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Intended use

The Hydrocodone Enzyme Immunoassay is an in vitro diagnostic test intended for the qualitative and semi‑quantitative determination of hydrocodone in human urine. The cutoffs for the assay are 100 ng/mL and 300 ng/mL when calibrated against hydrocodone. The assay is designed for prescription use on the Roche cobas c analyzers.

The semi‑quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for verification by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC‑MS or LC‑MS) or (2) permitting laboratories to establish quality control procedures.

The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC‑MS or LC‑MS) are the preferred confirmatory methods.

LREFUrine Testing for Drug of Abuse, National Institute on Drug Abuse (NIDA) Research Monograph 73 (1986).
,
LREFMandatory Guidelines for Federal Workplace Drug Testing Programs. Fed Regist 2017 Jan 23;82:7920-7970.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

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

Test principle

The Hydrocodone Enzyme Immunoassay is a homogeneous enzyme immunoassay ready‑for‑use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose‑6‑phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent.

LREFRubenstein KE, Schneider RS, Ullman EF. "Homogeneous" Enzyme Immunoassay: A New Immunochemical Technique, Biochem Biophys Res Commun 1972;47(1):846-851.
Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, hydrocodone‑labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when drug is present in the sample, antibody would bind to free drug; the unbound hydrocodone‑labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

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

Limitations

1. A preliminary positive result from the assay indicates only the presence of hydrocodone.

2. The test is not intended for quantifying this single analyte in patient samples.

3. A preliminary positive result does not necessarily indicate drug abuse.

4. A negative result does not necessarily mean a person did not take illegal drugs.

5. There is a possibility that other substances and/or factors not listed above may interfere with the test and cause incorrect results (e.g., technical or procedural error, fluid intake, endogenous or exogenous interferents).

6. Preliminary positive results should be confirmed by other affirmative, analytical chemistry methods (e.g., chromatography), preferably GC‑MS or LC‑MS.

7. The test is designed for use with human urine only.

8. The test is not for therapeutic drug monitoring.

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

09067736190

Hydrocodone Enzyme Immunoassay (240 tests)

System‑ID 2083 001

cobas c 503

08304718190

Hydrocodone 100 Semi‑Quantitative Calibrators Set
HYD 100 Negative Calibrator 0 ng/mL (1 x 5 mL)
HYD 100 Low Calibrator 50 ng/mL (1 x 5 mL)
HYD 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL)
HYD 100 Intermediate Calibrator 150 ng/mL (1 x 5 mL)
HYD 100 High Calibrator 300 ng/mL (1 x 5 mL)


Code 20613
Code 20614
Code 20615
Code 20616
Code 20617

08239827190

Hydrocodone 300 Semi‑Quantitative Calibrators Set
HYD 300 Negative Calibrator 0 ng/mL (1 x 5 mL)
HYD 300 Low Calibrator 150 ng/mL (1 x 5 mL)
HYD 300 Cutoff Calibrator 300 ng/mL (1 x 5 mL)
HYD 300 Intermediate Calibrator 500 ng/mL (1 x 5 mL)
HYD 300 High Calibrator 800 ng/mL (1 x 5 mL)


Code 20647
Code 20648
Code 20649
Code 20650
Code 20651

08304734190

Hydrocodone 100 Qualitative Calibrator Set
HYD Cutoff Calibrator 100 ng/mL (1 x 5 mL)


Code 20652

08239843190

Hydrocodone 300 Qualitative Calibrator Set
HYD Cutoff Calibrator 300 ng/mL (1 x 5 mL)


Code 20653

08304742190

Hydrocodone 100 Control Set
Negative Control 75 ng/mL (2 x 15 mL)
Positive Control 125 ng/mL (2 x 15 mL)


Code 20256
Code 20257

08239851190

Hydrocodone 300 Control Set
Negative Control 225 ng/mL (2 x 15 mL)
Positive Control 375 ng/mL (2 x 15 mL)


Code 20354
Code 20355

09330119190

DAT Opiates Multi Control I Set (for 100 ng/mL assay)
Negative Control 75 ng/mL (2 x 15 mL)
Positive Control 125 ng/mL (2 x 15 mL)


Code 20159
Code 20160

04908856160

Open/Close tool (5 pieces)

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

System information

HYD1Q: ACN 20830: for qualitative assay, 100 ng/mL

HYD1S: ACN 20832: for semi‑quantitative assay, 100 ng/mL

HYD3Q: ACN 20831: for qualitative assay, 300 ng/mL

HYD3S: ACN 20833: for semi‑quantitative assay, 300 ng/mL

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

Reagent handling

Ready for use

Filling the cobas c pack:

  1. Turn the cobas c pack toward you.

  2. Position B of the cobas c pack is on the left side and position C on the right side.

  3. Unscrew the screw cap of the bottle in position B on the left side of the cobas c pack using the Open/Close tool.

  4. Use one of the enclosed funnels to pour the content of the R1 bottle (24.0 mL) into the opened bottle of the cobas c pack (position B). Discard the funnel.

  5. Close the bottle tightly using the Open/Close tool.

  6. Unscrew the screw cap of the bottle in position C on the right side of the cobas c pack using the Open/Close tool.

  7. Use one of the enclosed funnels to pour the content of the R2 bottle (10.1 mL) into the opened bottle of the cobas c pack (position C). Discard the funnel.

  8. Close the bottle tightly using the Open/Close tool.

The HYD cobas c pack is now ready for use.

NOTE: Solutions must be at the reagent compartment storage temperature of the analyzer before performing assays.

Note
Always use a new cobas c pack when preparing fresh reagent. Never reuse accessories designed for single use, as this may result in reagent contamination and could affect test results. If the cobas c pack bottles are not filled correctly, this may result in faulty reagent pipetting and could cause erroneous results.

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

Applications for urine

Test definition - 100 ng/mL cutoff assay

Semi‑quantitative

Qualitative

Reporting time

10 min

10 min

Wavelength (sub/main)

415/340 nm

415/340 nm

Reagent pipetting

R1

65 µL

65 µL

R3

25 µL

25 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

9.8 µL

Decreased

9.8 µL

Increased

9.8 µL

Test definition - 300 ng/mL cutoff assay

Semi‑quantitative

Qualitative

Reporting time

10 min

10 min

Wavelength (sub/main)

415/340 nm

415/340 nm

Reagent pipetting

R1

65 µL

65 µL

R3

25 µL

25 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

3.3 µL

Decreased

3.3 µL

Increased

3.3 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:

95 days

Do not freeze.

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

Calibration

Calibrators

Semi‑quantitative applications

100 ng/mL cutoff assay

S1: Hydrocodone Calibrator 0

S2: Hydrocodone Calibrator 50

S3: Hydrocodone Calibrator 100

S4: Hydrocodone Calibrator 150

S5: Hydrocodone Calibrator 300

0, 50, 100, 150, 300 ng/mL

300 ng/mL cutoff assay

S1: Hydrocodone Calibrator 0

S2: Hydrocodone Calibrator 150

S3: Hydrocodone Calibrator 300

S4: Hydrocodone Calibrator 500

S5: Hydrocodone Calibrator 800

0, 150, 300, 500, 800 ng/mL

Qualitative applications

100 ng/mL cutoff assay

S1: Hydrocodone Calibrator 100

300 ng/mL cutoff assay

S1: Hydrocodone Calibrator 300

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

Calibration K Factor

For the qualitative application a K factor of 10000 is predefined in the application settings.

Calibration mode

Semi‑quantitative applications

Result Calculation Mode (RCM)

Qualitative applications

Linear

Calibration frequency

Full calibration
• every 14 days
• 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 or LC‑MS).

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

Specific performance data

Representative performance data on a Beckman Coulter AU480 analyzer are given below. Data was validated on a Roche cobas c 501, cobas c 502, and cobas c 503 analyzer and did not show any significant differences between the analyzers. Results obtained in individual laboratories may differ.

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

Precision on Beckman Coulter AU480 analyzer

Hydrocodone (100 ng/mL Cutoff)

The assay range from 0 ng/mL to 300 ng/mL was tested in qualitative (∆OD, mAU) and semi‑quantitative (ng/mL) mode using a modified NCCLS protocol. Results shown below were obtained by testing all samples in replicates of 2, 2 runs per day for 22 days on a Beckman Coulter AU480 automated clinical chemistry analyzer.

Qualitative analysis: Typical results (measured by ∆OD, mAU) are as follows:

100 ng/mL Cutoff

Within Run

Total Precision

Sample
[ng/mL]

% of
Cutoff

#
Samples

EIA
Result

#
Samples

EIA
Result

0 ng/mL

0 %

22

22 Neg

88

88 Neg

25 ng/mL

25 %

22

22 Neg

88

88 Neg

50 ng/mL

50 %

22

22 Neg

88

88 Neg

75 ng/mL

75 %

22

22 Neg

88

88 Neg

100 ng/mL

100 %

22

15 Neg/
7 Pos

88

60 Neg/
28 Pos

125 ng/mL

125 %

22

22 Pos

88

88 Pos

150 ng/mL

150 %

22

22 Pos

88

88 Pos

175 ng/mL

175 %

22

22 Pos

88

88 Pos

200 ng/mL

200 %

22

22 Pos

88

88 Pos

Semi‑quantitative analysis: The following concentrations were determined with reference curves from 5 calibrators. Typical results were measured in ng/mL. Preliminary positive/negative results are as follows:

100 ng/mL Cutoff

Within Run

Total Precision

Sample
[ng/mL]

% of
Cutoff

#
Samples

EIA
Result

#
Samples

EIA
Result

0 ng/mL

0 %

22

22 Neg

88

88 Neg

25 ng/mL

25 %

22

22 Neg

88

88 Neg

50 ng/mL

50 %

22

22 Neg

88

88 Neg

75 ng/mL

75 %

22

22 Neg

88

88 Neg

100 ng/mL

100 %

22

14 Neg/
8 Pos

88

45 Neg/
43 Pos

125 ng/mL

125 %

22

22 Pos

88

88 Pos

150 ng/mL

150 %

22

22 Pos

88

88 Pos

175 ng/mL

175 %

22

22 Pos

88

88 Pos

200 ng/mL

200 %

22

22 Pos

88

88 Pos

Hydrocodone (300 ng/mL Cutoff)

The assay range from 0 ng/mL to 600 ng/mL was tested in qualitative (∆OD, mAU) and semi‑quantitative (ng/mL) mode using a modified NCCLS protocol. Results shown below were obtained by testing all samples in replicates of 2, 2 runs per day for 22 days on a Beckman Coulter AU480 automated clinical chemistry analyzer.

Qualitative analysis: Typical results (measured by ∆OD, mAU) are as follows:

300 ng/mL Cutoff

Within Run

Total Precision

Sample
[ng/mL]

% of
Cutoff

#
Samples

EIA
Result

#
Samples

EIA
Result

0 ng/mL

0 %

22

22 Neg

88

88 Neg

75 ng/mL

25 %

22

22 Neg

88

88 Neg

150 ng/mL

50 %

22

22 Neg

88

88 Neg

225 ng/mL

75 %

22

22 Neg

88

88 Neg

300 ng/mL

100 %

22

11 Neg/
11 Pos

88

37 Neg/
51 Pos

375 ng/mL

125 %

22

22 Pos

88

88 Pos

450 ng/mL

150 %

22

22 Pos

88

88 Pos

525 ng/mL

175 %

22

22 Pos

88

88 Pos

600 ng/mL

200 %

22

22 Pos

88

88 Pos

Semi‑quantitative analysis: The following concentrations were determined with reference curves from 5 calibrators. Typical results were measured in ng/mL. Preliminary positive/negative results are as follows:

300 ng/mL Cutoff

Within Run

Total Precision

Sample
[ng/mL]

% of
Cutoff

#
Samples

EIA
Result

#
Samples

EIA
Result

0 ng/mL

0 %

22

22 Neg

88

88 Neg

75 ng/mL

25 %

22

22 Neg

88

88 Neg

150 ng/mL

50 %

22

22 Neg

88

88 Neg

225 ng/mL

75 %

22

22 Neg

88

88 Neg

300 ng/mL

100 %

22

8 Neg/
14 Pos

88

41 Neg/
47 Pos

375 ng/mL

125 %

22

22 Pos

88

88 Pos

450 ng/mL

150 %

22

22 Pos

88

88 Pos

525 ng/mL

175 %

22

22 Pos

88

88 Pos

600 ng/mL

200 %

22

22 Pos

88

88 Pos

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

Summary

Hydrocodone is an opioid compound derived from codeine. Hydrocodone acts on μ‑opioid receptors.

LREFVallejo R, Barkin RL, Wang VC. Pharmacology of opioids in the treatment of chronic pain syndromes. Pain physician 2011;14(4):E343-E360.
It is prescribed as a narcotic analgesic to treat moderate to severe pain and as an antitussive to treat cough.
LREFKarch SB. Pharmacokinetics and pharmacodynamics of abused drugs. CRC Press, Boca Raton 2008:55-56.
As an opioid compound, it is more potent than codeine but 1.5 times less potent than oxycodone.
LREFZacny JP, Gutierrez S. Within-subject comparison of the psychopharmacological profiles of oral hydrocodone and oxycodone combination products in non-drug-abusing volunteers. Drug and Alcohol Dependence 2009;101(1-2):107-114.
Hydrocodone can be addictive, causing physical and psychological dependence. Its risk of abuse is similar to morphine and lower than oxycodone’s.
LREFWightman R, Perrone J, Portelli I, et al. Likeability and abuse liability of commonly prescribed opioids. J Med Tox 2012;8(4):335-340.
Hydrocodone is often administered in combination with paracetamol (acetaminophen) or ibuprofen. Combination with other medication is often used to increase efficacy and reduce adverse side effects.
LREFBeaver WT, McMillan D. Methodological considerations in the evaluation of analgesic combinations: Acetaminophen (paracetamol) and hydrocodone in postpartum pain. British journal of clinical pharmacology 1980;10 (Suppl. 2):215S-223S.
,
LREFRaffa RB. Pharmacology of oral combination analgesics: Rational therapy for pain. J Clin Pharm and Ther 2001;26(4):257-264.
Use of hydrocodone in combination with alcohol, other opioids, antihistamines, antipsychotics, antianxiety medication, or other central nervous system (CNS) depressants can cause additive CNS depression.
LREF"REPREXAIN (hydrocodone bitartrate, ibuprofen) tablet, film coated" 2013;http://dailymed.nlm.nih.gov.
Hydrocodone may also interact with serotonergic medications.
LREFGnanadesigan N, Espinoza RT, Smith RL. The serotonin syndrome. N Engl J Med 2005;352(23):2454-2456.
The analgesic properties of hydrocodone begin 20‑30 minutes after consumption and last between 4 to 8 hours.
LREFVallejo R, Barkin RL, Wang VC. Pharmacology of opioids in the treatment of chronic pain syndromes. Pain physician 2011;14(4):E343-E360.
Hydrocodone is metabolized in the liver by the cytochrome p450 enzyme CYP2D6 which converts it to hydromorphone, an even more potent opioid than hydrocodone itself.
LREFGardiner SJ, Begg EJ. Pharmacogenetics, Drug-metabolizing enzymes, and clinical practice. Pharmacological Reviews 2006;58(3):521-590
In 72 hour urine, 26 % of the hydrocodone dose is eliminated as unchanged drug (12 %), norhydrocodone (5 %), conjugated hydromorphone (4 %), 6‑hydrocodol (3 %) and conjugated 6‑hydromorphol (0.1 %).
LREFCone EJ, Darwin WD. Simultaneous determination of hydromorphone, hydrocodone and their 6α- and 6β-hydroxymetabolites in urine using selected ion recording with methane chemical ionization. Biomed Mass Spect 1978;5:291-295.
,
LREFValtier S, Berbarta VS. Excretion profile of hydrocodone, hydromorphone, and norhydrocodone in urine following single dose administration of hydrocodone to healthy volunteers. J Anal Toxicol 2012;36(7):507-514.

The hydrocodone metabolite, hydromorphone, is also a minor urinary metabolite of morphine. Initial studies suggest that hydromorphone may have advantages as an analgesic as compared to morphine and is 7‑10 times more potent than morphine.

LREFFelden L, Walter C, Harder S, et al. Comparative clinical effects of hydromorphone and morphine. British Journal of Anaesthesia 2011;107(3):319-328.
,
LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 9th ed. Seal Beach, CA: Biomedical Publications 2011:818-820.
Hydromorphone is often prescribed alone under the brand name Dilaudid. In the 24 hour urine, an average of 6 % of the dosage is eliminated as free hydromorphone and 30 % as conjugated hydromorphone.
LREFCone EJ, Phelps BA, Gorodetzky CW. Urinary excretion of hydromorphone and metabolites in humans, rats, dogs guinea pigs, and rabbits. J Pharm Sci 1977;66:1709-1713.
The metabolite of hydromorphone, hydromorphone‑3‑glucuronide, has also been shown to have significant pharmacological activity.
LREFWright AW, Nocente ML, Smith MT. Hydromorphone-3-glucuronide:biochemical synthesis and preliminary pharmacological evaluation. Life Sci 1998;63:401-411.

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

Reagents - working solutions

R1

Contains a mouse monoclonal anti‑hydrocodone antibody, glucose‑6‑phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative.

R2

Contains glucose‑6‑phosphate dehydrogenase (G6PDH) labeled with hydrocodone in buffer with sodium azide (0.09 %) as a preservative.

For timing of reagent pipetting refer to the test definition section.

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

Precautions and warnings

  • This test is for in vitro diagnostic use only. Harmful if swallowed.

  • Reagents used in the assay contain sodium azide as a preservative, which may react with lead or copper plumbing to form potentially explosive metal azide. When disposing of such reagents or wastes, always flush with a large volume of water to prevent azide build‑up. See National Institute for Occupational Safety and Health Bulletin: Explosive Azide Hazards.

    LREFSodium Azide. National Institute for Occupational Safety (NIOSH). Pocket Guide to Chemical Hazards. Third Printing, September 2007. Available online at: https://www.cdc.gov/niosh/npg/default.html

  • Do not use the reagents beyond their expiration dates.

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

Good laboratory practices recommend the use of at least two levels of control specimens (one positive and one negative control near the cutoff) to ensure proper assay performance. Controls should be run with each new calibration and after specific maintenance or troubleshooting procedures as detailed in the instrument manual. Each laboratory should establish its own control frequency. If any trends or sudden change in control value are observed, review all operating parameters, or contact Lin-Zhi International, Inc. (LZI) technical support for further assistance. Laboratories should comply with all federal, state, and local laws, as well as all guidelines and regulations.

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

In addition, other suitable control material can be used.

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 14 days.

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

Urine samples may be collected in plastic or glass containers. Some plastics may adsorb drugs. Use of plastics such as polyethylene is recommended.

LREFYahya AM, McElnay JC, D’Arcy PF. Drug absorption to glass and plastics. Drug Metabol Drug Interact 1988;6(1):1-45.
Use fresh urine specimens for the test. If a sample cannot be analyzed immediately, it may be refrigerated at 2‑8 °C for up to 30 days.
LREFGonzales EG, Ng G, Pesce AJ et al. Stability of commonly prescribed opioids and other pain medications in urine. AAPM Annual Meeting Presentation 2012.
For longer storage, keep sample frozen at ‑20 °C and then thaw before use. Studies have shown that urine hydrocodone samples are stable at ‑20 °C for up to 3 years.
LREFARUP Consult Physician's Guide. http://www.aruplab.com/guides/ug/tests/0090364.jsp.
Samples should be equilibrated to room temperature (18‑25 °C) for testing. Samples with high turbidity should be centrifuged before analysis. Adulteration may cause erroneous results. If sample adulteration is suspected, obtain a new sample and both samples should be forwarded to a laboratory for 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.

Handle all urine specimens as if they were potentially infectious.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008239819190c501", "ProductName": "HYD", "ProductLongName": "Hydrocodone Enzyme Immunoassay", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF00000004F18D0E", "DocumentOriginID": "FF000000025B750E", "MaterialNumbers": [ "08239819190" ], "InstrumentReferences": [ { "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

The Hydrocodone Enzyme Immunoassay is intended for the qualitative and semi‑quantitative determination of hydrocodone in human urine at a cutoff value of 100 ng/mL and 300 ng/mL. The assay is designed for prescription use with the Roche cobas c 501/502 automated clinical chemistry analyzers.

The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC‑MS or LC‑MS) are the preferred confirmatory methods.

LREFUrine Testing for Drug of Abuse, National Institute on Drug Abuse (NIDA) Research Monograph 73 (1986).
,
LREFMandatory Guidelines for Federal Workplace Drug Testing Program, National Institute on Drug Abuse, Federal Register 1988;53(69):11970.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.

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

Test principle

The hydrocodone assay is a homogeneous enzyme immunoassay ready‑for‑use liquid reagent. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose‑6‑phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent.

LREFRubenstein KE, Schneider RS, Ullman EF. "Homogeneous" Enzyme Immunoassay: A New Immunochemical Technique, Biochem Biophys Res Commun 1972;47(1):846-851.
Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, hydrocodone‑labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when drug is present in the sample, antibody would bind to free drug; the unbound hydrocodone‑labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.

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

Limitations

1. A preliminary positive result from the assay indicates only the presence of hydrocodone.

2. The test is not intended for quantifying this single analyte in patient samples.

3. A preliminary positive result does not necessarily indicate drug abuse.

4. A negative result does not necessarily mean a person did not take illegal drugs.

5. There is a possibility that other substances and/or factors not listed above may interfere with the test and cause incorrect results (e.g., technical or procedural error, fluid intake, endogenous or exogenous interferents).

6. Preliminary positive results should be confirmed by other affirmative, analytical chemistry methods (e.g., chromatography), preferably GC‑MS or LC‑MS.

7. The test is designed for use with human urine only.

8. The test is not for therapeutic drug monitoring.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together on 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 required in certain cases.

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

08239819190

Hydrocodone Enzyme Immunoassay (200 tests)

System‑ID 07 7611 4

cobas c 501/502

Materials required (but not provided):

08304718190

Hydrocodone 100 Semi‑Quantitative Calibrators Set
HYD 100 Negative Calibrator 0 ng/mL (1 x 5 mL)
HYD 100 Low Calibrator 50 ng/mL (1 x 5 mL)
HYD 100 Cutoff Calibrator 100 ng/mL (1 x 5 mL)
HYD 100 Intermediate Calibrator 150 ng/mL (1 x 5 mL)
HYD 100 High Calibrator 300 ng/mL (1 x 5 mL)


Code 613
Code 614
Code 615
Code 616
Code 617

08239827190

Hydrocodone 300 Semi‑Quantitative Calibrators Set
HYD 300 Negative Calibrator 0 ng/mL (1 x 5 mL)
HYD 300 Low Calibrator 150 ng/mL (1 x 5 mL)
HYD 300 Cutoff Calibrator 300 ng/mL (1 x 5 mL)
HYD 300 Intermediate Calibrator 500 ng/mL (1 x 5 mL)
HYD 300 High Calibrator 800 ng/mL (1 x 5 mL)


Code 647
Code 648
Code 649
Code 650
Code 651

08304734190

Hydrocodone 100 Qualitative Calibrator Set
HYD Cutoff Calibrator 100 ng/mL (1 x 5 mL)


Code 652

08239843190

Hydrocodone 300 Qualitative Calibrator Set
HYD Cutoff Calibrator 300 ng/mL (1 x 5 mL)


Code 653

08304742190

Hydrocodone 100 Control Set
Negative Control 75 ng/mL (2 x 15 mL)
Positive Control 125 ng/mL (2 x 15 mL)

08239851190

Hydrocodone 300 Control Set
Negative Control 225 ng/mL (2 x 15 mL)
Positive Control 375 ng/mL (2 x 15 mL)

09330119190

DAT Opiates Multi Control I Set (for 100 ng/mL assay)
Negative Control 75 ng/mL (2 x 15 mL)
Positive Control 125 ng/mL (2 x 15 mL)

04908856160a

Open/Close tool (5 pieces)

a) Catalog number is for USA only. Open/Close tool is available upon request in other countries.

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

System information

For cobas c 501 analyzer:

HYD1Q: ACN 184: for qualitative assay, 100 ng/mL

HYD1S: ACN 193: for semi‑quantitative assay, 100 ng/mL

HYD3Q: ACN 190: for qualitative assay, 300 ng/mL

HYD3S: ACN 196: for semi‑quantitative assay, 300 ng/mL

For cobas c 502 analyzer:

HYD1Q: ACN 8184: for qualitative assay, 100 ng/mL

HYD1S: ACN 8193: for semi‑quantitative assay, 100 ng/mL

HYD3Q: ACN 8190: for qualitative assay, 300 ng/mL

HYD3S: ACN 8196: for semi‑quantitative assay, 300 ng/mL

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

Reagent handling

Ready for use

Filling the cobas c pack:

  1. Turn the cobas c pack toward you as shown above.

  2. Position A of the cobas c pack is now in the center, position B on the left side, position C on the right side of the cobas c pack.

  3. Unscrew the screw cap of the bottle in position A in the center of the cobas c pack using the Open/Close tool.

  4. Use one of the enclosed funnels to pour the content of the R1 bottle (24.0 mL) into the opened bottle of the cobas c pack (position A). Discard the funnel.

  5. Close the bottle tightly using the Open/Close tool.

  6. Unscrew the screw cap of the bottle in position C on the right side of the cobas c pack using the Open/Close tool.

  7. Use one of the enclosed funnels to pour the content of the R2 bottle (10.1 mL) into the opened bottle of the cobas c pack (position C). Discard the funnel.

  8. Close the bottle tightly using the Open/Close tool.

  9. Leave position B empty.

The HYD cobas c pack is now ready for use.

NOTE: Solutions must be at the reagent compartment storage temperature of the analyzer before performing assays.

Note
Always use a new cobas c pack when preparing fresh reagent. Never reuse accessories designed for single use, as this may result in reagent contamination and could affect test results. If the cobas c pack bottles are not filled correctly, this may result in faulty reagent pipetting and could cause erroneous results.

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

Applications for urine

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

cobas c 501/502 test definition - 100 ng/mL cutoff assay

Semi‑Quantitative

Qualitative

Assay type

Rate A

Rate A

Reaction time / Assay points

10 / 14‑21

10 / 14‑21

Wavelength (sub/main)

415/340 nm

415/340 nm

Reaction direction

Increase

Increase

Unit

ng/mL

mA/min

Reagent pipetting

R1

90 µL

90 µL

R2

34 µL

34 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

13.5 µL

Decreased

13.5 µL

Increased

13.5 µL

cobas c 501/502 test definition - 300 ng/mL cutoff assay

Semi‑Quantitative

Qualitative

Assay type

Rate A

Rate A

Reaction time / Assay points

10 / 14‑21

10 / 14‑21

Wavelength (sub/main)

415/340 nm

415/340 nm

Reaction direction

Increase

Increase

Unit

ng/mL

mA/min

Reagent pipetting

R1

90 µL

90 µL

R2

34 µL

34 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (H2O)

Normal

4.5 µL

Decreased

4.5 µL

Increased

4.5 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:

95 days

Do not freeze.

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

Calibration

Calibrators

Semi‑Quantitative applications

100 ng/mL cutoff assay

S1: Hydrocodone Calibrator 0

S2: Hydrocodone Calibrator 50

S3: Hydrocodone Calibrator 100

S4: Hydrocodone Calibrator 150

S5: Hydrocodone Calibrator 300

0, 50, 100, 150, 300 ng/mL

300 ng/mL cutoff assay

S1: Hydrocodone Calibrator 0

S2: Hydrocodone Calibrator 150

S3: Hydrocodone Calibrator 300

S4: Hydrocodone Calibrator 500

S5: Hydrocodone Calibrator 800

0, 150, 300, 500, 800 ng/mL

Qualitative applications

100 ng/mL cutoff assay

S1: Hydrocodone Calibrator 100

100 ng/mL (but set the concentration to 0.0 ng/mL)

300 ng/mL cutoff assay

S1: Hydrocodone Calibrator 300

300 ng/mL (but set the concentration to 0.0 ng/mL)

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

Calibration K Factor

For the qualitative applications, enter the K Factor as positive 10000 into the Calibration menu, Status screen, Calibration Result window.

Calibration mode

Semi‑Quantitative applications

Result Calculation Mode (RCM)b

Qualitative applications

Linear

Calibration frequency

Full (semi‑quantitative) or blank (qualitative) calibration
• every 14 days
• after reagent lot change
• as required following quality control procedures

b) 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 or LC‑MS).

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

Specific performance data

Representative performance data on a Beckman Coulter AU480 analyzer are given below. Data was validated on a Roche cobas c 501 and cobas c 502 analyzer and did not show any differences between the analyzers. Results obtained in individual laboratories may differ.

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

Precision

Hydrocodone (100 ng/mL Cutoff)

The assay range from 0 ng/mL to 300 ng/mL was tested in qualitative (∆OD, mAU) and semi‑quantitative (ng/mL) mode using a modified NCCLS protocol. Results shown below were obtained by testing all samples in replicates of 2, 2 runs per day for 22 days on a Beckman Coulter AU480 automated clinical chemistry analyzer.

Qualitative analysis: Typical results (measured by ∆OD, mAU) are as follows:

100 ng/mL Cutoff

Within Run

Total Precision

Sample
[ng/mL]

% of
Cutoff

#
Samples

EIA
Result

#
Samples

EIA
Result

0 ng/mL

0 %

22

22 Neg

88

88 Neg

25 ng/mL

25 %

22

22 Neg

88

88 Neg

50 ng/mL

50 %

22

22 Neg

88

88 Neg

75 ng/mL

75 %

22

22 Neg

88

88 Neg

100 ng/mL

100 %

22

7 Pos/
15 Neg

88

28 Pos/
60 Neg

125 ng/mL

125 %

22

22 Pos

88

88 Pos

150 ng/mL

150 %

22

22 Pos

88

88 Pos

175 ng/mL

175 %

22

22 Pos

88

88 Pos

200 ng/mL

200 %

22

22 Pos

88

88 Pos

Semi‑Quantitative analysis: The following concentrations were determined with reference curves from 5 calibrators. Typical results were measured in ng/mL. Preliminary positive/negative results are as follows:

100 ng/mL Cutoff

Within Run

Total Precision

Sample
[ng/mL]

% of
Cutoff

#
Samples

EIA
Result

#
Samples

EIA
Result

0 ng/mL

0 %

22

22 Neg

88

88 Neg

25 ng/mL

25 %

22

22 Neg

88

88 Neg

50 ng/mL

50 %

22

22 Neg

88

88 Neg

75 ng/mL

75 %

22

22 Neg

88

88 Neg

100 ng/mL

100 %

22

8 Pos/
14 Neg

88

43 Pos/
45 Neg

125 ng/mL

125 %

22

22 Pos

88

88 Pos

150 ng/mL

150 %

22

22 Pos

88

88 Pos

175 ng/mL

175 %

22

22 Pos

88

88 Pos

200 ng/mL

200 %

22

22 Pos

88

88 Pos

Hydrocodone (300 ng/mL Cutoff)

The assay range from 0 ng/mL to 600 ng/mL was tested in qualitative (∆OD, mAU) and semi‑quantitative (ng/mL) mode using a modified NCCLS protocol. Results shown below were obtained by testing all samples in replicates of 2, 2 runs per day for 22 days on a Beckman Coulter AU480 automated clinical chemistry analyzer.

Qualitative analysis: Typical results (measured by ∆OD, mAU) are as follows:

300 ng/mL Cutoff

Within Run

Total Precision

Sample
[ng/mL]

% of
Cutoff

#
Samples

EIA
Result

#
Samples

EIA
Result

0 ng/mL

0 %

22

22 Neg

88

88 Neg

75 ng/mL

25 %

22

22 Neg

88

88 Neg

150 ng/mL

50 %

22

22 Neg

88

88 Neg

225 ng/mL

75 %

22

22 Neg

88

88 Neg

300 ng/mL

100 %

22

11 Pos/
11 Neg

88

51 Pos/
37 Neg

375 ng/mL

125 %

22

22 Pos

88

88 Pos

450 ng/mL

150 %

22

22 Pos

88

88 Pos

525 ng/mL

175 %

22

22 Pos

88

88 Pos

600 ng/mL

200 %

22

22 Pos

88

88 Pos

Semi‑Quantitative analysis: The following concentrations were determined with reference curves from 5 calibrators. Typical results were measured in ng/mL. Preliminary positive/negative results are as follows:

300 ng/mL Cutoff

Within Run

Total Precision

Sample
[ng/mL]

% of
Cutoff

#
Samples

EIA
Result

#
Samples

EIA
Result

0 ng/mL

0 %

22

22 Neg

88

88 Neg

75 ng/mL

25 %

22

22 Neg

88

88 Neg

150 ng/mL

50 %

22

22 Neg

88

88 Neg

225 ng/mL

75 %

22

22 Neg

88

88 Neg

300 ng/mL

100 %

22

14 Pos/
8 Neg

88

47 Pos/
41 Neg

375 ng/mL

125 %

22

22 Pos

88

88 Pos

450 ng/mL

150 %

22

22 Pos

88

88 Pos

525 ng/mL

175 %

22

22 Pos

88

88 Pos

600 ng/mL

200 %

22

22 Pos

88

88 Pos

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

Summary

Hydrocodone is an opioid compound derived from codeine. Hydrocodone acts on μ‑opioid receptors.

LREFVallejo R, Barkin RL, Wang VC. Pharmacology of opioids in the treatment of chronic pain syndromes. Pain physician 2011;14(4):E343-E360.
It is prescribed as a narcotic analgesic to treat moderate to severe pain and as an antitussive to treat cough.
LREFKarch SB. Pharmacokinetics and pharmacodynamics of abused drugs. CRC Press, Boca Raton 2008:55-56.
As an opioid compound, it is more potent than codeine but 1.5 times less potent than oxycodone.
LREFZacny JP, Gutierrez S. Within-subject comparison of the psychopharmacological profiles of oral hydrocodone and oxycodone combination products in non-drug-abusing volunteers. Drug and Alcohol Dependence 2009;101(1-2):107-114.
Hydrocodone can be addictive, causing physical and psychological dependence. Its risk of abuse is similar to morphine and lower than oxycodone’s.
LREFWightman R, Perrone J, Portelli I, et al. Likeability and abuse liability of commonly prescribed opioids. J Med Tox 2012;8(4):335-340.
Hydrocodone is often administered in combination with paracetamol (acetaminophen) or ibuprofen. Combination with other medication is often used to increase efficacy and reduce adverse side effects.
LREFBeaver WT, McMillan D. Methodological considerations in the evaluation of analgesic combinations: Acetaminophen (paracetamol) and hydrocodone in postpartum pain. British journal of clinical pharmacology 1980;10 (Suppl. 2):215S-223S.
,
LREFRaffa RB. Pharmacology of oral combination analgesics: Rational therapy for pain. J Clin Pharm and Ther 2001;26(4):257-264.
Use of hydrocodone in combination with alcohol, other opioids, antihistamines, antipsychotics, antianxiety medication, or other central nervous system (CNS) depressants can cause additive CNS depression.
LREF"REPREXAIN (hydrocodone bitartrate, ibuprofen) tablet, film coated" 2013;http://dailymed.nlm.nih.gov.
Hydrocodone may also interact with serotonergic medications.
LREFGnanadesigan N, Espinoza RT, Smith RL. The serotonin syndrome. N Engl J Med 2005;352(23):2454-2456.
The analgesic properties of hydrocodone begin 20‑30 minutes after consumption and last between 4 to 8 hours.
LREFVallejo R, Barkin RL, Wang VC. Pharmacology of opioids in the treatment of chronic pain syndromes. Pain physician 2011;14(4):E343-E360.
Hydrocodone is metabolized in the liver by the cytochrome p450 enzyme CYP2D6 which converts it to hydromorphone, an even more potent opioid than hydrocodone itself.
LREFGardiner SJ, Begg EJ. Pharmacogenetics, Drug-metabolizing enzymes, and clinical practice. Pharmacological Reviews 2006;58(3):521-590
In 72 hour urine, 26 % of the hydrocodone dose is eliminated as unchanged drug (12 %), norhydrocodone (5 %), conjugated hydromorphone (4 %), 6‑hydrocodol (3 %) and conjugated 6‑hydromorphol (0.1 %).
LREFCone EJ, Darwin WD. Simultaneous determination of hydromorphone, hydrocodone and their 6α- and 6β-hydroxymetabolites in urine using selected ion recording with methane chemical ionization. Biomed Mass Spect 1978;5:291-295.
,
LREFValtier S, Berbarta VS. Excretion profile of hydrocodone, hydromorphone, and norhydrocodone in urine following single dose administration of hydrocodone to healthy volunteers. J Anal Toxicol 2012;36(7):507-514.

The hydrocodone metabolite, hydromorphone, is also a minor urinary metabolite of morphine. Initial studies suggest that hydromorphone may have advantages as an analgesic as compared to morphine and is 7‑10 times more potent than morphine.

LREFFelden L, Walter C, Harder S, et al. Comparative clinical effects of hydromorphone and morphine. British Journal of Anaesthesia 2011;107(3):319-328.
,
LREFBaselt RC. Disposition of Toxic Drugs and Chemicals in Man. 9th ed. Seal Beach, CA: Biomedical Publications 2011:818-820.
Hydromorphone is often prescribed alone under the brand name Dilaudid. In the 24 hour urine, an average of 6 % of the dosage is eliminated as free hydromorphone and 30 % as conjugated hydromorphone.
LREFCone EJ, Phelps BA, Gorodetzky CW. Urinary excretion of hydromorphone and metabolites in humans, rats, dogs guinea pigs, and rabbits. J Pharm Sci 1977;66:1709-1713.
The metabolite of hydromorphone, hydromorphone‑3‑glucuronide, has also been shown to have significant pharmacological activity.
LREFWright AW, Nocente ML, Smith MT. Hydromorphone-3-glucuronide:biochemical synthesis and preliminary pharmacological evaluation. Life Sci 1998;63:401-411.

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

Reagents - working solutions

R1

Contains a mouse monoclonal anti‑hydrocodone antibody, glucose‑6‑phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative.

R2

Contains glucose‑6‑phosphate dehydrogenase (G6PDH) labeled with hydrocodone in buffer with sodium azide (0.09 %) as a preservative.

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Precautions and warnings

  • This test is for in vitro diagnostic use only. Harmful if swallowed.

  • Reagents used in the assay contain sodium azide as a preservative, which may react with lead or copper plumbing to form potentially explosive metal azide. When disposing of such reagents or wastes, always flush with a large volume of water to prevent azide build‑up. See National Institute for Occupational Safety and Health Bulletin: Explosive Azide Hazards (8/16/76).

  • Do not use the reagents beyond their expiration dates.

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

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Quality control

Good laboratory practices recommend the use of at least two levels of control specimens (one positive and one negative control near the cutoff) to ensure proper assay performance. Controls should be run with each new calibration and after specific maintenance or troubleshooting procedures as detailed in the instrument manual. Each laboratory should establish its own control frequency. If any trends or sudden change in control value are observed, review all operating parameters, or contact Lin‑Zhi International, Inc. (LZI) technical support for further assistance. Laboratories should comply with all federal, state, and local laws, as well as all guidelines and regulations.

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

Specimen collection and preparation

Urine samples may be collected in plastic or glass containers. Some plastics may adsorb drugs. Use of plastics such as polyethylene is recommended.

LREFYahya AM, McElnay JC, D’Arcy PF. Drug absorption to glass and plastics. Drug Metabol Drug Interact 1988;6(1):1-45.
Use fresh urine specimens for the test. If a sample cannot be analyzed immediately, it may be refrigerated at 2‑8 °C for up to 30 days.
LREFGonzales EG, Ng G, Pesce AJ et al. Stability of commonly prescribed opioids and other pain medications in urine. AAPM Annual Meeting Presentation 2012.
For longer storage, keep sample frozen at ‑20 °C and then thaw before use. Studies have shown that urine hydrocodone samples are stable at ‑20 °C for up to 3 years.
LREFARUP Consult Physician's Guide. http://www.aruplab.com/guides/ug/tests/0090364.jsp.
Samples should be equilibrated to room temperature (18‑25 °C) for testing. Samples with high turbidity should be centrifuged before analysis. Adulteration may cause erroneous results. If sample adulteration is suspected, obtain a new sample and both samples should be forwarded to a laboratory for 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.

Handle all urine specimens as if they were potentially infectious.

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

HYD

Hydrocodone Enzyme Immunoassay

IVD For in vitro diagnostic use.
HYD

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

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    Technical Documents

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