Serum Amyloid A protein Rapid Test Kit
1. INTEDED USE
This test kit is suitable for quantitative detec-tion of serum amyloid A (SAA) in humanserum/plasma/whole blood sample in vitro,which is mainly used for auxiliary diagnosis ofacute and chronic inflammation or infection.The test result should be analyzed in combi-nation with other clinical information.
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 evaluation performance of the product is assessed through collecting 160 clinical samples. Use the marketed kit of chemiluminescence assay as the control reagent. Compare the SAA test results. Use linear regression to investigate their comparability. Correlation coefficients of two tests are y =Y= 1.003x+0.565 and R=0.9766 respectively. Compare the SAA test results. Use linear regression to investigate their comparability. Correlation coefficients of two tests 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
