INTENDED USE TMEzDx Chikungunya IgM is a visual, rapid, qualita�ve immunoassay for detec�on of

Chikungunya specific IgM an�bodies in human serum, plasma and whole blood. The test is intended for professional use and must be use by trained personnel.

CLINICAL SIGNIFICANCE

Chikungunya fever is a viral disease transmi�ed through the bite of infected Aedes aegyp� and Aedes albopictus mosquitoes. Its symptoms are a fever frequently accompanied by joint pain, muscle pain, headache, nausea, fa�gue and rash. There have been recent breakouts of Chikungunya virus associated with severe illness. Chikungunya virus manifests itself with an acute febrile phase of the illness las�ng only two to five days, followed by a prolonged arthralgic diseases that affects the joint of the extremi�es. The pain associated with Chikungunya virus infec�on of the joint persists for weeks or months, or in some cases years. As clinical symptoms and signs of this infec�on resemble those of many other infec�ous diseases including Dengue fever, clinical findings need to be confirmed by laboratory diagnos�c techniques.

PRINCIPLETMEzDx Chikungunya IgM is a chromatographic immunoassay kit for rapid and

qualita�ve detec�on of Chikungunya IgM an�bodies in serum, plasma and whole blood from human. The nitrocellulose membrane of the test is immobilized with recombinant Chikungunya an�gens. And also, an� human IgM monoclonal an�body is conjugated to 40nm of colloidal gold par�cles. This conjugate is placed on a polyester or glass pad as conjugate pad. When the sample is dropped into the sample well the device, the solubilized conjugate migrates with the sample by passive diffusion and both the conjugate and sample come into contact with the recombinant an�gens that immobilized onto the nitrocellulose. If the sample contains IgM an�bodies against Chikungunya, the result is visible within 10 minutes in the form of a red line that develops on the membrane at test line (T). The solu�on con�nues to migrate to encounter a control reagent that binds a control conjugate, thereby producing a second line at control line (C). A procedural control line “C” should always develop in the test device window to indicate that the test has been performed properly.

MATERIALS PROVIDEDTMA EzDx Chikungunya IgM kit contains the following items to perform the assay:TM1. EzDx Chikungunya IgM Test Device individually foil pouched with a Desiccant

2. Sample Applicator3. Buffer Solu�on. 4. Product Insert.

Timer

PRECAUTIONS

1. Read the insert carefully before carrying out the test and instruc�on must be followed exactly to get accurate results.

2. The device is sensi�ve to humidity as well as to heat. Therefore take out the Device from sealed pouch just before carrying out the test.

TM3. Store the EzDx Chikungunya IgM kit at the temperature men�oned on the kit in a dry atmosphere

4. Do not use the kit a�er expira�on date. 5. Do not mix reagents from different lots.6. For In Vitro diagnos�c use only.7. Wear protec�ve gloves while handling samples and wash hands thoroughly a�er

performing the test.8. Dispose all the samples and kits properly as per the instruc�on a�er test in

accordance with GLP.9. Do not pipe�e reagents or blood samples by mouth.10. When transpor�ng or storing the kits, avoid exposure to high temperature(over

045C) for a period longer than 1 week.

SPECIMAN COLLECTION AND STORAGE

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Rapid detection test for Chikungunya IgMantibodies in human serum, plasma and whole blood

Chikungunya IgM

MATERIALS REQUIRED BUT NOT PROVIDED

Ref. No.: 001RCH010KI - 2

SYMBOL LEGENDSSymbol Explanation of symbol Symbol Explanation of symbol

Consult instruction for use

Do not use if package is damaged

In vitro diagnostic device

Store at 2 C - 30 C

Keep away from sunlight

Do not re-use

Keep Dry

Batch code No.

Manufacturer

Date of Manufacture

Use by (date or month of expiry)

2

2

Date Issued: 2017-08

ADVY CHEMICAL PVT. LTD.

030C

C T

C T

C T

C T

C T

Every precau�on has been taken to ensure the diagnos�c ability and accuracy of this product. This product is used outside of the control of the manufacturer and the distributor and the result may accordingly be affected by environmental factors and / oruser error. A person who is the subject of the diagnosis should consult a doctor for further confirma�on of the result.

PACK SIZE PRODUCT CODE

10 Tests / Kit RK CHK 001 - 10

25 Tests / Kit RK CHK 001 - 25

ORDERING INFORMATION

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24