Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
With CE
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | WB/S/P |
| Certificate | CE |
| Reading Time | 15 minutes |
| Pack | 40 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
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.
| Cat. No. | Product Description | Specimen | Format | Kit Size | Cut-Off | Status |
| ILEP-402 | Leptospira IgG/IgM Rapid Test Cassette | WB/S/P | Cassette | 40 T | See Insert | CE |
