INTENDED USE
The Chikungunya IgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgM anti-chikungunya virus (CHIK) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with CHIK. Any reactive specimen with the Chikungunya IgM Rapid Test must be confirmed with alternative testing method(s) and clinical findings.
INTRODUCTION
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 name is derived from the Makonde word meaning "that which bends up" in reference to the stooped posture developed as a result of the arthritic symptoms of the disease. It occurs during the rainy season in tropical areas of the world, primarily in Africa, SouthEast Asia, southern India and Pakistan12.
The symptoms are most often clinically indistinguishable form those observed in dengue fever. Indeed, dual infection of dengue and chikungunya has been reported in India3. 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.
CHIK is diagnosed based on serological analysis and viral isolation in mice or tissue culture. An IgM immunoassay is the most practical lab test method4.
The Chikungunya IgM Rapid Test utilizes recombinant antigens derived from its structure protein5, it detects IgM anti-CHIK in patient serum or plasma within 15 minutes. The test can be performed by untrained or minimally skilled personnel, without cumbersome laboratory equipment.
KIT COMPONENTS
1.Each kit contains 30 test devices, each sealed in a foil pouch with three items inside:
a. One cassette device.
b. One pipette dropper.
c. One desiccant.
2.Sample Diluent (1 bottle, 5 mL)
3.One package insert (instruction for use).
PROCEDURE
Don’t read result after 15 minutes. To avoid confusion, discard the test device after interpreting the result
PERFORMANCE CHARACTERISTICS
1. Comparison of the CHIK IgM Rapid Test with MAC-ELISA
An evaluation study was carried out at Unite de virologie , Institute de Medecine Tropicale de Service de Sante des Armees, Ministere De la Defense, France.
The evaluation specimen panel consisted of 72 recently infected specimens diagnosed by MAC-ELISA and 21 specimens containing 10 from other arbovirus infection, 3 from O’Nyong nyong infection, and 8 negative for all the tests. The evaluation data are showed in the following table.
|
|
CHIK IgM Rapid Test
|
|
|
MAC-ELISA
|
Positive
|
Negative
|
Total
|
|
Positive
|
65
|
7
|
72
|
|
Negative
|
0
|
21*
|
21
|
|
Total
|
65
|
28
|
93
|
Relative Sensitivity: 90.3% , Relative Specificity: 100%, Overall Agreement: 92.4%
2.Comparison of the CHIK IgM Rapid Test with CHIK IHA and CHIK Neutralization Test
|
ID
|
Dengue Titer*
|
Yellow Fever Titer*
|
CHIK IHA**
Titer*
|
CHIK Neutralization
|
CHIK IgM
|
|
140
|
<10
|
10
|
>=1280
|
Positive
|
Positive
|
|
547
|
160
|
160
|
>1280
|
80% neg 50% pos
|
Positive
|
|
1959
|
<10
|
<10
|
40
|
Positive
|
Doubtful
|
|
41
|
<10
|
80
|
>=1280
|
Positive
|
Positive
|
|
1709
|
>=1280
|
>=1280
|
<10
|
N/A
|
Positive
|
|
1793
|
>=1280
|
>=1280
|
<10
|
N/A
|
Positive
|
|
1016
|
10
|
40
|
>=1280
|
80% neg 50% pos
|
Positive
|
|
746
|
<10
|
320
|
>=1280
|
80% neg 50% pos
|
Negative
|
|
701
|
<10
|
20
|
>=1280
|
80% neg 50% pos
|
Positive
|
|
660
|
<10
|
640
|
>=1280
|
80% neg 50% pos
|
Positive
|
|
659
|
<10
|
40
|
>=1280
|
80% neg 50% pos
|
Positive
|
|
1505
|
<10
|
>=1280
|
<10
|
N/A
|
Negative
|
|
340
|
<10
|
10
|
>=1280
|
Positive
|
Positive
|
|
359
|
<10
|
10
|
80
|
N/A
|
Positive
|
|
429
|
<10
|
<10
|
>=1280
|
Positive
|
Doubtful
|
|
557
|
<10
|
<10
|
>=1280
|
Positive
|
Positive
|
|
430
|
<10
|
<10
|
<10
|
Negative
|
Negative
|
|
562
|
<10
|
10
|
>1280
|
Positive
|
Positive
|
|
1817
|
<10
|
<10
|
>=1280
|
N/A
|
Positive
|
*: Titer < 10: Negative.
**: IHA: Indirect hemagglutination Test
bio-equip.cn
Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.
Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.
Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.
Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.
With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.
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