Technical Release Bulletin for QC of Morphology Pre-stained Slides

Technical Release Bulletin for QC of Morphology Pre-stained Slides

Background:
To perform quality control of the Morphology pre-stained smears please follow the instructions below.

Preparing QC semen samples:

• Pool around 5 FRESH semen samples and wash according to the following procedure:
  1. Mix the semen sample well.
  2. Split into 5 equal volume samples.
  3. Dilute each sample to 10 ml with 0.9% (9 g/l) saline or Earle’s buffer.
  4. Centrifuge at 800g for 10 minutes.
  5. Tip off and discard all but 20–40 μl of the supernatant.
  6. Re-suspend the sperm pellet in the remaining supernatant by gentle pipetting.
  7. Pool all washed samples.
  8. Dilute the pool to 2 ml with 0.9% (9 g/l) saline or Earle’s buffer.
  9. Add 20 μl of 35% formalin.
• Distribute 50 μl aliquots of pooled semen samples into the screw cap cryo vials and store at 4 °C.
• Assay sperm Morphology of these QC pool using the standard lab method to establish Morphology Target Range (Papanicolaou is recommended).
• Establish pre-assayed Morphology Target Range: Mean Value +/- 3 standard deviations or 25% whatever is greater (please refer to the link below):
  http://www.mes-global.com/_blog/MES_Service_Blog/tag/Acceptable_Ranges_for_Semen_Analysis/

Morphology pre-stained slide QC procedure:
• Assess the QC samples using Morphology pre-stained slides at pre-defined by the lab intervals according to the product insert procedure.
• Compare Morphology QC results with the pre-assayed Morphology Target Range.
• PASS/FAIL: Morphology QC results should fall into the pre-assayed Target Range.

Reference:
WHO laboratory manual for the examination and processing of human semen – 5th ed., World Health Organization 2010.

Compliance Date: Effective October 7th, 2017
Authority: Dr. Lev Rabinovitch, CTO
Distribution: Morphology pre-stained slide users

DOWNLOAD Technical Release Bulletin for QC of Morphology Pre-stained Slides