Uncut sheet for EV71-IgM
1. INTEDED USE
The Enterovirus 71 (EV71) Antigen Rapid Test Device (the "uncut sheet" format for manufacturing use) is a rapid immunochromatographic assay intended for the qualitative detection of Enterovirus 71 antigen in human serum, plasma, whole blood specimen.
This test is intended for in vitro diagnostic professional use and serves as an aid in the early diagnosis of Enterovirus 71 infection in patients, particularly children, presenting with clinical signs and symptoms suggestive of hand, foot and mouth disease (HFMD) or herpangina, such as fever, rash on hands and feet, and oral ulcer
The device provides presumptive (preliminary) screening test results. the obtained result shall be analyzed in combination with other clinical information.
This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.
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
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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
6.EXHIBITION
