FSH - Vô tinh trùng, vô kinh, trứng đa nang, ...

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4 x 1 ml
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11775863  122             100

Elecsys  2010
cobas e 411
cobas e 601
cobas e 602


Intended use
Immunoassay for the in vitro quantitative determination of follicle‑stimulating hormone in human serum and plasma.
The electrochemiluminescence immunoassay  “ECLIA”  is intended for use on Elecsys  and cobas e immunoassay analyzers.
FSH (follicle stimulating hormone),  together with LH  (luteinizing hormone), belongs  to the gonadotropin family. FSH and LH  regulate and stimulate the growth and function of the gonads  (ovaries  and testes)  synergistically.1
Like LH, TSH  and hCG,  FSH  is a glycoprotein consisting of two subunits (α- and β‑chains). Its molecular weight is approx. 32000 daltons.
In women,  the gonadotropins  act within the hypothalamus‑pituitary‑ovary regulating circuit to control the menstrual  cycle.2,3
FSH and LH  are released  in pulses  from the gonadotropic cells of the anterior pituitary. The  levels of the circulating hormones are controlled by steroid hormones  via negative feedback  to the hypothalamus.  In the ovaries FSH, together with LH,  stimulates  the growth and maturation of the follicle and hence  also the biosynthesis  of estrogens in the follicles.
The FSH level shows  a peak at mid-cycle, although this is less  marked than with LH.  Due  to changes  in ovarian function and reduced estrogen
secretion, high FSH  concentrations occur during menopause.3
In men, FSH  serves  to induce spermatogonium development.
Determination  of the FSH concentration is used  in the elucidation of dysfunctions  within the hypothalamus‑pituitary‑gonads  system.
The  determination of FSH in conjunction with LH  is utilized for the following indications: congenital diseases with chromosome aberrations, polycystic ovaries (PCO),  amenorrhea (causes),  and menopausal syndrome. Depressed gonadotropin levels  in men occur  in azoospermia.1,3,4,5
The Elecsys FSH assay employs  two different monoclonal antibodies specifically directed against human FSH.  Cross‑reactivity with LH,  TSH, hCG,  hGH, and hPL is negligible.
Test principle
Sandwich  principle. Total duration of assay:  18 minutes.
▪          1st incubation: 40 µL of sample,  a biotinylated monoclonal  FSH‑specific antibody, and a monoclonal FSH‑specific antibody labeled  with a ruthenium complexa)   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.
▪          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 FSH.
M      Streptavidin-coated microparticles (transparent cap),  1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/mL; preservative.

R1   Anti-FSH-Ab~biotin  (gray cap),  1 bottle, 10 mL:
Biotinylated monoclonal anti‑FSH  antibody (mouse)  0.5 mg/L, MES
buffer 50 mmol/L, pH 6.0; preservative.
R2   Anti-FSH-Ab~Ru(bpy)     (black cap), 1 bottle, 10 mL: Monoclonal anti‑FSH  antibody (mouse)  labeled with ruthenium
complex 0.8 mg/L, MES  buffer 50 mmol/L, pH 6.0; preservative.
Precautions and warnings
For  in vitro diagnostic  use.
Exercise the normal precautions  required for handling all laboratory
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.
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.
Serum  collected using standard sampling tubes or tubes containing separating gel.
Li-, Na-, NH  ‑heparin, and K3‑EDTA plasma. When sodium citrate is used, the values obtained are by 20 % lower as  compared to serum, those for sodium fluoride/potassium oxalate are by approx. 14 % lower.
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 14 days at 2‑8 °C, 6 months  at -20  °C.6 Freeze  only once.7
Stability of serum  obtained with separating  tubes: 48 hours at 2‑8 °C (note the data provided by the tube manufacturer).
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)
▪           03032680122, FSH  CalSet  II, for 4 x 1 mL
▪           11731416190,  PreciControl Universal, for 2 x 3 mL each of
PreciControl Universal 1 and 2
▪           11731416160,  PreciControl Universal, for 2 x 3 mL each of
PreciControl Universal 1 and 2 (for USA)
▪          General  laboratory equipment
▪          Elecsys 2010, MODULAR ANALYTICS  E170 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 MODULAR ANALYTICS  E170, 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
▪           03004899190,  PreClean  M, 5 x 600 mL detection cleaning solution
▪           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)
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.
MODULAR ANALYTICS  E170, cobas e 601 and cobas e 602 analyzers: PreClean  M solution is necessary.
Resuspension of the microparticles  takes  place  automatically prior to use. Read  in the test‑specific  parameters  via the reagent barcode.  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.
Traceability: This  method has been standardized against the Enzymun‑Test FSH method. This  in turn has  been standardized  against the 2nd IRP  WHO reference standard 78/549.
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 Universal.
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.
The  analyzer automatically calculates  the analyte concentration of each sample  (either in mIU/mL  or in IU/L).
Limitations  - interference
The assay  is unaffected by icterus (bilirubin < 1094  µmol/L or < 64 mg/dL), hemolysis  (Hb < 0.621  mmol/L or < 1.0 g/dL), lipemia (Intralipid
< 1900  mg/dL)  and biotin (< 246  nmol/L or < 60 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 2250 IU/mL.
There is no high-dose hook effect at FSH  concentrations up to
2000 mIU/mL.
In vitro tests were performed on 17 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
0.100‑200  mIU/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  mIU/mL. Values  above the measuring range are reported as
> 200 mIU/mL.
Lower limits of measurement
Lower detection  limit of the test
Lower  detection  limit: < 0.100 mIU/mL
The  lower detection  limit represents  the lowest 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).
Not necessary  due to the broad measuring range.
Expected values
Studies  with the Elecsys FSH assay have  revealed  the following FSH
Test subjectsb)                                         N

FSH  (mIU/mL)
50th                      5th                      95th

τ   = 0.944                                           r = 0.998
The sample concentrations were between approx. 0.65 and 152 mIU/mL.
Analytical specificity

Men                                       319          4.6              1.5             12.4
• Follicular phase                     376          6.9              3.5             12.5
• Ovulation phase                      56          12.3             4.7             21.5
• Luteal phase                         349          3.6              1.7              7.7
• Postmenopause                     181          67.0            25.8            134.8
b) Reference  ranges for children are available on request and are also contained in the Elecsys
FSH product information.
LH/FSH quotient: Quotients have been calculated from the results obtained with the Elecsys  LH assay  and the Elecsys  FSH  assay  in the samples of healthy women of child‑bearing age.  The  following medians have been calculated:
Follicular phase:  0.82 (n = 315) Luteal phase: 1.12 (n = 279)
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  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); repeatability on MODULAR ANALYTICS  E170 analyzer,  n = 21. The  following results were obtained:
Elecsys  2010 and cobas e 411 analyzers
Repeatability        Intermediate precision

For  the monoclonal  antibodies  used,  the following cross‑reactivities were found:
LH, TSH,  hCG,  hGH and hPL < 0.1 %
1     Johnson MR, Carter G, Grint C, et al. Relationship between ovarian steroids,  gonadotropin and relaxin during the menstrual cycle. Acta Endocrinol 1983;129/2:121-125.
2      Beastall GH,  Ferguson KM, O’Reilly DSJ,  et al. Assays  for follicle stimulating hormone and luteinizing hormone: Guidelines  for the provision of a clinical biochemistry service. Ann Clin Biochem
3      Runnebaum B, Rabe  T. Gynäkologische  Endokrinologie und Fortpflanzungsmedizin Springer Verlag 1994. Band 1:17,253-255, Band 2:152-154,360,348. ISBN  3-540-57345-3, ISBN  3-540-57347-X.
4      Schmidt-Mathiesen H. Gynäkologie und Geburtshilfe. Schattauer
Verlag 1992.
5      Scott MG,  Ladenson  JH,  Green  ED,  et al. Hormonal evaluation of female  infertility and reproductive disorders. Clin Chem
6      DG  Klinische  Chemie  Mitteilungen 1995;26(5):210.
7      Wu AHB.  Tietz Clinical Guide To Laboratory Tests,  4th Edition, WB Saunders Co, 2006: 412 pp.
8     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.
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

Sample                          Mean mIU/mL

SD          CV
mIU/mL        %

SD          CV
mIU/mL        %

a decimal numeral. Separators  for thousands are not used.

Human serum 1                1.2          0.02           1.8           0.06           5.3
Human serum 2               50.4         0.74           1.5           1.90           3.8
Human serum 3                103          1.85           1.8           5.24           5.1
PCc) Universal 1              11.1         0.22           2.0           0.41           3.7
PC Universal 2                28.9         0.40           1.4           0.85           2.9
c) PC = PreciControl
MODULAR ANALYTICS  E170, cobas e 601 and cobas e 602 analyzers
Repeatability        Intermediate precision

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
Volume  after reconstitution or mixing

Sample                         Mean mIU/mL


CV     Mean
%      mIU/mL

SD       CV
mIU/mL     %

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

Human serum 1              5.97         0.15       2.6       5.33         0.19        3.6
Human serum 2              54.4         1.55       2.8       45.9         1.70        3.7
Human serum 3               178         4.54       2.5        229         10.3        4.5
PC Universal 1               9.53         0.14       1.5       8.29         0.33        4.0
PC Universal 2               24.6         0.31       1.3       21.6         0.84        3.9
Method comparison
A comparison of the Elecsys FSH assay (y) with the Enzymun‑Test FSH method (x) using clinical samples  gave  the following correlations  (mIU/mL): Number of samples measured: 160
Passing/Bablok8                                                  Linear regression
y = 1.093x + 0.213                              y = 1.098x + 0.114

COBAS, COBAS E, ELECSYS, MODULAR  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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