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Immunoassay Hormonal analysis Instruction sheet

Dear Participant:

Please find enclosed liquid urine sample number (…..).

INTENDED USE:

EQAS lyophilized Immunoassay  Control sample is intended for use as a quality control Immunoassay to monitor the precision and accuracy of hormonal test procedures.

SUMMARY AND PRINCIPLE :

The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use, and is an integral part of good laboratory practices.

SAMPLE :

This is a lyophilized human serum sample that has been modified to fit the purpose of the intended use of analysis

STORAGE AND STABILITY:

This product will be stable for 6 months when stored unopened at 2 to 8°C. Once the control reconstitution it will be stable for 4 days at 2 to 8°C or 4 weeks at -20°C. This product is shipped under refrigerated conditions.

PROCEDURE:

This product should be treated the same as patient specimens, and run in accordance with the instructions accompanying from the manufacturer. Before sampling, allow the control to reach room temperature (18 to 25°C).

 INSTRUCTION FOR USE:

  1. Place the vial of lyophilised QC on a flat surface, carefully remove the cap and the rubber stopper making sure not to spill any material
  2. Using a calibrated pipette and sterilized pipette tip, add exactly 1ml of distilled water directly into the QC vial, ensuring no water is left in the pipette tip, or on the rim/side of the vial.

  3. Place the rubber stopper and cap firmly back onto the QC vial, and leave to stand for 15 minutes>

  4. After 15 minutes, gently invert the QC vial 10-15 times to ensure the contents is completely dissolved, making sure to avoid the formation of foam. It is important that you DO NOT SHAKE the vial. Alternatively place the vial on a roller for 15 minutes to ensure the contents is thoroughly mixed.

  5. Once satisfied all material has been completely dissolved, Follow your test procedure in dealing with EQAS sample.

  6. Perform the following test items (TSH, FSH, LH, Free T3, Free T4, Prolactin, and β-hCG,) by your routine methods during your normal workload.
  7. Once finished, refrigerate or freeze itany unused material. It is good practice to label the vial with the date of reconstitution to prevent the use of material outside of the recommended stability period.

  8. Prior to reusing lyophilised material, mix the contents thoroughly by gentle inversion, as highlighted in Step 4

To enter your result to the website please first enter the methods and Instrument for each test provided by the EQAS Program.

Enter your results clearly in the appropriate result space ensuring they are in the concentration units indicated.

Return your results to EQAS office:

Through the web site of EQAS

For consultation and/or questions please contact Mr  Ziyad Al khdour 9:00- 15:00

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