| Customization: | Available |
|---|---|
| Type: | IVD Reagent |
| Assay Time: | 5-10 Minutes |
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| Detection time | 5 to 10 minutes |
| Specime | human whole blood, serum or plasma specimen. |
| Storage | 2 to 30 degree centigrade |
| Shelf life | 24 months |
| Package |
Individually packed test devices
Buffer
Package insert
Disposable pipettes
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| Advantages | 1) Good sensitivity and specificity 2) Strong R&D and technical support 3) Stable performance. 4) Friendly to end users |
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%.
The Leptospira IgG/IgM Rapid Test is a qualitative membrane-based immunoassay for the detection of Leptospira antibodies in whole blood, serum, or plasma. This test consists of two components, an IgG component and an IgM component. In the IgG component, antihuman IgG is coated in test line region G of the test. During testing, the specimen reacts with Leptospira antigen-coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with the anti-human IgG in test line region G. If the specimen contains IgG antibodies to Leptospira, a colored line will appear in test line region G. In the IgM component, anti-ligand is coated in test line region M of the test. During testing, the specimen reacts with ligand anti-human IgM. Leptospira IgM antibodies, if present in the specimen, reacts with the ligand anti-human IgM and the Leptospira antigen-coated particles in the test strip, and this complex is captured by the anti-ligand, forming a colored line in test line region M.
Therefore, if the specimen contains Leptospira IgG antibodies, a colored line will appear in test line region G. If the specimen contains Leptospira IgM antibodies, a colored line will appear in test line region M. If the specimen does not contain Leptospira antibodies, no colored line will appear in either of the test line regions, indicating a negative result. To serve as a procedural control, a colored line will always change from blue to red in the control line region, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
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 80uL) 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.
INTERPRETATION OF RESULTS
Hangzhou Immuno Biotech Co.,Ltd is the original organization in Immuno Group. The team of Hangzhou Immuno Biotech has developed a series of proteins and rapid test kits for the in vitro diagnostic industry in early stage. Gradually, IMMUNO was well known as a good R&D partner and good supplier of veterinary rapid test products. With great patience and continuous investment in design and development of IVD relative reagents and test kits, we got several encouraging achievements in the past year, especially in veterinary diagnostic field.
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