{ "ProductData": { "ID": "CPS_000180", "ProductType": "Others", "BrandName": "PCP", "ProductNameAddition": "ONLINE DAT Phencyclidine Plus", "RegulatoryDisclaimer1": "For in vitro diagnostic use.", "DisclaimerGroup1": "IVD", "RegulatoryDisclaimer2": null, "DisclaimerGroup2": null, "RegulatoryDisclaimer3": null, "SampleType": [ "Urine" ], "LicenseDisclaimers": [ ], "RelatedLinks": "", "Clone": "", "ControlTissue": [ "" ], "ISOtypes": "", "Species": [ "" ], "StainLocalization": [ "" ], "ProductNameGlobal": "PCP ONLINE DAT Phencyclidine Plus" }, "ProductImageDetails": { "ImagePath": "https://pim-media.roche.com/Images/Article_08058130190_im_en.png", "ImageType": "Image main" }, "Product2Taxonomy": { "Product2TaxonomyReferences": [ { "StructureSystemIdentifier": "Product_Grouping", "StructureSystemName": "Product Grouping", "NodeID": "01-0419", "StructureNodeStatus": "Active", "NodeName": "cobas Phencyclidine" }, { "StructureSystemIdentifier": "OWP_Product_Types", "StructureSystemName": "Product Types", "NodeID": "20-000-00", "StructureNodeStatus": "Active", "NodeName": "Assays Reagents and Strips" }, { "StructureSystemIdentifier": "Lab_Type", "StructureSystemName": "Lab Types", "NodeID": "050-00", "StructureNodeStatus": "Active", "NodeName": "Core Lab" }, { "StructureSystemIdentifier": "Disease_Areas", "StructureSystemName": "Disease Areas", "NodeID": "15-00-00", "StructureNodeStatus": "Active", "NodeName": "Drugs of abuse testing" }, { "StructureSystemIdentifier": "Product_Solutions", "StructureSystemName": "Product Solutions", "NodeID": "020", "StructureNodeStatus": "Active", "NodeName": "Clinical Chemistry" }, { "StructureSystemIdentifier": "Applications", "StructureSystemName": "Applications", "NodeID": "99-00-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "OWP_Techniques", "StructureSystemName": "Techniques", "NodeID": "999-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "Pathogens", "StructureSystemName": "Pathogens", "NodeID": "99-00-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "Health_Topics", "StructureSystemName": "Health Topics", "NodeID": "99-00-00", "StructureNodeStatus": "Inactive", "NodeName": "" }, { "StructureSystemIdentifier": "Indications", "StructureSystemName": "Indications", "NodeID": "96", "StructureNodeStatus": "Active", "NodeName": "DAT" }, { "StructureSystemIdentifier": "OWP_Family", "StructureSystemName": "Product Families", "NodeID": "697", "StructureNodeStatus": "Active", "NodeName": "ONLINE DAT" } ] }, "Product2Materials": { "P2MaterialReferences": [ { "MaterialNum": "08058130190", "MaterialDescription": "PCP, 850T, cobas c pack green", "RegisteredProductName": "PCP", "GTIN": "07613336121450", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "850 tests", "PackSizeDescPIM360": "cobas c 303/503", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" }, { "MaterialNum": "04490908190", "MaterialDescription": "PCP, 200T, cobas c", "RegisteredProductName": "PCP", "GTIN": "04015630998876", "ProductCategoryText": "Reagents, kits", "OldMaterialNumber": "", "PackSizePIM360": "200 tests", "PackSizeDescPIM360": "cobas c 311/501/502", "MaterialAnnotation": "", "ReadyForUse": "true", "OrderInformation": "" } ] }, "Product2Products": { "Product2ProductReference": [ { "ProductID": "INS_6347", "BrandName": "cobas® c 303 analytical unit", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "9493", "StructureGroupPath": "ClinChem fully automated->Systems / Digital Products->cobas c systems->cobas c 303", "StructureGroupName": "cobas c 303", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "020", "StructureGroupPath": "Clinical Chemistry", "StructureGroupName": "Clinical Chemistry", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "614", "StructureGroupPath": "cobas c", "StructureGroupName": "cobas c", "StructureNodeStatus": "Active" } ] }, { "ProductID": "INS_2043", "BrandName": "cobas® c 311 analyzer", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "308", "StructureGroupPath": "ClinChem fully automated->Systems / Digital Products->cobas c systems->cobas c 311", "StructureGroupName": "cobas c 311", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "020", "StructureGroupPath": "Clinical Chemistry", "StructureGroupName": "Clinical Chemistry", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "614", "StructureGroupPath": "cobas c", "StructureGroupName": "cobas c", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "560", "StructureGroupPath": "cobas 4000", "StructureGroupName": "cobas 4000", "StructureNodeStatus": "Active" } ] }, { "ProductID": "INS_338", "BrandName": "cobas® c 501 module", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "309", "StructureGroupPath": "ClinChem fully automated->Systems / Digital Products->cobas c systems->cobas c 501", "StructureGroupName": "cobas c 501", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "020", "StructureGroupPath": "Clinical Chemistry", "StructureGroupName": "Clinical Chemistry", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "614", "StructureGroupPath": "cobas c", "StructureGroupName": "cobas c", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "679", "StructureGroupPath": "cobas 6000", "StructureGroupName": "cobas 6000", "StructureNodeStatus": "Active" } ] }, { "ProductID": "INS_2113", "BrandName": "cobas® c 502 module", "ProductNameAddition": "", "ReferenceType": "Instrument", "Classification": [ { "IdentifierofStructureSystem": "1", "NameofStructureSystem": "GPCH", "StructureNodeID": "2324", "StructureGroupPath": "ClinChem fully automated->Systems / Digital Products->cobas c systems->cobas c 502", "StructureGroupName": "cobas c 502", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "OWP_Product_Types", "NameofStructureSystem": "Product Types", "StructureNodeID": "10-000-00", "StructureGroupPath": "Analyzer Instruments and Systems", "StructureGroupName": "Analyzer Instruments and Systems", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Lab_Type", "NameofStructureSystem": "Lab Types", "StructureNodeID": "050-00", "StructureGroupPath": "Core Lab", "StructureGroupName": "Core Lab", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Product_Solutions", "NameofStructureSystem": "Product Solutions", "StructureNodeID": "020", "StructureGroupPath": "Clinical Chemistry", "StructureGroupName": "Clinical Chemistry", "StructureNodeStatus": "Active" }, { "IdentifierofStructureSystem": "Applications", "NameofStructureSystem": "Applications", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Techniques", "NameofStructureSystem": "Techniques", "StructureNodeID": "999-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Disease_Areas", "NameofStructureSystem": "Disease Areas", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Pathogens", "NameofStructureSystem": "Pathogens", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "Health_Topics", "NameofStructureSystem": "Health Topics", "StructureNodeID": "99-00-00", "StructureGroupPath": "", "StructureGroupName": "", "StructureNodeStatus": "Inactive" }, { "IdentifierofStructureSystem": "OWP_Family", "NameofStructureSystem": "Product Families", "StructureNodeID": "614", "StructureGroupPath": "cobas c", "StructureGroupName": "cobas c", "StructureNodeStatus": "Active" } ] } ] }, "ProductSpec": [ { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008058130190c503", "ProductName": "PCP", "ProductLongName": "ONLINE DAT Phencyclidine Plus", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF000000047BB80E", "DocumentOriginID": "FF000000039E660E", "MaterialNumbers": [ "08058130190" ], "InstrumentReferences": [ { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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.

LREFKarch SB, ed. Drug Abuse Handbook. Boca Raton, FL: CRC Press LLC 1998.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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

LREFArmbruster DA, Schwarzhoff RH, Pierce BL, et al. Method comparison of EMIT II and ONLINE with RIA for drug screening. J Forensic Sci 1993;38:1326-1341.
as measured by changes in light transmission. In the absence of sample drug, free antibody binds to drug‑microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.

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.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

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).

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

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.

Substance

Concentration
tested

% Phencyclidine
recovery

Acetone

1 %

98

Ascorbic acid

1.5 %

105

Bilirubin

0.25 mg/mL

98

Creatinine

5 mg/mL

113

Ethanol

1 %

100

Glucose

2 %

105

Hemoglobin

7.5 g/L

94

Human albumin

0.5 %

102

Oxalic acid

2 mg/mL

98

Sodium chloride

0.5 M

100

Sodium chloride

1 M

102

Urea

6 %

106

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.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08058130 190

ONLINE DAT Phencyclidine Plus (cobas c pack 1), 850 tests

System‑ID 2096 011

Roche/Hitachi cobas c 503

ONLINE DAT Phencyclidine Plus (cobas c pack 2), 850 tests

System‑ID 2096 012

Materials required (but not provided):

03304671 190

Preciset DAT Plus I calibrators CAL 1‑6 (6 x 5 mL)

Codes 20431‑20436

03304698 190

C.f.a.s. DAT Qualitative Plus (6 x 5 mL)

Code 20698

04590856 190

C.f.a.s. DAT Qualitative Plus Clinical (3 x 5 mL)

Code 20699

03312950 190

Control Set DAT I

PreciPos DAT Set I (2 x 10 mL)

PreciNeg DAT Set I (2 x 10 mL)

04500873 190

Control Set DAT Clinical

PreciPos DAT Clinical (2 x 10 mL)

PreciNeg DAT Clinical (2 x 10 mL)

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

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

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

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

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for urine

Test definition

Semiquantitative

Qualitative

Reporting time

10 min

10 min

Wavelength (sub/main)

– /505 nm

– /505 nm

Reagent pipetting

Diluent

R1

26 µL

R2

26 µL

R3

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent

Normal

5 µL

Decreased

5 µL

Increased

5 µL

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

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label

On‑board in use and refrigerated on the analyzer:

8 weeks

Do not freeze.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

Semiquantitative application

S1-4: Preciset DAT Plus I calibrators, CAL 1‑4

0, 12.5, 25, 50 ng/mL

Qualitative application

S1: C.f.a.s. DAT Qualitative Plus, C.f.a.s. DAT Qualitative Plus Clinical, or Preciset DAT Plus I calibrator ‑ CAL 3
25 ng/mL

The drug concentrations of the calibrators have been verified by GC‑MS.

Calibration K factor

For the qualitative application a K factor of ‑1000 is predefined in the application settings.

Calibration mode

Semiquantitative application
Non‑linear

Qualitative application
Linear

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

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).

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

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.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

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:

Semiquantitative precision

Repeatability

Mean
ng/mL

SD
ng/mL

CV
%

Urine -50 %

11.0

0.432

3.9

DAT1N

19.8

0.498

2.5

DATCN

19.5

0.423

2.2

Cutoff urine

25.5

0.565

2.2

DAT1P

32.2

0.508

1.6

DATCP

31.7

0.653

2.1

Urine +50 %

38.2

0.524

1.4

Intermediate
precision

Mean
ng/mL

SD
ng/mL

CV
%

Urine -50 %

11.0

0.750

6.8

DAT1N

19.8

0.698

3.5

DATCN

19.5

0.760

3.9

Cutoff urine

25.5

0.920

3.6

DAT1P

32.2

0.702

2.2

DATCP

31.7

0.933

2.9

Urine +50 %

38.2

0.850

2.2

Qualitative precision

Number tested

Correct results

Confidence level

Urine -50 %

84

84

> 95 % negative reading

DAT1N

84

84

> 95 % negative reading

Cutoff urine

84

n.a.*

n.a.*

DAT1P

84

84

> 95 % positive reading

Urine +50 %

84

84

> 95 % positive reading

*n.a. = not applicable

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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

LREFKarch SB, ed. Drug Abuse Handbook. Boca Raton, FL: CRC Press LLC 1998.
,
LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Foster City, CA: Biomedical Publications 2004.
,
LREFClouet DH, ed. Phencyclidine: An Update. NIDA Research Monograph 64. National Institute on Drug Abuse 1986.
,
LREFDe Souza EB, Clouet D, London ED, eds. Sigma, PCP, and NMDA receptors. Research Monograph 133. National Institute on Drug Abuse 1993.
,
LREFLeshner AI. Hallucinogens and dissociative, including LSD, PCP, Ketamine, dextromethorphan. NIH Publication Number 01-4209, NIDA Research Report Series 2001.
Originally developed as an intravenous anesthetic, the occurrence of emergence psychosis side effects negated its potential clinical utility. PCP was never approved for human use because of the post-anesthetic confusion and delirium that arose during clinical studies. Illegally sold on the street, PCP is known by various names such as “angel dust”; whereas, names such as “supergrass” refer to PCP combined with marijuana. PCP possesses hallucinogenic, central nervous system (CNS)‑stimulant, and CNS‑depressant properties, the expression of which is dose‑ and species‑dependent.
LREFClouet DH, ed. Phencyclidine: An Update. NIDA Research Monograph 64. National Institute on Drug Abuse 1986.
PCP and its structural analog, ketamine, are NMDA (N‑methyl‑D‑aspartate) receptor antagonists.
LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFDe Souza EB, Clouet D, London ED, eds. Sigma, PCP, and NMDA receptors. Research Monograph 133. National Institute on Drug Abuse 1993.
Known as dissociative anesthetics, they produce mind‑altering feelings of dissociation from the environment and self. Dextromethorphan, a cough suppressant, can produce similar effects when taken in high doses.

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.

LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFLeshner AI. Hallucinogens and dissociative, including LSD, PCP, Ketamine, dextromethorphan. NIH Publication Number 01-4209, NIDA Research Report Series 2001.

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

LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Foster City, CA: Biomedical Publications 2004.
,
LREFLaurenzana EM, Owens SM. Metabolism of phencyclidine by human liver microsomes. Drug Metab Dispos 1997;25:557-663.
An amino acid metabolite of PCP exists in human urine in significant quantities.
LREFElSohly MA, Little TL Jr, Mitchell JM, et al. GC/MS analysis of phencyclidine acid metabolite in human urine. J Anal Toxicol 1988;12:180-182.
Significant variations in the PCP elimination half‑life have been found in humans; however, phase II metabolism of PCP sulfation and glucuronidation could also contribute to the variation in PCP half‑life.
LREFLaurenzana EM, Owens SM. Metabolism of phencyclidine by human liver microsomes. Drug Metab Dispos 1997;25:557-663.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Buffer; 0.09 % sodium azide

R2

PCP antibody (mouse monoclonal); buffer; bovine serum albumin; 0.09 % sodium azide

R3

Conjugated PCP derivative microparticles; buffer; 0.09 % sodium azide

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.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

LREFToxicology and Drug Testing in the Clinical Laboratory; Approved Guideline. 2nd ed. (C52-A2). Clinical and Laboratory Standards Institute 2007;27:33.

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.

LREFMandatory Guidelines for Federal Workplace Drug Testing Programs. Fed Regist 2017 Jan 23;82:7920-7970.

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.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0208058130190c503", "ProductName": "PCP", "ProductLongName": "ONLINE DAT Phencyclidine Plus", "Language": "en", "DocumentVersion": "2", "DocumentObjectID": "FF00000005B8130E", "DocumentOriginID": "FF00000005B8130E", "MaterialNumbers": [ "08058130190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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.

LREFKarch SB, ed. Drug Abuse Handbook. Boca Raton, FL: CRC Press LLC 1998.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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

LREFArmbruster DA, Schwarzhoff RH, Pierce BL, et al. Method comparison of EMIT II and ONLINE with RIA for drug screening. J Forensic Sci 1993;38:1326-1341.
as measured by changes in light transmission. In the absence of sample drug, free antibody binds to drug‑microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.

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.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

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).

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

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 cobas c 501 analyzer. The median % recoveries were calculated and are listed below.

Substance

Concentration
tested

% Phencyclidine
recovery

Acetone

1 %

98

Ascorbic acid

1.5 %

105

Bilirubin

0.25 mg/mL

98

Creatinine

5 mg/mL

113

Ethanol

1 %

100

Glucose

2 %

105

Hemoglobin

7.5 g/L

94

Human albumin

0.5 %

102

Oxalic acid

2 mg/mL

98

Sodium chloride

0.5 M

100

Sodium chloride

1 M

102

Urea

6 %

106

In very rare cases, gammopathy, in particularly type IgM (Waldenström's macroglobulinemia), may cause unreliable results.

LREFBakker AJ, Mücke M. Gammopathy interference in clinical chemistry assays: mechanisms, detection and prevention. Clin Chem Lab Med. 2007;45(9):1240-1243.

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 further instructions, refer to the operator’s manual.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08058130190

ONLINE DAT Phencyclidine Plus (cobas c pack 1), 850 tests

System‑ID 2096 011

cobas c 303, cobas c 503

ONLINE DAT Phencyclidine Plus (cobas c pack 2), 850 tests

System‑ID 2096 012

Materials required (but not provided):

03304671190

Preciset DAT Plus I calibrators CAL 1‑6 (6 x 5 mL)

Codes 20431‑20436

03304698190

C.f.a.s. DAT Qualitative Plus (6 x 5 mL)

Code 20698

04590856190

C.f.a.s. DAT Qualitative Plus Clinical (3 x 5 mL)

Code 20699

03312950190

Control Set DAT I
PreciPos DAT Set I (2 x 10 mL)
PreciNeg DAT Set I (2 x 10 mL)


Code 20123
Code 20124

04500873190

Control Set DAT Clinical
PreciPos DAT Clinical (2 x 10 mL)
PreciNeg DAT Clinical (2 x 10 mL)


Code 20129
Code 20130

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

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

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

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

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for urine

Test definition

Semiquantitative

Qualitative

Reporting time

10 min

10 min

Wavelength (sub/main)

– /505 nm

– /505 nm

Reagent pipetting

Diluent

R1

26 µL

R2

26 µL

R3

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent

Normal

5 µL

Decreased

5 µL

Increased

5 µL

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

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label

On‑board in use and refrigerated on the analyzer:

8 weeks

Do not freeze.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

Semiquantitative application

S1-4: Preciset DAT Plus I calibrators, CAL 1‑4

0, 12.5, 25, 50 ng/mL

Qualitative application

S1: C.f.a.s. DAT Qualitative Plus, C.f.a.s. DAT Qualitative Plus Clinical, or Preciset DAT Plus I calibrator ‑ CAL 3
25 ng/mL

The drug concentrations of the calibrators have been verified by GC‑MS.

Calibration K factor

For the qualitative application a K factor of ‑1000 is predefined in the application settings.

Calibration mode

Semiquantitative application
Non‑linear

Qualitative application
Linear

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

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).

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

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.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

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.

Semiquantitative precision

Repeatability

Mean
ng/mL

SD
ng/mL

CV
%

Urine - 50 %

11.0

0.432

3.9

DAT1N

19.8

0.498

2.5

DATCN

19.5

0.423

2.2

Cutoff urine

25.5

0.565

2.2

DAT1P

32.2

0.508

1.6

DATCP

31.7

0.653

2.1

Urine + 50 %

38.2

0.524

1.4

Intermediate
precision

Mean
ng/mL

SD
ng/mL

CV
%

Urine - 50 %

11.0

0.750

6.8

DAT1N

19.8

0.698

3.5

DATCN

19.5

0.760

3.9

Cutoff urine

25.5

0.920

3.6

DAT1P

32.2

0.702

2.2

DATCP

31.7

0.933

2.9

Urine + 50 %

38.2

0.850

2.2

Qualitative precision

Number tested

Correct results

Confidence level

Urine - 50 %

84

84

> 95 % negative reading

DAT1N

84

84

> 95 % negative reading

Cutoff urine

84

n.a.*

n.a.*

DAT1P

84

84

> 95 % positive reading

Urine + 50 %

84

84

> 95 % positive reading

*n.a. = not applicable

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

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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

LREFKarch SB, ed. Drug Abuse Handbook. Boca Raton, FL: CRC Press LLC 1998.
,
LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Foster City, CA: Biomedical Publications 2004.
,
LREFClouet DH, ed. Phencyclidine: An Update. NIDA Research Monograph 64. National Institute on Drug Abuse 1986.
,
LREFDe Souza EB, Clouet D, London ED, eds. Sigma, PCP, and NMDA receptors. Research Monograph 133. National Institute on Drug Abuse 1993.
,
LREFLeshner AI. Hallucinogens and dissociative, including LSD, PCP, Ketamine, dextromethorphan. NIH Publication Number 01-4209, NIDA Research Report Series 2001.
Originally developed as an intravenous anesthetic, the occurrence of emergence psychosis side effects negated its potential clinical utility. PCP was never approved for human use because of the post-anesthetic confusion and delirium that arose during clinical studies. Illegally sold on the street, PCP is known by various names such as “angel dust”; whereas, names such as “supergrass” refer to PCP combined with marijuana. PCP possesses hallucinogenic, central nervous system (CNS)‑stimulant, and CNS‑depressant properties, the expression of which is dose‑ and species‑dependent.
LREFClouet DH, ed. Phencyclidine: An Update. NIDA Research Monograph 64. National Institute on Drug Abuse 1986.
PCP and its structural analog, ketamine, are NMDA (N‑methyl‑D‑aspartate) receptor antagonists.
LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFDe Souza EB, Clouet D, London ED, eds. Sigma, PCP, and NMDA receptors. Research Monograph 133. National Institute on Drug Abuse 1993.
Known as dissociative anesthetics, they produce mind‑altering feelings of dissociation from the environment and self. Dextromethorphan, a cough suppressant, can produce similar effects when taken in high doses.

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.

LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFLeshner AI. Hallucinogens and dissociative, including LSD, PCP, Ketamine, dextromethorphan. NIH Publication Number 01-4209, NIDA Research Report Series 2001.

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

LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Foster City, CA: Biomedical Publications 2004.
,
LREFLaurenzana EM, Owens SM. Metabolism of phencyclidine by human liver microsomes. Drug Metab Dispos 1997;25:557-663.
An amino acid metabolite of PCP exists in human urine in significant quantities.
LREFElSohly MA, Little TL Jr, Mitchell JM, et al. GC/MS analysis of phencyclidine acid metabolite in human urine. J Anal Toxicol 1988;12:180-182.
Significant variations in the PCP elimination half‑life have been found in humans; however, phase II metabolism of PCP sulfation and glucuronidation could also contribute to the variation in PCP half‑life.
LREFLaurenzana EM, Owens SM. Metabolism of phencyclidine by human liver microsomes. Drug Metab Dispos 1997;25:557-663.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Buffer; 0.09 % sodium azide

R2

PCP antibody (mouse monoclonal); buffer; bovine serum albumin; 0.09 % sodium azide

R3

Conjugated PCP derivative microparticles; buffer; 0.09 % sodium azide

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.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

LREFToxicology and Drug Testing in the Clinical Laboratory; Approved Guideline. 2nd ed. (C52-A2). Clinical and Laboratory Standards Institute 2007;27:33.

For prolonged storage, freezing of the sample 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.

LREFMandatory Guidelines for Federal Workplace Drug Testing Programs. Fed Regist 2017 Jan 23;82:7920-7970.

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.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108058130190c503", "ProductName": "PCP", "ProductLongName": "ONLINE DAT Phencyclidine Plus", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF000000051DEF0E", "DocumentOriginID": "FF000000051DEF0E", "MaterialNumbers": [ "08058130190" ], "InstrumentReferences": [ { "ID": "9493", "BrandName": "cobas c 303" }, { "ID": "8481", "BrandName": "cobas c 503" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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.

LREFKarch SB, ed. Drug Abuse Handbook. Boca Raton, FL: CRC Press LLC 1998.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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

LREFArmbruster DA, Schwarzhoff RH, Pierce BL, et al. Method comparison of EMIT II and ONLINE with RIA for drug screening. J Forensic Sci 1993;38:1326-1341.
as measured by changes in light transmission. In the absence of sample drug, free antibody binds to drug‑microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.

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.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

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).

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

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 cobas c 501 analyzer. The median % recoveries were calculated and are listed below.

Substance

Concentration
tested

% Phencyclidine
recovery

Acetone

1 %

98

Ascorbic acid

1.5 %

105

Bilirubin

0.25 mg/mL

98

Creatinine

5 mg/mL

113

Ethanol

1 %

100

Glucose

2 %

105

Hemoglobin

7.5 g/L

94

Human albumin

0.5 %

102

Oxalic acid

2 mg/mL

98

Sodium chloride

0.5 M

100

Sodium chloride

1 M

102

Urea

6 %

106

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.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

08058130190

ONLINE DAT Phencyclidine Plus (cobas c pack 1), 850 tests

System‑ID 2096 011

cobas c 303, cobas c 503

ONLINE DAT Phencyclidine Plus (cobas c pack 2), 850 tests

System‑ID 2096 012

Materials required (but not provided):

03304671190

Preciset DAT Plus I calibrators CAL 1‑6 (6 x 5 mL)

Codes 20431‑20436

03304698190

C.f.a.s. DAT Qualitative Plus (6 x 5 mL)

Code 20698

04590856190

C.f.a.s. DAT Qualitative Plus Clinical (3 x 5 mL)

Code 20699

03312950190

Control Set DAT I

PreciPos DAT Set I (2 x 10 mL)

PreciNeg DAT Set I (2 x 10 mL)

04500873190

Control Set DAT Clinical

PreciPos DAT Clinical (2 x 10 mL)

PreciNeg DAT Clinical (2 x 10 mL)

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

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

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

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

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for urine

Test definition

Semiquantitative

Qualitative

Reporting time

10 min

10 min

Wavelength (sub/main)

– /505 nm

– /505 nm

Reagent pipetting

Diluent

R1

26 µL

R2

26 µL

R3

24 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent

Normal

5 µL

Decreased

5 µL

Increased

5 µL

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

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label

On‑board in use and refrigerated on the analyzer:

8 weeks

Do not freeze.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

Semiquantitative application

S1-4: Preciset DAT Plus I calibrators, CAL 1‑4

0, 12.5, 25, 50 ng/mL

Qualitative application

S1: C.f.a.s. DAT Qualitative Plus, C.f.a.s. DAT Qualitative Plus Clinical, or Preciset DAT Plus I calibrator ‑ CAL 3
25 ng/mL

The drug concentrations of the calibrators have been verified by GC‑MS.

Calibration K factor

For the qualitative application a K factor of ‑1000 is predefined in the application settings.

Calibration mode

Semiquantitative application
Non‑linear

Qualitative application
Linear

Calibration frequency

Full calibration
- after reagent lot change
- as required following quality control procedures

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).

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

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.

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

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.

Semiquantitative precision

Repeatability

Mean
ng/mL

SD
ng/mL

CV
%

Urine -50 %

11.0

0.432

3.9

DAT1N

19.8

0.498

2.5

DATCN

19.5

0.423

2.2

Cutoff urine

25.5

0.565

2.2

DAT1P

32.2

0.508

1.6

DATCP

31.7

0.653

2.1

Urine +50 %

38.2

0.524

1.4

Intermediate
precision

Mean
ng/mL

SD
ng/mL

CV
%

Urine -50 %

11.0

0.750

6.8

DAT1N

19.8

0.698

3.5

DATCN

19.5

0.760

3.9

Cutoff urine

25.5

0.920

3.6

DAT1P

32.2

0.702

2.2

DATCP

31.7

0.933

2.9

Urine +50 %

38.2

0.850

2.2

Qualitative precision

Number tested

Correct results

Confidence level

Urine -50 %

84

84

> 95 % negative reading

DAT1N

84

84

> 95 % negative reading

Cutoff urine

84

n.a.*

n.a.*

DAT1P

84

84

> 95 % positive reading

Urine +50 %

84

84

> 95 % positive reading

*n.a. = not applicable

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

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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

LREFKarch SB, ed. Drug Abuse Handbook. Boca Raton, FL: CRC Press LLC 1998.
,
LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Foster City, CA: Biomedical Publications 2004.
,
LREFClouet DH, ed. Phencyclidine: An Update. NIDA Research Monograph 64. National Institute on Drug Abuse 1986.
,
LREFDe Souza EB, Clouet D, London ED, eds. Sigma, PCP, and NMDA receptors. Research Monograph 133. National Institute on Drug Abuse 1993.
,
LREFLeshner AI. Hallucinogens and dissociative, including LSD, PCP, Ketamine, dextromethorphan. NIH Publication Number 01-4209, NIDA Research Report Series 2001.
Originally developed as an intravenous anesthetic, the occurrence of emergence psychosis side effects negated its potential clinical utility. PCP was never approved for human use because of the post-anesthetic confusion and delirium that arose during clinical studies. Illegally sold on the street, PCP is known by various names such as “angel dust”; whereas, names such as “supergrass” refer to PCP combined with marijuana. PCP possesses hallucinogenic, central nervous system (CNS)‑stimulant, and CNS‑depressant properties, the expression of which is dose‑ and species‑dependent.
LREFClouet DH, ed. Phencyclidine: An Update. NIDA Research Monograph 64. National Institute on Drug Abuse 1986.
PCP and its structural analog, ketamine, are NMDA (N‑methyl‑D‑aspartate) receptor antagonists.
LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFDe Souza EB, Clouet D, London ED, eds. Sigma, PCP, and NMDA receptors. Research Monograph 133. National Institute on Drug Abuse 1993.
Known as dissociative anesthetics, they produce mind‑altering feelings of dissociation from the environment and self. Dextromethorphan, a cough suppressant, can produce similar effects when taken in high doses.

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.

LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFLeshner AI. Hallucinogens and dissociative, including LSD, PCP, Ketamine, dextromethorphan. NIH Publication Number 01-4209, NIDA Research Report Series 2001.

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

LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Foster City, CA: Biomedical Publications 2004.
,
LREFLaurenzana EM, Owens SM. Metabolism of phencyclidine by human liver microsomes. Drug Metab Dispos 1997;25:557-663.
An amino acid metabolite of PCP exists in human urine in significant quantities.
LREFElSohly MA, Little TL Jr, Mitchell JM, et al. GC/MS analysis of phencyclidine acid metabolite in human urine. J Anal Toxicol 1988;12:180-182.
Significant variations in the PCP elimination half‑life have been found in humans; however, phase II metabolism of PCP sulfation and glucuronidation could also contribute to the variation in PCP half‑life.
LREFLaurenzana EM, Owens SM. Metabolism of phencyclidine by human liver microsomes. Drug Metab Dispos 1997;25:557-663.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Buffer; 0.09 % sodium azide

R2

PCP antibody (mouse monoclonal); buffer; bovine serum albumin; 0.09 % sodium azide

R3

Conjugated PCP derivative microparticles; buffer; 0.09 % sodium azide

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.

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

LREFToxicology and Drug Testing in the Clinical Laboratory; Approved Guideline. 2nd ed. (C52-A2). Clinical and Laboratory Standards Institute 2007;27:33.

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.

LREFMandatory Guidelines for Federal Workplace Drug Testing Programs. Fed Regist 2017 Jan 23;82:7920-7970.

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.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0004490908190c501", "ProductName": "PCP", "ProductLongName": "ONLINE DAT Phencyclidine Plus", "Language": "en", "DocumentVersion": "13", "DocumentObjectID": "FF000000047C0A0E", "DocumentOriginID": "FF00000000741C0E", "MaterialNumbers": [ "04490908190" ], "InstrumentReferences": [ { "ID": "308", "BrandName": "cobas c 311" }, { "ID": "2324", "BrandName": "cobas c 502" }, { "ID": "309", "BrandName": "cobas c 501" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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.

LREFKarch SB, ed. Drug Abuse Handbook. Boca Raton, FL: CRC Press LLC 1998.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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

LREFArmbruster DA, Schwarzhoff RH, Pierce BL, et al. Method comparison of EMIT II and ONLINE with RIA for drug screening. J Forensic Sci 1993;38:1326-1341.
as measured by changes in light transmission. In the absence of sample drug, free antibody binds to drug‑microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.

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.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Lower detection limit of the test

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).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

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).

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

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.

Substance

Concentration
Tested

% Phencyclidine
Recovery

Acetone

1 %

98

Ascorbic acid

1.5 %

105

Bilirubin

0.25 mg/mL

98

Creatinine

5 mg/mL

113

Ethanol

1 %

100

Glucose

2 %

105

Hemoglobin

7.5 g/L

94

Human albumin

0.5 %

102

Oxalic acid

2 mg/mL

98

Sodium chloride

0.5 M

100

Sodium chloride

1 M

102

Urea

6 %

106

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. The latest version of the carry‑over evasion list can be found with the NaOHD-SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the operator’s manual. cobas c 502 analyzer: All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is not required.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

04490908 190

ONLINE DAT Phencyclidine Plus (200 tests)

System‑ID 07 6919 3

Roche/Hitachi cobas c  311, cobas c 501/502

Materials required (but not provided):

03304671 190

Preciset DAT Plus I calibrators CAL 1‑6 (6 x 5 mL)

Codes 431‑436

03304698 190

C.f.a.s. DAT Qualitative Plus (6 x 5 mL)

04590856 190

C.f.a.s. DAT Qualitative Plus Clinical (3 x 5 mL)

Code 699

03312950 190

Control Set DAT I

PreciPos DAT Set I (2 x 10 mL)

PreciNeg DAT Set I (2 x 10 mL)

04500873 190

Control Set DAT Clinical

PreciPos DAT Clinical (2 x 10 mL)

PreciNeg DAT Clinical (2 x 10 mL)

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

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

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

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

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for urine

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

cobas c 311 test definition

Semiquantitative

Qualitative

Assay type

2‑Point End

2‑Point End

Reaction time / Assay points

10 / 27‑51

10 / 27‑51

Wavelength (sub/main)

– /505 nm

– /505 nm

Reaction direction

Increase

Increase

Unit

ng/mL

mAbs

Reagent pipetting

Diluent (H2O)

R1

59 µL

R2

59 µL

R3

54 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent NaCl

Normal

11.3 µL

Decreased

11.3 µL

Increased

11.3 µL

cobas c 501/502 test definition

Semiquantitative

Qualitative

Assay type

2‑Point End

2‑Point End

Reaction time / Assay points

10 / 40‑58

10 / 40‑58

Wavelength (sub/main)

– /505 nm

– /505 nm

Reaction direction

Increase

Increase

Unit

ng/mL

mAbs

Reagent pipetting

Diluent (H2O)

R1

59 µL

R2

59 µL

R3

54 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent NaCl

Normal

11.3 µL

Decreased

11.3 µL

Increased

11.3 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label

On‑board in use and refrigerated on the analyzer:

8 weeks

Do not freeze.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

Semiquantitative application

S1-4: Preciset DAT Plus I calibrators, CAL 1‑4

0, 12.5, 25, 50 ng/mL

Qualitative application

S1: C.f.a.s. DAT Qualitative Plus, C.f.a.s. DAT Qualitative Plus Clinical, or Preciset DAT Plus I calibrator ‑ CAL 3
25 ng/mL

The drug concentrations of the calibrators have been verified by GC‑MS.

Calibration K Factor

For the qualitative application, enter the K Factor as ‑1000 into the Calibration menu, Status screen, Calibration Result window.

Calibration mode

Semiquantitative application
Result Calculation Mode (RCM)a

Qualitative application
Linear

Calibration frequency

Full (semiquantitative) or blank (qualitative) calibration

- after reagent lot change

- as required following quality control procedures

a) See Results section.

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).

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

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

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

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.

Semiquantitative precision

Repeatability

Mean
ng/mL

SD
ng/mL

CV
%

Level 1

18.0

0.6

3.6

Level 2

25.1

0.7

2.9

Level 3

30.6

0.6

1.9

Intermediate
precision

Mean
ng/mL

SD
ng/mL

CV
%

Level 1

18.1

0.8

4.3

Level 2

24.6

0.8

3.1

Level 3

31.2

0.7

2.2

Qualitative precision

Cutoff (25)

Number tested

Correct results

Confidence level

0.75x

100

100

> 95 % negative reading

1.25x

100

100

> 95 % positive reading

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

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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

LREFKarch SB, ed. Drug Abuse Handbook. Boca Raton, FL: CRC Press LLC 1998.
,
LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Foster City, CA: Biomedical Publications 2004.
,
LREFClouet DH, ed. Phencyclidine: An Update. NIDA Research Monograph 64. National Institute on Drug Abuse 1986.
,
LREFDe Souza EB, Clouet D, London ED, eds. Sigma, PCP, and NMDA receptors. Research Monograph 133. National Institute on Drug Abuse 1993.
,
LREFLeshner AI. Hallucinogens and dissociative, including LSD, PCP, Ketamine, dextromethorphan. NIH Publication Number 01-4209, NIDA Research Report Series 2001.
Originally developed as an intravenous anesthetic, the occurrence of emergence psychosis side effects negated its potential clinical utility. PCP was never approved for human use because of the post-anesthetic confusion and delirium that arose during clinical studies. Illegally sold on the street, PCP is known by various names such as “angel dust”; whereas, names such as “supergrass” refer to PCP combined with marijuana. PCP possesses hallucinogenic, central nervous system (CNS)‑stimulant, and CNS‑depressant properties, the expression of which is dose‑ and species‑dependent.
LREFClouet DH, ed. Phencyclidine: An Update. NIDA Research Monograph 64. National Institute on Drug Abuse 1986.
PCP and its structural analog, ketamine, are NMDA (N‑methyl‑D‑aspartate) receptor antagonists.
LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFDe Souza EB, Clouet D, London ED, eds. Sigma, PCP, and NMDA receptors. Research Monograph 133. National Institute on Drug Abuse 1993.
Known as dissociative anesthetics, they produce mind‑altering feelings of dissociation from the environment and self. Dextromethorphan, a cough suppressant, can produce similar effects when taken in high doses.

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.

LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFLeshner AI. Hallucinogens and dissociative, including LSD, PCP, Ketamine, dextromethorphan. NIH Publication Number 01-4209, NIDA Research Report Series 2001.

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

LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Foster City, CA: Biomedical Publications 2004.
,
LREFLaurenzana EM, Owens SM. Metabolism of phencyclidine by human liver microsomes. Drug Metab Dispos 1997;25:557-663.
An amino acid metabolite of PCP exists in human urine in significant quantities.
LREFElSohly MA, Little TL Jr, Mitchell JM, et al. GC/MS analysis of phencyclidine acid metabolite in human urine. J Anal Toxicol 1988;12:180-182.
Significant variations in the PCP elimination half‑life have been found in humans; however, phase II metabolism of PCP sulfation and glucuronidation could also contribute to the variation in PCP half‑life.
LREFLaurenzana EM, Owens SM. Metabolism of phencyclidine by human liver microsomes. Drug Metab Dispos 1997;25:557-663.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Buffer; 0.09 % sodium azide

R2

PCP antibody (mouse monoclonal); buffer; bovine serum albumin; 0.09 % sodium azide

R3

Conjugated PCP derivative microparticles; buffer; 0.09 % sodium azide

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

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

For in vitro diagnostic use for health care professionals. Exercise the normal precautions required for handling all laboratory reagents.

Infectious or microbial waste:
Warning: handle waste as potentially biohazardous material. Dispose of waste according to accepted laboratory instructions and procedures.

Environmental hazards:
Apply all relevant local disposal regulations to determine the safe disposal.

Safety data sheet available for professional user on request.

For USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

LREFToxicology and Drug Testing in the Clinical Laboratory; Approved Guideline. 2nd ed. (C52-A2). Clinical and Laboratory Standards Institute 2007;27:33.

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.

LREFMandatory Guidelines for Federal Workplace Drug Testing Programs. Fed Regist 2008 Nov 25;73:71858-71907.

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.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0004490908190c501", "ProductName": "PCP", "ProductLongName": "Phencyclidine Plus", "Language": "en", "DocumentVersion": "12", "DocumentObjectID": "FF00000001DCC70E", "DocumentOriginID": "FF0000000034AB0E", "MaterialNumbers": [ "04490908190" ], "InstrumentReferences": [ { "ID": "308", "BrandName": "cobas c 311" }, { "ID": "2324", "BrandName": "cobas c 502" }, { "ID": "309", "BrandName": "cobas c 501" } ], "DisclaimerText": "Product information shown on this page contains elements of the officially released Method Sheet. If you require further information please refer to the full Method Sheet PDF under the given link, or contact your local Roche country representative." }, "Chapters": [ { "Name": "IntendedUse", "Value": "

Intended use

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.

LREFKarch SB, ed. Drug Abuse Handbook. Boca Raton, FL: CRC Press LLC 1998.
Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

", "Language": "en" }, { "Name": "TestPrinciple", "Value": "

Test principle

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

LREFArmbruster DA, Schwarzhoff RH, Pierce BL, et al. Method comparison of EMIT II and ONLINE with RIA for drug screening. J Forensic Sci 1993;38:1326-1341.
as measured by changes in light transmission. In the absence of sample drug, free antibody binds to drug‑microparticle conjugates causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases.

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.

", "Language": "en" }, { "Name": "MeasuringRange", "Value": "

Lower detection limit of the test

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).

", "Language": "en" }, { "Name": "ExpectedValues", "Value": "

Expected values

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).

", "Language": "en" }, { "Name": "LimitationInterference", "Value": "

Limitations - interference

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.

Substance

Concentration
Tested

% Phencyclidine
Recovery

Acetone

1 %

98

Ascorbic acid

1.5 %

105

Bilirubin

0.25 mg/mL

98

Creatinine

5 mg/mL

113

Ethanol

1 %

100

Glucose

2 %

105

Hemoglobin

7.5 g/L

94

Human albumin

0.5 %

102

Oxalic acid

2 mg/mL

98

Sodium chloride

0.5 M

100

Sodium chloride

1 M

102

Urea

6 %

106

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. The latest version of the carry‑over evasion list can be found with the NaOHD-SMS-SmpCln1+2-SCCS Method Sheets. For further instructions refer to the operator’s manual. cobas c 502 analyzer: All special wash programming necessary for avoiding carry‑over is available via the cobas link, manual input is not required.

Where required, special wash/carry‑over evasion programming must be implemented prior to reporting results with this test.

", "Language": "en" }, { "Name": "OrderInformation", "Value": "

OrderInformation (CC Reagents - cobas + Integra)

Order information

Analyzer(s) on which cobas c pack(s) can be used

04490908 190

ONLINE DAT Phencyclidine Plus (200 tests)

System‑ID 07 6919 3

Roche/Hitachi cobas c  311, cobas c 501/502

03304671 190

Preciset DAT Plus I calibrators CAL 1‑6 (6 x 5 mL)

Codes 431‑436

03304698 190

C.f.a.s. DAT Qualitative Plus (6 x 5 mL)

04590856 190

C.f.a.s. DAT Qualitative Plus Clinical (3 x 5 mL)

Code 699

03312950 190

Control Set DAT I

PreciPos DAT Set I (2 x 10 mL)

PreciNeg DAT Set I (2 x 10 mL)

04500873 190

Control Set DAT Clinical

PreciPos DAT Clinical (2 x 10 mL)

PreciNeg DAT Clinical (2 x 10 mL)

", "Language": "en" }, { "Name": "SystemInformation", "Value": "

System information

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

", "Language": "en" }, { "Name": "Handling", "Value": "

Reagent handling

Ready for use

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

", "Language": "en" }, { "Name": "TestDefinition", "Value": "

Application for urine

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

cobas c 311 test definition

Semiquantitative

Qualitative

Assay type

2‑Point End

2‑Point End

Reaction time / Assay points

10 / 27‑51

10 / 27‑51

Wavelength (sub/main)

– /505 nm

– /505 nm

Reaction direction

Increase

Increase

Unit

ng/mL

mAbs

Reagent pipetting

Diluent (H2O)

R1

59 µL

R2

59 µL

R3

54 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent NaCl

Normal

11.3 µL

Decreased

11.3 µL

Increased

11.3 µL

cobas c 501/502 test definition

Semiquantitative

Qualitative

Assay type

2‑Point End

2‑Point End

Reaction time / Assay points

10 / 40‑58

10 / 40‑58

Wavelength (sub/main)

– /505 nm

– /505 nm

Reaction direction

Increase

Increase

Unit

ng/mL

mAbs

Reagent pipetting

Diluent (H2O)

R1

59 µL

R2

59 µL

R3

54 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent NaCl

Normal

11.3 µL

Decreased

11.3 µL

Increased

11.3 µL

", "Language": "en" }, { "Name": "StorageStability", "Value": "

Storage and stability

Shelf life at 2‑8 °C:

See expiration date on cobas c pack label

On‑board in use and refrigerated on the analyzer:

8 weeks

Do not freeze.

", "Language": "en" }, { "Name": "Calibration", "Value": "

Calibration

Calibrators

Semiquantitative application

S1-4: Preciset DAT Plus I calibrators, CAL 1‑4

0, 12.5, 25, 50 ng/mL

Qualitative application

S1: C.f.a.s. DAT Qualitative Plus, C.f.a.s. DAT Qualitative Plus Clinical, or Preciset DAT Plus I calibrator ‑ CAL 3
25 ng/mL

The drug concentrations of the calibrators have been verified by GC‑MS.

Calibration K Factor

For the qualitative application, enter the K Factor as ‑1000 into the Calibration menu, Status screen, Calibration Result window.

Calibration mode

Semiquantitative application
Result Calculation Mode (RCM)a

Qualitative application
Linear

Calibration frequency

Full (semiquantitative) or blank (qualitative) calibration

- after reagent lot change

- as required following quality control procedures

a) See Results section.

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).

", "Language": "en" }, { "Name": "Limitations", "Value": "", "Language": "en" }, { "Name": "PerformanceData", "Value": "

Specific performance data

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

", "Language": "en" }, { "Name": "Precision", "Value": "

Precision

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.

Semiquantitative precision

Repeatability

Mean
ng/mL

SD
ng/mL

CV
%

Level 1

18.0

0.6

3.6

Level 2

25.1

0.7

2.9

Level 3

30.6

0.6

1.9

Intermediate
precision

Mean
ng/mL

SD
ng/mL

CV
%

Level 1

18.1

0.8

4.3

Level 2

24.6

0.8

3.1

Level 3

31.2

0.7

2.2

Qualitative precision

Cutoff (25)

Number tested

Correct results

Confidence level

0.75x

100

100

> 95 % negative reading

1.25x

100

100

> 95 % positive reading

", "Language": "en" }, { "Name": "MethodComparison", "Value": "", "Language": "en" }, { "Name": "Summary", "Value": "

Summary

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

LREFKarch SB, ed. Drug Abuse Handbook. Boca Raton, FL: CRC Press LLC 1998.
,
LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Foster City, CA: Biomedical Publications 2004.
,
LREFClouet DH, ed. Phencyclidine: An Update. NIDA Research Monograph 64. National Institute on Drug Abuse 1986.
,
LREFDe Souza EB, Clouet D, London ED, eds. Sigma, PCP, and NMDA receptors. Research Monograph 133. National Institute on Drug Abuse 1993.
,
LREFLeshner AI. Hallucinogens and dissociative, including LSD, PCP, Ketamine, dextromethorphan. NIH Publication Number 01-4209, NIDA Research Report Series 2001.
Originally developed as an intravenous anesthetic, the occurrence of emergence psychosis side effects negated its potential clinical utility. PCP was never approved for human use because of the post-anesthetic confusion and delirium that arose during clinical studies. Illegally sold on the street, PCP is known by various names such as “angel dust”; whereas, names such as “supergrass” refer to PCP combined with marijuana. PCP possesses hallucinogenic, central nervous system (CNS)‑stimulant, and CNS‑depressant properties, the expression of which is dose‑ and species‑dependent.
LREFClouet DH, ed. Phencyclidine: An Update. NIDA Research Monograph 64. National Institute on Drug Abuse 1986.
PCP and its structural analog, ketamine, are NMDA (N‑methyl‑D‑aspartate) receptor antagonists.
LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFDe Souza EB, Clouet D, London ED, eds. Sigma, PCP, and NMDA receptors. Research Monograph 133. National Institute on Drug Abuse 1993.
Known as dissociative anesthetics, they produce mind‑altering feelings of dissociation from the environment and self. Dextromethorphan, a cough suppressant, can produce similar effects when taken in high doses.

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.

LREFHardman JG, Limbird LE, Gilman A, eds. Goodman and Gilman’s The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw Hill Pub Co. 2001.
,
LREFLeshner AI. Hallucinogens and dissociative, including LSD, PCP, Ketamine, dextromethorphan. NIH Publication Number 01-4209, NIDA Research Report Series 2001.

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

LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 7th ed. Foster City, CA: Biomedical Publications 2004.
,
LREFLaurenzana EM, Owens SM. Metabolism of phencyclidine by human liver microsomes. Drug Metab Dispos 1997;25:557-663.
An amino acid metabolite of PCP exists in human urine in significant quantities.
LREFElSohly MA, Little TL Jr, Mitchell JM, et al. GC/MS analysis of phencyclidine acid metabolite in human urine. J Anal Toxicol 1988;12:180-182.
Significant variations in the PCP elimination half‑life have been found in humans; however, phase II metabolism of PCP sulfation and glucuronidation could also contribute to the variation in PCP half‑life.
LREFLaurenzana EM, Owens SM. Metabolism of phencyclidine by human liver microsomes. Drug Metab Dispos 1997;25:557-663.

", "Language": "en" }, { "Name": "Reagents", "Value": "

Reagents - working solutions

R1

Buffer; 0.09 % sodium azide

R2

PCP antibody (mouse monoclonal); buffer; bovine serum albumin; 0.09 % sodium azide

R3

Conjugated PCP derivative microparticles; buffer; 0.09 % sodium azide

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

", "Language": "en" }, { "Name": "PrecautionsWarnings", "Value": "

Precautions and warnings

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 USA: Caution: Federal law restricts this device to sale by or on the order of a physician.

", "Language": "en" }, { "Name": "Caution", "Value": "", "Language": "en" }, { "Name": "QualityControl", "Value": "

Quality control

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.

", "Language": "en" }, { "Name": "SpecimenPreparation", "Value": "

Specimen collection and preparation

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.

LREFToxicology and Drug Testing in the Clinical Laboratory; Approved Guideline. 2nd ed. (C52-A2). Clinical and Laboratory Standards Institute 2007;27:33.

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.

LREFMandatory Guidelines for Federal Workplace Drug Testing Programs. Fed Regist 2008 Nov 25;73:71858-71907.

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.

", "Language": "en" } ] } } ] }

PCP

ONLINE DAT Phencyclidine Plus

IVD For in vitro diagnostic use.
PCP

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

...
    ...

    Technical Documents

    Access Material Data Sheets, Certificates of Analysis, and other product documentation.

    After clicking below, you will be redirected to eLabDoc, where you can choose your local country.
    error errorMessage
    Sorry, we couldn't find the content you are looking for
    Please try again later