CE ILEP-402 Leptospira IgG IgM Test Cassette Whole Blood Serum Plasma

Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) With CE

A rapid test for the qualitative detection of IgG and IgM antibodies to Leptospira interrogans in human’s whole blood, serum or plasma specimen. For professional in vitro diagnostic use only.

Applications:

The Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Leptospira interrogans in human’s whole blood, serum or plasma.

Description:

Leptospirosis occurs worldwide and is a common mild to severe health problem for humans and animals, particularly in area 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 Leptospira interrogans, the pathogenic member of the genus of Leprospira . 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-Leptospira 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- Leptospira interrogans antibodies is also a common diagnostic method. Tests are available under this category:1) The microscopic agglutination test (MAT) ; 2) ELISA; 3) Indirect fluorescent antibody tests (IFATs) 6 . However, all above mentioned methods require a sophisticated facility and well- trained technicians.

How to 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.

INTERPRETATION OF RESULTS

(Please refer to the illustration above)
 

IgG POSITIVE: Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the IgG region.
 

IgM POSITIVE: Two distinct colored lines appear. One colored line should be in the control region (C) and another colored line should be in the IgM region.
 

IgG and IgM POSITIVE: Three distinct colored lines appear. One colored line should be in the control region (C) and another two colored lines should be in the IgG and IgM regions.
NOTE: The intensity of the color in the IgG and IgM region(s) will vary depending on the concentration of Leptospira antibodies present in the specimen. Therefore, any shade of red in the IgG and IgM region(s) should be considered positive.
 

NEGATIVE: One colored line appears in the control region (C). No apparent red or pink line appears in the IgG and IgM region(s).
 

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.