Uncut sheet for Typhoid IgG/IgM Rapid test

Short Description:

 uncut sheet for  Typhoid IgG/IgM 

 

Methodology: Colloidal Gold


  • Testing time: 15 minutes
  • Storage temperature: 2°C-30°C
  • Valid Time: 24 months
  • Accurancy: More than 99%
  • Specification: 25 test/box
  • Product Detail

    Product Tags

    1. INTEDED USE

    The Typhoid IgG/IgM Rapid Test Device (Uncut Sheet  format for manufacturing use) is a rapid colloidal Gold   intended for the qualitative and differential detection of IgG and IgM antibodies to Salmonella typhi (S. typhi) and Salmonella paratyphi (S. paratyphi) in human serum, plasma, or whole blood specimens

    This test is intended for in vitro diagnostic professional use and serves as an aid in the diagnosis of typhoid fever and paratyphoid fever in patients presenting with clinical signs and symptoms suggestive of enteric fever

    The test provides presumptive screening results. Results should be interpreted as follows:

    • IgM positive, IgG negative: suggests recent or current (acute) infection .
    • IgG positive, IgM negative: suggests past exposure or resolved infection .
    • IgM and IgG negative: indicates no current or past infection, though negative results do not rule out typhoid infection, particularly if the specimen is collected during the early stage of infection when antibody titers may be below the detection limit 

    Positive results are preliminary and should be confirmed by alternative diagnostic methods such as blood culture or other confirmatory testing . This test is not intended for use as the sole basis for diagnosis, and results should be interpreted in conjunction with clinical presentation and exposure history .

    This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.

    2. PRODUCT SPECIFICATION

    Model No. Typhoid IgG/IgM   Uncut sheet
    Methodology Colloidal Gold 
    Sample Type Serum,Plasma,Whole blood
    Time to Result 15 mins
    Storage 2~30 ℃/36~86℉
    Shelf Life 24 months
    Certificate ISO13485, CE Certificate, UCKA MHRA Certificate
    uncut sheet
    uncut sheet

    Feature

      High sensitive

    •  result reading in 5 minutes

    •  Easy operation

    •  High Accuracy

    PACKING

    * 20 bags /CTN

    * Aluminum foil bag labeling

    * shrink wrap

     

    3.TEST METHOD

    1 Take out the test device from sealed foil pouch and place on a dry, clean and level surface.
    2 Be sure to label the device with specimen’s ID number.
    3 Fill the pipette dropper with the specimen. Hold the dropper vertically and transfer 1 drop of whole blood/serum/plasma specimen (approximately 10 μL) into the specimen well (S) , and make sure that there are no air bubbles. Then add 3 drops of sample diluent (approximately 80-100 μL) into the diluent well (D) immediately. See illustration below.
     4 Start the timer.
     5 Wait for the colored line(s) to appear. Read test results at 15 minutes. Positive results maybe visible in as short as 1 minute. Negative results must be confirmed at the end of the 20 minutes only. Do not interpret the result after 20 minutes.

     

    5. CERTIFICATE

    * ISO System Certificate

    * CE Certificate

    * EU Registration

    * UCKA MHRA Registration


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