Enterovirus 71 (EV71) Igm Rapid Test for Hand-Foot-and-Mouth Disease

• Customization: Available
• Type: IVD Reagent
• Component: Rapid Test + Buffer + Pipettes
• Model NO.: EV71
• Specimen: Whole Blood, Serum, Plasma
• Result Time: Within 15 Mins
• Storage: 2~30°c
• Principle: Immunochromatography
• Shelf Life: 24 Months
• Certificate: CE
• Usage: Professional Used
• Transport Package: 40tests/Box; 25tests/Box
• Specification: 1000tests/Carton
• Trademark: Dewei
• Origin: China

Product Description

INTENDED USE

This product is a rapid test intended for qualitative detection of IgM-class antibodies to human Enterovirus 71 (EV71) in serum, plasma or whole blood samples. It is intended to be used in clinical laboratories for early diagnosis and management of patients related to infection with EV71.
 

Storage	2~30 º C
Specimen	Whole Blood/Serum/Plasma
Component	Rapid Test + Buffer + Pipettes
Principle	Colloidal gold rapid tests
Reading	Within 15mins
Package	40tests/box; 25tests/box
Trademark	Dewei
Origin	China

WARNINGS AND PRECAUTIONS
Immunoassay for in vitro diagnostic use only.
Do not use after expiration date.
The test should remain in the sealed pouch until use.
The used test should be discarded according to local regulations.

STORAGE AND STABILITY
The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
Keep away from direct sunlight, moisture and heat.
Do not freeze.
Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results. 

OPERATION
Bring tests, specimens, buffer and/or controls to room temperature (1530°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2. Testing
Transfer 1 drops of whole blood, serum or plasma sample to the specimen well (S) with the provided disposable pipette.
Then add 2 drops of buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the result area in the center of the device.
3. Wait for the colored band(s) to appear. The result should be read within 15 minutes. Do not interpret the result after 20 minutes.

 

INTERPRETATION OF RESULTS
Preliminary positive (+)Only one colored band appears, in the control region (C). No colored band appears in the test region (T).Negative (-)Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).InvalidControl band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

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