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Key Product Characteristics

Kit Name: Progesterone Detection kit 

Method: Fluorescence dry quantitative immunoassay

Assay measuring range: 0.37ng/mL ~40.00ng/mL

Incubation time: 10 minutes

Sample: Human serum, plasma (EDTA-K2 anticoagulant)50ul, whole blood (EDTA-K2 anticoagulant)80ul

Reference range: 



reference range


Follicular phase

<0.37-1.98ng/mL (5%CI-95%CI)

Luteal phase

<0.88-30.43ng/mL (5%CI-95%CI)


<0.37-0.8ng/mL (5%CI-95%CI)

Early stage pregnancy

<4.7-40ng/mL (10%CI-90%CI)

Storage and Stability: 

Detection Buffer is stable for 12 months at 2°C ~8°C. 

Sealed Test Device is stable for 12 months at 4°C30°C.


For the in vitro quantitative determination of progesterone (P) concentrations in female serum/plasma/whole blood.

In women with normal menstruation.

Progesterone is maintained at low levels during the follicular phase, with a surge in luteinising hormone production and a sharp rise in progesterone during the luteal phase following ovulation, and can therefore be used as a reliable indicator of natural or induced ovulation .

The result leads to changes in the uterus and prepares the ovary for implantation of the fertilised egg. Insufficient progesterone in the luteal phase is thought to be the cause of endometrial dysplasia if abnormally low levels of progesterone occur.

If conception does not occur, progesterone drops in the last four days of the cycle as the corpus luteum degenerates. If conception occurs, the corpus luteum maintains progesterone at mid-luteal concentrations until the sixth week of gestation. At that point, the placenta becomes the source of progesterone for as long as it takes, and progesterone levels are continuously elevated. In early pregnancy, low levels of progesterone indicate a high likelihood of preterm abortion or ectopic pregnancy .

In conclusion, progesterone testing can be used to detect ovulation in women and to assess the luteal phase, which can help in fertility determination .

Consensus & Guidelines

The Society of Obstetricians and Gynaecologists of Canada,SOGCClinical Practice Guideline: Progesterone for Prevention of Spontaneous Preterm Birth(2020)》

Early in pregnancy, progesterone production by the corpus luteum is essential for the maintenance of pregnancy, with the placenta taking over this function by 7-9 weeks of gestation. In the second trimester, progesterone maintains the resting state of the uterus and its activity decreases functionally towards the onset of labour, both in preterm and term births.

In addition, progesterone prevents apoptosis of the fetal membrane explants in both basal and inflammatory response activation conditions

The latest clinical research evidence of progesterone in the prevention of SPB, and provided clinical guidance and recommendations for the mechanism of action, the appropriate population, unsuitable population, dosage, timing and side effects of progesterone in the prevention of SPB

Clinical Applications

Ovulation monitoring 

Blood progesterone levels >5ng/ml suggest ovulation.

Evaluation of luteal function

Evaluation of luteal function: A lower than physiological blood progesterone level during the luteal phase is indicative of luteal insufficiency.

Ancillary diagnosis of ectopic pregnancy

In ectopic pregnancy, blood progesterone levels is very low, most patients < 15ng/ml.


Aids in the diagnosis of pre-eclampsia, observation of placental function, prognostic assessment of in vitro fertilisation-embryo transfer, etc.

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