Uncut sheet for EV71-IgM
1. INTEDED USE
This kit is applicable to the in vitro quantitative detection on the content of IgM Antibody to Enterovirus 71 in human whole blood, serum or plasma and is mainly used for implementing auxiliary diagnosis of acute EV71 infection. This kit only provides the test result of IgM Antibody to Enterovirus 71 and 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. | EV-71 IgM Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | whole blood/Serum/Plasma |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
|
3.TEST METHOD
| 1 | Remove detection reagent and sample to be detected from storage condition and equilibrate them to room temperature. |
| 2 | Open aluminum foil pouch of reagent, take out test device, and place it horizontally on laboratory bench; |
| 3 | Add 10uL of serum or plasma sample or 20uL of whole blood to sample hole, and then drip 100uL (about 2-3 drops) of sample diluent to sample hole and start timing. |
| 4 | Result should be read within 10-15 minutes. Test result will be invalid after 15 minutes. |
4.RESULT EVALUATION AND EXPLANATION
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration
