Leishmania Igg/Igm Rapid Test

• Customization: Available
• Type: Detection Card
• Specimen: Whole Blood, Serum or Plasma
• Model NO.: HLSH003T
• Assay Time: 10-15 Minutes
• Storage Temperature: 2-30°c
• Customized: Accpet
• Payment: T/T, Western Union, Paypal
• Delivery Time: 3~5days After Get Payment
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

Intended Use

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.



 

Materials

MATERIALS

Materials Provided

Individually packed test devices Disposable pipettes

Package insert Buffer

Materials Required but Not provided

Specimen collection container Centrifuge Micropipette

Timer Lancets

 

Performance

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

The Leishmania IgG/IgM Rapid Test has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals. Results were confirmed by a leading commercial Leishmania PCR kit.

Leishmania IgG/IgM Rapid Test vs. PCR kit

Leishmania Infection	Result	IgM	IgG
Primary Infection	Positive	36	1
	Negative	5	40
	Total	41	41
	Relative Sensitivity	87.8%	2.4%
Secondary Infection	Positive	42	60
	Negative	18	0
	Total	60	60
	Relative Sensitivity	70.0%	>99.0%
Non-Leishmania Infection	Positive	0	0
	Negative	320	320
	Total	320	320
	Relative Specificity	>99.0%	>99.0%

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%.

Precision

Intra-Assay
Within-run precision has been determined by using 10 replicates of four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. The specimens were correctly identified >99% of the time.
Inter-Assay
Between-run precision has been determined by 10 independent assays on the same four specimens: a negative, an IgG positive, an IgM positive and an IgG/IgM dual positive. Three different lots of the Leishmania IgG/IgM Rapid Test have been tested using these specimens. The specimens were correctly identified >99% of the time. 



 

Company Profile

Hangzhou lmmuno Biotech Co., Ltd is the original organization in lmmuno Group. The team of Hangzhou lmmuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage. Over time, Immuno has established itself as a trusted R&D partner and reliable supplier of veterinary rapid test products. Through persistent dedication and continuous investment in the design and development of IVD reagents and test kits, we have achieved significant milestones in recent years-particularly in veterinary diagnostics.
Hangzhou lmmuno Biotech Co., Ltd. will focus on the human medical diagnostic field and mainly cover the following directions: rapid tests for vector-borne diseases(VBDs), rapid tests for sexually transmitted diseases (STDs), rapid tests for respiratory system diseases and rapid tests for digestive system diseases. Additionally, with strong R&D capabilities, we are intensifying efforts in the diagnosis of neglected tropical diseases (NTDs). Immuno will continue to drive innovation in diagnostic solutions for global health challenges.

 

Certifications