Enterovirus 71 (EV71) IgM Rapid Test in whole blood, serum and plasma for hand-foot-and-mouth disease
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 |
INTRODUCTION
Human Enterovirus 71 (EV71), the newest member of Enterovirudae, is notable for its etiological role in epidemics of severe neurological diseases in children. It appears to be emerging as an important virulent neurotropic enterovirus in the upcoming era of poliomyelitis eradication. The illness usually peaks in June or July. EV71 infection may be asymptomatic or may cause diarrhea and rashes. EV71 one of the major causative agents for hand, foot and mouth disease (HFMD), is sometimes associated with severe central nervous system diseases.
MAIN CONTENTS
Rapid Test Cassette in Pouch
Buffer
Disposable dropper
Package insert
SRORAGE
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C).
The test is stable through the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until use.
DO NOT FREEZE.
Do not use beyond the expiration date.
OPERATION PROCEDURE
Bring tests, specimens, buffer and/or controls to room temperature (15-30°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.
FRQ:
1) What is EV71 infection?
Enterovirus 71 (EV71) is one of a large family of viruses which multiply in the human gastrointestinal tract (gut). EV71 infection can cause illness ranging from mild through to serious with life threatening complications. Reports of EV71 infection occur from time to time in Australia.
2) What is EV71 neurological disease?
Enterovirus 71 (EV71) neurological disease is a rare but serious complication of infection with enterovirus 71, a virus which most commonly causes the mild childhood illness hand, foot and mouth disease. Cases and outbreaks of enterovirus 71 neurological disease are rare.
3) What is enterovirus 71 responsible for?
EV71 is best known for causing hand-foot-mouth disease, largely in the Asia-Pacific region, and in some cases severe neurological symptoms. However, the virus is also associated with respiratory disease such as pharyngitis, bronchiolitis, croup and pneumonia, mostly in young children.
4) What are the complications of enterovirus 71?
EV71 virus causes a range of effects from asymptomatic infection and mild HFMD to neurological disease with severe central nervous system complications and cardiopulmonary failure. In severe cases mortality rates can be high, especially in children aged 5 years and younger.
5) How did I get enterovirus?
Enteroviruses spread easily from person to person, usually on unwashed hands and surfaces contaminated by poop, where they can live for several days. They also can spread through droplets when someone with an infection coughs or sneezes, or through fluid in skin blisters.
6) How do you treat enterovirus in adults?
Management and Treatment:
Mild symptoms of EV-D68 infection typically improve in a week or two with minimal at-home care. Antiviral medications aren't effective against this virus. You can take these steps to ease symptoms: Drink lots of fluids and get plenty of rest.
7) What is the life cycle of EV71 virus?
The lifecycle of EV-71 consists of five steps: virus adsorption to host cells, entry into host cells, viral RNA replication, protein translation, and assembly and release of intact viral particles (Baggen et al., 2018).
8) What is the incubation period of enterovirus a71?
Incubation period is 3–6 days, and illness usually is self-limited, with recovery within 7–10 days.
9) What is encephalitis caused by enterovirus 71?
Most of the fatal cases of EV 71 occur in children aged <3. years. The primary site of attack is the central nervous system, particularly the brainstem. They develop rapidly progressive sympathetic hyperactivity, pulmonary edema (PE) and/or pulmonary hemorrhage, and cardiopulmonary collapse.
10) What is the mortality rate of enterovirus 71?
The mortality rate also decreased significantly, from 3.52 per 100,000 children under six in 1998 to 0 per 100,000 children under six in 2020 (P < 0.0001). The numbers of EVSC and fatalities were significantly higher in the years when EV A71 accounted for more than 10% of the annual predominant serotypes (p < 0.05).
11) Is there a vaccine for EV71?
Currently, there is no US FDA-approved antiviral agent or vaccine against EV-A71. However, there are three inactivated, EV-A71 whole-virus vaccines approved by the China National Medical Products Administration (NMPA) and are commercially available in China.
For details, please contact Dewei staff for Instruction Manual!
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