lef46en v2 chikungunya igm (1)

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SD Chikungunya IgM Distinguish Chikungunya from Dengue virus infection www.standardia.com Rapid, Qualitative detection of Chikungunya IgM antibody Immunochromatographic assay (ICA) rapid test Fully covered device to prevent drying Specimen : Serum, Plasma or Whole blood Fast results : 10 minutes.

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Page 1: LEF46EN v2 Chikungunya IgM (1)

SDChikungunya IgM

Distinguish Chikungunya from Dengue virus infection

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Rapid, Qualitative detection of Chikungunya IgM antibody

Immunochromatographic assay (ICA) rapid test

Fully covered device to prevent drying

Specimen : Serum, Plasma or Whole blood

Fast results : 10 minutes.

Page 2: LEF46EN v2 Chikungunya IgM (1)

http://www.cdc.gov/ncidod/dvbid/Chikungunya/CH_Globalmap.html

Africa

Benin, Burundi, Cameroon, C. Africa, Congo DRC, Gabon, Guinea , Kenya , Madagascar, Malawi , Nigeria, Senegal, Seychelles, S. Africa, Tanzania, Uganda, Zimbabwe

Asia

Cambodia, India, Indonesia, Malaysia, Myanmar, Philippines, Singapore, Sri Lanka, Taiwan, Thailand, Vietnam

Europe Italy

Chikungunya and Dengue are among the most difficult diseases to distinguish, especially because

simultaneous co-infection can occur.

Why is important to distinguish Chikungunya from Dengue

Overlap and confusion with dengue fever.

--> The differential diagnosis of these two infections is essential for clinical managent and epidemiological study in the tropics.

The disease shares some clinical signs with dengue, and can be misdiagnosed in areas where dengue is common. Hence the number of cases of Chikungunya fever is much higher than that reported.

Chikungunya fever has similar symptoms but requires different management than dengue.

The word 'Chikungunya' is derived from the Makonde language in southeastern

Tanzania and means "bent down or become contorted," which indicates the

classic posture the patient adopts because of severe joint pain.

SD BIOLINE Chikungunya IgM

General Information

Chikungunya feverChikungunya fever is a viral disease transmitted through

the bite of infected Aedes aegypti and Aedes albopictus

mosquitoes.

Signs and symptomsAn abrupt onset of fever frequently accompanied by joint

pain, muscle pain, headache, nausea, fatigue and rash.

Incubation periodTime from the infected bite to the onset of illness can be

3-12 days, but is usually 4-7 days.

TreatmentCurrently specific drug treatment and vaccines are not

available.

Distinguish Chikungunya from Dengue virus infection

Approximate Global Distribution of Chikungunya Virus, by Country, 2008

Page 3: LEF46EN v2 Chikungunya IgM (1)

Excellent performance

Internal Evaluation

Sensitivity : 97.1% (vs. ELISA)�

Specificity : 98.9% (vs. ELISA)

Clinical study

Chikungunya Case Definition ( WHO Recommended)

IgM antibody levels are highest three to five weeks after the onset of illness and persist for about two months.

Day-4 to day-2 Day 0 Day 4 to day 7 Day 15

Clinical symptoms

MosquitoBite

Early detection of IgM

Inoculation viral RNA IgMIgG

Laboratory criteria: at least one of the following tests in the acute phaseVirus isolationPresence of viral RNA by RT-PCRPresence of virus specific IgM antibodies in single serum sample collected in acute or convalescent stage.Four-fold rising of IgG titers in samples collected at least three weeks apart

Early detection is important in order to stop further transmission and case

management is necessary to prevent severe development of the disease.

Detection of Chikungunya IgM in acute phase

CHIK: Chikungunya

According to the research performed in southern Thailand(Chikungunya outbreak, 2008), SD BIOLINE Chikungunya IgM shows equivalent performance when compared to RT-PCR for collected CHIKV positive samples after onset of fever. RT-PCR for CHIKV was positive in every serum obtained from patients within the first three days after the onset of fever whereas the IgM antibody may become detectable after 3 days of the onset of fever. In this research, author emphasizes that serological or molecular methods are required to arrive at a definite diagnosis of either infection. RT-PCR and serology to detect IgM antibodies or paired sera for IgG against CHIKV ought to be performed in all patients with presumed hemorrhagic fever to detect outbreaks of CHIKV early. This precaution would help control global epidemics of this virus.

Page 4: LEF46EN v2 Chikungunya IgM (1)

Specification

Test Procedure

Reference

Ordering Information

46FK10

Cat. No

Chikungunya IgM

Product

Serum/Plasma/ Whole blood

Specimen

Device

Type

1T x 25/Kit

Pack size Storage

1 drop(50l)

2 drops(100l)

1 drop

Negative

Positive

Invalid

Specimen : Serum, Plasma (50l) , Whole blood (100l)Assay Time : 10 minutesDetection : Chikungunya IgM antibodySensitivity : 97.1%, Specificity : 98.9% (vs. ELISA)Component : Test device/ Assay diluent/ Disposable droppers

http://www.searo.who.int/LinkFiles/Chikungunya_FactSheet_Chikungunyafever.pdfhttp://www.who.int/mediacentre/factsheets/fs327/en/http://www.searo.who.int/LinkFiles/Chikungunya_Draft_Prevention&Control_CHIK_25_Nov.pdfhttp://ecdc.europa.eu/pdf/071030CHK_mission_ITA.pdfhttp://www.cdc.gov/ncidod/dvbid/Chikungunya/CH_GlobalMap.html

24 months1~30 C

ELISA available

Rapid Test

46EK10

Rev. 1310-00C

at. No. LEF46EN

Cat. No

Chikungunya IgMELISA

Product

Serum

Specimen

Well

Type

96wells/Kit

Pack size Storage

12 months2~8 C

Whole Blood

Serum or Plasma

10 min.

65, Borahagal-ro, Giheung-gu, Yongin-si, Gyeonggi-do, Republic of KoreaTel : +82-31-899-9700 Fax : +82-31-899-9740E-mail : [email protected]