Accurex T4 Fast Test Kit

Overview Accurex T4 Fast Test Kit

The Accurex T4 Fast Test Kit provides a rapid, quantitative measurement of total thyroxine (T4), a crucial indicator of thyroid function. Elevated T4 signifies hyperthyroidism (excess thyroid hormone), while low T4 suggests hypothyroidism (insufficient hormone). This assay employs fluorescence-labeled anti-human T4 monoclonal antibodies bound to latex particles, which react with T4 in the sample. Capillary action carries the resulting antigen-antibody complex to a detection zone where it's captured by immobilized T4 antigen. The fluorescence intensity, directly proportional to T4 concentration, is quantified using the AccuDxCQ Immunofluorescence Quantitative Analyzer (AccuDx CQ). The AccuDx CQ displays, stores, and allows for downloading of the results, facilitating seamless integration with laboratory or hospital information systems. **Intended Use:** In-vitro quantitative T4 determination in serum/plasma. Useful in hyperthyroidism/hypothyroidism monitoring and thyroid function diagnosis. **Kit Contents:** AccuDx CQ T4 test card (25), disposable pipette (25), blood sample diluent (1), SD card (1), user manual (1). Results are digitally stored and downloadable. The AccuDx CQ screen displays the results, which can be electronically transmitted. The system offers ease of use and operation. **Instructions:** Follow the manual for specimen collection. Bring all components to room temperature. Verify SD card and kit lot number compatibility, calibrating as needed (see Getein1100 manual section 8.5.2). On the Getein1110 main interface, press "ENT" to begin. Remove the test card, label it, and place it horizontally. Mix 100 µl of sample with 100 µl of diluent (or three drops using the pipette), then apply 100 µl to the sample port. After 10 minutes, insert the card into the Getein1100 and press "ENT." The result will be displayed. **Safety Precautions:** Follow label instructions. Store in a cool, dry, dark place, away from children. Store test cards at 4-30°C (24-month shelf life); use within 1 hour of pouch opening. Store diluent at 0-30°C (24-month shelf life); 2-8°C for optimal performance. For in-vitro diagnostic use by professionals only. Do not use beyond expiry, if the pouch is damaged, or reuse components. Handle samples as potentially infectious and dispose of appropriately. Always adhere to local regulations and the provided instructions for accurate results.

How to Use Accurex T4 Fast Test Kit:

Gather samples as per the device's instructions. Ensure the test card, sample, and reagent reach ambient temperature before commencing. Verify the SD card's lot number matches the test kit's lot number; conduct an "SD card calib" calibration if needed (consult section 8.5.2 of the Getein1100 user manual). On the Getein1100's main screen, initiate testing by pressing "ENT". Immediately prior to use, remove the test card from its protective packaging and label it with patient or control identifiers. Position the test card flat on a clean surface. Using a transfer pipette, combine 100 μl of the sample with the sample diluent in a tube, mixing well. Add 100 μl (or three drops using a disposable pipette) of this mixture to the designated sample well on the test card. After a 10-minute incubation, insert the card into the Getein1100 and press "ENT" to initiate reading. The results will then display.

Safety Instruction of Accurex T4 Fast Test Kit:

• Always check the product label before administering.
• Keep in a cool, dry location, protected from direct sunlight.
• Store in a location inaccessible to children.
• Maintain the diagnostic test strip between 4 and 30 degrees Celsius for a shelf life of two years.
• The test card must be used within sixty minutes of opening the foil package.
• Maintain the blood sample diluent at a temperature between 0 and 30 degrees Celsius for up to 24 months to ensure usability.
• Maintain the blood sample diluent at a temperature between 2 and 8 degrees Celsius for optimal performance.
• Intended solely for laboratory diagnostic applications.
• Exclusive to healthcare practitioners.
• Discard the kit after the expiration date has passed.
• Discard the test card if its foil packaging is compromised.
• Keep the pouches unopened until the test is to be administered.
• Discard the test strip after use.
• Discard the pipette after use.
• Treat all samples as if they are capable of transmitting infection.
• Adhere to local guidelines for safe handling and waste disposal.
• Observe the instructions meticulously for accurate test results.