Ferr Testosterona Free Tes ELISA Test Kit

INTENDED USE

This kit is a quantitative detection of Ferr Testosterona(Ferr Tes) in human serum/plasma in vitro. The kit is suitable for clinical screening and diagnosis.

PRINCIPLE OF THE TEST

This kit uses the Competitive-ELISA principle. The microtiter plate strips has been pre-coated with Coating antibody for Testo. Standards or samples containing Testo and biotin labeled Testo are added to the plate, A competitive inhibition reaction is launched between labeled Testo and free Testo (Standards or samples) with the solid phase antibody specific to Testo. After that, Streptavidin-Horseradish Peroxidase(SA-HRP) is added to form a sandwich complex of solid phase antibody-biotin labeled antigen-SA-HRP. And then, TMB substrate solution is added to all wells and incubated. An enzyme-catalyzed reaction generates a blue color in the solution, thereafter, stop solution is added to stop the substrate reaction and the color turns yellow. The yellow solution is read at a wavelength of 450nm. The concentration of Testo in the samples is then calculated from the OD value by establishing a standard curve.

MAIN COMPONENTS

Note: Different batches of reagent kit, and different component cannot be exchanged for use. Once open, stable for 3 months at 2-8°C.

PERFORMANCE CHARACTERISTICS

1.Expected value

The cut-off value of Tes concentration for healthy subjects is:

Male: 2.19~8.82ng/ml, mean value:5.07ng/ml;

Famale: 0.53~1.56ng/ml, mean value:0.78ng/ml;

Conversion: 1ng/ml = 3.46nmol/ml.

2.Sensitivity

The detection limit of the assay is approximately 0.1ng/ml.

3.Precision

Interassay≤15%

LIMITATIONS

1. It is no insignificance for abnormal results must be confirmed with another available method, and it should be interpreted in conjunction with the patient clinical information.

2. This reagent is only used for the detection of human serum/plasma samples.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world