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"08252670190" ], "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

In vitro test for the quantitative determination of quinidine in serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Kinetic interaction of microparticles in solution (KIMS) as measured by changes in light transmission.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with quinidine and rapidly aggregate in the presence of a quinidine antibody solution. When a sample containing quinidine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formation is inhibited. Thus, a classic inhibition curve with respect to quinidine concentration is obtained, with the maximum rate of aggregation at the lowest quinidine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.

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

Limits and ranges

Measuring range

0.11‑8 µg/mL (0.34‑24.6 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM II Diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.11 µg/mL (0.34 µmol/L)

Limit of Detection

= 0.11 µg/mL (0.34 µmol/L)

Limit of Quantitation

= 0.30 µg/mL (0.92 µmol/L)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration quinidine samples.

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

Expected values

Quinidine is approximately 75 % bound to serum protein.

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
The elimination half-life of quinidine ranges from 4 to 10 hours in healthy individuals and may be prolonged in the elderly. From 60 to 80 % of the dose is metabolized by the liver with renal excretion of the unchanged drug accounting for much of the remainder.
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
,
LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.

Serum quinidine levels of 1.5 to 5 µg/mL (4.6 to 15.4 µmol/L*) have been reported as therapeutic, based on nonspecific methodologies that measure quinidine metabolites as well as quinidine.

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
,
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.

The therapeutic range using newer, more specific assays has not been established. However, effective reduction of premature ventricular contractions has been reported with blood levels less than 1.0 µg/mL (3.1 µmol/L*).

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Toxicity has been reported at a level of 6 µg/mL (18.5 µmol/L*).

LREFGoodman, Gilman. The Pharmacological Basis of Therapeutics 8th ed. New York, NY: Pergamon Press 1990;1704-1705.

* calculated by conversion factor

Toxic side effects include ventricular tachycardia, heart block, thrombocytopenia and “cinchonism”, a group of symptoms including headache, dizziness, tinnitus, nervousness, blurred vision, nausea, and vomiting. Measured quinidine levels are lower using specific methods (HPLC and immunoassays). Clinicians requesting serum quinidine determinations should ask that the method of analysis be specified.

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Metabolites of quinidine which may be found in serum are 3(S)‑hydroxyquinidine, 2'‑oxoquinidinone, quinidine‑N-oxide, o‑desmethylquinidine, and the quinidine 10,11‑dihydrodiols. Most of these have been shown to have pharmacological activity in human or animal studies, and some quinidine metabolites may be as potent as the parent drug.

LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.
,
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.
,
LREFDrayer DE, Lowenthal DT, Restivo KM, et al. Steady-state serum levels of quinidine and active metabolites in cardiac patients with varying degrees of renal function. Clin Pharmacol Ther 1978;24(1):31-39.
,
LREFDrayer DE, Restivo K, Reidenberg MM. Specific determination of quinidine and (3S)-3-hydroxyquinidine in human serum by high-pressure liquid chromatography. J Lab Clin Med 1977;90(5):816-822.
Because of variability seen in patient metabolism, relative proportions of these metabolites are reported in the literature in differing amounts.
LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.
,
LREFBonora MR, Guantert TW, Upton RA, et al. Determination of quinidine and metabolites in urine by reverse-phase high-pressure chromatography. Clin Chem Acta 1979;91:277-284.
,
LREFLeroyer R, Jarreau C, Pays M. Specific determination of quinidine and metabolites in biological fluids by reversed-phase high-performance liquid chromatography. J Chromatography 1982;228:366-371.
,
LREFLeroyer R, Varoquaux O, Advenier C, et al. Quinidine oxidative metabolism. Identification and biosynthesis of quinidine 10,11-dihydrodiol steroisomers. Biomedical Chromatography 1980;4(2):61-64.
Quinidine serum specimens may also contain dihydroquinidine, an analog contained in quinidine formulations at levels of 5 to 10 % of the dosage. Dihydroquinidine has anti-arrhythmic activity comparable to quinidine.
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.
,
LREFDrayer DE, Hughes M, Lorenzo B, et al. Prevalence of high (3S)-3-hydroxyquinidine/quinidine ratios in serum, and clearance of quinidine in cardiac patients of age. Clin Pharmacol Ther 1980;27(1):72-75.
Recent reports indicate that plasma concentrations of digoxin increase when quinidine is given concurrently. Patients on concomitant therapy should be carefully monitored.
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

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

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at quinidine levels of approximately 2 and 5 µg/mL (6.2 and 15.4 µmol/L).

Serum/Plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 50 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 855 µmol/L or 50 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 600 mg/dL.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

Criterion: Recovery within ± 10 % of initial value at quinidine levels of approximately 2 µg/mL (6.2 µmol/L).

Total protein: No significant interference from total protein in the concentration range of 2‑10 g/dL.

In very rare cases, gammopathy, in particular 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.

A test result flagged with \">Kin3\" indicates unusual reaction kinetics.

Sample dilution, as described for samples above the measuring range, avoids this non‑specific reaction.

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

08252670190

ONLINE TDM Quinidine (100 tests)

System‑ID 2103 001

cobas c 303, cobas c 503

Materials required (but not provided):

03375781190

Preciset TDM II
CAL A-F (1 x 5 mL)
Diluent (1 x 10 mL)

Codes 20743-20748

04521536190

TDM Control Set
Level I (2 x 5 mL)
Level II (2 x 5 mL)
Level III (2 x 5 mL)


Code 20310
Code 20311
Code 20312

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

System information

QUIN2: ACN 21030

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

Reagent handling

Ready for use

Mix reagents by gentle inversion numerous times before placing on‑board the analyzer.

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

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

– /600 nm

Reagent pipetting

Diluent (H2O)

R1

84 µL

R2

-

R3

25 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.0 µL

Decreased

1.0 µL

Increased

1.0 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 :

26 weeks

Do not freeze.

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

Calibration

Calibrators

S1‑6: Preciset TDM II Calibrators

Calibration mode

Non‑linear

Calibration frequency

Full calibration
- after reagent lot change
- every 6 weeks
- as required following quality control procedures

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

Traceability: This method has been standardized against USP reference standards.

LREFUSP 39-NF (U.S. Pharmacopeia National Formulary) 2016:5647-5648.
The calibrators are prepared to contain known quantities of quinidine in normal human serum.

", "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.

Serum/plasma

Repeatability

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1a)

1.07

0.0167

1.6

TDMC2b)

3.07

0.0412

1.3

TDMC3c)

4.75

0.0537

1.1

Human serum 1

0.232

0.0128

5.5

Human serum 2

3.11

0.0377

1.2

Human serum 3

4.04

0.0396

1.0

Human serum 4

4.91

0.0801

1.6

Human serum 5

7.25

0.155

2.1

Intermediate precision

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1

FREFTDM Control Set Level I

1.07

0.0361

3.4

TDMC2

FREFTDM Control Set Level II

3.16

0.0571

1.8

TDMC3

FREFTDM Control Set Level III

4.88

0.0765

1.6

Human serum 1

0.251

0.0330

13.2

Human serum 2

3.11

0.0613

2.0

Human serum 3

3.94

0.0610

1.5

Human serum 4

4.91

0.0995

2.0

Human serum 5

7.25

0.162

2.2

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

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

Method comparison

Serum/plasma

Quinidine values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 75

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.072x - 0.0813 µg/mL

y = 1.070x - 0.0781 µg/mL

τ = 0.970

r = 0.998

The sample concentrations were between 0.110 and 7.32 µg/mL.

Quinidine values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 74

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.023x - 0.00365 µg/mL

y = 1.017x - 0.0349 µg/mL

τ = 0.958

r = 0.997

The sample concentrations were between 0.190 and 7.38 µg/mL.

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

Summary

Quinidine is used for the prevention and treatment of ventricular arrhythmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic serum levels is dependent on the drug formulation, patient age, and individual variability in absorption and metabolism.

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

Reagents - working solutions

R1

Anti-quinidine antibody (mouse monoclonal) and human-sourced material in buffer with preservative

R3

Conjugated quinidine derivative microparticles, human-sourced material, and preservative

R1 is in position B and R3 is in position C.

", "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.

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods use assays that have been approved by the FDA or that are in compliance with the legal rules applicable to placing in vitro diagnostic medical devices for human use on the market in the European Union.
However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
,
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear eye protection/ face protection.

Response:

P305 + P351 + P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P337 + P313

If eye irritation persists: Get medical advice/attention.

Product safety labeling follows EU GHS guidance.

Contact phone: 1-800-428-2336

", "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.

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 26 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

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.

Serum: Collect serum using standard sampling tubes.

Plasma: K2‑ or K3‑EDTA, or sodium or lithium heparinized plasma.

Stability:

8 hours capped at 15‑25 °C
48 hours capped at 2‑8 °C
4 weeks capped at -20 °C

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

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.

Do not induce foaming of specimens. Specimens should not be repeatedly frozen and thawed.

Invert thawed specimens several times prior to testing.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0108252670190c503", "ProductName": "QUIN2", "ProductLongName": "ONLINE TDM Quinidine", "Language": "en", "DocumentVersion": "3", "DocumentObjectID": "FF0000000586A30E", "DocumentOriginID": "FF0000000586A30E", "MaterialNumbers": [ "08252670190" ], "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

In vitro test for the quantitative determination of quinidine in serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Kinetic interaction of microparticles in solution (KIMS) as measured by changes in light transmission.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with quinidine and rapidly aggregate in the presence of a quinidine antibody solution. When a sample containing quinidine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formation is inhibited. Thus, a classic inhibition curve with respect to quinidine concentration is obtained, with the maximum rate of aggregation at the lowest quinidine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.

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

Limits and ranges

Measuring range

0.11‑8 µg/mL (0.34‑24.6 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM II Diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.11 µg/mL (0.34 µmol/L)

Limit of Detection

= 0.11 µg/mL (0.34 µmol/L)

Limit of Quantitation

= 0.30 µg/mL (0.92 µmol/L)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration quinidine samples.

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

Expected values

Quinidine is approximately 75 % bound to serum protein.

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
The elimination half-life of quinidine ranges from 4 to 10 hours in healthy individuals and may be prolonged in the elderly. From 60 to 80 % of the dose is metabolized by the liver with renal excretion of the unchanged drug accounting for much of the remainder.
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
,
LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.

Serum quinidine levels of 1.5 to 5 µg/mL
(4.6 to 15.4 µmol/L*)
have been reported as therapeutic, based on nonspecific methodologies that measure quinidine metabolites as well as quinidine.

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
,
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.

The therapeutic range using newer, more specific assays has not been established. However, effective reduction of premature ventricular contractions has been reported with blood levels less than 1.0 µg/mL
(3.1 µmol/L*).

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Toxicity has been reported at a level of 6 µg/mL
(18.5 µmol/L*).

LREFGoodman, Gilman. The Pharmacological Basis of Therapeutics 8th ed. New York, NY: Pergamon Press 1990;1704-1705.

* calculated by conversion factor

Toxic side effects include ventricular tachycardia, heart block, thrombocytopenia and “cinchonism”, a group of symptoms including headache, dizziness, tinnitus, nervousness, blurred vision, nausea, and vomiting. Measured quinidine levels are lower using specific methods (HPLC and immunoassays). Clinicians requesting serum quinidine determinations should ask that the method of analysis be specified.

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Metabolites of quinidine which may be found in serum are 3(S)‑hydroxyquinidine, 2'‑oxoquinidinone, quinidine‑N-oxide, o‑desmethylquinidine, and the quinidine 10,11‑dihydrodiols. Most of these have been shown to have pharmacological activity in human or animal studies, and some quinidine metabolites may be as potent as the parent drug.

LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.
,
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.
,
LREFDrayer DE, Lowenthal DT, Restivo KM, et al. Steady-state serum levels of quinidine and active metabolites in cardiac patients with varying degrees of renal function. Clin Pharmacol Ther 1978;24(1):31-39.
,
LREFDrayer DE, Restivo K, Reidenberg MM. Specific determination of quinidine and (3S)-3-hydroxyquinidine in human serum by high-pressure liquid chromatography. J Lab Clin Med 1977;90(5):816-822.
Because of variability seen in patient metabolism, relative proportions of these metabolites are reported in the literature in differing amounts.
LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.
,
LREFBonora MR, Guantert TW, Upton RA, et al. Determination of quinidine and metabolites in urine by reverse-phase high-pressure chromatography. Clin Chem Acta 1979;91:277-284.
,
LREFLeroyer R, Jarreau C, Pays M. Specific determination of quinidine and metabolites in biological fluids by reversed-phase high-performance liquid chromatography. J Chromatography 1982;228:366-371.
,
LREFLeroyer R, Varoquaux O, Advenier C, et al. Quinidine oxidative metabolism. Identification and biosynthesis of quinidine 10,11-dihydrodiol steroisomers. Biomedical Chromatography 1980;4(2):61-64.
Quinidine serum specimens may also contain dihydroquinidine, an analog contained in quinidine formulations at levels of 5 to 10 % of the dosage. Dihydroquinidine has anti-arrhythmic activity comparable to quinidine.
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.
,
LREFDrayer DE, Hughes M, Lorenzo B, et al. Prevalence of high (3S)-3-hydroxyquinidine/quinidine ratios in serum, and clearance of quinidine in cardiac patients of age. Clin Pharmacol Ther 1980;27(1):72-75.
Recent reports indicate that plasma concentrations of digoxin increase when quinidine is given concurrently. Patients on concomitant therapy should be carefully monitored.
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

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

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at quinidine levels of approximately 2 and 5 µg/mL (6.2 and 15.4 µmol/L).

Serum/Plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 50 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 855 µmol/L or 50 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 600 mg/dL.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

Criterion: Recovery within ± 10 % of initial value at quinidine levels of approximately 2 µg/mL (6.2 µmol/L).

Total protein: No significant interference from total protein in the concentration range of 2‑10 g/dL.

In very rare cases, gammopathy, in particular 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.

A test result flagged with \">Kin3\" indicates unusual reaction kinetics.

Sample dilution, as described for samples above the measuring range, avoids this non‑specific reaction.

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

08252670190

ONLINE TDM Quinidine (100 tests)

System‑ID 2103 001

cobas c 303, cobas c 503

Materials required (but not provided):

03375781190

Preciset TDM II Calibrators
CAL A-F (6 x 5 mL)
Diluent (1 x 10 mL)

Codes 20743-20748

04521536190

TDM Control Set
Level I (2 x 5 mL)
Level II (2 x 5 mL)
Level III (2 x 5 mL)

Code 20310

Code 20311

Code 20312

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

System information

QUIN2: ACN 21030

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

Reagent handling

Ready for use

Mix reagents by gentle inversion numerous times before placing on‑board the analyzer.

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

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

– /600 nm

Reagent pipetting

Diluent (H2O)

R1

84 µL

R2

-

R3

25 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.0 µL

Decreased

1.0 µL

Increased

1.0 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 :

26 weeks

Do not freeze.

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

Calibration

Calibrators

S1‑6: Preciset TDM II Calibrators

Calibration mode

Non‑linear

Calibration frequency

Full calibration
- after reagent lot change
- every 6 weeks
- as required following quality control procedures

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

Traceability: This method has been standardized against USP reference standards.

LREFUSP 39-NF (U.S. Pharmacopeia National Formulary) 2016:5647-5648.
The calibrators are prepared to contain known quantities of quinidine in normal human serum.

", "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 heterogeneous 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.

Serum/plasma

Repeatability

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1a)

1.07

0.0167

1.6

TDMC2b)

3.07

0.0412

1.3

TDMC3c)

4.75

0.0537

1.1

Human serum 1

0.232

0.0128

5.5

Human serum 2

3.11

0.0377

1.2

Human serum 3

4.04

0.0396

1.0

Human serum 4

4.91

0.0801

1.6

Human serum 5

7.25

0.155

2.1

Intermediate precision

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1

FREFTDM Control Set Level I

1.07

0.0361

3.4

TDMC2

FREFTDM Control Set Level II

3.16

0.0571

1.8

TDMC3

FREFTDM Control Set Level III

4.88

0.0765

1.6

Human serum 1

0.251

0.0330

13.2

Human serum 2

3.11

0.0613

2.0

Human serum 3

3.94

0.0610

1.5

Human serum 4

4.91

0.0995

2.0

Human serum 5

7.25

0.162

2.2

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

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

Method comparison

Serum/plasma

Quinidine values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 75

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.072x - 0.0813 µg/mL

y = 1.070x  - 0.0781 µg/mL

τ = 0.970

r = 0.998

The sample concentrations were between 0.110 and 7.32 µg/mL.

Quinidine values for human serum and plasma samples obtained on a cobas c 303 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 74

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.023x - 0.00365 µg/mL

y = 1.017x  - 0.0349 µg/mL

τ = 0.958

r = 0.997

The sample concentrations were between 0.190 and 7.38 µg/mL.

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

Summary

Quinidine is used for the prevention and treatment of ventricular arrhythmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic serum levels is dependent on the drug formulation, patient age, and individual variability in absorption and metabolism.

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

Reagents - working solutions

R1

Anti-quinidine antibody (mouse monoclonal) and human-sourced material in buffer with preservative

R3

Conjugated quinidine derivative microparticles, human-sourced material, and preservative

R1 is in position B and R3 is in position C.

", "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.

Warning

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear eye protection/ face protection.

Response:

P305 + P351 + P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P337 + P313

If eye irritation persists: Get medical advice/attention.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods use assays that have been approved by the FDA or that are in compliance with the legal rules applicable to placing in vitro diagnostic medical devices for human use on the market in the European Union.
However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
,
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

", "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.

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 26 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

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.

Serum: Collect serum using standard sampling tubes.

Plasma: K2‑ or K3‑EDTA, or sodium or lithium heparinized plasma.

Stability:

8 hours capped at 15‑25 °C
48 hours capped at 2‑8 °C
4 weeks capped at -20 °C

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

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.

Do not induce foaming of specimens. Specimens should not be repeatedly frozen and thawed.

Invert thawed specimens several times prior to testing.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0008252670190c503", "ProductName": "QUIN2", "ProductLongName": "ONLINE TDM Quinidine", "Language": "en", "DocumentVersion": "1", "DocumentObjectID": "FF000000047D7C0E", "DocumentOriginID": "FF000000047D7C0E", "MaterialNumbers": [ "08252670190" ], "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

In vitro test for the quantitative determination of quinidine in serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Kinetic interaction of microparticles in solution (KIMS) as measured by changes in light transmission.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with quinidine and rapidly aggregate in the presence of a quinidine antibody solution. When a sample containing quinidine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formation is inhibited. Thus, a classic inhibition curve with respect to quinidine concentration is obtained, with the maximum rate of aggregation at the lowest quinidine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.

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

Limits and ranges

Measuring range

0.11‑8 µg/mL (0.34‑24.6 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM II Diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Limit of Blank, Limit of Detection and Limit of Quantitation

Limit of Blank

= 0.11 µg/mL (0.34 µmol/L)

Limit of Detection

= 0.11 µg/mL (0.34 µmol/L)

Limit of Quantitation

= 0.30 µg/mL (0.92 µmol/L)

The Limit of Blank, Limit of Detection and Limit of Quantitation were determined in accordance with the CLSI (Clinical and Laboratory Standards Institute) EP17‑A2 requirements.

The Limit of Blank is the 95th percentile value from n ≥ 60 measurements of analyte‑free samples over several independent series. The Limit of Blank corresponds to the concentration below which analyte‑free samples are found with a probability of 95 %.

The Limit of Detection is determined based on the Limit of Blank and the standard deviation of low concentration samples.

The Limit of Detection corresponds to the lowest analyte concentration which can be detected (value above the Limit of Blank with a probability of 95 %).

The Limit of Quantitation is the lowest analyte concentration that can be reproducibly measured with a total error of 20 %. It has been determined using low concentration quinidine samples.

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

Expected values

Quinidine is approximately 75 % bound to serum protein.

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
The elimination half-life of quinidine ranges from 4 to 10 hours in healthy individuals and may be prolonged in the elderly. From 60 to 80 % of the dose is metabolized by the liver with renal excretion of the unchanged drug accounting for much of the remainder.
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
,
LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.

Serum quinidine levels of 1.5 to 5 µg/mL
(4.6 to 15.4 µmol/L*)
have been reported as therapeutic, based on nonspecific methodologies that measure quinidine metabolites as well as quinidine.

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
,
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.

The therapeutic range using newer, more specific assays has not been established. However, effective reduction of premature ventricular contractions has been reported with blood levels less than 1.0 µg/mL
(3.1 µmol/L*).

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Toxicity has been reported at a level of 6 µg/mL
(18.5 µmol/L*).

LREFGoodman, Gilman. The Pharmacological Basis of Therapeutics 8th ed. New York, NY: Pergamon Press 1990;1704-1705.

* calculated by conversion factor

Toxic side effects include ventricular tachycardia, heart block, thrombocytopenia and “cinchonism”, a group of symptoms including headache, dizziness, tinnitus, nervousness, blurred vision, nausea, and vomiting. Measured quinidine levels are lower using specific methods (HPLC and immunoassays). Clinicians requesting serum quinidine determinations should ask that the method of analysis be specified.

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Metabolites of quinidine which may be found in serum are 3(S)‑hydroxyquinidine, 2'‑oxoquinidinone, quinidine‑N-oxide, o‑desmethylquinidine, and the quinidine 10,11‑dihydrodiols. Most of these have been shown to have pharmacological activity in human or animal studies, and some quinidine metabolites may be as potent as the parent drug.

LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.
,
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.
,
LREFDrayer DE, Lowenthal DT, Restivo KM, et al. Steady-state serum levels of quinidine and active metabolites in cardiac patients with varying degrees of renal function. Clin Pharmacol Ther 1978;24(1):31-39.
,
LREFDrayer DE, Restivo K, Reidenberg MM. Specific determination of quinidine and (3S)-3-hydroxyquinidine in human serum by high-pressure liquid chromatography. J Lab Clin Med 1977;90(5):816-822.
Because of variability seen in patient metabolism, relative proportions of these metabolites are reported in the literature in differing amounts.
LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.
,
LREFBonora MR, Guantert TW, Upton RA, et al. Determination of quinidine and metabolites in urine by reverse-phase high-pressure chromatography. Clin Chem Acta 1979;91:277-284.
,
LREFLeroyer R, Jarreau C, Pays M. Specific determination of quinidine and metabolites in biological fluids by reversed-phase high-performance liquid chromatography. J Chromatography 1982;228:366-371.
,
LREFLeroyer R, Varoquaux O, Advenier C, et al. Quinidine oxidative metabolism. Identification and biosynthesis of quinidine 10,11-dihydrodiol steroisomers. Biomedical Chromatography 1980;4(2):61-64.
Quinidine serum specimens may also contain dihydroquinidine, an analog contained in quinidine formulations at levels of 5 to 10 % of the dosage. Dihydroquinidine has anti-arrhythmic activity comparable to quinidine.
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.
,
LREFDrayer DE, Hughes M, Lorenzo B, et al. Prevalence of high (3S)-3-hydroxyquinidine/quinidine ratios in serum, and clearance of quinidine in cardiac patients of age. Clin Pharmacol Ther 1980;27(1):72-75.
Recent reports indicate that plasma concentrations of digoxin increase when quinidine is given concurrently. Patients on concomitant therapy should be carefully monitored.
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

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

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at quinidine levels of approximately 2 and 5 µg/mL (6.2 and 15.4 µmol/L).

Serum/Plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 50 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 855 µmol/L or 50 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 600 mg/dL.

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

Criterion: Recovery within ± 10 % of initial value at quinidine levels of approximately 2 µg/mL (6.2 µmol/L).

Total protein: No significant interference from total protein in the concentration range of 2‑10 g/dL.

In very rare cases, gammopathy, in particular 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.

A test result flagged with \">Kin3\" indicates unusual reaction kinetics.

Sample dilution, as described for samples above the measuring range, avoids this non‑specific reaction.

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

08252670190

ONLINE TDM Quinidine (100 tests)

System‑ID 2103 001

cobas c 503

03375781190

Preciset TDM II Calibrators
CAL A-F (6 x 5 mL)
Diluent (1 x 10 mL)

Codes 20743-20748

04521536190

TDM Control Set
Level I (2 x 5 mL)
Level II (2 x 5 mL)
Level III (2 x 5 mL)

Code 20310

Code 20311

Code 20312

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

System information

QUIN2: ACN 21030

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

Reagent handling

Ready for use

Mix reagents by gentle inversion numerous times before placing on‑board the analyzer.

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

Application for serum and plasma

Test definition

Reporting time

10 min

Wavelength (sub/main)

– /600 nm

Reagent pipetting

Diluent (H2O)

R1

84 µL

R2

-

R3

25 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

1.0 µL

Decreased

1.0 µL

Increased

1.0 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 :

26 weeks

Do not freeze.

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

Calibration

Calibrators

S1‑6: Preciset TDM II Calibrators

Calibration mode

Non‑linear

Calibration frequency

Full calibration
- after reagent lot change
- every 6 weeks
- as required following quality control procedures

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

Traceability: This method has been standardized against USP reference standards.

LREFUSP 39-NF (U.S. Pharmacopeia National Formulary) 2016:5647-5648.
The calibrators are prepared to contain known quantities of quinidine in normal human serum.

", "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 heterogeneous 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:

Serum/plasma

Repeatability

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1a)

1.07

0.0167

1.6

TDMC2b)

3.07

0.0412

1.3

TDMC3c)

4.75

0.0537

1.1

Human serum 1

0.232

0.0128

5.5

Human serum 2

3.11

0.0377

1.2

Human serum 3

4.04

0.0396

1.0

Human serum 4

4.91

0.0801

1.6

Human serum 5

7.25

0.155

2.1

Intermediate precision

Mean
µg/mL

SD
µg/mL

CV
%

TDMC1

FREFTDM Control Set Level I

1.07

0.0361

3.4

TDMC2

FREFTDM Control Set Level II

3.16

0.0571

1.8

TDMC3

FREFTDM Control Set Level III

4.88

0.0765

1.6

Human serum 1

0.251

0.0330

13.2

Human serum 2

3.11

0.0613

2.0

Human serum 3

3.94

0.0610

1.5

Human serum 4

4.91

0.0995

2.0

Human serum 5

7.25

0.162

2.2

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

Method comparison

Serum/plasma

Quinidine values for human serum and plasma samples obtained on a cobas c 503 analyzer (y) were compared with those determined using the corresponding reagent on a cobas c 501 analyzer (x).

Sample size (n) = 75

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.072x - 0.0813 µg/mL

y = 1.070x  - 0.0781 µg/mL

τ = 0.970

r = 0.998

The sample concentrations were between 0.110 and 7.32 µg/mL.

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

Summary

Quinidine is used for the prevention and treatment of ventricular arrhythmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic serum levels is dependent on the drug formulation, patient age, and individual variability in absorption and metabolism.

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

Reagents - working solutions

R1

Anti-quinidine antibody (mouse monoclonal) and human-sourced material in buffer with preservative

R3

Conjugated quinidine derivative microparticles, human-sourced material, and preservative

R1 is in position B and R3 is in position C.

", "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.

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods used assays approved by the FDA or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.
However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
,
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

", "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.

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 26 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

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.

Serum: Collect serum using standard sampling tubes.

Plasma: K2‑ or K3‑EDTA, or sodium or lithium heparinized plasma.

Stability:

8 hours capped at 15‑25 °C
48 hours capped at 2‑8 °C
4 weeks capped at -20 °C

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

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.

Do not induce foaming of specimens. Specimens should not be repeatedly frozen and thawed.

Invert thawed specimens several times prior to testing.

", "Language": "en" } ] } }, { "ProductSpecVariant": { "MetaData": { "DocumentMaterialNumber": "0004490991190c501", "ProductName": "QUIN2", "ProductLongName": "ONLINE TDM Quinidine", "Language": "en", "DocumentVersion": "11", "DocumentObjectID": "FF0000000517F80E", "DocumentOriginID": "FF00000001047C0E", "MaterialNumbers": [ "04490991190" ], "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

In vitro test for the quantitative determination of quinidine in serum and plasma on Roche/Hitachi cobas c systems.

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

Test principle

Kinetic interaction of microparticles in solution (KIMS) as measured by changes in light transmission.

The assay is a homogeneous immunoassay based on the principle of measuring changes in scattered light or absorbance which result when activated microparticles aggregate. The microparticles are coated with quinidine and rapidly aggregate in the presence of a quinidine antibody solution. When a sample containing quinidine is introduced, the aggregation reaction is partially inhibited, slowing the rate of the aggregation process. Antibody bound to sample drug is no longer available to promote microparticle aggregation, and subsequent particle lattice formation is inhibited. Thus, a classic inhibition curve with respect to quinidine concentration is obtained, with the maximum rate of aggregation at the lowest quinidine concentration. By monitoring the change in scattered light or absorbance, a concentration-dependent curve is obtained.

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

Limits and ranges

Measuring range

0.11‑8 µg/mL (0.34‑24.6 µmol/L)

Manually dilute samples above the measuring range 1 + 1 with the Preciset TDM II Diluent (0 µg/mL) and reassay. Multiply the result by 2 to obtain the specimen value.

Lower limits of measurement

Lower detection limit of the test

0.09 μg/mL (0.28 μmol/L)

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 0 µg/mL calibrator (standard 1 + 2 SD, repeatability, n = 21).

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

Expected values

Quinidine is approximately 75 % bound to serum protein.

LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
The elimination half-life of quinidine ranges from 4 to 10 hours in healthy individuals and may be prolonged in the elderly. From 60 to 80 % of the dose is metabolized by the liver with renal excretion of the unchanged drug accounting for much of the remainder.
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
,
LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.
Serum quinidine levels of 1.5 to 5 µg/mL (4.6 to 15.4 µmol/L) have been reported as therapeutic, based on nonspecific methodologies that measure quinidine metabolites as well as quinidine.
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
,
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.
The therapeutic range using newer, more specific assays has not been established. However, effective reduction of premature ventricular contractions has been reported with blood levels less than 1.0 µg/mL (3.1 µmol/L).
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.
Toxicity has been reported at a level of 6 µg/mL (18.5 µmol/L).
LREFGoodman, Gilman. The Pharmacological Basis of Therapeutics 8th ed. New York, NY: Pergamon Press 1990;1704-1705.
Toxic side effects include ventricular tachycardia, heart block, thrombocytopenia and “cinchonism”, a group of symptoms including headache, dizziness, tinnitus, nervousness, blurred vision, nausea, and vomiting. Measured quinidine levels are lower using specific methods (HPLC and immunoassays). Clinicians requesting serum quinidine determinations should ask that the method of analysis be specified.
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Metabolites of quinidine which may be found in serum are 3(S)‑hydroxyquinidine, 2'‑oxoquinidinone, quinidine‑N-oxide, o‑desmethylquinidine, and the quinidine 10,11‑dihydrodiols. Most of these have been shown to have pharmacological activity in human or animal studies, and some quinidine metabolites may be as potent as the parent drug.

LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.
,
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.
,
LREFDrayer DE, Lowenthal DT, Restivo KM, et al. Steady-state serum levels of quinidine and active metabolites in cardiac patients with varying degrees of renal function. Clin Pharmacol Ther 1978;24(1):31-39.
,
LREFDrayer DE, Restivo K, Reidenberg MM. Specific determination of quinidine and (3S)-3-hydroxyquinidine in human serum by high-pressure liquid chromatography. J Lab Clin Med 1977;90(5):816-822.
Because of variability seen in patient metabolism, relative proportions of these metabolites are reported in the literature in differing amounts.
LREFHoyer GL, Clawson DC, Brookshier LA, et al. High-performance liquid chromatographic method for the quantitation of quinidine and selected quinidine metabolites. J Chromatography 1991;572:159-169.
,
LREFBonora MR, Guantert TW, Upton RA, et al. Determination of quinidine and metabolites in urine by reverse-phase high-pressure chromatography. Clin Chem Acta 1979;91:277-284.
,
LREFLeroyer R, Jarreau C, Pays M. Specific determination of quinidine and metabolites in biological fluids by reversed-phase high-performance liquid chromatography. J Chromatography 1982;228:366-371.
,
LREFLeroyer R, Varoquaux O, Advenier C, et al. Quinidine oxidative metabolism. Identification and biosynthesis of quinidine 10,11-dihydrodiol steroisomers. Biomedical Chromatography 1980;4(2):61-64.
Quinidine serum specimens may also contain dihydroquinidine, an analog contained in quinidine formulations at levels of 5 to 10 % of the dosage. Dihydroquinidine has anti-arrhythmic activity comparable to quinidine.
LREFGerson B, ed. Essentials of Therapeutic Drug Monitoring New York. IGAKU-SHOIN 1983;133-140.
,
LREFDrayer DE, Hughes M, Lorenzo B, et al. Prevalence of high (3S)-3-hydroxyquinidine/quinidine ratios in serum, and clearance of quinidine in cardiac patients of age. Clin Pharmacol Ther 1980;27(1):72-75.
Recent reports indicate that plasma concentrations of digoxin increase when quinidine is given concurrently. Patients on concomitant therapy should be carefully monitored.
LREFPhysicians’ Desk Reference 47th ed. Montvale NJ: Medical Economics Data 1993;688-689.

Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges.

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

Limitations - interference

Criterion: Recovery within ± 10 % of initial value at quinidine levels of approximately 2 and 5 µg/mL (6.2 and 15.4 µmol/L).

Serum/Plasma

Icterus:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an I index of 50 for conjugated bilirubin and unconjugated bilirubin (approximate conjugated and unconjugated bilirubin concentration: 855 µmol/L or 50 mg/dL).

Hemolysis:

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an H index of 1000 (approximate hemoglobin concentration: 621 µmol/L or 1000 mg/dL).

Lipemia (Intralipid):

LREFGlick MR, Ryder KW, Jackson SA. Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation. Clin Chem 1986;32:470-475.
No significant interference up to an L index of 1000. There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration.

Triglycerides: No significant interference from triglycerides up to a concentration of 600 mg/dL.

Criterion: Recovery within ± 10 % of initial value at quinidine levels of approximately 2 µg/mL (6.2 µmol/L).

Rheumatoid factors: No significant interference from rheumatoid factors up to a concentration of 100 IU/mL.

Total protein: No significant interference from total protein in the concentration range of 2‑10 g/dL.

In very rare cases, gammopathy, in particular 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.

A test result flagged with \">Proz\" indicates unusual reaction kinetics. Sample dilution, as described for samples above the measuring range, avoids this non‑specific reaction.

ACTION REQUIRED
Special Wash Programming: The use of special wash steps is mandatory when certain test combinations are run together oncobas 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

04490991 190

ONLINE TDM Quinidine (75 tests)

System‑ID 07 6984 3

cobas c 311, cobas c 501/502

Materials required (but not provided):

03375781 190

Preciset TDM II Calibrators
CAL A-F (6 x 5 mL)
Diluent (1 x 10 mL)

Codes 743-748

04521536 190

TDM Control Set
Level I (2 x 5 mL)
Level II (2 x 5 mL)
Level III (2 x 5 mL)

Code 310

Code 311

Code 312

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

System information

For cobas c 311/501 analyzers:
QUIN2: ACN 437

For cobas c 502 analyzers:
QUIN2: ACN 8437

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

Reagent handling

Ready for use

Mix reagents by gentle inversion numerous times before placing on‑board the analyzer.

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

Application for serum and plasma

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

cobas c 311 test definition

Assay type

2‑Point End

Reaction time /Assay points:

10 / 26‑54

Wavelength (sub/main)

– /600 nm

Reaction direction

Increase

Unit

µg/mL

Reagent pipetting

Diluent (H2O)

R1

85 µL

R2

82 µL

R3

50 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.0 µL

Decreased

2.0 µL

Increased

2.0 µL

cobas c 501/502 test definition

Assay type

2‑Point End

Reaction time /Assay points:

10 / 40‑66

Wavelength (sub/main)

– /600 nm

Reaction direction

Increase

Unit

µg/mL

Reagent pipetting

Diluent (H2O)

R1

85 µL

R2

82 µL

R3

50 µL

Sample volumes

Sample

Sample dilution

Sample

Diluent (NaCl)

Normal

2.0 µL

Decreased

2.0 µL

Increased

2.0 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 :

12 weeks

Do not freeze.

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

Calibration

Calibrators

S1‑6: Preciset TDM II Calibrators

Calibration mode

RCM

Calibration frequency

6‑point calibration
- after reagent lot change
- every 6 weeks
- as required following quality control procedures

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

Traceability: This method has been standardized against USP reference standards.

LREFUSP 39-NF (U.S. Pharmacopeia National Formulary) 2016:5647-5648.
The calibrators are prepared to contain known quantities of quinidine in normal human serum.

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

Specific performance data

Representative performance data on the analyzers are given below. Results obtained in individual laboratories may differ.

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

Precision

Precision was determined using human samples and controls in a modified NCCLS EP5‑A protocol (repeatability n = 63, intermediate precision n = 63). The following results were obtained on a cobas c 501 analyzer.

Serum/Plasma

Repeatability

Mean

SD

CV

µg/mL

µmol/L

µg/mL

µmol/L

%

Control 1

1.04

3.20

0.02

0.06

2.2

Control 2

3.12

9.61

0.03

0.09

1.1

Control 3

5.00

15.4

0.05

0.2

1.0

HS 1

1.87

5.76

0.03

0.09

1.5

HS 2

6.75

20.8

0.08

0.3

1.1

Intermediate precision

Mean

SD

CV

µg/mL

µmol/L

µg/mL

µmol/L

%

Control 1

1.04

3.20

0.03

0.09

3.3

Control 2

3.12

9.61

0.05

0.15

1.7

Control 3

5.00

15.4

0.06

0.2

1.3

HS 1

1.87

5.76

0.04

0.12

2.3

HS 2

6.75

20.8

0.09

0.3

1.3

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

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

Method comparison

Serum/plasma

Quinidine values for human serum and plasma samples obtained on a cobas c 501 analyzer (y) were compared with those determined using the corresponding reagent on a Roche/Hitachi 917 analyzer (x) and on a COBAS INTEGRA 700 analyzer (x).

Roche/Hitachi 917 analyzer

Sample size (n) = 74

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 0.962x - 0.054 µg/mL

y = 0.969x - 0.061 µg/mL

τ = 0.959

r = 0.996

The sample concentrations were between 0.5 and 6.8 µg/mL (1.5 and 20.9 µmol/L).

COBAS  INTEGRA  700 analyzer

Sample size (n) = 74

Passing/Bablok

LREFBablok W, Passing H, Bender R, et al. A general regression procedure for method transformation. Application of linear regression procedures for method comparison studies in clinical chemistry, Part III. J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.

Linear regression

y = 1.099x - 0.022 µg/mL

y = 1.096x - 0.030  µg/mL

τ = 0.919

r = 0.991

The sample concentrations were between 0.4 and 5.8 µg/mL (1.2 and 17.9 µmol/L).

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

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

Summary

Quinidine is used for the prevention and treatment of ventricular arrhythmias, junctional (nodal) arrhythmias, and supraventricular (atrial) arrhythmias. The quinidine dosage required to achieve therapeutic serum levels is dependent on the drug formulation, patient age, and individual variability in absorption and metabolism.

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

Reagents - working solutions

R1+R2

Anti-quinidine antibody (mouse monoclonal) and human-sourced material in buffer with preservative

R3

Conjugated quinidine derivative microparticles, human-sourced material, and preservative

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

", "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.

This kit contains components classified as follows in accordance with the Regulation (EC) No. 1272/2008:

Warning

H319

Causes serious eye irritation.

Prevention:

P264

Wash skin thoroughly after handling.

P280

Wear eye protection/ face protection.

Response:

P305 + P351 + P338

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P337 + P313

If eye irritation persists: Get medical advice/attention.

Product safety labeling follows EU GHS guidance.

Contact phone: all countries: +49-621-7590, USA: 1-800-428-2336

All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods use assays that have been approved by the FDA or that are in compliance with the legal rules applicable to placing in vitro diagnostic medical devices for human use on the market in the European Union.
However, as no testing method can rule out the potential risk of infection with absolute certainty, the material should be handled with the same level of care as a patient specimen. In the event of exposure, the directives of the responsible health authorities should be followed.

LREFOccupational Safety and Health Standards: Bloodborne pathogens. (29 CFR Part 1910.1030). Fed. Register.
,
LREFDirective 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work.

", "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.

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

For specimen collection and preparation only use suitable tubes or collection containers.

Only the specimens listed below were tested and found acceptable.

Serum: Collect serum using standard sampling tubes.

Plasma: K2‑ or K3‑EDTA, or sodium or lithium heparinized plasma.

Stability:

8 hours capped at 15‑25 °C
48 hours capped at 2‑8 °C
4 weeks capped at -20 °C

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, i.e. not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases. When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Centrifuge samples containing precipitates before performing the assay.

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.

Do not induce foaming of specimens. Specimens should not be repeatedly frozen and thawed.

Invert thawed specimens several times prior to testing.

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

QUIN2

ONLINE TDM Quinidine

IVD For in vitro diagnostic use.
QUIN2

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

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    Technical Documents

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