C-reactive protein and serum amyloid A protein combo test kit
1. INTEDED USE
The kit is applicable to the in vitro quantitative detection of concentration of C-reactive protein (CRP) and Serum Amyloid A (SAA) in human serum/plasma/whole blood samples, for auxiliary diagnosis of acute and chronic inflammation or infection. The kit only provides test result of C-reactive protein and serum amyloid A. The obtained result shall be analyzed in combination with other clinical information. It must only be used by healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | CRP/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 CRP test results. Use linear regression to investigate their comparability. Correlation coefficients of two tests are y = 0.991x+0.165 and R=0.9817 respectively. Compare the SAA test results. Use linear regression to investigate their comparability. Correlation coefficients of two tests are y =0.949x +1.164 and R=0.9853 respectively.
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
6.EXHIBITION
7.GLOBAL PARTNER
