Serum Amyloid a (SAA) Assay Kit (magnetic particle chemiluminescence) in Vitro Diagnostic Reagent

• Classification: Ivd
• Type: Ivd
• Certification: CE
• Group: All
• Test Item: SAA
• Specimen: Serum / Plasma
• Model NO.: 30/50/60/100 tests
• Applicable Platform: Clite-160I / Smart 500h
• Temperature: 2-8
• Transport Package: Foam Box
• Specification: 30/50/60/100 tests
• Trademark: Biochip Langdao
• Origin: Tianjin
• HS Code: 3006300000
• Production Capacity: 10000/Week

Product Description

Basic Info.
Name:                                     SAA
Test Time:                              15 Min
Temperature:                          2-8ºC
Transport Package :               Foam box
Specimen :                            Serum/Plasma                 
Production Capacity:           10000/Week
Applicable Device :             CLite-160i/SMART 500H
Shelf life :                            12 months
Specification:            30/60 tests/box (CLite-160i)
                                  50/100 tests/box (SMART 500H)

 

Product Description:
Serum amyloid A (SAA) is an acute phase reaction protein with a relative molecular weight of 12KD, which is mainly produced by liver cells, and is also produced outside the liver such as heart and skeletal muscle. Under normal circumstances, SAA exists in trace levels, and the reference range of SAA is less than 10mg/L. It rises rapidly in the acute response period of inflammation and can rise to 100 to 1000 times the initial concentration. In clinical diagnosis, the level of SAA is a sensitive index to reflect infectious diseases, which is helpful for the diagnosis of infection, disease assessment and prognosis.

The Clinical Significance
 1.rapid diagnosis of bacterial and viral infections.

2.can provide better identification, SAA half-life is very short, only about 50 minutes, conducive to early diagnosis and prognosis observation.

3.It is widely used in auxiliary diagnosis of infectious diseases, risk prediction of coronary heart disease,dynamic monitoring of efficacy and prognosis of tumor patients, monitoring of transplant rejection, and monitoring of improvement of rheumatoid arthritis

Test Principle
Double antibody sandwich method was used in the kit. The detection principle is: the sample to be tested, R1 reagent, R2 reagent and M reagent are mixed for incubation, and the fluorescein (FITC) labeled SAA  antibody 1 in R1 reagent and the alkaline phosphatase (ALP) labeled SAA  antibody 2 in R2 reagent are combined with the SAA antigen molecules in the sample to form an immune complex. The immune complex is further captured by anti-FITC antibodies coupled to the surface of the magnetic particle and adsorbed to the surface of the magnetic particle. After washing, the unbound material was removed and the luminescent substrate was added, ALP catalyzed the luminescence of the substrate, and the relative luminescence intensity (RLU) was determined.

 

Product Parameter
Specimen	Serum/Plasma
Detection range	3~500.0 (mg/L)
Precision	CV<5%
Test Time	15 Min
LOD	3mg/L

Certificate
Applicable Device

Automated Chemiluminescence Immunoassay Analyzer CLite-160i

Company Profile
Biochip Langdao (Tianjin)Medical Technology Ltd. is a R&D based biotechnology company, specializing in the research and production of in vitro diagnostics, medical devices, and medical products for public health. "Biochip Langdao" has been awarded National High-tech Enterprise by the Chinese government, products are widely used in hospital laboratories, independent medical laboratories, physical examination centers, clinics, and pharmacies.  Its holding company Beijing Promed Medical Technology Co.,Ltd. is a public company listed at BSE (Ticker: 835373).
"Biochip Langdao" owns Magnetic microparticle chemiluminescence technology, and has developed a patented strip-based fully automatic chemiluminescence immunoassay analyzer: CLite-160i analyzer. 12 testing reagents have been successfully developed on   CLite-160i analyzer including 5 myocardial biomarkers, 4 inflammatory biomarkers, and 3 gastritis markers, all of which have obtained NMPA and CE certificate. More testing reagents are in R&D pipeline and are expected to launch by March 31, 2024, including thyroid hormones, sex hormones, tumor markers, brain injury, acute renal disfunction.
In addition, the company has established production lines for sprays, powders, gel, and granules medical products.  These include medical equipment, disinfectant, personal care products. Among them, "Well-Fit" Anti-allergy nasal barrier gel is unique in this field which has a special formula and unique dosage form, indicated to use for prevention and treatment of allergic rhinitis and prevention of flu.
The company owns the registered trademark "Biochip Langdao" covering fields such as in vitro diagnostics, medical devices, and biological preparations, and the registered trademark "Well-Fit" covering fields such as oral and nasal medication, disinfectant, and medical dressings.
"Biochip Langdao" adheres to its business philosophy of "Developing by Innovation, Integrity as Cornerstone", keeps investing for more advanced technology and improving products quality.
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FAQ
1.How to ship the product?
The shipping way normally depends on your quantity,total CBM and weight.
We have our own shipping company to provide best shipping cost and efficient way.
2. Do you provide samples?  Is it free or extra?
Yes, if you buy equipment we could offer a sample test for free charge but do not pay the cost of freight.
3.what can you buy from us?
Chemiluminescence Immunoassay Analyzer,In Vitro Diagnostic Reagent ,Healthy Care etc.
4. What is your warranty?
 For most products the warranty is for 12 months, for some products we provide 18 months warranty.
5.Do you have the CE certificate ?
Yes, most of our products have the CE certificate.