Indication Progesterone is the hormone that, prior to pregnancy, triggers conversion of the uterine mucosa into a tissue rich in glands and prepared for implantation of the fertilized ovum. During pregnancy, progesterone stops the myometrium contracting and promotes, along with estrogen, the proliferation and secretion disposition of the alveoli in the mammary glands. Progesterone is mainly produced in the corpus luteum and the placenta during pregnancy. Progesterone concentration correlates with the development and regression of the corpus luteum and therefore increases the day before ovulation and remains elevated during the luteal phase of the female cycle.Progesterone measurements are used clinically to detect ovulation and to assess the luteal phase of the cycle.

ELECSYS® PROGESTERONE IIElectrochemiluminescence immunoassay (ECLIA) for the in vitro quantitative determination of progesterone in human serum and plasma

Free progesterone in the sample

Biotinylated monoclonal murine anti-progesterone

Protein-bound progesterone in the sample

Danazol

Ruthenylated progesterone conjugate

9 min

Ru

Ru

Ru

9 min

Streptavidin-coated microparticle

Ru

Ru

Ru

MeasurementRu

Ru

Test principle: competitive immunoassay with analyte liberation

1st Incubation (9 minutes): 30 μL of the sample is incubated with a biotinylated, monoclonal progesterone-specific antibody, ruthenylated progesterone derivative, and danazol (to release progesterone). The antibody binding sites are occupied by either progesterone or the ruthenylated derivative, with the proportion of each depending on the concentration of progesterone in the sample.

2nd Incubation (9 minutes): Streptavidin-coated microparticles are added to the reaction mixture and the immune complexes bind to the solid phase via biotin–streptavidin interactions.

Measurement: The reaction mixture is transferred to a measuring cell and the microparticles are magnetically captured onto the surface of an electrode; unbound sample is washed away before a chemiluminescent reaction is induced by applying a voltage to the electrode. Chemiluminescence is measured by a photomultiplier and the concentration of Progesterone within the sample is calculated using a calibration curve.

Elecsys® Progesterone II test characteristicsTesting time 18 minutes

Test principle Competitive immunoassay with analyte liberation

Calibration 2 point

Sample material Serum, Na-, Li-heparin, K3-EDTA, sodium citrate, and sodium fluoride/potassium oxalate plasma

Sample volume 30 μL

Lower detection limit 0.095 nmol/L (0.030 ng/mL)

Measuring range 0.095 – 191 nmol/L (0.030 - 60.0 ng/mL)

Traceability Standardized via isotope dilution gas chromatography mass spectrometry (ID-GC/MS)

Intermediate precision (CLSI) Elecsys® 2010 analyzer, cobas e 411 analyzer: 3.7 – 5.5 % (4.99-96.0 nmol/L or 1.57-30.2 ng/mL)MODULAR ANALYTICS E170, cobas e 601 module, cobas e 602 module: 1.8 – 4.8 % (2.52 – 112 nmol/L or 0.79-35.3 ng/mL)

Expected values N Percentiles, nmol/L Percentiles, ng/mL

50th 5th-95th 50th 5th-95th

Men 33 1.8 0.7-4.3 0.6 0.2-1.4

Women

Follicular phase 192 2.1 0.6-4.7 0.7 0.2-1.5

Ovulation phase 13 3.9 2.4-9.4 1.2 0.8-3.0

Luteal phase 158 36 5.3-86 11 1.7-2.7

Postmenopause 89 1.0 0.3-2.5 0.3 0.1-0.8

Order informationElecsys® Progesterone II 100 tests 12145383 160

Progesterone II CalSet 4 x 1 mL 12145391 122

PreciControl Universal 1 and 2 2 x 3 mL each 11731416 160

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