Serum Amiloid A Diagnostic kit
1. INTEDED USE
This kit is applicable to in vitro quantitative detection of antibody to serum amyloid A (SAA) in human serum/plasma/whole blood sample, and it’s used for auxiliary diagnosis of acute and chronic inflammation or infection. This kit only provides serum amyloid A (SAA) test results, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | SAA |
| Methodology | Fluorescence Immunochromatographic Assay |
| Sample Type | serum/Plasma/Whole Blood |
| Time to Result | 10-15mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485,CE,MHRA |
| MAIN KIT COMPONENTS
* Test device * Sample diluents * Instructions for Use |
PACKING
* 25 test /kit * Aluminum foil bag labeling * shrink wrap |
3.TEST METHOD
4.CLINICAL PERFORMANCE
Clinical performance of this product’s assessed through collection of 182 cases of clinical samples. Corresponding marketed kit of electrochemiluminescence assay’s used as reference reagent, detection results have been compared and their comparability has been studied through linear regression, and correlation coefficients of the two assays are y = 1.003x+0.565 and R=0.9766 respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
7.GLOBAL PARTNER
