Product Name                                         Advantage Leptospira IgM & IgG Card

Brand                                            J MITRA & CO PVT LTD

Pack Size                                                  10 Tests

Catalog No.                                               IR081010

Kit Type:                                                   Leptospira test kit (IgM, IgG)
Result Time:                                             Within 20 Minutes
Sensitivity:                                                99%
Specificity:                                                99.5%

Intended Use

Advantage Leptospira IgM & IgG card is visual, rapid, sensitive and qualitative immunoassay for the detection of Leptospira specific IgM & IgG antibodies in human serum or plasma.

Salient Features

• Rapid qualitative test for differential detection of Leptospira specific IgM and IgG Antibodies in
• Human serum/plasma.
• One step test procedure, add sample & read results
• Infection free see through device.
• Results with in 20 minutes.
• Shelf life of 30 months at 2-30°C.
• Excellent Sensitivity- 99 % and Excellent Specificity- 99.5%

Principle

Advantage Leptospira IgM & IgG card test is based on Immunochromatographic assay principle. The test sample is introduced to and flows laterally through an absorbent pad where it mixes with the conjugate. If the sample contains Leptospira specific IgM and/or IgG antibodies, it forms a complex with the conjugate. The complex then migrates through the nitrocellulose membrane by capillary action. When the complex meets the immobilized antibodies (Test line ‘M & G’), it generates a red line, indicating that the sample is reactive. To serve as a procedural control, an additional control line ‘C’ has been immobilized at a distance from the test line on the strip. If the test is performed correctly, this will result in the formation of a red line at the control region upon contact with the conjugate.

Performance Characteristics Of Advantage Leptospira IgM & IgG Card

Sensitivity:                  98.16% (for IgMAntibodies) & 100% (for IgG Antibodies)
Specificity:                   99.61%
Precision:
Within run(Intra assay) & between run (Interassay) precision have been determined by testing10 replicates of five specimens – one negative, three Lepto IgM positive andone Lepto IgG Positive. The C.V. (%) of all the five samples were within 10% ofthe time.