Basic Info.
Model NO.
HLSH003T
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 
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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% |
Precision
Intra-AssayWithin-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.
