Testsealabs Leptospira IgG/IgM Rapid Test Kit

Short Description:

Leptospira IgG/IgM Combo Rapid Test is a lateral flow chromatographic immunoassay.
This test is intended to be used for the simultaneous detection and differentiation of IgG and IgM antibodies to Leptospira interrogans (L. interrogans) in human serum, plasma or whole blood. It is intended to be used as a screening test by professionals, and provides a preliminary test result to aid in the diagnosis of infection with L. interrogans.


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Intended Use

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Leptospirosis occurs worldwide and is a common mild to severe health problem for humans and animals, particularly in areas with a hot and humid climate. The natural reservoirs for leptospirosis are rodents as well as a large variety of domesticated mammals. Human infection is caused by L. interrogans, the pathogenic member of the genus of Leptospira1,2. The infection is spread via urine from the host animal.

After infection, leptospires are present in the blood until they are cleared after 4 to 7 days following the production of anti-L. interrogans antibodies, initially of the IgM class. Culture of the blood, urine and cerebrospinal fluid is an effective means of confirming the diagnosis during 1st to 2nd weeks after exposure. Serological detection of anti- L. interrogans antibodies is also a common diagnostic method. Tests are available under this category: 1) The microscopic agglutination test (MAT)3; 2) ELISA4-5; 3) Indirect fluorescent antibody tests (IFATs)6.  However, all above mentioned methods require a sophisticated facility and well-trained technicians.

The Leptospira IgG/IgM is a simple serological test that utilizes antigens from L. interrogans and detects IgG and IgM antibodies to these microorganisms simultaneously. The test can be performed by untrained or minimally skilled personnel, without cumbersome laboratory equipment and the result is available within 15 minutes.

Leptospira Rapid Test Procedure

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Directions For Use

Allow test cassette, specimen, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the cassette on a clean and level surface.
For Serum or Plasma specimen: Hold the dropper vertically and transfer 1 drop of serum or plasma (approximately 40 μL) to the specimen well, then add 2 drops of buffer (approximately 80 mL),and start the timer, see illustration below.
For Venipuncture Whole Blood specimen: Hold the dropper vertically and transfer 1 drop of whole blood (approximately 40 mL) to the specimen well, then add 2 drops of buffer (approximately 80mL), and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
· To use a capillary tube: Fill the capillary tube and transfer approximately 40 μLof fingerstick whole blood specimen to the specimen well of test cassette, then add 2 drops of buffer (approximately 80 mL) and start the timer. See illustration below.
· To use hanging drops: Allow 1 hanging drop of fingerstick whole blood specimen (approximately 40 μL) to fall into the specimen well of test cassette, then add 2 drops of buffer (approximately 80 mL) and start the timer. See illustration below.
3. Wait for the colored line(s) to appear. Read the results at 15 minutes, do not interpret the results after 20 minutes.

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