CLIA Kit for Thyroid Stimulating Hormone (TSH)
Thyrotropin
- Product No.CCA463Ca
- Organism SpeciesCanis familiaris; Canine (Dog) Same name, Different species.
- Test MethodCompetitive Inhibition
- Assay Length2h
- Detection Range78.1-20,000pg/mL
- SensitivityThe minimum detectable dose of this kit is typically less than 28.5pg/mL.
- Sample TypeSerum, plasma and other biological fluids
- Download Instruction Manual
- UOM 48T96T 96T*5 96T*10 96T*100
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Packages (Simulation)
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Packages (Simulation)
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Results demonstration
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Typical Standard Curve
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ISO9001: 2008, ISO13485: 2003 Registered
Specificity of the CLIA Kit for Thyroid Stimulating Hormone (TSH)
This assay has high sensitivity and excellent specificity for detection of Thyroid Stimulating Hormone (TSH).
No significant cross-reactivity or interference between Thyroid Stimulating Hormone (TSH) and analogues was observed.
Recovery of the CLIA Kit for Thyroid Stimulating Hormone (TSH)
Matrices listed below were spiked with certain level of recombinant Thyroid Stimulating Hormone (TSH) and the recovery rates were calculated by comparing the measured value to the expected amount of Thyroid Stimulating Hormone (TSH) in samples.
| Matrix | Recovery range (%) | Average(%) |
| serum(n=5) | 83-93 | 89 |
| EDTA plasma(n=5) | 81-98 | 90 |
| heparin plasma(n=5) | 82-90 | 86 |
Precision of the CLIA Kit for Thyroid Stimulating Hormone (TSH)
Intra-assay Precision (Precision within an assay): 3 samples with low, middle and high level Thyroid Stimulating Hormone (TSH) were tested 20 times on one plate, respectively.
Inter-assay Precision (Precision between assays): 3 samples with low, middle and high level Thyroid Stimulating Hormone (TSH) were tested on 3 different plates, 8 replicates in each plate.
CV(%) = SD/meanX100
Intra-Assay: CV<10%
Inter-Assay: CV<12%
Linearity of the CLIA Kit for Thyroid Stimulating Hormone (TSH)
The linearity of the kit was assayed by testing samples spiked with appropriate concentration of Thyroid Stimulating Hormone (TSH) 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) | 99-105% | 81-95% | 87-98% | 80-92% |
| EDTA plasma(n=5) | 98-105% | 82-102% | 78-104% | 97-104% |
| heparin plasma(n=5) | 94-105% | 79-102% | 97-105% | 80-101% |
Stability of the CLIA Kit for Thyroid Stimulating Hormone (TSH)
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.
Assay procedure summary of the CLIA Kit for Thyroid Stimulating Hormone (TSH)
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.
Test principle of the CLIA Kit for Thyroid Stimulating Hormone (TSH)
The microplate provided in this kit has been pre-coated with a monoclonal antibody specific to Thyroid Stimulating Hormone (TSH). A competitive inhibition reaction is launched between biotin labeled Thyroid Stimulating Hormone (TSH) and unlabeled Thyroid Stimulating Hormone (TSH) (Standards or samples) with the pre-coated antibody specific to Thyroid Stimulating Hormone (TSH). After incubation the unbound conjugate is washed off. Next, avidin conjugated to Horseradish Peroxidase (HRP) is added to each microplate well and incubated. The amount of bound HRP conjugate is reverse proportional to the concentration of Thyroid Stimulating Hormone (TSH) in the sample. Then the mixture of substrate A and B is added to generate glow light emission kinetics. Upon plate development, the intensity of the emitted light is reverse proportional to the Thyroid Stimulating Hormone (TSH) level in the sample or standard.
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