Leptospira Rapid Kit

│ Descriptions │

ImmnuneMed Leptospira Rapid" tests the antibodies against Leptospira in the patient's plasma, serum or blood using Lateral Flow ImmunoChromatographic Assay. After applying diluted serum, plasma or blood onto the hole of testing device, for IgM, patient`s sample first react with gold conjugated anti-human IgM antibody and for IgG, with gold conjugated protein A. After that, 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) is ugently required accurate differential early diagnosis and proper therapy against different causative microorganisms with similar clinical symptoms. This Leptospira Rapid provides not only rapid diagnosis of Leptospirosis among AFI 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.

│ Feature │

1) Testing device: one round hole for sample applying on the plastic cassette and two detection window for IgM and IgG. There are 2 different markings, such as C for control line and T for Leptospirosis by Leptospira on each detection window. 2) Sample diluent: colorless liquid in the semi-transparent plastic bottle

│ Specification │

 

1) Specimen

(1) Use serum, plasma or whole blood as specimen.
(2) Collected blood containing anti-coagulant should be used immediately or the blood kept in 2~8 ℃ for 3 days is possible to use.
(3) Separated serum and plasma could be used until one month if kept in 2~8 ℃ or 1 year if kept frozen.

2) Methods

(1) If each specimen and reagent is kept frozen, place it for 30 min at room temperature before use.
(2) After pulling out the testing cassette from the closed pouch, place it on the flat position.
(3) In case of serum or plasma, 3 kl is diluted about 100 fold with 300 kl sample diluent. If whole blood, take 6 kl and it is diluted about 50 fold with 300 kl sample diluent. After that, apply 300 kl of this diluted sample to the hole. * Or when 3 kl of serum or plasma, or 6 kl of whole blood are directly applied to the sample pad in the hole, immediately add 7 drops of sample diluent provided.
(4) 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.

3) Interpretation

 ① 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).
② 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). ③ 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). 
 

a. positive b. positive c. positive d. negative e. invalid Fig 

1. Interpretation for Leptospirosis

 4) Quality control

① Red lines should appear on both control lines for each testing.
② 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.