Basic Info.
Model NO.
HLEP002T
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 Leptospira IgG/IgM Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Leptospira donovani in human whole blood, serum or plasma specimen.
MATERIALS
Materials Provided 
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TEST PROCEDURE
Allow the test device, specimen, buffer, and/or controls to reach room temperature (15 30°C) prior to testing.- Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
- Place the test device on a clean and level surface.
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.
3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes.
PERFORMANCE CHARACTERISTICS
Clinical Sensitivity, Specificity and Accuracy
The Leptospira 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 Leptospira PCR kit.Leptospira IgG/IgM Rapid Test vs. PCR kit
| Leptospira Infection | Result | IgM | IgG |
| Primary Infection | Positive | 20 | 1 |
| Negative | 0 | 19 | |
| Total | 20 | 20 | |
| Relative Sensitivity | >99.0% | 5.0% | |
| Secondary Infection | Positive | 18 | 30 |
| Negative | 12 | 0 | |
| Total | 30 | 30 | |
| Relative Sensitivity | 60.0% | >99.0% | |
| Non-Leptospira Infection | Positive | 0 | 0 |
| Negative | 170 | 170 | |
| Total | 170 | 170 | |
| 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 Leptospira IgG/IgM Rapid Test have been tested using these specimens. The specimens were correctly identified >99% of the time.
