FT4 набор для количественной диагностики щитовидной железы Wondfo

Описание и отзывы

Характеристики

Wondfo is a globally recognized fast growing POCT company devoted to R&D, manufacture and sales of rapid diagnostic reagents and medical devices in IVD field. Apart from the Guangzhou headquarters, Wondfo also owns one overseas lab in San Diego, one branch in Chicago and several overseas offices.“Quality is life!” is paramount in everything we do. Wondfo has won good reputation worldwide by providing premium products and professional services. We aim at serving the public, and hence people will trust Wondfo.

1. Quick and easy operation and 99% accuracy.

2. Wondfo has 27 years history, and has won good reputation around the world for good quality products and professional services..

3. Wondfo have got CE certificates, FSC certificates, ISO 9001:2008 and ISO 13485:2012 quality system certification.

4. For in vitro diagnostic use only. For self-testing use only.

 INTENDED USE                                                                                                               

The Finecare™ fT4 Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of free thyroxine (fT4) in human whole blood, serum or plasma. The test is used as an aid to the assessment of thyroid function.

For in vitro diagnostic use only. For professional use only.

TEST PROCEDURE                                                                                                         

   For complete information and operating procedures, please refer to Finecare™ FIA System Operation Manual. Test should be         performed at room temperature.

Step 1: Preparation

Before testing, activate “use” in setting then save it.

Ensure that the lot number of the Test Cartridge matches ID Chip as well as the Detection Buffer. Insert ID Chip into Finecare™ FIA System.

Step 2: Sampling

Draw 75 μL of whole blood or serum or plasma with a transfer pipette and add into the Detection Buffer tube.

Step 3: Mixing

Close the lid of Detection Buffer tube and mix the sample mixture thoroughly by shaking it about 10 times.

Step 4: Loading

Pipette 75 μL of sample mixture and load it into the sample well of the Test cartridge.

Step5: Testing

There are two test modes for Finecare™ FIA system, standard test mode and quick test mode. Please refer to the operation manual of Finecare™ FIA system for details.

a) For Standard Test mode: Insert the Test Cartridge onto the Test Cartridge holder of Finecare™ FIA System right after adding sample mixture to the sample well. Press “Test” to start testing. (Apply to FS-112, FS-113 and FS-205)

b) For Quick Test mode: Set the timer and count down right after adding sample mixture into the sample well and leave it at room temperature for 15 minutes. Then insert the Test Cartridge onto the Test Cartridge holder of Finecare™ FIA System. Press “Test” to start testing. Finecare™ FIA System will start scanning the sample-loaded Test Cartridge immediately. (Apply to FS-112 and FS-113).

Results are displayed on main screen or be printed by press “Print”.

Discard the used Test Cartridge according to local regulations and procedures after released from Finecare™ FIA System.

INTERPRETATION OF RESULTS                                                                                   

The Finecare™ FIA System calculates fT4 test results automatically and displays the concentration of fT4 on the screen as form of XXX.XX pmol/L. For further information, please refer to the Operation Manual for the Finecare™ FIA System.

    Normal Reference Value:

12-22 pmol/L(0.94-1.72 ng/dL)