CK-MB STAT - Nhồi máu cơ tim, viêm cơ tim, vv

Mục
CK-MB STAT CALSET
Mã sản phẩm
RCKMBSCAL
Loại
CK-MB STAT CALSET
Quy cách
4 x 1 ml
Yêu cầu báo giá
 
11731432 122              100

Elecsys  2010
cobas  e 411
cobas  e 601
cobas  e 602

 

English
Intended use
Immunoassay for the in vitro quantitative determination of the
MB isoenzyme  of creatine kinase in human serum and plasma.
The electrochemiluminescence immunoassay “ECLIA” is intended  for use on Elecsys  and cobas  e immunoassay analyzers.
Summary
Creatine kinase (CK)  is a dimeric enzyme which occurs  in four different forms: a mitochondrial isoenzyme and the cytosolic isoenzymes  CK‑MM (muscle type), CK‑BB  (brain type) and CK‑MB.1,2
The  determination of CK‑MB mass in serum  is an important element in the diagnosis of myocardial ischemia,  e.g. in acute myocardial infarction, myocarditis, etc.1,2  CK‑MB is detectable  in the blood about 3‑8 hours after the onset of cardiac symptoms and can remain detectable over a lengthy period of time, depending on the course  of the condition.1
CK‑MB may also appear in other clinical conditions, e.g. in rhabdomyolysis and stroke.1   Within the scope  of laboratory diagnostics,  the determination of total CK,   troponin T and/or myoglobin can  contribute to the differentiation of these clinical pictures.
The  sensitivity of a CK‑MB determination is dependent upon the time at which a sample was taken. Follow-up assays are therefore meaningful.1,3
The Elecsys CK‑MB STAT assay employs  two different monoclonal antibodies directed against human CK‑MB.
Test principle
Sandwich  principle. Total duration of assay:  9 minutes.
Elecsys  2010 and cobas  e 411 analyzers:
▪          1st incubation: 15 µL of sample,  a biotinylated monoclonal  anti‑CK‑MB antibody, and a monoclonal CK‑MB‑specific antibody labeled  with a ruthenium complexa)   react to form a sandwich complex.
▪          2nd incubation: After addition of streptavidin-coated  microparticles,  the complex becomes  bound to the solid phase  via interaction of biotin and streptavidin.
cobas  e 601 and cobas  e 602 analyzers:
▪          During a 9 minute incubation, antigen in the sample  (15 µL),  a biotinylated monoclonal  anti‑CK‑MB  antibody, a monoclonal CK‑MB‑specific antibody labeled with a ruthenium complex and streptavidin-coated  microparticles  react to form a sandwich complex, which is bound to the solid phase.
All analyzers:
▪          The  reaction mixture is aspirated into the measuring  cell where the microparticles are magnetically captured onto the surface  of the electrode. Unbound substances  are then removed with
ProCell/ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
▪          Results  are determined via a calibration curve which is instrument- specifically  generated by 2‑point calibration and a master curve provided via the reagent barcode.
a) Tris(2,2'-bipyridyl)ruthenium(II)-complex (Ru(bpy)  )
Reagents  - working solutions
The reagent rackpack is labeled as CKMBSTAT.
M      Streptavidin-coated microparticles (transparent cap),  1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative.
R1   Anti‑CK‑MB‑Ab~biotin  (gray cap),  1 bottle, 10 mL:
Biotinylated monoclonal anti‑CK‑MB  antibody (mouse)  1.2 mg/L;
phosphate  buffer 100 mmol/L, pH 7.0; preservative.

R2   Anti‑CK‑MB‑Ab~Ru(bpy)    (black cap), 1 bottle, 10 mL: Monoclonal anti‑CK‑MB  antibody (mouse)  labeled with ruthenium
complex 1.2 mg/L; phosphate buffer 100 mmol/L, pH 7.0;
preservative.
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.
Avoid foam formation in all reagents and sample types (specimens, calibrators and controls).
Reagent handling
The  reagents  in the kit have been assembled  into a ready‑for‑use  unit that cannot be separated.
All information required for correct  operation is read in from the respective reagent barcodes.
Storage and stability
Store  at 2‑8  °C.
Do not freeze.
Store the Elecsys  reagent  kit upright  in order to ensure complete availability of the microparticles  during automatic  mixing prior to use.
Stability:
unopened at 2‑8 °C                            up to the stated expiration date
after opening at 2‑8 °C                       12 weeks
on the analyzers                                8 weeks
Specimen collection and preparation
Only the specimens  listed below were tested and found acceptable.
Serum  collected using standard sampling tubes or tubes containing separating gel.
Li‑heparin, Na‑heparin, K3‑EDTA and sodium citrate plasma.  When sodium citrate is used, the results must be corrected by + 10 %.
Criterion: Recovery  within 90‑110 % of serum value or slope
0.9‑1.1   + intercept  within < ±  2x analytical sensitivity (LDL)  + coefficient of
correlation  > 0.95.
Stable for 4 hours at 18‑23 °C, 8 hours at 2‑8 °C, 3 months at ‑20  °C. Freeze  only once.
CK‑MB stability is extremely  temperature-dependent.  A CK‑MB  decrease of
> 10 % can  occur  after the sample  has  stood for 1 hour at 32 °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. Do not use heat‑inactivated samples.
Do not use  samples  and controls stabilized with azide.
Ensure  the samples,  calibrators and controls are at 20‑25 °C prior to measurement.
Due to possible evaporation effects, samples,  calibrators and controls on the analyzers  should be analyzed/measured within 2 hours.

 

Materials provided
See  “Reagents  – working solutions” section  for reagents.
Materials required (but not provided)
▪           11731572122, CK‑MB  STAT  CalSet,  for 4 x 1 mL
▪           04917049190,  PreciControl Cardiac  II, for 2 x 2 mL each of
PreciControl Cardiac II 1 and 2
▪           04917049160,  PreciControl Cardiac  II, for 2 x 2 mL each of
PreciControl Cardiac  II 1 and 2 (for USA)
▪           11732277122,  Diluent Universal,  2 x 16 mL sample diluent or
03183971122,  Diluent Universal,  2 x 36 mL sample diluent
▪           03609987190,  Diluent MultiAssay,  2 x 16 mL sample diluent
▪          General  laboratory equipment
▪          Elecsys  2010 or cobas  e analyzer
Accessories for Elecsys  2010 and cobas  e 411 analyzers:
▪           11662988122, ProCell, 6 x 380 mL system buffer
▪           11662970122, CleanCell,  6 x 380 mL measuring cell cleaning solution
▪           11930346122, Elecsys  SysWash,  1 x 500 mL washwater additive
▪           11933159001,  Adapter for SysClean
▪           11706802001, Elecsys  2010 AssayCup,  60 x 60 reaction vessels
▪           11706799001, Elecsys  2010 AssayTip, 30 x 120 pipette tips
Accessories for cobas  e 601 and cobas  e 602 analyzers:
▪           04880340190, ProCell M, 2 x 2 L system buffer
▪           04880293190, CleanCell  M, 2 x 2 L measuring cell cleaning solution
▪           03023141001, PC/CC‑Cups,  12 cups to prewarm ProCell  M and
CleanCell  M before use
▪           03005712190, ProbeWash  M, 12 x 70 mL cleaning solution for run finalization and rinsing during reagent change
▪           12102137001, AssayTip/AssayCup  Combimagazine M,
48 magazines x 84 reaction vessels  or pipette tips, waste bags
▪           03023150001, WasteLiner, waste bags
▪           03027651001, SysClean  Adapter M Accessories for all analyzers:
▪           11298500316, Elecsys  SysClean,  5 x 100 mL system cleaning solution
▪           11298500160, Elecsys  SysClean,  5 x 100 mL system cleaning solution (for USA)
Assay
For optimum performance  of the assay  follow the directions given in this document for the analyzer concerned.  Refer  to the appropriate operator’s manual for analyzer‑specific assay  instructions.
Resuspension of the microparticles  prior to use  and the reading  in of the test‑specific parameters via the reagent barcode take place automatically. No manual  input is necessary.  If in exceptional cases  the barcode cannot be read, enter the 15‑digit sequence  of numbers.
Bring the cooled reagents  to approx. 20 °C and place on the reagent disk (20   °C) of the analyzer.  Avoid foam formation. The  system  automatically regulates  the temperature of the reagents  and the opening/closing of the bottles.
Calibration
Traceability:  The  linearity of the Elecsys CK‑MB STAT  assay was improved by using human recombinant CK‑MB4 from Seradyn  (            AKC0325;
Lot No. M25082). The test was standardized against the previous Elecsys CK‑MB STAT assay in the range of 0‑20.0  ng/mL; this leads  up to a 30 % reduction of the test results in the range of 20.0‑500  ng/mL (see  graph under Method comparison).
Every Elecsys reagent set has  a barcoded label containing specific information for calibration of the particular reagent  lot. The predefined master curve is adapted to the analyzer  using the relevant CalSet.

Calibration frequency:  Calibration must be performed once  per reagent lot using fresh reagent (i.e. not more than 24 hours since  the reagent kit was registered on the analyzer).  Renewed  calibration is recommended  as follows:
▪          after 1 month (28 days)  when using the same  reagent lot
▪          after 7 days  (when using the same  reagent kit on the analyzer)
▪          as  required: e.g. quality control findings outside the defined limits
Quality control
For quality control, use PreciControl Cardiac II.
In addition, other suitable control material can be used.
Controls  for the various  concentration ranges  should be run individually at least once every 24 hours when the test is in use,  once per reagent kit, and following each calibration.
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.
Calculation
The  analyzer automatically calculates  the analyte concentration of each sample in ng/mL.
Limitations - interference
The assay  is unaffected by icterus (bilirubin < 581  µmol/L or < 34 mg/dL), hemolysis  (Hb < 0.932  mmol/L or < 1.5 g/dL), lipemia (Intralipid
< 1500  mg/dL)  and biotin (< 409  nmol/L or < 100 ng/mL).
Criterion: Recovery  within ±  10 % of initial value.
Samples  should not be taken from patients receiving therapy with high biotin doses  (i.e.  > 5 mg/day)  until at least  8 hours  following the last biotin administration.
No interference was  observed  from rheumatoid factors up to a concentration of 1500 IU/mL and samples  from dialysis patients. There is no high-dose hook effect at CK‑MB  concentrations  up to
5000 ng/mL.
In vitro tests were performed on 50 commonly used pharmaceuticals.  No interference  with the assay  was found.
In rare cases,  interference due to extremely high titers of antibodies to analyte‑specific  antibodies,  streptavidin or ruthenium can  occur.  These effects are minimized by suitable test design.
For diagnostic purposes, the results should always be assessed  in conjunction with the patient’s medical  history, clinical examination and other findings.
Limits and ranges
Measuring range
0.100‑500  ng/mL (defined by the lower detection limit and  the maximum  of the master curve).  Values  below the lower detection limit are  reported as
< 0.100  ng/mL. Values  above the measuring range are reported as
> 500 ng/mL (or up to 1000  ng/mL for 2‑fold diluted samples).
Lower limits of measurement
Lower detection  limit of the test
Lower  detection  limit: < 0.100 ng/mL
The  lower detection  limit represents the lowest measurable  analyte level that can  be distinguished from zero. It is calculated as  the value lying two standard deviations above that of the lowest standard (master  calibrator, standard 1 + 2 SD,  repeatability study, n = 21).
Dilution
Samples with CK‑MB concentrations above the measuring range can be diluted with Diluent Universal.  The  recommended  dilution is 1:2 (either automatically by the Elecsys  2010 or cobas  e analyzers, or manually).
On the cobas  e 601 and cobas  e 602 analyzers, Diluent MultiAssay can also  be used.  The  concentration of the diluted sample must be
> 50.0 ng/mL.
After manual  dilution, multiply the result by the dilution factor.

After dilution by the analyzers, the Elecsys  2010 and cobas  e software automatically  takes  the dilution into account  when calculating  the sample concentration.
Expected values
In studies  with the Elecsys CK‑MB STAT assay the following results were obtained (ng/mL):
N             Median       97.5th  percentile       99th percentile
Women           760             0.97                   2.88                      3.77
Men               628             1.35                   4.94                      6.73
Data (status July 1999) combined from: FRISC II (Fragmin  during instability in coronary artery disease)  study, results from Uppsala,  January  1999, and International Elecsys  1010 study, cardiac marker, March 1999.
Each  laboratory should investigate the transferability of the expected values to its own  patient population  and  if necessary  determine its own reference ranges.
Specific  performance data
Representative  performance data on the analyzers  are given below. Results  obtained in individual laboratories may differ.
Precision
Precision  was determined using Elecsys reagents, pooled human sera and controls in a modified protocol (EP5‑A)  of the CLSI  (Clinical and Laboratory Standards  Institute): 6 times daily for 10 days  (n = 60).  The  following results were obtained:
Elecsys  2010 and cobas  e 411 analyzers
Repeatability     Intermediate precision

Passing/Bablok5                                                 Linear regression
y = 0.96x + 0.24                                 y = 0.93x + 0.32
τ   = 0.958                                          r = 0.999
▪          Sample concentrations between 0 and 500 ng/mL Number of samples measured: 479
Elecsys CK‑MB STAT assay
 
y 500
 
 
400
 
 
300
 
 
200
 
 
100
 
 
0 0                                              100                                           200                                          300                                          400                                         500
x
x: Elecsys  CK‑MB  STAT  assay  - previous test version - ng/mL
y: Elecsys CK‑MB STAT assay - linearized - ng/mL
The  new values  in the upper concentration range must be taken into consideration  when monitoring and estimating the magnitude  of an

Sample                         Mean
ng/mL

SD       CV
ng/mL      %

SD              CV
ng/mL             %

infarction  with Elecsys CK‑MB STAT assays.
Analytical specificity
For  the monoclonal  antibodies  used,  the following cross‑reactivities were

Human serum 1              5.77         0.09       1.5           0.13              2.3
Human serum 2              12.4         0.26       2.1           0.32              2.6
Human serum 3              39.7         0.73       1.8           0.91              2.3
PreciControl Card1           5.86         0.11       1.9           0.14              2.4
PreciControl Card2           53.1         0.99       1.9           1.26              2.7
Precision  was determined using Elecsys reagents, samples  and controls in a protocol (EP5‑A2)  of the CLSI  (Clinical and Laboratory Standards Institute): 2 runs per day in duplication each  for 21 days  (n = 84). The following results were obtained:
cobas  e 601 and cobas  e 602 analyzers
Repeatability     Intermediate precision

found:
CK‑MM none, CK‑BB  0.10 %.
References
1     Rozenman Y, Gotsman MS.  The earliest diagnosis of acute myocardial infarction. Annu Rev Med 1994;45:31-44.
2     Adams JE, Abendschein DR,  Jaffe AS.  Biochemical markers of myocardial injury: Is MB creatine kinase the choice for the 1990s? Circulation 1993;88:750-763.
3      Apple FS. Diagnostic markers for detection of acute myocardial infarction and reperfusion. Laboratory Medicine 1992;23(5):297-322.
4      Christenson  RH,  Vaidya H, Landt Y, et al. Standardization of Creatine Kinase-MB  (CK-MB)  Mass  Assays:  The Use  of Recombinant CK-MB  as a Reference  Material. Clin Chem 1999;45(9):1414-1423.

Sample                         Mean
ng/mL

SD       CV
ng/mL      %

SD              CV
ng/mL             %

5     Bablok 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.

Human serum 1                 1.38           0.04         2.8              0.08                   5.5
Human serum 2                 2.16           0.04         2.0              0.08                   3.7
Human serum 3                 3.65           0.07         1.8              0.12                   3.2
Human serum 4                 8.64           0.25         2.9              0.31                   3.6
Human serum 5                  361            8.69         2.4              12.2                   3.4
PreciControl Card1           4.02           0.06         1.6              0.09                   2.3
PreciControl Card2           54.8           0.96         1.8              0.99                   1.8
Method comparison
A comparison of the Elecsys CK‑MB STAT assay - linearized (y) with the Elecsys  CK‑MB  STAT  assay  - previous version (x) using clinical samples gave  the following correlations:
▪          Sample concentrations between 0 and 20.0 ng/mL Number of samples measured: 366

J Clin Chem Clin Biochem 1988 Nov;26(11):783-790.
For  further information, please  refer to the appropriate operator’s  manual  for the analyzer concerned,  the respective application sheets,  the product information and the Method Sheets  of all necessary  components (if
available in your country).
A point (period/stop) is always  used  in this Method Sheet  as  the decimal separator  to mark the border between the integral and the fractional parts of a decimal numeral. Separators  for thousands are not used.
Symbols
Roche Diagnostics uses the following symbols  and signs  in addition to those listed in the ISO  15223‑1 standard.
Contents   of kit
Analyzers/Instruments on which reagents can be used
Reagent
Calibrator
Volume  after reconstitution or mixing

 
FOR US CUSTOMERS  ONLY: LIMITED WARRANTY
Roche  Diagnostics  warrants that this product will meet the specifications
stated in the labeling when used in accordance  with such  labeling and will
be free from defects  in material and workmanship  until the expiration date
printed on the label. THIS LIMITED WARRANTY IS IN LIEU OF ANY
OTHER WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR
PURPOSE.  IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE
FOR INCIDENTAL, INDIRECT, SPECIAL  OR CONSEQUENTIAL
DAMAGES.
COBAS, COBAS E, ELECSYS and PRECICONTROL are trademarks of Roche. INTRALIPID is a trademark  of
Fresenius Kabi AB.
All other product names  and trademarks  are the property of their respective owners.
Significant additions or changes  are indicated by a change bar in the margin.
© 2013, Roche Diagnostics
 
 
 
Roche Diagnostics GmbH, Sandhofer Strasse  116, D-68305 Mannheim www.roche.com
Distribution in USA by:
Roche  Diagnostics,  Indianapolis, IN
US  Customer Technical Support 1-800-428-2336

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