AMH - Cobas

Elecsys® AMH
Electrochemiluminescence immunoassay (ECLIA)
for the in vitro quantitative determination of antiMullerian Hormone in human serum and plasma
Indication
Immunoassay for the in vitro quantitative determination of anti-Mullerian Hormone (AMH) in human serum and lithium heparin
plasma. The determination of AMH is used for the assessment of the ovarian reserve in conjunction with other clinical and laboratory findings.
AMH plays a fundamental role in the regression of Mullerian ducts in male embryo and in its absence, Mullerian ducts develop
into female inner reproductive organs. In females, it is secreted by the granulosa cells of pre-antral and small antral ovarian follicles. AMH regulates follicle recruitment and growth of small ovarian follicles while preventing exhaustion of follicular pool.1,2
Test principle: Sandwich principle
Anti-AMH-Ab~Bi
Streptavidin
microparticle
+
Antigen in
the sample
9 min
+
9 min
+
Ru
Ru
Detection
Ru
Anti-AMH-Ab~Ru
1st Incubation (9 minutes):
50 µL of sample, a biotinylated monoclonal mammalian AMH-specific antibody and a monoclonal mammalian
AMH-specific antibody labeled with
a ruthenium complex react to form a
sandwich complex.
2nd Incubation (9 minutes):
After addition of streptavidin-coated
microparticles, the complex becomes
bound to the solid phase via interaction of biotin and streptavidin.
Measurement:
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. 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.
Elecsys technology
ECL (ElectroChemiLuminescence) is Roche’s technology
for immunoassay detection. Based on this technology
and combined with well-designed, specific and sensitive immunoassays, Elecsys delivers reliable results. The
development of ECL immunoassays is based on the use of
a ruthenium-complex and tripropylamine (TPA). The chemiluminescence reaction for the detection of the reaction
complex is initiated by applying a voltage to the sample
solution resulting in a precisely controlled reaction. ECL
technology can accommodate many immunoassay principles while providing superior performance.
Elecsys Anti-Mullerian Hormone (AMH) test characteristics
Testing time
18 min
Test principle
Sandwich assay
Calibration
2 point
Traceability
Standardized against BCI AMH Gen II
ELISA (unmodified)
Sample material
Sample volume
LoB, LoD, LoQ***
Serum and Li-heparin plasma
50 μL
0.007 ng/mL, (0.05 pmol/L), 0.010 ng/mL,
(0.071 pmol/L), 0.030 ng/mL,
(0.214 pmol/L)
Measuring
range
0.01 - 23 ng/mL
(0.071 - 164.2 pmol/L)
Intermediate
imprecision
cobas e 411 analyzer:
2.9 – 4.4 %
cobas e 601/e 602 modules: 2.7 – 3.5 %
Lowest conc. measured:
0.232 ng/mL
Expected values
N
5th perc. ng/mL
(95 % CIb)
Healthy men
148
1.43 (0.256 – 1.97)
Healthy women (years)
20 – 24
115
1.66 (0.862 – 1.85)
25 – 29
142
1.18 (0.853 – 1.81)
30 – 34
110
0.672 (0.473 – 0.932)
35 – 39
57*
–
40 – 44
41*
–
45 – 50
28*
–
PCOS women**
149
2.41 (1.67 – 3.01)
10th perc. ng/mL
(95 % CIb)
Median ng/mL
(95 % CIb)
90th perc. ng/mL
(95 % CIb)
95th perc. ng/mL
(95 % CIb)
2.15 (1.35 – 2.43)
4.79 (4.35 – 5.35)
10.1 (9.14 – 11.6)
11.6 (10.3 – 17.0)
1.88 (1.49 – 2.28)
1.83 (1.18 – 2.07)
0.946 (0.602 – 1.19)
0.777 (0.159 – 0.932)
0.097 (0.021 – 0.247)
0.046 (0.018 – 4.16)
3.97(3.55 – 4.33)
3.34 (3.03 – 3.87)
2.76 (2.34 – 3.55)
2.05 (1.78 – 3.24)
1.06 (0.734 – 2.13)
0.223 (0.125 – 0.498)
7.29 (6.82 – 10.1)
7.53 (6.74 – 9.16)
6.70 (5.57 – 7.64)
5.24 (4.83 – 7.34)
2.96 (2.59 – 5.70)
2.06 (0.018 – 4.16)
9.49 (7.38 – 11.5)
9.16 (7.63 – 10.1)
7.55 (6.76 – 9.34)
–
–
–
3.12 (2.29 – 3.77)
6.81 (6.30 – 7.42)
12.6 (11.5– 17.1)
17.1 (13.3 – 20.3)
Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own
reference ranges.
b) CI = confidence interval
* Due to the lower number of patients in these age groups the extreme percentiles were not calculated
** According to the revised diagnostic criteria of PCOS defined by the Rotterdam ESHRE/ASRM-sponsored PCOS consensus workshop group3
*** LoB = Limit of Blank; LoD = Limit of Detection; LoQ = Limit of Quantitation (20 % total error)
Order information
Elecsys AMH
Elecsys AMH CalSet
PreciControl AMH
Universal Diluent 2
100 tests
4 x 1.0 mL
4 x 2.0 mL
2 x 36 mL
COBAS, COBAS E, ELECSYS and LIFE NEEDS ANSWERS
are trademarks of Roche.
©2014 Roche
Roche Diagnostics International Ltd.
CH-6343 Rotkreuz
Switzerland
www.cobas.com
06331076 190
06331084 190
06709966 190
05192943 190
References
1.Visser, J.A., Themmen, A.P. (2005). Mol Cell Endocrinol; 234(1-2):81–6.
2.La Marca, A., Volpe, A. (2007). Hum Reprod Update; 13(3):265–73.
3.Rotterdam ESHRE/ASRM-Sponsored PCOS consensus workshop
group (2004). Revised 2003 consensus on diagnostic criteria and longterm health risks related to polycystic ovary syndrome (PCOS). Hum
Reprod;19(1): 41-47.

Download Report