Chikungunya IgM Rapid Test-Cassette/medical/laboratory/health diagnosis,Zhuhai Encode Medical Engineering Co.,Ltd_specification/price/image

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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

Dengue Titer*

Yellow Fever Titer*

CHIK IHA**

Titer*

CHIK Neutralization

CHIK IgM

140

<10

>=1280

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