CLIA Kit for Growth Differentiation Factor 15 (GDF15)

PDF; MIC1; NAG-1; PLAB; PTGFB; Macrophage inhibitory cytokine 1; NSAID-activated gene 1 protein; Placental bone morphogenetic protein; Prostate differentiation factor

Specificity

This assay has high sensitivity and excellent specificity for detection of Growth Differentiation Factor 15 (GDF15).
No significant cross-reactivity or interference between Growth Differentiation Factor 15 (GDF15) and analogues was observed.

Recovery

Matrices listed below were spiked with certain level of recombinant Growth Differentiation Factor 15 (GDF15) and the recovery rates were calculated by comparing the measured value to the expected amount of Growth Differentiation Factor 15 (GDF15) in samples.

Matrix Recovery range (%) Average(%)
serum(n=5) 93-101 97
EDTA plasma(n=5) 84-94 90
heparin plasma(n=5) 79-97 88

Precision

Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level Growth Differentiation Factor 15 (GDF15) were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level Growth Differentiation Factor 15 (GDF15) 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 Growth Differentiation Factor 15 (GDF15) 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) 89-101% 95-103% 83-99% 97-105%
EDTA plasma(n=5) 78-99% 92-103% 97-105% 85-95%
heparin plasma(n=5) 94-105% 93-105% 96-104% 99-105%

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 100µL standard or sample to each well. Incubate 1 hours at 37°C;
3. Aspirate and add 100µL prepared Detection Reagent A. Incubate 1 hour at 37°C;
4. Aspirate and wash 3 times;
5. Add 100µL prepared Detection Reagent B. Incubate 30 minutes at 37°C;
6. Aspirate and wash 5 times;
7. Add 100µL Substrate Solution. Incubate 10 minutes at 37°C;
8. Read RLU value immediately.

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Magazine Citations
Clinical cardiology Growth Differentiation Factor 15 and Coronary Collateral Formation PubMed: 20014173
Personalized Medicine Elevated levels of GDF-15 is associated with increased angiotensin II in hypertensive patients with Type 2 diabetes pme-2016-0030
LIFE SCIENCES Rapamycin improves renal injury induced by Iodixanol in diabetic rats by deactivating the mTOR/p70S6K signaling pathway Pubmed: 32798557
Microbiome changes in patients with chronic heart failure with preserved ejection fraction correlate with fibrosis markers: Description of a Russian cohort
SEMINARS IN DIALYSIS Serum NT©\proBNP levels are associated with cognitive functions in hemodialysis patients 33423325
Taiwanese Journal of Obstetrics & Gynecology Is GDF-15 level associated with gestational diabetes mellitus and adverse perinatal outcomes? 33678319
J Inflamm Res Changes in Plasma Growth Differentiation Factor-15 After Laparoscopic Sleeve Gastrectomy in Morbidly Obese Patients: A Prospective Study 33880052
Russian Journal of Cardiology Predictive value of growth differentiation factor-15 in patients with myocardial infarction
Nutrients High Fat, High Sugar Diet and DJOS Bariatric Surgery Influence Plasma Levels of Fetuin-B, Growth Differentiation Factor-15, and Pentraxin 3 in Diet-Induced Obese … 34684637
Nat Metab Small extracellular vesicle-mediated targeting of hypothalamic AMPKα1 corrects obesity through BAT activation 34675439
Acta Cardiol Sin Growth Differentiation Factor 15 is Related with Left Ventricular Recovery in Patients with ST-Elevation Myocardial Infarction after Successful Reperfusion by … 34584380
Surgical Endoscopy The effect of bariatric surgery on the expression of Growth Differentiation Factor-15/Macrophage-Inhibitory Cytokine-1 (GDF-15/MIC-1) in rat Pubmed:35029766
Journal of Clinical Laboratory Analysis Plasma growth differentiation factor‐15 in patients with “lone” atrial fibrillation Pubmed:35334497
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