title: [Internal quality control of sperm concentrations in semen analysis: establishment of a method].
abstract: OBJECTIVE
  To establish a method for internal quality control (IQC) of sperm concentration test in the laboratory.
  
  
  METHODS
  We set the concentrations of frozen semen at 20 x 10(6) and 80 x 10(6) as low and high concentrations of putative IQC products, with QC-BEADSTM quality control beads (QCBs) as the control. Using the double-blind method, four technicians determined the sperm concentrations of the IQC products and QCBs by computer-assisted sperm analysis, and drew a quality control chart (Xbar chart and Sbar chart) for each product. Through a month of continuous detection, we calculated and compared the intra- and inter-batch coefficients of variation (CV%) of the quality control products of high and low concentrations.
  
  
  RESULTS
  The intra-batch coefficients of variation of the assumed IQC products of high and low concentrations were CV3.5% and CV2.4%, and their inter-batch coefficients of variation were CV10.2% and CV9.6%. The intra-batch coefficients of variation of the QCBs of high and low concentrations were CV5.1% and CV7.1%, and their inter-batch coefficients of variation were CV7.1% and CV8%. The intra-batch coefficients of variation of both IQC products and QCBs of high and low concentrations were <10%, and their inter-batch coefficients of variation were <15%, which conformed to Levey-Jennings quality control principles and achieved IQC purposes. No significant differences were found in either intra- or inter-batch coefficients of variation between the IQC products and QCBs of high and low concentrations (P>0.05), indicating that assumed IQC products can replace QCBs for internal quality control in the laboratory.
  
  
  CONCLUSIONS
  The IQC method we established for determining sperm concentration is simple, feasible and reliable.
authors.affiliation: National Research Center for Assisted Reproductive Technology and Reproductive Genetics, Key Laboratory for Reproductive Endocrinology of the Chinese Ministry of Education, Center for Reproductive Medicine, Shandong Provincial Hospital Affiliated to Shandong University, Jinan, Shandong 250021, China. stemgx@163.com
authors.forename: Xuan
authors.initials: X
authors.lastname: Gao
authors.forename: Xiao-Dan
authors.initials: XD
authors.lastname: Liu
authors.forename: Li-Juan
authors.initials: LJ
authors.lastname: Zhao
authors.forename: Shao-Ming
authors.initials: SM
authors.lastname: Lu
authors.forename: Da-Wei
authors.initials: DW
authors.lastname: Zheng
authors.forename: Jin-Long
authors.initials: JL
authors.lastname: Ma
mesh_terms: D004311:Double-Blind Method; D006801:Humans; D008297:Male; D011786:Quality Control; D055101:Semen Analysis / Q000379:methods* / Q000592:standards*; D012662:Semen Preservation; D013076:Sperm Count; D013081:Sperm Motility; D013094:Spermatozoa