Scrub Typhus (Tsutsugamushi) IgM & IgG Card

Intended Use

Scrub Typhus (Tsutsugamushi) IgM & IgG Card is a rapid solid phase immuno-chromatographic assay for the qualitative and differential detection of IgM and IgG antibodies to Scrub Typhus antibodies in human serum / plasma. This test is for in vitro diagnostic use only and is intended as an aid to early diagnosis of Scrub Typhus infection in patient with clinical symptoms.

Salient Features

• Rapid ,visual and qualitative Immunoassay.
• Differential detection of IgM & IgG antiobodies to Scrub Typhus (Tsutsugamushi) in Human Serum / Plasma.
• Based on Immunochromatography Technique.
• See through device for easy interpretation of results.
• Results with in 20 minutes
• Shelf life 30 months at 2-30°C
• Convenient pack size: 20T & 50T.
• Sensitivity & Specificity: 100% (In house Evaluation)

Principle

Scrub Typhus (Tsutsugamushi) IgM & IgG Card test device contains three lines; “C” (Control line), “M” (IgM test line) & “G” (IgG test line). IgM test line is coated with anti-human IgM and IgG test line is coated with anti-human IgG. When a sample is added to the sample well of the device followed by two drops of buffer in the buffer well, IgM and IgG antibodies in the sample reacts with anti-human IgM and anti-human IgG antibodies coated on the membrane respectively.

If the sample contain Scrub Typhus (Tsutsugamushi) antibodies, colloidal gold conjugate containing Scrub Typhus antigens is captured by the bound anti-Tsutsugamushi IgM &/or IgG on respective test bands forming a pale to dark red band at the IgM &/or IgG region of the test device. The intensity of the test bands in the device will vary depending upon the amount of antibodies present in the sample. The appearance of any pink/red colour in a specific test region should be considered as positive for that particular antibody type (IgM or IgG). A red procedural control line should always develop in the test device window to indicate that the test has been performed properly.

Ordering Information

Performance Characteristics

The performance of the test is evaluated in- house and compared with a licensed commercially available test kit by using a known panel of Serum/ Plasma Scrub Typhus negative (50 clinical samples) ,33 cross reacting samples & 50 positive samples. The cross-reacting samples included in the evaluation are; HIV positive, HCV positive, HBV positive, Dengue positive, Chikungunya positive, Leptospira positive, Malaria positive, Typhi positive, Rheumatoid factor positive, CRP positive and ASO positive samples.
The results obtained are as follows:
Sensitivity : 100% (In house Evaluation) Specificity : 100% (In house Evaluation)