Accurex Typhoid IgG/IgM Chromatographic Immunoassay

Overview Accurex Typhoid IgG/IgM Chromatographic Immunoassay

The Accurex Typhoid IgG/IgM Lateral Flow Assay utilizes immunochromatography. The device incorporates a conjugate pad (pink-purple) containing S. Typhi H and O antigens conjugated to colloidal gold, plus rabbit IgG-gold conjugates. A nitrocellulose membrane displays IgM (test line M), IgG (test line G), and control (C) regions. Test line M is pre-coated with anti-human IgM; test line G with anti-human IgG; and the control line with goat anti-rabbit IgG. Sample application initiates capillary flow. Patient IgM antibodies, if present, bind to the Typhi conjugates and are captured at line M, producing a pink-purple line indicating a positive IgM result. Similarly, IgG antibodies binding to conjugates are captured at line G, signifying a positive IgG result. Absence of lines at M and G denotes a negative test. The control line (C), showing a pink-purple line regardless of test results, validates the assay; its absence invalidates the test. Intended use: screening and diagnostic aid for S. Typhi infection. Confirmation with alternative methods is required for reactive specimens. The assay simultaneously detects and differentiates anti-S. Typhi IgG and IgM in whole blood/serum/plasma. Directions for plasma/serum processing involve standard centrifugation techniques from appropriately collected blood samples (lavender, blue, green, or red top tubes). Test specimens promptly; store at 2-8°C for up to 5 days or freeze at -20°C. Safety precautions: follow all instructions; use only as directed; handle specimens and reagents using universal precautions, protective equipment, and proper biohazard disposal methods. Results should be interpreted within 15 minutes; avoid strong airflow during testing.

Safety Instruction of Accurex Typhoid IgG/IgM Chromatographic Immunoassay:

• Thorough review of this instruction leaflet is required prior to test initiation. Deviation from these instructions will compromise test accuracy.
• Keep the sealed pouch unopened until you are prepared to perform the test.
• Discard any expired medical devices.
• Allow all reactants to reach ambient temperature (15°C-30°C) prior to application.
• This kit's components are not interchangeable with those of other test kits.
• Avoid using hemolyzed blood samples for analysis. Protective apparel and single-use gloves are mandatory when handling test components and patient samples. Always wash your hands completely after the procedure.
• Individuals administering or handling this test must adhere to the U.S. Centers for Disease Control and Prevention's standard precautions for preventing the spread of HIV, HBV, and other bloodborne pathogens.
• Refrain from smoking, consuming food, or beverages where samples or test components are being processed.
• Discard all test samples and materials as medical waste.
• Process negative and positive controls identically to patient samples.
• Interpret the test results within 15 minutes of applying the specimen to the device's sample well or pad. Readings taken after this time may be inaccurate.
• Avoid testing in areas with significant air currents, such as those generated by fans or air conditioners.