Scrub Typhus IgM/IgG/IgA Card

Intended Use

Scrub Typhus IgM/IgG/IgA Card is a rapid solid phase immuno-chromatographic assay for the qualitative detection of IgM, IgG& IgA antibodies to Scrub Typhus in human serum / plasma / whole blood. 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

• Finger prick, rapid, visual and qualitative Immunoassay.
• Detection of all antibodies (IgM, IgG, IgA) to Scrub Typhus (Tsutsugamushi) in Whole blood/serum / plasma.
• Based on Immunochromatography Technique.
• See through device for easy interpretation of results.
• Results within 20 minutes
• Shelf life 30 months at 2-30°C
• Convenient pack size: 25 T.
• Sensitivity & Specificity: 100%

Principle (Antigen-Antibody Reaction)

Scrub Typhus IgM/ IgG/ IgA Card is an immunoassay based on ‘sandwich’ principle. The test device contains two lines; “C” (Control line), “T” (Scrub Typhus IgM/IgG/IgA antibody detection test line). Test line is coated with Scrub Typhus antigen. When a sample is added to the device, Scrub Typhus IgM/IgG/IgA antibodies if present in the sample will bind to the Scrub Typhus antigen gold colloid conjugate making antigen-antibodies complex. On addition of assay buffer, this complex migrates along the nitrocellulose membrane by capillary action to the test region and forms the visible purplish pink line at “T” as antigen-antibody antigen gold conjugate complex. The intensity of the test band in the device will vary depending upon the amount of antibodies present in the sample. The appearance of any purplish pink/red colour in test region should be considered as reactive for, Scrub Typhus IgM/IgG/IgA antibodies. A red procedural control line should always develop in the control Region “C” to indicate that the test has been performed properly.

Ordering Information

Performance Characteristics

(i) In-house Evaluation:

The performance of the test is evaluated in- house and compared with a licensed commercially available rapid test kit by using a known panel of Serum, Plasma, and Whole blood samples ;Scrub Typhus negative (240 clinical samples) ,33 cross reacting samples & 10 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% Specificity: 100%

(ii) External Evaluation:

The performance of the kit has also been evaluated with clinical samples; scrub typhus positive (35), scrub typhus negative (95) and 6 cross-reacting; 2 each of dengue, chikungunya and typhoid positive samples in comparison to commercially available (Inbios) ELISA. The results obtained are as follows:

Sensitivity: 100% Specificity: 100%