Leptospira Igg/Igm Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• 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

Individually packed test devices Disposable pipettes

Package insert Buffer

Materials Required but Not provided

Specimen collection container Centrifuge Micropipette

Timer Lancets

 

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to reach room temperature (1530°C) prior to testing.

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.

      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%

For the primary and secondary infection, the overall sensitivity is IgM 76.0%, IgG 62.0%, the overall specificity is IgM >99.0%, IgG  IgM >99.0% and the overall accuracy is IgM 94.5%, IgG 91.4%.

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 Leptospira IgG/IgM Rapid Test have been tested using these specimens. The specimens were correctly identified >99% of the time.