Leishmania Igg/Igm Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HLSH003T
• Blood Sampling Needle: None
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

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 Provided

Individually packed test devices Disposable pipettes

Package insert Buffer

Materials Required but Not provided

Specimen collection container Centrifuge Micropipette

Timer Lancets

 

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.