Leishmania Igg/Igm Rapid Test Chromatographic Immunoassay

• Customization: Available
• Type: IVD Reagent
• Assay Time: 5-10 Minutes
• Model NO.: HLSH003T
• Shelf Life: 24 Months
• Storage Temperature: 2-30 Degree
• Certificate: CE
• OEM/ODM: Support
• Transport Package: Carton
• Specification: 20Tests/Kit
• Trademark: IMINUO
• Origin: Hangzhou
• HS Code: 3822120000
• Production Capacity: 5000000PCS/Year

Product Description

Leishmania IgG/IgM Rapid Test chromatographic immunoassay

Detection time	5 to 10 minutes
Specime	human whole blood, serum or plasma specimen.
Storage	2 to 30 degree centigrade
Shelf life	24 months
Package	Individually packed test devices Buffer Package insert Disposable pipettes
Advantages	1) Good sensitivity and specificity 2) Strong R&D and technical support 3) Stable performance.  4) Friendly to end users

INTENDED USE

The Leishmania IgG/IgM Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Leishmania donovani in human whole blood, serum or plasma specimen. 

Assay Time:  5-10 minutes

For the primary and secondary infection, the overall sensitivity is IgM 77.2%, IgG 60.4%, the overall specificity is IgM >99.0%, IgG  IgM >99.0% and the overall accuracy is IgM 94.5%, IgG 90.5%.

PRINCIPLE

The Leishmania IgG/IgM Rapid Test is a qualitative membrane-based immunoassay for the detection of Leishmania antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, anti-human IgG is coated in test line region G of the test. During testing, the specimen reacts with Leishmania antigen-coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in test line region G. If the specimen contains IgG antibodies to Leishmania, a colored line will appear in test line region G. In the IgM component, anti-ligand is coated in test line region M of the test. During testing, the specimen reacts with ligand anti-human IgM. Leishmania IgM antibodies, if present in the specimen, reacts with the ligand anti-human IgM and the Leishmania antigen-coated particles in the test strip, and this complex is captured by the anti-ligand, forming a colored line in test line region M.
Therefore, if the specimen contains Leishmania IgG antibodies, a colored line will appear in test line region G. If the specimen contains Leishmania IgM antibodies, a colored line will appear in test line region M. If the specimen does not contain Leishmania antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always change from blue to red in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
 

TEST PROCEDURE

 

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface. 

For Serum or Plasma Specimens: 
Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10 uL), and transfer the specimen to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 mL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).
For Whole Blood (Venipuncture/Fingerstick) Specimens: 
To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 2 drops of whole blood (approximately 20 µL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 uL) and start the timer. See illustration below.
To use a micropipette: Pipette and dispense 20 µL of whole blood to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 80 µL) and start the timer. 

1. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes. 

 

 

INTERPRETATION OF RESULTS

COMPANY INTRODUCTION

Hangzhou Immuno Biotech Co.,Ltd is the original organization in Immuno Group. The team of Hangzhou Immuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage. Gradually, IMMUNO was well known as a good R&D partner and good supplier of veterinary rapid test products. With great patience and continuous investment in design and development of IVD relative reagents and test kits, we got several encouraging achievements in the past year, especially in veterinary diagnostic field.

Immunobio is providing all the products strictly following with quality management system. We are running the ISO9001 and ISO13485 quality control system to ensure the good quality of our products, and also the Intellectual Property Management system to protect the intellectual properties of both our clients and ourselves. Immunobio is supplying its recombinant proteins, such as recombinant N protein, S protein, to our esteemed rapid test partners. Immunobio is also supplying uncut sheet format semi-product to our global partners. Immunobio is also providing rapid tests and OEM/private label services to our customers from every corner of the world.