Chikungunya IgG/IgM Rapid Test Cassette

Chikungunya IgG/IgM Rapid Test

Chikungunya antibody rapid test cassette is intended to be used as a screening test and as an aid in the diagnosis of infection with Chikungunya disease.

Intended Use

Chikungunya IgM/IgG Rapid Test cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgM/IgG to the Chikungunya virus in human serum, plasma or whole blood. It is intended to be used as a screening test and as an aid in the diagnosis of infection with Chikungunya disease.

Our Chikungunya IgM/IgG Rapid Test utilizes recombinant antigens derived from the structure protein of Chikungunya, and the test process takes up to 15 minutes. The test can be performed by untrained personnel, without cumbersome laboratory equipment.

Reagents Used

The Chikungunya IgM/IgG Rapid Test consists of:

a burgundy colored conjugate pad containing recombinant antigen and rabbit IgG-gold, conjugated with colloid gold;
a nitrocellulose membrane strip containing two test bands: the M band is pre-coated with monoclonal anti-human IgM , G band with reagent for the detection of IgG to Chikungunya;
and the C band is pre-coated with goat anti rabbit IgG, acting as an internal control.

Trypanosomiasis Disease

Chikungunya is a rare viral infection transmitted by the bite of an infected Aedes aegypti mosquito. It is characterized by a rash, fever, and severe joint pain (arthralgias) that usually lasts for three to seven days.

The symptoms are most often clinically indistinguishable from those observed in dengue fever. Unlike dengue, hemorrhagic manifestations are relatively rare and most often the disease is a self-limiting febrile illness. Therefore it is very important to clinically distinguish dengue from CHIK infection. An IgM immunoassay is the most practical test method in laboratories.

Chikungunya Test Kits: Principle, Packing...

Cat. No.	Description (& Details)	Specimen	PCS/Box	Quan. per CTN	Quantity (Tests)
CHIK 441	Chikungunya IgM/IgG Test Card	serum/WB/plasma	25	Bulk: 1600 PCS Boxed: 40 Boxes

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General Info.
Packing
Specimen
Principle

General Information

(IVD Kit »-» Arthropod Borne Disease -» One Step Lateral Flow Immunochromatographic Assay)

Catalog No.:	CHIK 441
Description:	Chikungunya IgM/IgG Test Card
Category:	Arthropod Borne Disease
Style:	Card
Unit:	PCS
Specimen:	serum/WB/plasma
No. of Step:	One Step
Reading Time:	15 Minutes
Cut Off:
Specification:	4.0 mm
Quan. or Qual.:	Qualitative
Sensitivity:
Specificity:
Method:	Lateral Flow Indirect

Packing Specification

Tests per Kit:	25 Tests
Box Dimension:	21.0 * 12.5 * 6.5 CM
Kits per CTN:	40 Kits
Carton Dimension:	53 * 45 * 36 CM
Tests per CTN (BULK):	1600 Tests
Carton Volume:	0.085 CBM
GW per CTN (Boxed):	14.0 KG
GW per CTN (Bulk):	16.5 KG

Materials Provided in the Test Kit

Test cassette in single foil pouch with desiccant;
Disposable sample dropper;
Specimen Diluents;
Instruction leaflet.

Specimen

Serum Collection

Collect blood specimen into a red top blood collection tube by vein puncture, which contains no anticoagulants.

Allow the blood to clot, or separate the serum by centrifugation.

Carefully withdraw the serum into a new pre-labeled tube.

Whole Blood Collection

Whole blood can be collected with blood collection tube with venipuncture into blood collection tube (containing EDTA, citrate or heparin).

Or, by lancet lancing. Clean the area to be lanced with an alcohol swab. Squeeze the end of the fingertip and pierce with a sterile lancet. Wipe away the first drop of blood with sterile gauze or cotton. Take a dropper provided, while gently squeezing the dropper tube, immerse the open end in the blood drop and then gently release the pressure to draw blood into the dropper.

Plasma Collection

Collect blood specimen into a lavender, blue or green top blood collection tube, containing EDTA, citrate or heparin, respectively, by vein puncture.

Separate the plasma by centrifugation.

Carefully withdraw the plasma into a new pre-labeled tube.

serum/WB/plasma Storage Condition

Test specimens as soon as possible after collecting.

The specimens can be stored up to 3 days at 2-8°C if not tested immediately. The specimens should be frozen at -20°C for longer time storage. Don’t freeze and thaw the specimens for many times.

Prior to testing, bring frozen specimens to room temperature slowly and mix gently.

Specimens containing visible particulate matter should be clarified by centrifugation before testing.

Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

Testing Principle of Lateral Flow Indirect

In the lateral flow indirect chromatographic rapid test, recombinant or purified antigens are immobilized in the test band region. In the end of the Conjugate pad of the membrane strip where the samples are supposed to be added, rabbit or mouse anti-human IgG antibodies conjugated with colloidal gold particles is embedded.

During the testing process, specimen is added to the end of the membrane strip. anti-IgG colloidal gold particles resolve into the specimen, where the anti-IgG conjugate will react and bound with the target IgG antibody, if present.

This complex of IgG and anti-IgG will move along the membrane strip to the testing band region, under capillary effect, where the immobilized antigen captures the IgG antibody. When the antigen-IgG-Anti-IgG complex accumulate on the test band region, the congregated colloidal gold particle will develop red or pink color, indicating there are target IgG antibodies in the specimen.

If there is no target IgG antibody in the specimen, the secondary anti-IgG conjugate will not bind to the immobilized antigen in the test band region, and no color will develop.

As a procedural quality control, a secondary antibody or recombinant antigen will be immobilized in the control band region. When the specimen climb to this region, the unbound anti-IgG colloidal gold particle will be captured, thus a red band will always develop. This inner control process ensure that enough specimen is added, proper testing procedure has been followed, and the reagent has not deteriorated.