- 30 tests/kit box
- 2 bottles of sample diluent
- 2 explanatory sheets
- 2 test procedure sheets
Benefits & effects
This Leptospira Rapid provides not only rapid diagnosis of Leptospirosis among AFI (Acute Febrile Illness) but also sensitive detection of each IgM and IgG antibody simultaneously. Furthermore, this kit is easy to handle and provides rapid interpretation of the result with no equipment. In addition, this kit is useful for the follow up study and the estimation of reinfection and residual antibody.
“ImmuneMed Leptospira Rapid” is an ImmunoChromatographic assay for qualitative detection of IgM, IgG antibodies to Leptospira in the patient’s serum, plasma or whole blood.
After applying diluted serum, plasma or whole blood onto the hole of test device, each reactant diffuses on the membrane to the recombinant antigens marked as test lines. If positive, the test line turns to red color because antigen-antibody-gold conjugate complex is formed on the test lines.
AFI(Acute Febrile Illness) urgently requires accurate differential early diagnosis and proper therapy against different causative microorganisms with similar clinical symptoms.
1. Testing Device
2. Sample Diluents
Materials and Methods
- Use serum, plasma or whole blood as specimen.
- Collected blood containing anti-coagulant should be used immediately or the blood kept in 2~8 ℃ for 3 days is possible to use.
- Separated serum and plasma could be used until one month if kept in 2~8 ℃ or 1 year if kept frozen.
2. Testing Method
- If each specimen and reagent is kept frozen, place it for 30 min at room temperature before use.
- After pulling out the testing cassette from the closed pouch, place it to the flat position.
- In case of serum or plasma, 3 ㎕ is diluted about 100 fold with 300 ㎕ sample diluent. If using whole blood, take 6 ㎕ and it is diluted about 50 fold with 300 ㎕ sample diluent. After that, apply 300 ㎕ of this diluted sample to the hole. * Or when 3 ㎕ of serum or plasma, or 6 ㎕ of whole blood are directly applied to the sample pad in the hole, immediately add 7 drops of sample diluent provided.
- Wait for 15 min until the red line appears on the control line. Read and interpret the result exactly after 15 min from applying the diluted sample. Ignore the red line appeared after 15 min for interpretation.
- Positive: Red line must appear on each C line of IgM and IgG in the detection windows and one or two red lines should appear on the test line, T in the windows (Fig 1. a,b,c).
- Negative: Red lines only appear on both control lines of IgM and IgG in the detection windows and no red line should appear on the test line, T (Fig 1. d).
- Invalid: If red line does not appear from at least one out of two C lines, this result is interpreted as invalid, and do test again (Fig 1. e).
4. Quality Control
- Red lines should appear on both control lines for each testing.
- If the red line does not appear from at least one out of two C lines, re-test is recommended because the directions may not have been followed correctly or the testing device may have deteriorated.
- In vitro diagnostic use only
- Due to deterioration in quality when testing device is exposed to moisture in storage, pull out the device from the closed pouch right before use and use it within 30 min.
- Do not touch the membrane in the detection window of this kit by hands directly, or it affects the test result.
- Avoid moisture, direct sunlight and heat, and keep it in room temperature.
- Do not use the kit after expiration date.
- If the testing result of test line is positive, It means the antibody positive against Leptospira. This kit should be used as the first line diagnosis only. The confirmation test would be necessary if positive, and the final diagnosis should be made by doctor after analysing this test result and other clinical data in conjunction with inquiries.
- Especially in endemic area, when the kit shows faint line on test (T) line, and the clinical symptom is not remarkable, it may not be leptospirosis. So continuous monitoring is necessary for 1 to 7 days. During this period, please take the new blood and test again, if red color on T line increases, the possibility of leptospirosis also increases. However, if the line is faint although the symptom is severe and suspicious, please send for microscopic agglutination test (MAT) immediately.
- Precautions of specimen handling and storage
- Contaminated or heated specimen should not be used for testing.
- Serious haemolysis or microbial contaminated specimen may cause inaccurate result.
- Be careful with handling specimens which may impregnate dangerous sources of unknown viral or bacterial infection. Use a disposable glove when handle the specimen and wash your hands after handling.
- Solid and liquid waste from experiments should be discarded after high-pressure autoclaving for 15 min at 121℃.