CLIA Kit for Progesterone (PG)

P4; Pregn-4-Ene-3,20-Dione

Specificity

This assay has high sensitivity and excellent specificity for detection of Progesterone (PG).
No significant cross-reactivity or interference between Progesterone (PG) and analogues was observed.

Recovery

Matrices listed below were spiked with certain level of Progesterone (PG) and the recovery rates were calculated by comparing the measured value to the expected amount of Progesterone (PG) in samples.

Matrix Recovery range (%) Average(%)
serum(n=5) 97-105 101
EDTA plasma(n=5) 93-105 101
heparin plasma(n=5) 80-96 84

Precision

Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level Progesterone (PG) were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level Progesterone (PG) were tested on 3 different plates, 8 replicates in each plate.
CV(%) = SD/meanX100
Intra-Assay: CV<10%
Inter-Assay: CV<12%

Linearity

The linearity of the kit was assayed by testing samples spiked with appropriate concentration of Progesterone (PG) and their serial dilutions. The results were demonstrated by the percentage of calculated concentration to the expected.

Sample 1:2 1:4 1:8 1:16
serum(n=5) 89-102% 95-102% 83-104% 98-105%
EDTA plasma(n=5) 95-105% 98-105% 96-104% 96-103%
heparin plasma(n=5) 80-104% 79-95% 82-97% 96-105%

Stability

The stability of kit is determined by the loss rate of activity. The loss rate of this kit is less than 5% within the expiration date under appropriate storage condition.
To minimize extra influence on the performance, operation procedures and lab conditions, especially room temperature, air humidity, incubator temperature should be strictly controlled. It is also strongly suggested that the whole assay is performed by the same operator from the beginning to the end.

Reagents and materials provided

Reagents Quantity Reagents Quantity
Pre-coated, ready to use 96-well strip plate 1 Plate sealer for 96 wells 4
Standard 2 Standard Diluent 1×20mL
Detection Reagent A 1×120µL Assay Diluent A 1×12mL
Detection Reagent B 1×120µL Assay Diluent B 1×12mL
Substrate A 1×10mL Substrate B 1×2mL
Wash Buffer (30 × concentrate) 1×20mL Instruction manual 1

Assay procedure summary

1. Prepare all reagents, samples and standards;
2. Add 50µL standard or sample to each well.
    And then add 50µL prepared Detection Reagent A immediately.
    Shake and mix. Incubate 1 hour at 37°C;
3. Aspirate and wash 3 times;
4. Add 100µL prepared Detection Reagent B. Incubate 30 minutes at 37°C;
5. Aspirate and wash 5 times;
6. Add 100µL Substrate Solution. Incubate 10 minutes at 37°C;
7. Read RLU value immediately.

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Magazine Citations
Fertility and Sterility Growth differential factor-9 inhibits testosterone production in mouse theca interstitial cells Pubmed: 23954356
Am J Obstet Gynecol. Prevention of preterm birth by progestational agents: what are the molecular mechanisms? Pubmed: 23433326
Placenta The role of Sep (O-phosphoserine) tRNA: Sec (selenocysteine) synthase (SEPSECS) in proliferation, apoptosis and hormone secretion of trophoblast cells Pubmed: 23966103
Veterinary Immunology and Immunopathology Neutrophil gene dynamics and plasma cytokine levels in dairy cattle during peri-implantation period Pubmed:27090626
Clinical and Experimental Hypertension Assessment of ADMA, estradiol, and progesterone in severe preeclampsia Pubmed:27152507
Scientific Reports The Reproductive Toxicity of CdSe/ZnS Quantum Dots on the in vivo Ovarian Function and in vitro Fertilization pubmed:27876896
Scientific Reports Molecular characterization of insulin resistance and glycolytic metabolism in the rat uterus pubmed:27461373
33 Metformin Ameliorates Uterine Defects in a Rat Model of Polycystic Ovary Syndrome. pubmed:28336389
Toxicological Sciences Exposure of pregnant mice to perfluorobutanesulfonate causes hypothyroxinemia and developmental abnormalities in female offspring pubmed:27803384
Molecular Neurobiology Middle-Aged Diabetic Females and Males Present Distinct Susceptibility to Alzheimer Disease-like Pathology. pubmed:27730513
Sci Rep Exposure of pregnant mice to triclosan impairs placental development and nutrient transport. pubmed:28322267
Interact Cardiovasc Thorac Surg Acute administration of oestradiol or progesterone in a spinal cord ischaemia–reperfusion model in rats pubmed:29049608
Toxicological Sciences Exposure of Pregnant Mice to Triclosan Causes Insulin Resistance via Thyroxine Reduction pubmed:28973666
Life Sciences The anorectic agent, lorcaserin, disturbs estrous cyclicity and produces endometrial hyperplasia without affecting ovarian population in female rats pubmed:28599864
Placenta Progesterone attenuates hypertension and autoantibody levels to the angiotensin II type 1 receptor in response to elevated cadmium during pregnancy 10.1016:j.placenta.2017.12.004
Nanotheranostics The biocompatibility studies of polymer dots on pregnant mice and fetuses pubmed:29071192
DARU Journal of Pharmaceutical Sciences Beneficial effects of Heqi san on rat model of polycystic ovary syndrome through the PI3K/AKT pathway pubmed:29020999
Toxicological Sciences Impact of Perfluorooctane Sulfonate on Reproductive Ability of Female Mice through Suppression of Estrogen Receptor a-Activated Kisspeptin Neurons 10.1093:toxsci
Frontiers in Molecular Neuroscience Impact of Triclosan on Female Reproduction through Reducing Thyroid Hormones to Suppress Hypothalamic Kisspeptin Neurons in Mice Pubmed:29403355
Medical Science Monitor Up-Regulation of Long Noncoding RNA SRA Promotes Cell Growth, Inhibits Cell Apoptosis, and Induces Secretion of Estradiol and Progesterone in Ovarian … Pubmed:29674607
Oncology Letters Prostaglandin E2 triggers cytochrome P450 17α hydroxylase overexpression via signal transducer and activator of transcription 3 phosphorylation and promotes … 10.3892:ol.2018.9165
Biomedicine & Pharmacotherapy Crocetin attenuates DHT-induced polycystic ovary syndrome in mice via revising kisspeptin neurons Doi: 10.1016/j.biopha.2018.08.135
Journal of Endocrinology Uterine progesterone signaling is a target for metformin therapy in polycystic ovary syndrome Pubmed: 29535146
Stem Cell Research & Therapy Endometrial mesenchymal stem cells isolated from menstrual blood repaired epirubicin-induced damage to human ovarian granulosa cells by inhibiting the … Pubmed: 30606243
Journal of Cellular Physiology Dihydrotestosterone synthesis in the sheep corpus luteum and its potential mechanism in luteal regression Pubmed: 30671954
Experimental and Therapeutic Medicine Tanshinone IIA attenuates estradiol‑induced polycystic ovarian syndrome in mice by ameliorating FSHR expression in the ovary
Experimental Neurology Reduced serotonin impairs long-term depression in basolateral amygdala complex and causes anxiety-like behaviors in a mouse model of perimenopause Pubmed: 31377402
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