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group namekit swab samples
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modelamyloid
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update timeWed, 16 Mar 2022 14:12:24 GMT
Paramtents
Type Immunoassay System
Function clinical detection
Language version English
Certificate CE ISO9001 ISO13485
Packging & Delivery
Min Order10 piece
Briefing
Serium amyloid rapid test reagent, This product is used to determine the content of Serun amyloid protein(SAA) in human serum.
Detailed
serium amyloid A rapid test reagent POCT
Quick Details
Model Number |
amyloid
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Origin |
China
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Instrument classification | Class II | ||
Function | clinical detection | ||
Certificate | CE ISO9001 ISO13485 | ||
Language version | English | ||
Package Insert
Hipro™SAA Test
(Rate Scattering Turbidimetric Method)
[Product Name]
General name:Serun amyloid protein Test Kit
(Rate Scattering Turbidimetric Method)
Trade Name: SAA test
[Intended Use]
This product is used to determine the content of Serun amyloid protein(SAA) in human serum.
[Principle]
The antibody of Serun amyloid protein is coated on the latex surface. The SAA in the sample and the antibody become to immune complexes by Latex agglutination reaction. The immune complexes will produce the phenomenon of light scattering which is proportional to the intensity of scattered light and samples of SAA levels. Using specific protein analyzer to measure the intensity of scattered light, the concentration of SAA is determined by comparing the turbidity of samples to the standard concentration.
[Packing of the Kits]
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Name
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Quantity and specification
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1 test
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25 tests
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50 tests
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100 tests | |
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R1
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300μl×1
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300μl×25
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300μl×50
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300μl×100 |
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R2
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50μl×1
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50μl×25
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50μl×50
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50μl×100 |
[Main Components]
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Component
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content
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Phosphate buffer (pH 7.4)
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0.1mol/L
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Sodium chloride
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9%
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Polyethylene glycol 6000
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Appropriate
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Sheep anti - human serum amyloid A antibody latex particles | 0.35mg/L |
[Storage and Validity Period]
Store at: 2~8℃
Validity Period: 1 year
[Suitable Machine]
This product is suitable for HP-083/4-I, HP-083/4-II, HP-AFS nephelometry immunoassay analyzers.
[Sample Requirements]
Fasting blood collection and separation of serum as soon as possible; avoid hemolysis; store at 2~4℃ for 3 days.
[Testing Procedure]
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Patient sample
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2.5μl
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Reagent (R1)
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300μl
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Mixing
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Reagent (R2)
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50μl
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Mixing, and then put the reaction cup into the test channel. The analyzer will test and display the results automatically. | |
[Reference Range]
<6.4mg/L
Recommended that each laboratory establish its own reference range
[Limitations of the Method]
1. This product is based on latex agglutination system, only suitable for the specific analyzer.
2. This result is for clinical reference only; comprehensive consideration should be combined with the clinical management of patients with symptoms / signs, medical history, other laboratory tests and treatment response.
3. When hemoglobin≤6g/L, triglyceride≤10mmol/L, or bilirubin≤400μmol/L, it has no interference to this determination
[Technical Parameter]
Linearity range: 3mg/l~200mg/l,r≥0.990
Accuracy: recovery rate ±15%
Limit of detection: 1.8mg/l
Within-batch Precision: ≤10%
Batch-batch Difference: ≤15%
[Precautions]
1,This kit is only for IVD.
2,If the regent is splashed on the skin or eyes, wash with water.
3,Do not use the kits beyond shelf life. Do not mix different batches of reagents.
Description
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Use By
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Batch Code
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Manufacturer
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Keep Away from Sunlight
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Temperature Limitation |
In Vitro Diagnostic Medical Device |
Authorized Representative in the European Community |
CE Mark |
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