816700

CLIA Kit for Testosterone (Testo) General

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Products specifications
Species General
Format 96T
Sample Type Serum, plasma and other biological fluids
Assay Length 2.5 h
Detection Range 39.06-10000pg/mL The standard curve concentrations used for the CLIA’s were 10000pg/mL, 2500pg/mL, 625pg/mL, 156.25pg/mL, 39.06pg/mL
Sensitivity 52.8pg/mL
Specificity This assay has high sensitivity and excellent specificity for detection of Testosterone (Testo). No significant cross-reactivity or interference between Testosterone (Testo) and analogues was observed.
Intra-Assay Precision <10%
Inter-Assay Precision <12%
Storage Temperature -20 °C
Shipping Conditions 2-8 °C
Handling Instruction The activity loss rate (stability) of this kit is less than 5% within the expiration date under appropriate storage conditions. To minimize extra influence on the stability, operation procedures and lab conditions, especially room temperature, air humidity, incubator temperature should be strictly controlled. When not in use, kit components should be refrigerated. All reagents should be brought to room temperature before use. It is recommended that all standards, controls, and samples be run in duplicate. Do not mix or interchange different reagent lots from various kit lots.
Test Principle The microtiter plate provided in this kit has been pre-coated with a monoclonal antigen. A competitive inhibition reaction is launched between biotin labeled Testosterone (Testo) and unlabeled Testosterone (Testo) (Standards or samples) with the pre-coated secondary antibody. 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 Testosterone (Testo) 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 Testosterone (Testo) level in the sample or standard.
Notes All kits are custom made on-demand. Please allow 10-15 working days for production and 2-3 days for shipment.
Legal Information Marketed under license from USCN Life Science Inc.
ReagentsQuantity
Pre-coated, ready to use 96-well strip plate1
Standard2
Detection Reagent A1×120µL
Detection Reagent B1×120µL
Substrate A1×10mL
Wash Buffer (30 × concentrate)1×20mL
Plate sealer for 96 wells4
Standard Diluent1×20mL
Assay Diluent A1×12mL
Assay Diluent B1×12mL
Substrate B1×2mL
Instruction manual1

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

Sample1:21:41:81:16
serum(n=5)84-101%90-104%88-95%84-94%
EDTA plasma(n=5)81-101%84-104%85-99%91-105%
heparin plasma(n=5)84-97%78-102%78-91%89-98%

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

MatrixRecovery range (%)Average(%)
serum(n=5)94-10297
EDTA plasma(n=5)78-10185
heparin plasma(n=5)96-105101
Products specifications
Species General
Format 96T
Sample Type Serum, plasma and other biological fluids
Assay Length 2.5 h
Detection Range 39.06-10000pg/mL The standard curve concentrations used for the CLIA’s were 10000pg/mL, 2500pg/mL, 625pg/mL, 156.25pg/mL, 39.06pg/mL
Sensitivity 52.8pg/mL
Specificity This assay has high sensitivity and excellent specificity for detection of Testosterone (Testo). No significant cross-reactivity or interference between Testosterone (Testo) and analogues was observed.
Intra-Assay Precision <10%
Inter-Assay Precision <12%
Storage Temperature -20 °C
Shipping Conditions 2-8 °C
Handling Instruction The activity loss rate (stability) of this kit is less than 5% within the expiration date under appropriate storage conditions. To minimize extra influence on the stability, operation procedures and lab conditions, especially room temperature, air humidity, incubator temperature should be strictly controlled. When not in use, kit components should be refrigerated. All reagents should be brought to room temperature before use. It is recommended that all standards, controls, and samples be run in duplicate. Do not mix or interchange different reagent lots from various kit lots.
Test Principle The microtiter plate provided in this kit has been pre-coated with a monoclonal antigen. A competitive inhibition reaction is launched between biotin labeled Testosterone (Testo) and unlabeled Testosterone (Testo) (Standards or samples) with the pre-coated secondary antibody. 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 Testosterone (Testo) 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 Testosterone (Testo) level in the sample or standard.
Notes All kits are custom made on-demand. Please allow 10-15 working days for production and 2-3 days for shipment.
Legal Information Marketed under license from USCN Life Science Inc.