Accurex TSH Fast Test Kit

Overview Accurex TSH Fast Test Kit

The Accurex TSH Fast Test Kit employs a sensitive fluorescence immunoassay to quantify thyroid-stimulating hormone (TSH) levels, a key indicator of hypothalamic-pituitary-thyroid axis function. The assay utilizes two anti-human TSH monoclonal antibodies: one conjugated to fluorescent latex, the other immobilized on the test strip. Following sample application, the labeled antibody binds to TSH, forming a complex which migrates to the detection zone via capillary action. This complex is then captured by the immobilized antibody, resulting in fluorescence intensity directly proportional to TSH concentration. Results are readily transferable to laboratory information systems. Intended for the in vitro quantitative measurement of serum/plasma TSH, this test aids in thyroid disease screening, diagnosis, prognosis, and treatment monitoring. **Kit Contents:** Available in 25-test and 10-test configurations. Each box includes: TSH test cards (individually sealed with desiccant), disposable pipette, user manual, and SD/RFID card. **Sample Diluent:** Phosphate-buffered saline, proteins, detergent, preservative, stabilizer. **Test Card Components:** A plastic casing houses a reagent strip comprising a sample pad, nitrocellulose membrane (with fluorescently labeled anti-human TSH antibody on one end, anti-human TSH antibody on the test line, and rabbit anti-mouse IgG on the control line), absorbent paper, and a liner. **Compatible Analyzer:** AccuDx CQ immunofluorescence quantitative analyzer. **Procedure:** 1. Specimen collection as per the manual. 2. Equilibrate reagents and test card to room temperature. 3. Verify SD card and kit lot number congruity. 4. Calibrate the SD card (Getein1100 manual, section 8.5.2). 5. Navigate to the Getein1100 testing interface. 6. Remove and label the test card. 7. Add 100 µl of sample to 100 µl of diluent, mix thoroughly, and apply 100 µl to the sample port. 8. After 10 minutes, insert the card into the Getein1100. 9. Results display on screen. **Safety Precautions:** * Adhere strictly to all instructions. * Store in a cool, dry, dark place. * Keep out of reach of children. * Store test cards at 4-30°C for up to 24 months. * Use cards within 1 hour of pouch opening. * Store diluent at 0-30°C (2-8°C preferred) for 24 months. * Opened AccuDx CQ cartridges are stable for 24 hours. * Unused cards must be resealed and used within 7 days. * For in vitro diagnostic use only. Do not use beyond expiration. * Do not use damaged cards or reuse components. * Handle specimens as potentially infectious. * Dispose of waste according to regulations. * Avoid mixing kits from different batches.

How to Use Accurex TSH Fast Test Kit:

Gather samples as per the instruction manual. Ensure the test card, sample, and reagent reach ambient temperature prior to analysis. Verify the SD card lot number matches the test kit lot number. Calibrate the SD card using the “SD card calib” function if needed (consult section 8.5.2 of the Getein1100 user manual for details). Navigate to the Getein1100 testing screen by pressing "ENT" on the main menu. Immediately before testing, remove the test card from its protective packaging. Clearly identify the test card with the patient or control identifier. Position the test card horizontally on a clean, flat surface. Using a calibrated transfer pipette, add 100 μl of sample to one vial of sample diluent, mixing gently but completely. Subsequently, dispense 100 μl (or three drops using a disposable pipette) of this mixture into the designated sample well on the test card. Following a 10-minute incubation period, insert the test card into the Getein1100 and press "ENT." The assay results will then be displayed.

Safety Instruction of Accurex TSH Fast Test Kit:

• Always check the product label before administering.
• Keep in a cool, dry area, protected from direct sunlight.
• Store where children cannot access.
• Keep the diagnostic test strip between 4 and 30 degrees Celsius for up to two years.
• The test card must be used within one hour of opening the foil pouch.
• Maintain the blood sample diluent at a temperature between 0 and 30 degrees Celsius for up to 24 months.
• Maintain the blood sample diluent at a temperature between 2 and 8 degrees Celsius to optimize test outcomes.
• AccuDx CQ test cartridges, once opened, maintain stability for up to 24 hours after air exposure.
• Unused test cartridges should be returned to their foil pouches and the zip seal completely closed.
• Unused test cards must be discarded after seven days.
• Intended solely for laboratory diagnostic applications.
• Discard the kit after the expiry date.
• 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 infectious.
• Adhere to local guidelines for safe medication handling and disposal.
• Closely adhere to the instructions in the user guide for accurate test results.
• Avoid combining or substituting kits from varying production runs.