
Results of this assay yield only approximate cumulative concentrations of the drug and its metabolites (see \"Analytical specificity\" section).

See the \"Specific performance data\" section of this document for information on substances tested with this assay. There is the possibility that other substances and/or factors may interfere with the test and cause erroneous results (e.g., technical or procedural errors).

A preliminary positive result with this assay indicates the presence of PCP and/or its metabolites in urine. It does not measure the level of intoxication.

Interfering substances were added to drug free urine at the concentration listed below. These samples were then spiked to 25 ng/mL using a PCP stock solution. Samples were tested in triplicate (n = 3) on a Roche/Hitachi cobas c 501 analyzer. The median % recoveries were calculated and are listed below.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on Roche/Hitachi cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

Materials required (but not provided):

PC2QP: ACN 20960: for qualitative assay

PC2SP: ACN 20961: for semiquantitative assay

PC2QC: ACN 20962: for qualitative assay; using C.f.a.s. DAT Qualitative Plus Clinical

PC2‑QP: ACN 20963: for qualitative assay; using C.f.a.s. DAT Qualitative Plus

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

For the cutoff calibrator a value of \"0\" is encoded in the e‑barcode in order to ensure flagging of positive samples with >Test and negative absorbance values for negative samples.

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against a primary reference method (GC‑MS).

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). The following results were obtained:

^{*n.a. = not applicable}

Phencyclidine (PCP) is an arylcyclohexylamine with potent analgesic and anesthetic properties.

The water‑soluble powder of PCP can be ingested, snorted, injected intravenously, or smoked. Typical street doses (1‑10 mg) can cause tachycardia, hypertension, hallucinations, stupor, lethargy, sensory isolation, and loss of coordination. Excitation and agitation may also occur, leading to unpredictably violent behavior not usually encountered with other hallucinogens. Repeated use of PCP can result in addiction and higher doses can cause symptoms that mimic schizophrenia and can culminate in convulsions and prolonged or fatal coma.

PCP is metabolized via ring‑hydroxylation and oxidation by the cytochrome P450 enzymes.

Cat. No. 08058130 190 consists of 2 cobas c packs: 1 x R1 + R2 and 1 x R3. R1 is in position B and R2 is in position C of cobas c pack 1. R3 is in position C of cobas c pack 2.

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

Drug concentrations of Control Set DAT I, II and Clinical have been verified by GC‑MS.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 8 weeks.

Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

Only the specimens listed below were tested and found acceptable.

Urine: Collect urine samples in clean glass or plastic containers. Fresh urine specimens do not require any special handling or pretreatment, but an effort should be made to keep pipetted samples free of gross debris. Samples should be within the normal physiological pH range of 5‑8. No additives or preservatives are required. It is recommended that urine specimens be stored at 2‑8 °C and tested within 5 days of collection.

For prolonged storage, freezing of samples is recommended.

Centrifuge highly turbid specimens before testing.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Adulteration or dilution of the sample can cause erroneous results. If adulteration is suspected, another sample should be collected. Specimen validity testing is required for specimens collected under the Mandatory Guidelines for Federal Workplace Drug Testing Programs.

CAUTION: Specimen dilutions should only be used to interpret results of Calc.? and Samp.? alarms, or when estimating concentration in preparation for GC‑MS. Dilution results are not intended for patient values. Dilution procedures, when used, should be validated.

Phencyclidine Plus (PCP) is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on Roche/Hitachi cobas c systems at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC‑MS).

Phencyclidine Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC‑MS is the preferred confirmatory method.

The assay is based on the kinetic interaction of microparticles in a solution (KIMS)

When a urine sample contains the drug in question, this drug competes with the particle‑bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

Qualitative assay

Results of this assay distinguish preliminary positive (≥ 25 ng/mL) from negative samples only. The amount of drug detected in a preliminary positive sample cannot be estimated.

Semiquantitative assay
Results of this assay yield only approximate cumulative concentrations of the drug and its metabolites (see \"Analytical specificity\" section).

See the \"Specific performance data\" section of this document for information on substances tested with this assay. There is the possibility that other substances and/or factors may interfere with the test and cause erroneous results (e.g., technical or procedural errors).

A preliminary positive result with this assay indicates the presence of PCP and/or its metabolites in urine. It does not measure the level of intoxication.

Interfering substances were added to drug free urine at the concentration listed below. These samples were then spiked to 25 ng/mL using a PCP stock solution. Samples were tested in triplicate (n = 3) on a cobas c 501 analyzer. The median % recoveries were calculated and are listed below.

Materials required (but not provided):

PC2QP: ACN 20960: for qualitative assay

PC2SP: ACN 20961: for semiquantitative assay

PC2QC: ACN 20962: for qualitative assay; using C.f.a.s. DAT Qualitative Plus Clinical

PC2‑QP: ACN 20963: for qualitative assay; using C.f.a.s. DAT Qualitative Plus

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

For the cutoff calibrator a value of \"0\" is encoded in the e‑barcode in order to ensure flagging of positive samples with >Test and negative absorbance values for negative samples.

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against a primary reference method (GC‑MS).

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

^{*n.a. = not applicable}

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

Phencyclidine (PCP) is an arylcyclohexylamine with potent analgesic and anesthetic properties.

The water‑soluble powder of PCP can be ingested, snorted, injected intravenously, or smoked. Typical street doses (1‑10 mg) can cause tachycardia, hypertension, hallucinations, stupor, lethargy, sensory isolation, and loss of coordination. Excitation and agitation may also occur, leading to unpredictably violent behavior not usually encountered with other hallucinogens. Repeated use of PCP can result in addiction and higher doses can cause symptoms that mimic schizophrenia and can culminate in convulsions and prolonged or fatal coma.

PCP is metabolized via ring‑hydroxylation and oxidation by the cytochrome P450 enzymes.

Cat. No. 08058130190 consists of 2 cobas c packs: 1 x R1 + R2 and 1 x R3. R1 is in position B and R2 is in position C of cobas c pack 1. R3 is in position C of cobas c pack 2.

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

Drug concentrations of Control Set DAT I, II and Clinical have been verified by GC‑MS.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 8 weeks.

Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

Only the specimens listed below were tested and found acceptable.

Urine: Collect urine samples in clean glass or plastic containers. Fresh urine specimens do not require any special handling or pretreatment, but an effort should be made to keep pipetted samples free of gross debris. Samples should be within the normal physiological pH range of 5‑8. No additives or preservatives are required. It is recommended that urine specimens be stored at 2‑8 °C and tested within 5 days of collection.

Phencyclidine Plus (PCP) is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on Roche/Hitachi cobas c systems at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC‑MS).

Phencyclidine Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC‑MS is the preferred confirmatory method.

The assay is based on the kinetic interaction of microparticles in a solution (KIMS)

When a urine sample contains the drug in question, this drug competes with the particle‑bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

Qualitative assay

Results of this assay distinguish preliminary positive (≥ 25 ng/mL) from negative samples only. The amount of drug detected in a preliminary positive sample cannot be estimated.

Semiquantitative assay
Results of this assay yield only approximate cumulative concentrations of the drug and its metabolites (see \"Analytical specificity\" section).

See the \"Specific performance data\" section of this document for information on substances tested with this assay. There is the possibility that other substances and/or factors may interfere with the test and cause erroneous results (e.g., technical or procedural errors).

A preliminary positive result with this assay indicates the presence of PCP and/or its metabolites in urine. It does not measure the level of intoxication.

Interfering substances were added to drug free urine at the concentration listed below. These samples were then spiked to 25 ng/mL using a PCP stock solution. Samples were tested in triplicate (n = 3) on a cobas c 501 analyzer. The median % recoveries were calculated and are listed below.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on cobas c systems. All special wash programming necessary for avoiding carry‑over is available via the cobas link. The latest version of the carry‑over evasion list can be found with the NaOHD/SMS/SCCS Method Sheet for information. For further instructions refer to the operator’s manual.

Materials required (but not provided):

PC2QP: ACN 20960: for qualitative assay

PC2SP: ACN 20961: for semiquantitative assay

PC2QC: ACN 20962: for qualitative assay; using C.f.a.s. DAT Qualitative Plus Clinical

PC2‑QP: ACN 20963: for qualitative assay; using C.f.a.s. DAT Qualitative Plus

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

For further information about the assay test definitions refer to the application parameters setting screen of the corresponding analyzer and assay.

For the cutoff calibrator a value of \"0\" is encoded in the e‑barcode in order to ensure flagging of positive samples with >Test and negative absorbance values for negative samples.

Calibration interval may be extended based on acceptable verification of calibration by the laboratory.

Traceability: This method has been standardized against a primary reference method (GC‑MS).

Representative performance data on the analyzers are given below. These data represent the performance of the analytical procedure itself.

Results obtained in individual laboratories may differ due to heterogenous sample materials, aging of analyzer components and mixture of reagents running on the analyzer.

Precision was determined using human samples and controls in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP05‑A3 requirements with repeatability (n = 84) and intermediate precision (2 aliquots per run, 2 runs per day, 21 days). Results for repeatability and intermediate precision were obtained on the cobas c 503 analyzer.

^{*n.a. = not applicable}

The data obtained on cobas c 503 analyzer(s) are representative for cobas c 303 analyzer(s).

Phencyclidine (PCP) is an arylcyclohexylamine with potent analgesic and anesthetic properties.

The water‑soluble powder of PCP can be ingested, snorted, injected intravenously, or smoked. Typical street doses (1‑10 mg) can cause tachycardia, hypertension, hallucinations, stupor, lethargy, sensory isolation, and loss of coordination. Excitation and agitation may also occur, leading to unpredictably violent behavior not usually encountered with other hallucinogens. Repeated use of PCP can result in addiction and higher doses can cause symptoms that mimic schizophrenia and can culminate in convulsions and prolonged or fatal coma.

PCP is metabolized via ring‑hydroxylation and oxidation by the cytochrome P450 enzymes.

Cat. No. 08058130190 consists of 2 cobas c packs: 1 x R1 + R2 and 1 x R3. R1 is in position B and R2 is in position C of cobas c pack 1. R3 is in position C of cobas c pack 2.

For quality control, use control materials as listed in the “Order information” section. In addition, other suitable control material can be used.

Drug concentrations of Control Set DAT I, II and Clinical have been verified by GC‑MS.

The control intervals and limits should be adapted to each laboratory’s individual requirements. It is recommended to perform quality control always after lot calibration and subsequently at least every 8 weeks.

Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

Only the specimens listed below were tested and found acceptable.

Urine: Collect urine samples in clean glass or plastic containers. Fresh urine specimens do not require any special handling or pretreatment, but an effort should be made to keep pipetted samples free of gross debris. Samples should be within the normal physiological pH range of 5‑8. No additives or preservatives are required. It is recommended that urine specimens be stored at 2‑8 °C and tested within 5 days of collection.

For prolonged storage, freezing of samples is recommended.

Centrifuge highly turbid specimens before testing.

See the limitations and interferences section for details about possible sample interferences.

Sample stability claims were established by experimental data by the manufacturer or based on reference literature and only for the temperatures/time frames as stated in the method sheet. It is the responsibility of the individual laboratory to use all available references and/or its own studies to determine specific stability criteria for its laboratory.

Adulteration or dilution of the sample can cause erroneous results. If adulteration is suspected, another sample should be collected. Specimen validity testing is required for specimens collected under the Mandatory Guidelines for Federal Workplace Drug Testing Programs.

CAUTION: Specimen dilutions should only be used to interpret results of Calc.? and Samp.? alarms, or when estimating concentration in preparation for GC‑MS. Dilution results are not intended for patient values. Dilution procedures, when used, should be validated.

Phencyclidine Plus (PCP) is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on Roche/Hitachi cobas c systems at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC‑MS).

Phencyclidine Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC‑MS is the preferred confirmatory method.

The assay is based on the kinetic interaction of microparticles in a solution (KIMS)

When a urine sample contains the drug in question, this drug competes with the particle‑bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

1.6 ng/mL

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 2 standard deviations above that of the lowest standard (standard 1 + 2 SD, repeatability, n  = 21).

Qualitative assay

Results of this assay distinguish preliminary positive (≥ 25 ng/mL) from negative samples only. The amount of drug detected in a preliminary positive sample cannot be estimated.

Semiquantitative assay
Results of this assay yield only approximate cumulative concentrations of the drug and its metabolites (see \"Analytical specificity\" section).

Limitations - interference

See the \"Specific performance data\" section of this document for information on substances tested with this assay. There is the possibility that other substances and/or factors may interfere with the test and cause erroneous results (e.g., technical or procedural errors).

A preliminary positive result with this assay indicates the presence of PCP and/or its metabolites in urine. It does not measure the level of intoxication.

Interfering substances were added to drug free urine at the concentration listed below. These samples were then spiked to 25 ng/mL using a PCP stock solution. Samples were tested in triplicate (n = 3) on a Roche/Hitachi cobas c 501 analyzer. The median % recoveries were calculated and are listed below.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

Materials required (but not provided):

For cobas c 311/501 analyzers:

PC2QP: ACN 518: for qualitative assay

PC2SP: ACN 519: for semiquantitative assay

PC2QC: ACN 795: for qualitative assay; using C.f.a.s. DAT Qualitative Plus Clinical

For cobas c 502 analyzer:

PC2QP: ACN 8518: for qualitative assay

PC2SP: ACN 8519: for semiquantitative assay

PC2QC: ACN 8795: for qualitative assay; using C.f.a.s. DAT Qualitative Plus Clinical

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

Deselect Automatic Rerun for these applications in the Utility menu, Application screen, Range tab.

^{a) See Results section.}

Representative performance data on a Roche/Hitachi analyzer are given below. Results obtained in individual laboratories may differ.

Precision was determined in an internal protocol by running a series of calibrator and controls (repeatability n = 20, intermediate precision n = 100). The following results were obtained on a Roche/Hitachi cobas c 501 analyzer.

The data obtained on cobas c 501 analyzer(s) are representative for cobas c 311 analyzer(s).

Phencyclidine (PCP) is an arylcyclohexylamine with potent analgesic and anesthetic properties.

The water‑soluble powder of PCP can be ingested, snorted, injected intravenously, or smoked. Typical street doses (1‑10 mg) can cause tachycardia, hypertension, hallucinations, stupor, lethargy, sensory isolation, and loss of coordination. Excitation and agitation may also occur, leading to unpredictably violent behavior not usually encountered with other hallucinogens. Repeated use of PCP can result in addiction and higher doses can cause symptoms that mimic schizophrenia and can culminate in convulsions and prolonged or fatal coma.

PCP is metabolized via ring‑hydroxylation and oxidation by the cytochrome P450 enzymes.

R1 is in position B, R2 is in position C, and R3 is in position A.

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

Drug concentrations of the Control Set DAT I and Clinical have been verified by GC‑MS.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

Only the specimens listed below were tested and found acceptable.

Urine: Collect urine samples in clean glass or plastic containers. Fresh urine specimens do not require any special handling or pretreatment, but an effort should be made to keep pipetted samples free of gross debris. Samples should be within the normal physiological pH range of 5‑8. No additives or preservatives are required. It is recommended that urine specimens be stored at 2‑8 °C and tested within 5 days of collection.

For prolonged storage, freezing of samples is recommended.

Centrifuge highly turbid specimens before testing.

Adulteration or dilution of the sample can cause erroneous results. If adulteration is suspected, another sample should be collected. Specimen validity testing is required for specimens collected under the Mandatory Guidelines for Federal Workplace Drug Testing Programs.

CAUTION: Specimen dilutions should only be used to interpret results of Calc.? and Samp.? alarms, or when estimating concentration in preparation for GC‑MS. Dilution results are not intended for patient values. Dilution procedures, when used, should be validated.

Phencyclidine Plus (PCP) is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on Roche/Hitachi cobas c systems at a cutoff concentration of 25 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC‑MS).

Phencyclidine Plus provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC‑MS is the preferred confirmatory method.

The assay is based on the kinetic interaction of microparticles in a solution (KIMS)

When a urine sample contains the drug in question, this drug competes with the particle‑bound drug derivative for free antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

1.6 ng/mL

The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero. It is calculated as the value lying 2 standard deviations above that of the lowest standard (standard 1 + 2 SD, repeatability, n  = 21).

Qualitative assay

Results of this assay distinguish preliminary positive (≥ 25 ng/mL) from negative samples only. The amount of drug detected in a preliminary positive sample cannot be estimated.

Semiquantitative assay
Results of this assay yield only approximate cumulative concentrations of the drug and its metabolites (see \"Analytical specificity\" section).

Limitations - interference

See the \"Specific performance data\" section of this document for information on substances tested with this assay. There is the possibility that other substances and/or factors may interfere with the test and cause erroneous results (e.g., technical or procedural errors).

A preliminary positive result with this assay indicates the presence of PCP and/or its metabolites in urine. It does not measure the level of intoxication.

Interfering substances were added to drug free urine at the concentration listed below. These samples were then spiked to 25 ng/mL using a PCP stock solution. Samples were tested in triplicate (n = 3) on a Roche/Hitachi cobas c 501 analyzer. The median % recoveries were calculated and are listed below.

For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings.

For cobas c 311/501 analyzers:

PC2QP: ACN 518: for qualitative assay

PC2SP: ACN 519: for semiquantitative assay

PC2QC: ACN 795: for qualitative assay; using C.f.a.s. DAT Qualitative Plus Clinical

For cobas c 502 analyzer:

PC2QP: ACN 8518: for qualitative assay

PC2SP: ACN 8519: for semiquantitative assay

PC2QC: ACN 8795: for qualitative assay; using C.f.a.s. DAT Qualitative Plus Clinical

Ready for use

Carefully invert reagent container several times prior to use to ensure that the reagent components are mixed.

Deselect Automatic Rerun for these applications in the Utility menu, Application screen, Range tab.

^{a) See Results section.}

Representative performance data on a Roche/Hitachi analyzer are given below. Results obtained in individual laboratories may differ.

Precision was determined in an internal protocol by running a series of calibrator and controls (repeatability n = 20, intermediate precision n = 100). The following results were obtained on a Roche/Hitachi cobas c 501 analyzer.

Phencyclidine (PCP) is an arylcyclohexylamine with potent analgesic and anesthetic properties.

The water‑soluble powder of PCP can be ingested, snorted, injected intravenously, or smoked. Typical street doses (1‑10 mg) can cause tachycardia, hypertension, hallucinations, stupor, lethargy, sensory isolation, and loss of coordination. Excitation and agitation may also occur, leading to unpredictably violent behavior not usually encountered with other hallucinogens. Repeated use of PCP can result in addiction and higher doses can cause symptoms that mimic schizophrenia and can culminate in convulsions and prolonged or fatal coma.

PCP is metabolized via ring‑hydroxylation and oxidation by the cytochrome P450 enzymes.

R1 is in position B, R2 is in position C, and R3 is in position A.

For in vitro diagnostic use.
Exercise the normal precautions required for handling all laboratory reagents.
Disposal of all waste material should be in accordance with local guidelines.
Safety data sheet available for professional user on request.

For quality control, use control materials as listed in the \"Order information\" section.

In addition, other suitable control material can be used.

Drug concentrations of the Control Set DAT I and Clinical have been verified by GC‑MS.

The control intervals and limits should be adapted to each laboratory’s individual requirements. Values obtained should fall within the defined limits. Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.

Follow the applicable government regulations and local guidelines for quality control.

Only the specimens listed below were tested and found acceptable.

Urine: Collect urine samples in clean glass or plastic containers. Fresh urine specimens do not require any special handling or pretreatment, but an effort should be made to keep pipetted samples free of gross debris. Samples should be within the normal physiological pH range of 5‑8. No additives or preservatives are required. It is recommended that urine specimens be stored at 2‑8 °C and tested within 5 days of collection.

For prolonged storage, freezing of samples is recommended.

Centrifuge highly turbid specimens before testing.

Adulteration or dilution of the sample can cause erroneous results. If adulteration is suspected, another sample should be collected. Specimen validity testing is required for specimens collected under the Mandatory Guidelines for Federal Workplace Drug Testing Programs.

CAUTION: Specimen dilutions should only be used to interpret results of Calc.? and Samp.? alarms, or when estimating concentration in preparation for GC‑MS. Dilution results are not intended for patient values. Dilution procedures, when used, should be validated.