For Laboratory Or Hospital High Accuracy Free Prostate-Specific Antigen Elisa Test Kit

High Accuracy Free Prostate-Specific Antigen Elisa Test Kit

INTENDED USE

The free PSA assay is an enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative determination of free prostate-specific antigen (fPSA) in human serum.

Test principle

• Sample, PSA-specific antibody coated microwells and enzyme labeled Anti-Free PSA monoclonal antibody are combined.

• During the incubation, Free PSA presents in the sample is allowed to react simultaneously with the two antibodies, resulting in the Free PSA molecules being sandwiched between the solid phase and enzyme-linked antibodies.

• After washing, a complex is generated between the solid phase, the Free PSA within the sample and enzyme-linked antibodies by immunological reactions.

• Substrate solution is then added and catalyzed by this complex, resulting in a chromogenic reaction. The resulting chromogenic reaction is measured as absorbance.

• The absorbance is proportional to the amount of Free PSA in the sample.

Materials provided

• Coated Microplate - symbol fPSA PLATE mouse monoclonal PSA-specific antibody.

• Calibrators - symbol fPSA PLATE 8 x 12 strips, 96 wells, pre-coated with 6 vials, 1 mL each, ready to use; Concentrations: 0(A), 1(B), 2.5(C), 5(D), 10(E) and 20(F) ng/mL.

• Enzyme Conjugate - symbol fPSA CONJ 1 vial, 11 mL of HRP (horseradish peroxidase) labeled Anti-Free PSA monoclonal antibody in Tris-NaCl buffer containing BSA (bovine serum albumin). Contains 0.1% ProClin300 preservative.

• Substrate - symbol TMB. SUBSTRATE STOP 1 vial, 11mL, ready to use, (tetramethylbenzidine) • Stop Solution - symbol 1 vial, 6.0 mL of 1 mol/L sulfuric acid.

• Wash Solution Concentrate - symbol PBS-Tween wash solution.

• IFU - 1 copy.

• Plate Lid: 1 piece.

• Plate Lid: 1 piece.

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