ELISA Assay And Diagnostic Reagent Detection Fully Automatic Enzyme Marker

Result Precisionc TSH (0-40 ΜIU/ML) ELISA Reagent Test Kits

Description

This product is used in laboratories, community hospitals, large hospitals, etc.One product can test 96 people, and the operation is rigorous, the results are accurate, and the process is clear.99.99% accuracy.

Intended

Use The TSH assay is an enzyme-linked immunosorbent assay (ELISA) for the in vitro quantitative determination of thyroid stimulating hormone (TSH) in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders. For professional use only. Not intended for newborn screening.

Features of Hbasg Elisa Kit:

1. Sensitive
2. Accurate
3. High quality
4. Economic price

5. Reliable and Easy to Use

Description

• Immunoassay for the in vitro quantitative determination of thyrotropin in human serum.

• The assay is unaffected by icterus (bilirubin < 600 µmol/L or < 35 mg/dL), hemolysis (Hb < 0.559 mmol/L or < 0.9 g/dL), lipemia (Intralipid < 1200 mg/dL), and biotin < 94 nmol/L or < 23 ng/mL

. • Criterion: Recovery within ± 10 % of initial value.

• For diagnostic purposes, the results should always be assessed in conjunction with the patient’s medical history, clinical examination and other findings

. • Serum TSH values may be elevated by pharmacological intervention. Domperiodone, amiodazon, iodide,, and phenytoin have been reported to increase TSH levels.

• The presence of autoantibodies may induce high molecular weight complexes (macro TSH) which may cause unexpected high values of TSH.

• Serum TSH values may be elevated by pharmacological intervention. Domperiodone, amiodazon, iodide, , and phenytoin have been reported to increase TSH levels.

• A decrease in thyrotropin values has been reported with the administration of propranolol, methimazol, dopamine and thyroxine.

• Patients who have received mouse monoclonal antibodies for either diagnosis or therapy can develop HAMA (human Anti-mouse antibodies). HAMA can produce either falsely high or falsely low values in immunoassays which use mouse monoclonal antibodies.

Precision

Precision was determined using reagents, pooled human sera, and controls in a modifified protocol (TSH (0-40 ΜIU/ML)) of the CLSI (Clinical and Laboratory Standards Institute): 2 times daily for 20 days (n = 40). The following results were obtained

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