Medomics Crp&SAA Combo Test

• Customization: Available
• Type: Test Strips & Test Tube
• Material: Plastic
• Model NO.: CRP/SAA
• Quality Guarantee Period: One Year
• Group: Adult
• Logo Printing: With Logo Printing
• Certificate: ISO, CE
• Transport Package: Box+Carton
• Trademark: OBM/OEM
• Origin: China

Product Description

are acute phase proteins. Measuring their concentration in serum helps diagnose inflammation, evaluate its activity, monitor its activity and treatment. Compared with the traditional inflammatory marker white blood cell, its advantage is that the virus infection also causes its significant increase, it is a sensitive indicator for the diagnosis of virus infection. The combined detection of SAA and CRP can provide strong evidence for the early diagnosis of infectious diseases (such as neonatal sepsis and sepsis).

Intended Use

Intended Use

CRP/SAA Combo Rapid Test Kit(LFIA) is used for the in vitro qualitative detection of C-Reactive Protein/Serum Amyloid A (CRP/SAA) content in human whole blood, plasma and serum.

Product Performance
1. Precision
The CRP and SAA positive controls were tested, and the results were all positive.
 

2.Repeatability

When 10 kits in the same batch detect CRP and SAA precision control samples with concentrations of 200mg/L, 75mg/L and 20mg/L, the results should be consistent, the color rendering should be consistent, and should be all positive.

3.Analysis of specificity
The result of detection of CRP and SAA specific quality control products (negative serum or plasma samples) should be negative.

4. The limit of detection
CRP is no higher than 10mg/L, SAA is no higher than 10mg/L.

5. Interfering substances
The samples with hemolysis, hyperlipemia, and jaundice do not interfere with the test results and can be used as testing sample.

6. Clinical results
The rapid detection method and CLIA method were used to detect 1,120 cases of susceptible persons. The comparison of each subject is shown in the following table:

CRP/SAA Combo Rapid Test Kit	CLIA		Total
	SAA Positive	Negative
SAA Positive	263	5	268
Negative	3	551	554
Total	266	556	822

Sensitivity: 98.1%, specificity: 99.45%, overall consistency: 99.02%

 

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